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Sunday, March 18, 2012

Thiothixene

Class: Thioxanthenes
VA Class: CN709
Chemical Name: N,N-dimethyl-9-[3-(4-methyl-1-piperazinyl)-propylidene]thioxanthene-2-sulfonamide
Molecular Formula: C₂₃H₂₉N₃O₂S₂
CAS Number: 5591-45-7
Brands: Navane

Special Alerts:

[Posted 02/22/2011] ISSUE: FDA notified healthcare professionals that the Pregnancy section of drug labels for the entire class of antipsychotic drugs has been updated. The new drug labels now contain more and consistent information about the potential risk for abnormal muscle movements (extrapyramidal signs or EPS) and withdrawal symptoms in newborns whose mothers were treated with these drugs during the third trimester of pregnancy.

The symptoms of EPS and withdrawal in newborns may include agitation, abnormally increased or decreased muscle tone, tremor, sleepiness, severe difficulty breathing, and difficulty in feeding. In some newborns, the symptoms subside within hours or days and do not require specific treatment; other newborns may require longer hospital stays.

BACKGROUND: Antipsychotic drugs are used to treat symptoms of psychiatric disorders such as schizophrenia and bipolar disorder.

RECOMMENDATION: Healthcare professionals should be aware of the effects of antipsychotic medications on newborns when the medications are used during pregnancy. Patients should not stop taking these medications if they become pregnant without talking to their healthcare professional, as abruptly stopping antipsychotic medications can cause significant complications for treatment. For more information visit the FDA website at: and .

[Posted 06/16/2008] FDA notified healthcare professionals that both conventional and atypical antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis. In April 2005, FDA notified healthcare professionals that patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death. Since issuing that notification, FDA has reviewed additional information that indicates the risk is also associated with conventional antipsychotics. Antipsychotics are not indicated for the treatment of dementia-related psychosis. The prescribing information for all antipsychotic drugs will now include the same information about this risk in a BOXED WARNING and the WARNINGS section. For more information visit the FDA website at: , and .

Introduction

Thioxanthene-derivative, conventional (prototypical, first-generation) antipsychotic agent; structurally and pharmacologically related to chlorprothixene (no longer commercially available in the US) and trifluoperazine.^a ^b ^c ^d ^e ^g ^u

Uses for Thiothixene

Psychotic Disorders

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Symptomatic management of psychotic disorders (i.e., schizophrenia).^a ^b ^c ^d ^u

Has been used in the management of refractory or treatment-resistant schizophrenia.^c

Mental Retardation

Efficacy not established for the management of behavioral complications in patients with mental retardation.^a ^b ^c ^u

Thiothixene Dosage and Administration

General

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Adjust dosage carefully according to individual requirements and response; use the lowest possible effective dosage.^a ^b ^c ^u

Periodically evaluate patients receiving long-term therapy to determine whether maintenance dosage can be decreased or drug therapy discontinued.^a ^b ^u ^w (See Tardive Dyskinesia under Cautions.)

For symptomatic relief of psychotic disorders, initial therapeutic response to antipsychotic therapy usually occurs within 2–4 weeks and optimum therapeutic response occurs within 6 months or longer.^d ^w

Administration

Oral Administration

Thiothixene is administered orally once daily or in divided doses 2 or 3 times daily.^a ^b ^c ^k ^t ^u Thiothixene hydrochloride has been given orally and parenterally, but no longer is commercially available in the US.^a ^c ^h ^v

Dosage

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Pediatric Patients

Psychotic Disorders

Oral

Children ≥12 years of age: Initially, 2 mg 3 times daily for mild to moderate psychotic disorders; may gradually increase dosage, if necessary, up to 15 mg daily.^a ^b ^c ^u

For more severe psychotic disorders in children ≥12 years of age: Initially, 5 mg twice daily; may then increase dosage until satisfactory response obtained.^a ^b ^c ^u

Optimal maintenance dosage usually 20–30 mg daily; may be increased up to 60 mg daily, if necessary; once-daily administration may be adequate.^a ^b ^c ^k ^u

Daily dosages >60 mg rarely provide additional therapeutic effect.^a ^b ^c ^u

Adults

Psychotic Disorders

Oral

For mild to moderate psychotic disorders: Initially, 2 mg 3 times daily; may gradually increase dosage, if necessary, up to 15 mg daily.^a ^b ^c ^u

For more severe psychotic disorders: Initially, 5 mg twice daily; may then increase dosage until satisfactory response obtained.^a ^b ^c ^u

Optimal maintenance dosage usually 20–30 mg daily; may be increased up to 60 mg daily, if necessary; once-daily administration may be adequate.^a ^b ^c ^k ^u

Daily dosages >60 mg rarely provide additional therapeutic effect.^a ^b ^c ^u

Prescribing Limits

Pediatric Patients

Psychotic Disorders

Oral

Children ≥12 years of age: Maximum 60 mg daily.^a ^b ^c ^u

Adults

Psychotic Disorders

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Oral

Maximum 60 mg daily.^a ^b ^c ^u

Special Populations

Geriatric Patients

No specific dosage recommendations for geriatric patients, but generally select dosage at the lower end of recommended range; increase dosage more gradually and monitor closely.^a ^b ^d ^h ^u ^w (See Geriatric Use under Cautions and see Special Populations under Pharmacokinetics.)

Cautions for Thiothixene

Contraindications

Circulatory collapse.^a ^b ^c ^u

Comatose states or CNS depression from any cause.^a ^b ^c ^u (See Specific Drugs and Laboratory Tests under Interactions.)

Blood dyscrasias.^a ^b ^c ^u

Known hypersensitivity to thiothixene.^a ^b ^c ^u Not known if cross-sensitivity exists between thioxanthenes and phenothiazines; consider possibility that cross-sensitivity may occur.^a ^b ^c ^u

Warnings/Precautions

Warnings

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Shares the toxic potentials of other antipsychotic agents (e.g., phenothiazines); observe the usual precautions associated with therapy with these agents.^a ^b ^c ^u

Tardive Dyskinesia

Tardive dyskinesia, a syndrome of potentially irreversible, involuntary, dyskinetic movements, may develop in patients receiving antipsychotic agents, including thiothixene.^a ^b ^c ^d ^u ^w Consider reducing thiothixene dosage or discontinuing drug and switching to a second-generation (atypical) antipsychotic agent.^a ^b ^c ^d ^u ^w

Neuroleptic Malignant Syndrome

Neuroleptic malignant syndrome (NMS), a potentially fatal syndrome requiring immediate discontinuance of the drug and intensive symptomatic treatment, has been reported with antipsychotic agents, including thiothixene.^a ^b ^c ^u ^w

CNS Depression

May impair mental and/or physical abilities, especially during the first few days of therapy; use caution with activities requiring alertness (e.g., operating vehicles or machinery).^a ^b ^u

Response to CNS depressants and alcohol may be potentiated.^a ^b ^u (See Specific Drugs and Laboratory Tests under Interactions.)

Sensitivity Reactions

Hypersensitivity and Cross-sensitivity

Possible sensitivity reactions reported with thiothixene (e.g., rash, pruritus, urticaria, anaphylactoid reactions) and related drugs (e.g., agranulocytosis, pancytopenia, thrombocytopenic purpura, jaundice, biliary stasis).^a ^b ^c ^u ^w

Not known if cross-sensitivity exists between thioxanthenes and phenothiazines; consider possibility that cross-sensitivity may occur.^a ^b ^u

Photosensitivity

Photosensitivity may occur; avoid excessive exposure to sunlight during therapy.^a ^b ^u ^w

General Precautions

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Seizures

Possible risk of seizures; may lower seizure threshold.^a ^b ^c ^u Use with extreme caution in patients with a history of seizures or during alcohol withdrawal.^a ^b ^c ^u (See Specific Drugs and Laboratory Tests under Interactions.)

Cardiovascular Effects

Possible hypotension, tachycardia, nonspecific ECG changes, dizziness, and/or syncope; use with caution in patients with cardiovascular disease.^a ^b ^c ^u

If severe hypotension occurs, administer norepinephrine or phenylephrine; epinephrine or dopamine should not be used.^a ^b ^c ^u ^w (See Specific Drugs and Laboratory Tests under Interactions.)

Anticholinergic Effects

Possible anticholinergic effects (e.g., dry mouth, blurred vision, constipation, increased perspiration, urinary retention, impotence).^a ^b ^c ^u

Use with caution in patients with glaucoma or prostatic hypertrophy.^c (See Specific Drugs and Laboratory Tests under Interactions.)

Ocular Effects

Pigmentary retinopathy and lenticular pigmentation reported with prolonged therapy with antipsychotic agents, including thiothixene.^a ^b ^c ^u Observe carefully.^a ^b ^c ^u

Prolactin Secretion

Elevated prolactin concentrations reported; elevation persists during chronic administration.^a ^b ^c ^u ^w

Clinical significance unknown; consider that approximately one-third of human breast cancers are prolactin dependent when prescribing thiothixene in patients with previously detected breast cancer.^a ^b ^c ^u ^w

Galactorrhea, amenorrhea, gynecomastia, and impotence reported.^a ^b ^c ^u ^w

Regulation of Body Temperature

Use with caution in patients exposed to extreme heat or cold.^a ^b ^c ^u ^w

Other Precautions

Antiemetic effects may mask signs of overdosage of other drugs (e.g., antineoplastic agents) or obscure cause of vomiting in various disorders (e.g., intestinal obstruction, Reye’s syndrome, brain tumor).^a ^b ^c ^u ^w

Specific Populations

Pregnancy

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Category C.^e

Lactation

Not known but considered likely to distribute into human milk; possible effects on nursing infant unknown.^e ^h ⁿ ^o ^r ^s Caution if used in nursing women; carefully assess potential benefits and risks.^e ⁿ ^o

Pediatric Use

Safety not established in children <12 years of age.^a ^b ^c ^u

Geriatric Use

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Geriatric patients appear to be particularly sensitive to adverse CNS (e.g., tardive dyskinesia, parkinsonian manifestations, akathisia, sedation), anticholinergic, and cardiovascular (e.g., orthostatic hypotension) effects of antipsychotic agents.^a ^b ^d ^h ⁱ ^u ^w

Use with caution.^h (See Geriatric Patients under Dosage and Administration and see Special Populations under Pharmacokinetics.)

Common Adverse Effects

Drowsiness or sedation, extrapyramidal reactions (e.g., Parkinson-like symptoms, dystonia, akathisia, tardive dyskinesia), anticholinergic effects (e.g., dry mouth, blurred vision), hypotension.^a ^b ^c ^u

Interactions for Thiothixene

Drugs Affecting Hepatic Microsomal Enzymes

Potential pharmacokinetic interaction (increased or decreased plasma thiothixene concentrations) with concomitant use of CYP enzyme inhibitors or inducers.^a ^b ^h ^j ^l ^u (See Specific Drugs and Laboratory Tests under Interactions.)

Specific Drugs and Laboratory Tests

Drug or Test	Interaction	Comments
Alcohol	Potential additive CNS effects and hypotension^a ^b ^u ^w	Use with caution^a ^b ^h ^u ^w
Anticholinergic drugs (e.g., atropine)	Possible potentiation of anticholinergic effects^a ^b ^c ^u	Use with caution^a ^b ^u
Anticonvulsants (e.g., carbamazepine, phenobarbital, phenytoin)	Anticonvulsants may decrease plasma thiothixene concentrations^a ^h ^j ^l Thiothixene may lower seizure threshold^a ^b ^c ^u Barbiturates: Thiothixene does not appear to potentiate the anticonvulsant activity of barbiturates^a ^b ^c ^u	Observe for signs and symptoms of reduced thiothixene effectiveness^a Dosage adjustments of anticonvulsants may be necessary ⁱ Barbiturates: Do not reduce anticonvulsant dosage during concurrent use^a ^b ^c ^u
Antidepressants, tricyclic (TCAs)	Possible increased plasma concentrations of thiothixene^j ^l
β-Blockers (e.g., propranolol)	Possible decreased thiothixene clearance^j ^l
Cimetidine	Possible decreased thiothixene clearance^h ^j ^l
CNS depressants (e.g., antihistamines, barbiturates, general anesthetics, opiate analgesics, sedative/hypnotics)	Possible additive CNS effects and hypotension^a ^b ^u	Use with caution to avoid excessive sedation or CNS depression; carefully adjust dosages of both agents as necessary^a ^b ^h ^u
Epinephrine or dopamine	Possible further lowering of BP^a ^b ^c ^u ^w	Do not use epinephrine or dopamine for thiothixene-induced hypotension^a ^b ^c ^u ^w (see Cardiovascular Effects under Cautions)
Hypotensive agents	Possible additive hypotensive effect^a ^c	Observe closely for signs of excessive hypotension^a ^c
Isoniazid	Possible decreased thiothixene clearance^l
Lithium	An acute encephalopathic syndrome reported occasionally, especially when high serum lithium concentrations present ^h ^w	Observe patients receiving combined therapy for evidence of adverse neurologic effects; promptly discontinue if such signs or symptoms appear^w
Paroxetine	Pharmacokinetic interaction unlikely^m
Smoking	Possible decreased plasma thiothixene concentrations ^h ^j ^l
Tests for pregnancy	False-positive results reported in some patients receiving phenothiazines; less likely to occur when serum test is used^a ^b ^u

Thiothixene Pharmacokinetics

Absorption

Bioavailability

Rapidly and well absorbed from GI tract following oral administration.^c ⁱ ^k Peak plasma concentrations usually occur within 1–3 hours.ⁱ ^k ^t

Onset

Antipsychotic effects usually are apparent within 2–4 weeks after initiation of oral therapy and optimum therapeutic response usually occurs within 6 months or longer.^c ^d ^w

Plasma Concentrations

Optimal therapeutic plasma concentrations not well defined, but clinical improvement associated with peak plasma concentrations of 2–15 mcg/L.^t ^y

Distribution

Extent

Widely distributed into body tissues.^c ⁱ

Crosses placenta in animals; considered likely to cross placenta in humans.^p ^x Not known if distributed into human milk but distribution into breast milk considered likely.^e ^h ^o ^r

Plasma Protein Binding

>99%.ⁱ

Elimination

Metabolism

Principally metabolized in the liver; undergoes extensive oxidative first-pass metabolism to form thiothixene sulfoxide and N-desmethylthiothixene.^c ^h ⁱ ^j

Elimination Route

Excreted mainly in feces via biliary elimination as unchanged drug and as demethyl, sulfoxide, demethylated sulfoxide, and hydroxylated metabolites.^c ⁱ

Unlikely to be removed by hemodialysis and peritoneal dialysis.^a ^b ^u ^w

Half-life

34–35 hours.^d ⁱ ^k ^m ^t

Special Populations

Clearance is reduced in females and in patients >50 years of age.^h

Stability

Storage

Oral

Capsules

Tight, light-resistant containers at 20–25°C; protect from light and moisture.^b ^c ^u

ActionsActions

Produces pharmacologic effects similar to those of other conventional antipsychotic agents (e.g., phenothiazines, butyrophenones, chlorprothixene).^a ^b ^c ^u ^w

Precise mechanism(s) of antipsychotic action not determined, but may be principally related to antidopaminergic effects.^w Acts principally at subcortical levels on the reticular formation, hypothalamus, and limbic system.^c ^w

Exhibits weak anticholinergic, antihistaminic, α-adrenergic, and sedative effects and strong extrapyramidal effects; appears to possess antiemetic activity.^a ^b ^c ^h ^u

Advice to Patients

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Potential for drug to impair mental alertness or physical coordination; use caution when driving or operating machinery until effects on individual are known.^a ^b ^c ^h ^u

Importance of clinicians informing patients in whom chronic use is contemplated of risk of tardive dyskinesia, taking into account clinical circumstances and competency of patient to understand information provided.^a ^b ^u

Importance of clinicians informing patients of risk of extrapyramidal reactions and providing reassurance that these reactions usually can be controlled by administration of antiparkinsonian drugs (e.g., benztropine) and by subsequent dosage reduction.^a ^b ^c ^u ^w

Advise patients to avoid excessive sunlight.^a ^b ^u ^w

Importance of avoiding exposure to temperature extremes.^a ^b ^c ^w

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.^a ^b ^u

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.^a ^b ^u

Importance of informing patients of other important precautionary information.^a ^b ^u (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Thiothixene
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Capsules	1 mg*	Navane	Pfizer
			Thiothixene Capsules	Mylan, Sandoz
		2 mg*	Navane	Pfizer
			Thiothixene Capsules	Mylan, Sandoz
		5 mg*	Navane	Pfizer
			Thiothixene Capsules	Mylan, Sandoz
		10 mg*	Navane	Pfizer
			Thiothixene Capsules	Mylan, Sandoz
		20 mg	Navane	Pfizer

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 04/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Navane 10MG Capsules (PFIZER U.S.): 90/$189.99 or 270/$565.95

Navane 2MG Capsules (PFIZER U.S.): 90/$92.99 or 270/$266.98

Navane 20MG Capsules (PFIZER U.S.): 90/$266 or 270/$779.99

Navane 5MG Capsules (PFIZER U.S.): 90/$139.99 or 270/$409.96

Thiothixene 1MG Capsules (SANDOZ): 90/$22.99 or 270/$49.97

Thiothixene 2MG Capsules (MYLAN): 90/$26.99 or 270/$71.97

Thiothixene 5MG Capsules (SANDOZ): 90/$25.99 or 270/$59.97

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions March 15, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

a. Roerig, Division of Pfizer Inc. Navane (thiothixene) capsules and solution, concentrate prescribing information. New York, NY. 2008 Mar.

b. Sandoz Inc. Thiothixene capsules prescribing information. Princeton, NJ. 2007 Feb.

c. AHFS drug information 2008. McEvoy GK, ed. Thiothixene. Bethesda, MD: American Society of Health-System Pharmacists; 2008:2516-7.

d. American Psychiatric Association. Practice guideline for the treatment of patients with schizophrenia, second edition. From the APA website

e. Briggs GG, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation. 7th ed. Baltimore, MD: Williams & Wilkins; 2005:1577-8.

f. American Academy of Pediatrics. Use of psychoactive medication during pregnancy and possible effects on the fetus and newborn. Pediatrics. 2000; 105:880-87. [PubMed 10742343]

g. The United States Pharmacopeial Convention, Inc. USAN and the USP Dictionary drug names. Rockville, MD: United States Pharmacopeial Convention, Inc; 2007:853.

h. AMA Division of Drugs. AMA drug evaluations. Chicago: American Medical Association; 1994:2:1-2:29.

i. Balant-Gorgia AE, Balant L. Antipsychotic drugs: clinical pharmacokinetics of potential candidates for plasma concentration monitoring. Clin Pharmacokinet. 1987: 13:65-90.

j. Ereshefsky L, Saklad SR, Watanabe MD, et al. Thiothixene pharmacokinetic interactions: a study of hepatic enzyme inducers, clearance inhibitors, and demographic variables. J Clin Psychopharmacol. 1991; 11:296-301. [PubMed 1765572]

k. Hobbs DC, Welch WM, Short MJ, et al. Pharmacokinetics of thiothixene in man. Clin Pharmacol Ther. 1974; 16:473-8. [PubMed 4415039]

l. Ereshefsky L, Jann MW, Saklad SR, et al. Bioavailability of psychotropic drugs: historical perspective and pharmacokinetic overview. J Clin Psychiatry. 1986; 47 (Suppl):6-15. [PubMed 3528134]

m. Guthrie SK, Hariharan M, Kumar AA, et al. The effect of paroxetine on thiothixene pharmacokinetics. J Clin Pharm Ther. 1997; 22:221-6. [PubMed 9447478]

n. Webb RT, Howard L, Abel KM. Antipsychotic drugs for non-affective psychosis during pregnancy and postpartum. Cochrane Database of Systematic Reviews 2004, Issue 2. Art. No.: CD004411. DOI: 10.1002/14651858.CD004411.pub2.

o. Cohen LS, Heller VL, Rosenbaum JF. Treatment guidelines for psychotropic drug use in pregnancy. Psychosomatics. 1989; 30:25-33. [PubMed 2643809]

p. Altshuler LL, Cohen L, Szuba MP, et al. Pharmacologic management of psychiatric illness during pregnancy: dilemmas and guidelines. Am J Psychiatry. 1996; 153:592-606. [PubMed 8615404]

q. Mortola JF. The use of psychotropic agents in pregnancy and lactation. Psychiatr Clin North Am. 1989; 12:69-87. [PubMed 2652114]

r. Goldberg H, Nissim R. Psychotropic drugs in pregnancy and lactation. Int J Psychiatry Med. 1994; 24:129-49. [PubMed 7960421]

s. Calabrese JR, Gulledge AD. Psychotropics during pregnancy and lactation: a review. Psychosomatics. 1985; 26:413-26. [PubMed 2859631]

t. Milton GV, Jann MW. Emergency treatment of psychotic symptoms: pharmacokinetic considerations for antipsychotic drugs. Clin Pharmacokinet. 1995; 28:494-504. [PubMed 7656507]

u. Mylan Pharmaceuticals Inc. Thiothixene capsules prescribing information. Morgantown, WV; 2003 Oct.

v. Roerig, Division of Pfizer Inc. Navane (thiothixene hydrochloride) intramuscular for injection prescribing information. New York, NY. 2008 Jan.

w. AHFS drug information 2008. McEvoy GK, ed. Phenothiazines general statement. Bethesda, MD: American Society of Health-System Pharmacists; 2008: 2497-508.

x. Schmidt MH, Lee T. Investigation of striatal dopamine D2 receptor acquisition following prenatal neuroleptic exposure. Psychiatry Res. 1991; 36:319-28. [PubMed 1676523]

y. Mavroidis ML, Kanter DR, Hirschowitz J et al. Clinical relevance of thiothixene plasma levels.J Clin Psychopharmacol. 1984; 4:155-7. [PubMed 6736276]

More Thiothixene resources

Thiothixene Side Effects (in more detail)
Thiothixene Dosage
Thiothixene Use in Pregnancy & Breastfeeding
Drug Images
Thiothixene Drug Interactions
Thiothixene Support Group
3 Reviews for Thiothixene - Add your own review/rating

Thiothixene Professional Patient Advice (Wolters Kluwer)

Thiothixene Prescribing Information (FDA)

Thiothixene MedFacts Consumer Leaflet (Wolters Kluwer)

thiothixene Concise Consumer Information (Cerner Multum)

thiothixene Advanced Consumer (Micromedex) - Includes Dosage Information

Navane Advanced Consumer (Micromedex) - Includes Dosage Information

Navane Prescribing Information (FDA)

Compare Thiothixene with other medications

Psychosis

alitretinoin topical

Generic Name: alitretinoin topical (ah lih TREH tin oyn)

Brand Names: Panretin

What is alitretinoin topical?

Alitretinoin is a topical retinoid. Alitretinoin affects the growth and development of skin cells.

Alitretinoin topical is used to treat skin lesions caused by AIDS-related Kaposi's sarcoma.

Alitretinoin topical may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about alitretinoin topical?

Avoid prolonged exposure to sunlight. Alitretinoin topical may increase the sensitivity of the skin to sunlight. Use a sunscreen and wear protective clothing when exposure to the sun is unavoidable.

Do not use products that contain DEET (N, N-diethyl-m-toluamide), a common component of insect repellent products, while using alitretinoin topical. There is an increased risk of harmful effects from DEET when it is used with alitretinoin topical.

Do not cover the treated lesions with any type of occlusive dressing (a dressing that does not allow air to circulate to the area).

Who should not use alitretinoin topical?

Before using alitretinoin topical, tell your doctor if you have cutaneous T-cell lymphoma. You may not be able to use alitretinoin topical, or you may require a dosage adjustment or special monitoring during your treatment.

Alitretinoin topical is the FDA pregnancy category D. This means that alitretinoin topical may be harmful to an unborn baby. Alitretinoin topical has caused birth defects in animal studies. Do not use alitretinoin topical without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether alitretinoin topical passes into breast milk. Do not use alitretinoin topical without first talking to your doctor if you are breast-feeding a baby.

How should I use alitretinoin topical?

Use alitretinoin topical exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before and after applying this medication.

Apply enough gel to cover the lesion with a generous coating. Allow the gel to dry for 3 to 5 minutes before covering the area with clothing.

Do not apply alitretinoin topical to normal skin surrounding a lesion. Also, do not apply alitretinoin topical on or near mucosal surfaces of the body such as the inside of the nose or mouth. Do not cover the treated lesions with any type of occlusive dressing (a dressing that does not allow air to circulate to the area).

Alitretinoin topical is usually applied two to four times a day. Follow your doctor's instructions.

Store alitretinoin topical at room temperature away from moisture and heat.

What happens if I miss a dose?

Apply the missed dose as soon as you remember.

What happens if I overdose?

An overdose of this medication is unlikely to occur. If you do suspect an overdose, or if alitretinoin topical has been ingested, call an emergency room or poison control center for advice.

What should I avoid while using alitretinoin topical?

Avoid prolonged exposure to sunlight. Alitretinoin topical may increase the sensitivity of the skin to sunlight. Use a sunscreen and wear protective clothing when exposure to the sun is unavoidable.

Do not cover the treated lesions with any type of occlusive dressing (a dressing that does not allow air to circulate to the area).

Alitretinoin topical side effects

Serious side effects are not likely to occur. Stop using alitretinoin topical and seek emergency medical attention if you experience an allergic reaction (shortness of breath; closing of your throat; swelling of your lips, face, or tongue; or hives).

If you experience any of the following less serious side effects at the application site(s), continue to use alitretinoin topical and notify your doctor

redness;

itching;

irritation;

warmth;

burning, stinging, or pain;

rash;

peeling;

swelling or inflammation;

numbness or tingling;

cracking, crusting, or scabbing; or

drainage.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Alitretinoin topical Dosing Information

Usual Adult Dose for Kaposi's Sarcoma:

For use in the topical treatment of cutaneous lesions in patients with AIDS-related Kaposi's sarcoma: Initially, a generous amount of alitretinoin topical gel should be applied to each lesion twice a day.

The application frequency may be gradually increased to 3 or 4 times a day according to individual lesion tolerance. If application site toxicity occurs, the application frequency may be reduced. If irritation is severe, application of the drug may be discontinued for a few days until symptoms subside.

Response of Kaposi's sarcoma lesions may be seen as early as 2 weeks after initiating therapy; however, most patients require longer treatment. Some patients required over 14 weeks to respond to therapy. In clinical trials, alitretinoin topical was applied for up to 96 weeks. The manufacturer recommends continuing therapy as long as the patient is deriving benefit.

What other drugs will affect alitretinoin topical?

Drugs other than those listed here may also interact with alitretinoin topical. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

Compare alitretinoin topical with other medications

Kaposi's Sarcoma

Where can I get more information?

Your pharmacist has additional information about alitretinoin topical written for health professionals that you may read.

See also: alitretinoin side effects (in more detail)

Saturday, March 17, 2012

Edluar

zolpidem tartrate

Dosage Form: sublingual tablets
FULL PRESCRIBING INFORMATION

Indications and Usage for Edluar

Edluar (zolpidem tartrate sublingual tablets) is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.

The clinical trials performed with Zolpidem tartrate in support of efficacy were 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment [see Clinical Studies (14)].

Edluar Dosage and Administration

The dose of Edluar should be individualized.

Dosage in adults

The recommended dose for Edluar for adults is 10 mg once daily immediately before bedtime. The total Edluar daily dose should not exceed 10 mg.

Special Populations

Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of Edluar in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.6)].

Use with CNS depressants

Dosage adjustment may be necessary when Edluar is combined with other CNS-depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].

Administration

The effect of Edluar may be slowed by ingestion with or immediately after a meal. Edluar should not be given with or immediately after a meal.

Edluar sublingual tablet should be placed under the tongue, where it will disintegrate. The tablet should not be swallowed and the tablet should not be taken with water.

Dosage Forms and Strengths

Edluar is available in 5 mg and 10 mg strength tablets for sublingual administration. Tablets are not scored.

Edluar 5 mg sublingual tablets are round white, flat-faced, bevel-edged, with debossed V on one side.

Edluar 10 mg sublingual tablets are round white, flat-faced, bevel-edged, with debossed X on one side.

Contraindications

Edluar is contraindicated in patients with known hypersensitivity to zolpidem tartrate or to any of the inactive ingredients in the formulation. Observed reactions include anaphylaxis and angioedema [see Warnings and Precautions (5.2) and Description (11)].

Warnings and Precautions

Need to evaluate for co-morbid diagnoses

Because sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder, symptomatic treatment of insomnia should be initiated only after a careful evaluation of the patient. The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated. Worsening of insomnia or the emergence of new thinking or behavior abnormalities may be the consequence of an unrecognized psychiatric or physical disorder. Such findings have emerged during the course of treatment with sedative/hypnotic drugs, including zolpidem tartrate.

Severe anaphylactic and anaphylactoid reactions

Rare cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics, including zolpidem tartrate. Some patients have had additional symptoms such as dyspnea, throat closing or nausea and vomiting that suggest anaphylaxis. Some patients have required medical therapy in the emergency department. If angioedema involves the throat, glottis or larynx, airway obstruction may occur and be fatal. Patients who develop angioedema after treatment with Edluar should not be rechallenged with the drug.

Abnormal thinking and behavioral changes

A variety of abnormal thinking and behavior changes have been reported to occur in association with the use of sedative/hypnotics. Some of these changes may be characterized by decreased inhibition (e.g. aggressiveness and extroversion that seemed out of character), similar to effects produced by alcohol and other CNS depressants. Visual and auditory hallucinations have been reported as well as behavioral changes such as bizarre behavior, agitation and depersonalization. In controlled trials, <1% of adults with insomnia who received zolpidem tartrate reported hallucinations. In a clinical trial, 7.4% of pediatric patients with insomnia associated with attention-deficit/hyperactivity disorder (ADHD), who received zolpidem reported hallucinations [see Use in Specific Populations (8.4)].

Complex behaviors such as “sleep-driving” (i.e., driving while not fully awake after ingestion of a sedative-hypnotic, with amnesia for the event) have been reported with sedative-hypnotics, including zolpidem tartrate. These events can occur in sedative-hypnotic-naive as well as in sedative-hypnotic-experienced persons. Although behaviors such as “sleep-driving” may occur with Edluar alone at therapeutic doses, the use of alcohol and other CNS depressants with Edluar appears to increase the risk of such behaviors, as does the use of Edluar at doses exceeding the maximum recommended dose. Due to the risk to the patient and the community, discontinuation of Edluar should be strongly considered for patients who report a “sleep-driving” episode. Other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative-hypnotic. As with “sleep-driving”, patients usually do not remember these events. Amnesia, anxiety and other neuro-psychiatric symptoms may occur unpredictably.

In primarily depressed patients, worsening of depression, including suicidal thoughts and actions (including completed suicides), has been reported in association with the use of sedative/hypnotics.

It can rarely be determined with certainty whether a particular instance of the abnormal behaviors listed above is drug-induced, spontaneous in origin, or a result of an underlying psychiatric or physical disorder. Nonetheless, the emergence of any new behavioral sign or symptom of concern requires careful and immediate evaluation.

Withdrawal effects

Following rapid dose decrease or abrupt discontinuation of sedative/hypnotics, there have been reports of signs and symptoms similar to those associated with withdrawal from other CNS-depressant drugs [see Drug Abuse and Dependence (9)].

CNS depressant effects

Edluar, like other sedative/hypnotic drugs, has CNS-depressant effects. Due to the rapid onset of action, Edluar should be ingested immediately prior to going to bed. Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness or motor coordination such as operating machinery or driving a motor vehicle after ingesting the drug, including potential impairment of the performance of such activities that may occur the day following ingestion of Edluar. Zolpidem tartrate showed additive effects when combined with alcohol and should not be taken with alcohol. Patients should also be cautioned about possible combined effects with other CNS-depressant drugs. Dosage adjustments of Edluar may be necessary when Edluar is administered with such agents because of the potentially additive effects.

Special Populations

Use in the elderly and/or debilitated patients:

Impaired motor and/or cognitive performance after repeated exposure or unusual sensitivity to sedative/hypnotic drugs is a concern in the treatment of elderly and/or debilitated patients. Therefore, the recommended Edluar dosage is 5 mg in the elderly and/or debilitated patients [see Dosage and Administration (2.2) and Geriatric Use (8.5)] to decrease the possibility of side effects. These patients should be closely monitored.

Use in patients with concomitant illness:

Clinical experience with zolpidem tartrate in patients with concomitant systemic illness is limited. Caution is advisable in using Edluar in patients with diseases or conditions that could affect metabolism or hemodynamic responses. Although studies did not reveal respiratory depressant effects at hypnotic doses of zolpidem tartrate in normal subjects or in patients with mild to moderate chronic obstructive pulmonary disease (COPD), a reduction in the Total Arousal Index together with a reduction in lowest oxygen saturation and increase in the times of oxygen desaturation below 80% and 90% was observed in patients with mild-to-moderate sleep apnea when treated with zolpidem tartrate (10 mg) when compared to placebo. Since sedative/hypnotics have the capacity to depress respiratory drive, precautions should be taken if Edluar is prescribed to patients with compromised respiratory function. Edluar should be used with caution in patients with sleep apnea syndrome or myasthenia gravis. Post-marketing reports of respiratory insufficiency following treatment with zolpidem tartrate, most of which involved patients with pre-existing respiratory impairment, have been received.

Data in end-stage renal failure patients repeatedly treated with zolpidem tartrate did not demonstrate drug accumulation or alterations in pharmacokinetic parameters. No dosage adjustment of Edluar in renally impaired patients is required; however, these patients should be closely monitored [see Clinical Pharmacology (12.3)].

A study in subjects with hepatic impairment treated with zolpidem tartrate did reveal prolonged elimination in this group; therefore, treatment with Edluar should be initiated with 5 mg in patients with hepatic compromise, and they should be closely monitored [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3)].

Use in patients with depression:

As with other sedative/hypnotic drugs, Edluar should be administered with caution to patients exhibiting signs or symptoms of depression. Suicidal tendencies may be present in such patients and protective measures may be required. Intentional over-dosage is more common in this group of patients; therefore, the least amount of drug that is feasible should be prescribed for the patient at any one time.

Pediatric patients:

Edluar is not recommended for use in children. Safety and effectiveness of Edluar have not been established in pediatric patients below the age of 18. In an 8-week study in pediatric patients (aged 6-17 years) with insomnia associated with ADHD, an oral solution of zolpidem did not decrease sleep latency compared to placebo. Hallucinations were reported in 7.4% of the pediatric patients who received zolpidem; none of the pediatric patients who received placebo reported hallucinations [see Use in Specific Populations (8.4)].

Adverse Reactions

The following serious adverse reactions are discussed in greater detail in other sections of the labeling:

Serious anaphylactic and anaphylactoid reactions [see Warning and Precautions (5.2)]

Abnormal thinking and behavior, complex behaviors [see Warning and Precautions (5.3)]

Withdrawal effects [see Warning and Precautions (5.4)]

CNS-depressant effects [see Warnings and Precautions (5.5)]

Clinical trials experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating incidence rates.

Associated with discontinuation of treatment:

Approximately 4% of 1,701 patients who received zolpidem tartrate at all doses (1.25 to 90 mg) in U.S. premarketing clinical trials discontinued treatment because of an adverse reaction. Reactions most commonly associated with discontinuation from U.S. trials were daytime drowsiness (0.5%), dizziness (0.4%), headache (0.5%), nausea (0.6%), and vomiting (0.5%).

Approximately 4% of 1,959 patients who received zolpidem tartrate at all doses (1 to 50 mg) in similar foreign trials discontinued treatment because of an adverse reaction. Reactions most commonly associated with discontinuation from these trials were daytime drowsiness (1.1%), dizziness/vertigo (0.8%), amnesia (0.5%), nausea (0.5%), headache (0.4%), and falls (0.4%).

Data from a clinical study in which selective serotonin reuptake inhibitor (SSRI)-treated patients were given zolpidem tartrate revealed that four of the seven discontinuations during double-blind treatment with zolpidem (n=95) were associated with impaired concentration, continuing or aggravated depression, and manic reaction; one patient treated with placebo (n=97) was discontinued after an attempted suicide.

Most commonly observed adverse reactions in controlled trials:

During short-term treatment (up to 10 nights) with zolpidem tartrate at doses up to 10 mg, the most commonly observed adverse reactions associated with the use of zolpidem and seen at statistically significant differences from placebo-treated patients were drowsiness (reported by 2% of zolpidem patients), dizziness (1%), and diarrhea (1%). During longer-term treatment (28 to 35 nights) with zolpidem tartrate at doses up to 10 mg, the most commonly observed adverse reactions associated with the use of zolpidem and seen at statistically significant differences from placebo-treated patients were dizziness (5%) and drugged feelings (3%).

Adverse reactions observed at an incidence of ≥1% in controlled trials:

The following tables enumerate treatment-emergent adverse event frequencies that were observed at an incidence equal to 1% or greater among patients with insomnia who received zolpidem tartrate and at a greater incidence than placebo in U.S. placebo-controlled trials. Events reported by investigators were classified utilizing a modified World Health Organization (WHO) dictionary of preferred terms for the purpose of establishing event frequencies. The prescriber should be aware that these figures cannot be used to predict the incidence of side effects in the course of usual medical practice, in which patient characteristics and other factors differ from those that prevailed in these clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigators involving related drug products and uses, since each group of drug trials is conducted under a different set of conditions. However, the cited figures provide the physician with a basis for estimating the relative contribution of drug and nondrug factors to the incidence of side effects in the population studied.

The following table was derived from a pool of 11 placebo-controlled short-term U.S. efficacy trials involving zolpidem in doses ranging from 1.25 to 20 mg. The table is limited to data from doses up to and including 10 mg, the highest dose recommended for use.

TABLE 1: Incidence of Treatment-Emergent Adverse Experiences in Placebo-Controlled Clinical Trials with zolpidem tartrate lasting up to 10 nights (Percentage of patients reporting)
*Reactions reported by at least 1% of patients treated with oral zolpidem and at a greater frequency than placebo.
Body System/ Adverse Event*	Zolipidem tartrate (≤ 10 mg) (N=685)	Placebo (N=473)
Central and Peripheral Nervous System
Headache	7	6
Drowsiness	2	-
Dizziness	1	-

Gastrointestinal System
Diarrhea	1

The following table was derived from a pool of three placebo-controlled long-term efficacy trials involving oral zolpidem. These trials involved patients with chronic insomnia who were treated for 28 to 35 nights with zolpidem at doses of 5, 10, or 15 mg. The table is limited to data from doses up to and including 10 mg, the highest dose recommended for use. The table includes only adverse events occurring at an incidence of at least 1% for zolpidem patients.

TABLE 2: Incidence of Treatment-Emergent Adverse Experiences in Placebo-Controlled Clinical Trials with zolpidem tartrate lasting up to 35 nights (Percentage of patients reporting)
*Reactions reported by at least 1% of patients treated with oral zolpidem and at a greater frequency than placebo.
Body System/ Adverse Event*	Zolpidem tartrate (≤ 10 mg) (N=152)	Placebo (N=161)
Autonomic Nervous System	3	1
Dry mouth
Body as a Whole
Allergy	4	1
Back Pain	3	2
Influenza-like symptoms	2	-
Chest pain	1	-
Cardiovascular System
Palpitation	2	-
Central and Peripheral Nervous System
Drowsiness	8	5
Dizziness	5	1
Lethargy	3	1
Drugged feeling	3	-
Lightheadedness	2	1
Depression	2	1
Abnormal dreams	1	-
Amnesia	1	-
Sleep disorder	1	-
Gastrointestinal System
Diarrhea	3	2
Abdominal pain	2	2
Constipation	2	1
Respiratory System
Sinusitis	4	2
Pharyngitis	3	1
Skin and Appendages
Rash	2	1

Dose relationship for adverse reactions associated with oral zolpidem:

There is evidence from dose comparison trials suggesting a dose relationship for many of the adverse reactions associated with oral zolpidem use, particularly for certain CNS and gastrointestinal adverse events.

Oral tissue-related adverse reactions to Edluar:

The effect of chronic daily administration of Edluar on oral tissue was evaluated in a 60-day open-label study in 60 insomniac patients. One patient developed transient sublingual erythema, and another transient paresthesia of the tongue.

Adverse event incidence across the entire preapproval oral zolpidem database:

Zolpidem was administered to 3,660 subjects in clinical trials throughout the U.S., Canada, and Europe. Treatment-emergent adverse events associated with clinical trial participation were recorded by clinical investigators using terminology of their own choosing. To provide a meaningful estimate of the proportion of individuals experiencing treatment-emergent adverse events, similar types of untoward events were grouped into a smaller number of standardized event categories and classified utilizing a modified World Health Organization (WHO) dictionary of preferred terms.

The frequencies presented, therefore, represent the proportions of the 3,660 individuals exposed to zolpidem, at all doses, who experienced an event of the type cited on at least one occasion while receiving zolpidem. All reported treatment-emergent adverse events are included, except those already listed in the table above of adverse events in placebo-controlled studies, those coding terms that are so general as to be uninformative, and those events where a drug cause was remote. It is important to emphasize that, although the events reported did occur during treatment with zolpidem, they were not necessarily caused by it.

Adverse events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are defined as those occurring in greater than 1/100 subjects; infrequent adverse events are those occurring in 1/100 to 1/1,000 patients; rare events are those occurring in less than 1/1,000 patients.

Autonomic nervous system: Infrequent: increased sweating, pallor, postural hypotension, syncope. Rare: abnormal accommodation, altered saliva, flushing, glaucoma, hypotension, impotence, increased saliva, tenesmus.

Body as a whole: Frequent: asthenia. Infrequent: edema, falling, fever, malaise, trauma. Rare: allergic reaction, allergy aggravated, anaphylactic shock, face edema, hot flashes, increased ESR, pain, restless legs, rigors, tolerance increased, weight decrease.

Cardiovascular system: Infrequent: cerebrovascular disorder, hypertension, tachycardia. Rare: angina pectoris, arrhythmia, arteritis, circulatory failure, extrasystoles, hypertension aggravated, myocardial infarction, phlebitis, pulmonary embolism, pulmonary edema, varicose veins, ventricular tachycardia.

Central and peripheral nervous system: Frequent: ataxia, confusion, euphoria, headache, insomnia, vertigo. Infrequent: agitation, anxiety, decreased cognition, detached, difficulty concentrating, dysarthria, emotional lability, hallucination, hypoesthesia, illusion, leg cramps, migraine, nervousness, paresthesia, sleeping (after daytime dosing), speech disorder, stupor, tremor. Rare: abnormal gait, abnormal thinking, aggressive reaction, apathy, appetite increased, decreased libido, delusion, dementia, depersonalization, dysphasia, feeling strange, hypokinesia, hypotonia, hysteria, intoxicated feeling, manic reaction, neuralgia, neuritis, neuropathy, neurosis, panic attacks, paresis, personality disorder, somnambulism, suicide attempts, tetany, yawning.

Gastrointestinal system: Frequent: dyspepsia, hiccup, nausea. Infrequent: anorexia, constipation, dysphagia, flatulence, gastroenteritis, vomiting. Rare: enteritis, eructation, esophagospasm, gastritis, hemorrhoids, intestinal obstruction, rectal hemorrhage, tooth caries.

Hematologic and lymphatic system: Rare: anemia, hyperhemoglobinemia, leukopenia, lymphadenopathy, macrocytic anemia, purpura, thrombosis.

Immunologic system: Infrequent: infection. Rare: abscess herpes simplex herpes zoster, otitis externa, otitis media.

Liver and biliary system: Infrequent: abnormal hepatic function, increased SGPT. Rare: bilirubinemia, increased SGOT.

Metabolic and nutritional: Infrequent: hyperglycemia, thirst. Rare: gout, hypercholesteremia, hyperlipidemia, increased alkaline phosphatase, increased BUN, periorbital edema.

Musculoskeletal system: Frequent: arthralgia, myalgia. Infrequent: arthritis. Rare: arthrosis, muscle weakness, sciatica, tendinitis.

Reproductive system: Infrequent: menstrual disorder, vaginitis. Rare: breast fibroadenosis, breast neoplasm, breast pain.

Respiratory system: Frequent: upper respiratory infection. Infrequent: bronchitis, coughing, dyspnea, rhinitis. Rare: bronchospasm, epistaxis, hypoxia, laryngitis, pneumonia.

Skin and appendages: Infrequent: pruritus. Rare: acne, bullous eruption, dermatitis, furunculosis, injection-site inflammation, photosensitivity reaction, urticaria.

Special senses: Frequent: diplopia, vision abnormal. Infrequent: eye irritation, eye pain, scleritis, taste perversion, tinnitus. Rare: conjunctivitis, corneal ulceration, lacrimation abnormal, parosmia, photopsia.

Urogenital system: Infrequent: urinary tract infection. Infrequent: cystitis, urinary incontinence. Rare: acute renal failure, dysuria, micturition frequency, nocturia, polyuria, pyelonephritis, renal pain, urinary retention.

Drug Interactions

For details of drug interactions, please refer to Clinical Pharmacology (12.3).

CNS-active drugs

Any drug with CNS-depressant effects could potentially enhance the CNS-depressant effects of zolpidem.

Imipramine in combination with zolpidem produced an additive effect of decreased alertness. Similarly, chlorpromazine in combination with zolpidem produced an additive effect of decreased alertness and psychomotor performance. These drugs did not show any significant pharmacokinetic interaction.

A study involving haloperidol and zolpidem revealed no effect of haloperidol on the pharmacokinetics or pharmacodynamics of zolpidem. The lack of a drug interaction following single-dose administration does not predict a lack following chronic administration.

An additive effect on psychomotor performance between alcohol and oral zolpidem was demonstrated [see Warnings and Precautions: CNS depressant effects (5.5)]. Concomitant administration of zolpidem and sertraline increased zolpidem Cmax (43%) and decreased Tmax (53%), whether or not these changes alter the pharmacodynamic effect of zolpidem is unknown.

Drugs that affect drug metabolism via cytochrome P450

Some compounds known to inhibit CYP3A may increase exposure to zolpidem. The effect of inhibitors of other P450 enzymes has not been carefully evaluated.

Co-administration of multiple doses of rifampin and a single dose of zolpidem tartrate (20 mg) given 17 hours after the last dose of rifampin showed significant reductions of the AUC (73%), Cmax (58%), and T1/2 (36%) of zolpidem together with significant reductions in the pharmacodynamic effects of zolpidem tartrate.

Co-administration of a single dose of zolpidem tartrate with 4 doses of ketoconazole, a potent CYP3A4 inhibitor increased Cmax of zolpidem (30%) and the total AUC of zolpidem (70%) compared to zolpidem alone and prolonged the elimination half-life (30%) along with an increase in the pharmacodynamic effects of zolpidem. Consideration should be given to using a lower dose of zolpidem when ketoconazole and zolpidem are given together. Patients should be advised that use of Edluar with ketoconazole may enhance the sedative effects.

Drug-laboratory test interactions

Zolpidem is not known to interfere with commonly employed clinical laboratory tests. In addition, clinical data indicate that zolpidem does not cross-react with benzodiazepines, opiates, barbiturates, cocaine, cannabinoids, or amphetamines in two standard urine drug screens.

USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy Category C:

There are no adequate and well-controlled studies of Edluar in pregnant women. Edluar should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Studies to assess the effects on children whose mothers took zolpidem during pregnancy have not been conducted. There is a published case report documenting the presence of zolpidem in human umbilical cord blood. Children born to mothers taking sedative-hypnotic drugs may be at some risk for withdrawal symptoms from the drug during the postnatal period. In addition, neonatal flaccidity has been reported in infants born to mothers who received sedative-hypnotic drugs during pregnancy.

Administration of zolpidem to pregnant rats and rabbits resulted in adverse effects on offspring development at doses greater than the maximum recommended human dose (MRHD) of 10 mg/day (8 mg/day zolpidem base); however, teratogenicity was not observed.

When zolpidem was administered at oral doses of 4, 20, and 100 mg base/kg (approximately 5, 24, and 120 times the MRHD on a mg/m2 basis) to pregnant rats during the period of organogenesis, dose-related decreases in fetal skull ossification occurred at all but the lowest dose, which is approximately 5 times the MRHD on a mg/m2 basis. In rabbits treated during organogenesis with zolpidem at oral doses of 1, 4, and 16 mg base/kg (approximately 2.5, 10, and 40 times the MRHD on a mg/m2 basis), increased embryo-fetal death and incomplete fetal skeletal ossification occurred at the highest dose. The no-effect dose for embryo-fetal toxicity in rabbits is approximately 10 times the MRHD on a mg/m2 basis. Administration of zolpidem to rats at oral doses of 4, 20, and 100 mg base/kg (approximately 5, 24, and 120 times the MRHD on a mg/m2 basis) during the latter part of pregnancy and throughout lactation produced decreased offspring growth and survival at all but the lowest dose, which is approximately 5 times the MRHD on a mg/m2 basis.

Labor and delivery

Edluar has no established use in labor and delivery [see Pregnancy (8.1)].

Nursing mothers

Zolpidem is excreted into human milk. Studies in lactating mothers indicate that the T1/2 of zolpidem is similar to that in non-lactating women (2.6 ± 0.3 hours). The effect of zolpidem on the nursing infant is not known. Caution should be exercised when Edluar is administered to a nursing mother.

Pediatric use

Safety and effectiveness of Edluar have not been established in pediatric patients below the age of 18.

In an 8-week controlled study, 201 pediatric patients (aged 6-17 years) with insomnia associated with attention-deficit/hyperactivity disorder (90% of the patients were using psychoanaleptics) were treated with an oral solution of zolpidem (n=136), or placebo (n=65). Zolpidem did not significantly decrease latency to persistent sleep, compared to placebo, as measured by polysomnography after 4 weeks of treatment. Psychiatric and nervous system disorders comprised the most frequent (>5%) treatment-emergent adverse reactions observed with zolpidem versus placebo and included dizziness (23.5% vs. 1.5%), headache (12.5% vs. 9.2%), and hallucinations (7.4% vs. 0%) [see Warnings and Precautions (5.6)]. Ten patients on zolpidem (7.4%) discontinued treatment due to an adverse reaction.

Geriatric use

A total of 154 patients in U.S. controlled clinical trials and 897 patients in non-U.S. clinical trials who received oral zolpidem were ≥60 years of age. For a pool of U.S. patients receiving zolpidem tartrate at doses of ≤10 mg or placebo, there were three adverse events occurring at an incidence of at least 3% for zolpidem and for which the zolpidem incidence was at least twice the placebo incidence (i.e., they could be considered drug-related).

Adverse Event	Zolpidem	Placebo
Dizziness	3%	0%
Drowsiness	5%	2%
Diarrhea	3%	1%

A total of 30/1,959 (1.5%) non-U.S. patients receiving zolpidem tartrate reported falls, including 28/30 (93%) who were ≥70 years of age. Of these 28 patients, 23 (82%) were receiving zolpidem doses >10 mg. A total of 24/1,959 (1.2%) non-U.S. patients receiving zolpidem reported confusion, including 18/24 (75%) who were ≥70 years of age. Of these 18 patients, 14 (78%) were receiving zolpidem doses >10 mg.

The dose of Edluar in elderly patients is 5 mg to minimize adverse effects related to impaired motor and/or cognitive performance and unusual sensitivity to sedative/hypnotic drugs [see Dosage and Administration (2), Warnings and Precautions (5) Clinical Pharmacology (12) and Clinical Studies (14)].

Drug Abuse and Dependence

Controlled substance

Edluar contains the same active substance, zolpidem tartrate, as zolpidem tartrate oral tablets and is classified as a Schedule IV controlled substance by federal regulation.

Abuse

Abuse and addiction are separate and distinct from physical dependence and tolerance. Abuse is characterized by misuse of the drug for non-medical purposes, often in combination with other psychoactive substances. Tolerance is a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug effects over time. Tolerance may occur to both desired and undesired effects of drugs and may develop at different rates for different effects.

Addiction is a primary, chronic, neurobiological disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disease, using a multidisciplinary approach, but relapse is common.

Studies of abuse potential in former drug abusers found that the effects of single doses of zolpidem tartrate 40 mg were similar, but not identical, to diazepam 20 mg, while zolpidem tartrate 10 mg was difficult to distinguish from placebo.

Because persons with a history of addiction to, or abuse of, drugs or alcohol are at increased risk for misuse, abuse, and addiction of Edluar, they should be monitored carefully when receiving Edluar or any other hypnotic.

Dependence

Physical dependence is a state of adaptation that is manifested by a specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug, and/or administration of an antagonist.

Sedative/hypnotics have produced withdrawal signs and symptoms following abrupt discontinuation. These reported symptoms range from mild dysphoria and insomnia to a withdrawal syndrome that may include abdominal and muscle cramps, vomiting, sweating, tremors, and convulsions. The following adverse events which are considered to meet the DSM-III-R criteria for uncomplicated sedative/hypnotic withdrawal were reported during U.S. clinical trials following placebo substitution occurring within 48 hours following last zolpidem tartrate treatment: fatigue, nausea, flushing, lightheadedness, uncontrolled crying, emesis, stomach cramps, panic attack, nervousness, and abdominal discomfort. These reported adverse events occurred at an incidence of 1% or less. However, available data cannot provide a reliable estimate of the incidence, if any, of dependence during treatment at recommended doses. Post-marketing reports of abuse, dependence and withdrawal have been received.

Overdosage

Signs and symptoms

In postmarketing experience of overdose with zolpidem tartrate alone, or in combination with CNS-depressant agents, impairment of consciousness ranging from somnolence to coma, cardiovascular and/or respiratory compromise, and fatal outcomes have been reported.

Recommended treatment

Based on data obtained for zolpidem tartrate, general symptomatic and supportive measures for overdose with Edluar should be used along with immediate gastric lavage where appropriate. Intravenous fluids should be administered as needed. Zolpidem’s sedative/hypnotic effect was shown to be reduced by flumazenil and therefore may be useful; however, flumazenil administration may contribute to the appearance of neurological symptoms (convulsions). As in all cases of drug overdose, respiration, pulse, blood pressure, and other appropriate signs should be monitored and general supportive measures employed. Hypotension and CNS depression should be monitored and treated by appropriate medical intervention. Sedating drugs should be withheld following zolpidem overdosage, even if excitation occurs. The value of dialysis in the treatment of overdosage has not been determined, although hemodialysis studies in patients with renal failure receiving therapeutic doses have demonstrated that zolpidem is not dialyzable.

As with the management of all overdosage, the possibility of multiple drug ingestion should be considered. The physician may wish to consider contacting a poison control center for up-to-date information on the management of hypnotic drug product overdosage.

Edluar Description

Edluar (zolpidem tartrate sublingual tablet) is a non-benzodiazepine hypnotic of the imidazopyridine class and is available in 5 mg and 10 mg strength tablets for sublingual administration.

Chemically, zolpidem tartrate is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure:

Zolpidem tartrate is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88.

Each Edluar tablet includes the following inactive ingredients: mannitol, colloidal silicon dioxide, silicified microcrystalline cellulose, croscarmellose sodium, saccharin sodium, and magnesium stearate.

Edluar - Clinical Pharmacology

Mechanism of action

Zolpidem, the active moiety of zolpidem tartrate, is a hypnotic agent with a chemical structure unrelated to benzodiazepines, barbiturates, or other drugs with known hypnotic properties. It interacts with a GABA-BZ receptor complex and shares some of the pharmacological properties of the benzodiazepines. In contrast to the benzodiazepines, which non-selectively bind to and activate all BZ receptor subtypes, zolpidem in vitro binds the BZ1 receptor preferentially with a high affinity ratio of the α1/α5 subunits. This selective binding of zolpidem on the BZ1 receptor is not absolute, but it may explain the relative absence of myorelaxant and anticonvulsant effects in animal studies as well as the preservation of deep sleep (stages 3 and 4) in human studies of zolpidem tartrate at hypnotic doses.

Pharmacokinetics

Absorption:

Edluar is bioequivalent to Ambien® tablets (Sanofi-Aventis) with respect to Cmax and AUC. Similar to zolpidem tartrate oral tablets, Edluar sublingual tablets result in a pharmacokinetic profile characterized by rapid absorption.

Following administration of single 10 mg Edluar, in 18 (18-65 years of age) healthy adult subjects, the mean peak concentration (Cmax) of zolpidem was 106 ng/mL (range: 52 to 205 ng/ml) occurring at a median time (Tmax) of 82 minutes (range: 30-180 min).

A food-effect study in 18 healthy volunteers compared the pharmacokinetics of Edluar 10 mg when administered while fasting or within 20 minutes after a high fat meal. The mean AUC and Cmax were decreased by 20% and 31%, respectively, while median Tmax was prolonged by 28% (from 82 to 105 min). The half-life remained unchanged. These results suggest that, for faster sleep onset, Edluar should not be administered with or immediately after a meal.

Distribution:

Based on data obtained with oral zolpidem, the total protein binding was found to be 92.5 ± 0.1% and remained constant, independent of concentration between 40 and 790 ng/mL.

Metabolism:

Based on data obtained with oral zolpidem, zolpidem is converted to inactive metabolites that are eliminated primarily by renal excretion.

Elimination:

When Edluar administered as a single 5 or 10 mg dose in healthy adult subjects, the mean zolpidem elimination half-life was 2.85 hours (range: 1.57-6.73 hr) and 2.65 hours (range: 1.75 to 3.77 hr) respectively.

Special Populations

Elderly:

In the elderly, the dose for Edluar should be 5 mg [see Warnings and Precautions (5) and Dosage and Administration (2)]. This recommendation is based on several studies with zolpidem tartrate in which the mean Cmax, T1/2, and AUC were significantly increased when compared to results in young adults. In one study of eight elderly subjects (>70 years), the means for Cmax, T1/2, and AUC significantly increased by 50% (255 vs. 384 ng/mL), 32% (2.2 vs. 2.9 hr), and 64% (955 vs. 1,562 ng•hr/mL), respectively, as compared to younger adults (20 to 40 years) following a single 20 mg oral dose. Zolpidem did not accumulate in elderly subjects following nightly oral dosing of 10 mg for 1 week.

Hepatic Impairment:

The pharmacokinetics of zolpidem tartrate in eight patients with chronic hepatic insufficiency were compared to results in healthy subjects. Following a single 20-mg oral zolpidem tartrate dose, mean Cmax and AUC were found to be two times (250 vs. 499 ng/mL) and five times (788 vs. 4,203 ng•hr/mL) higher, respectively, in hepatically-compromised patients. Tmax did not change. The mean half-life in cirrhotic patients of 9.9 hr (range: 4.1 to 25.8 hr) was greater than that observed in normals of 2.2 hr (range: 1.6 to 2.4 hr). Dosing with Edluar should be modified accordingly in patients with hepatic insufficiency [see Dosage and Administration (2.2) and Warnings and Precautions (5.6)].

Renal Impairment:

The pharmacokinetics of zolpidem tartrate were studied in 11 patients with end-stage 4 renal failure (mean ClCr = 6.5 ± 1.5 mL/min) undergoing hemodialysis three times a week, who were dosed with zolpidem tartrate 10 mg orally each day for 14 or 21 days. No statistically significant differences were observed for Cmax, Tmax, half-life, and AUC between the first and last day of drug administration when baseline concentration adjustments were made. On day 1, Cmax was 172 ± 29 ng/mL (range: 46 to 344 ng/mL). After repeated dosing for 14 or 21 days, Cmax was 203 ± 32 ng/mL (range: 28 to 316 ng/mL). On day 1, Tmax was 1.7 ± 0.3 hr (range: 0.5 to 3.0 hr); after repeated dosing Tmax was 0.8 ± 0.2 hr (range: 0.5 to 2.0 hr). This variation is accounted for by noting that last-day serum sampling began 10 hours after the previous dose, rather than after 24 hours. This resulted in residual drug concentration and a shorter period to reach maximal serum concentration. On day 1, T1/2 was 2.4 ± 0.4 hr (range: 0.4 to 5.1 hr). After repeated dosing, T1/2 was 2.5 ± 0.4 hr (range: 0.7 to 4.2 hr). AUC was 796 ± 159 ng•hr/mL after the first dose and 818 ± 170 ng•hr/mL after repeated dosing. Zolpidem was not hemodialyzable. No accumulation of unchanged drug appeared after 14 or 21 days. Zolpidem pharmacokinetics were not significantly different in renally-impaired patients. No dosage adjustment of Edluar is necessary in patients with compromised renal function.

Drug Interactions

CNS-active drugs:

Since the systematic evaluations of zolpidem in combination with other CNS-active drugs have been limited, careful consideration should be given to the pharmacology of any CNS-active drug to be used with zolpidem. Any drug with CNS-depressant effects could potentially enhance the CNS-depressant effects of zolpidem.

Zolpidem tartrate was evaluated in healthy volunteers in single-dose interaction studies for several CNS drugs. Imipramine in combination with zolpidem produced no pharmacokinetic interaction other than a 20% decrease in peak levels of imipramine, but there was an additive effect of decreased alertness. Similarly, chlorpromazine in combination with zolpidem produced no pharmacokinetic interaction, but there was an additive effect of decreased alertness and psychomotor performance.

An additive effect on psychomotor performance between alcohol and oral zolpidem was demonstrated [see Warnings and Precautions: CNS depressant effects (5.5)].

A single-dose int

Thursday, March 15, 2012

Thiotepa

Pronunciation: thye-oh-TEP-a
Generic Name: Thiotepa
Brand Name: Generic only. No brands available.

Thiotepa is used for:

Treating certain types of cancers, including cancer of the breast, ovaries, and bladder. It may also be used for other conditions as determined by your doctor.

Thiotepa is an antineoplastic. It works by killing cancer cells.

Do NOT use Thiotepa if:

you are allergic to any ingredient in Thiotepa

Contact your doctor or health care provider right away if any of these apply to you.

Before using Thiotepa:

Some medical conditions may interact with Thiotepa. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have a history of kidney or liver problems, bone marrow problems, or agranulocytosis

if you are receiving radiation therapy

Some MEDICINES MAY INTERACT with Thiotepa. However, no specific interactions with Thiotepa are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Thiotepa may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Thiotepa:

Use Thiotepa as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Thiotepa is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Thiotepa at home, carefully follow the injection procedures taught to you by your health care provider.

If Thiotepa spills on your skin, immediately wash it off with soap and water.

If Thiotepa contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.

Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.

If you miss a dose of Thiotepa, contact your doctor immediately.

Ask your health care provider any questions you may have about how to use Thiotepa.

Important safety information:

Thiotepa may cause dizziness or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Thiotepa. Using Thiotepa alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.

If nausea, vomiting, or loss of appetite occurs, ask your doctor or pharmacist for ways to lessen these effects.

Thiotepa may lower your body's ability to fight infection. Prevent infection by avoiding contact with people with colds or other infections. Notify your doctor of any signs of infection, including fever, sore throat, rash, or chills.

Thiotepa may reduce the number of clot-forming cells (platelets) in your blood. To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark, tarry stools to your doctor.

Avoid vaccinations with live virus vaccines (eg, measles, mumps, oral polio) while you are taking Thiotepa. Vaccinations may be less effective.

Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Thiotepa.

Thiotepa may decrease the effectiveness of your birth control pill. To prevent pregnancy, be sure to use an additional form of birth control (eg, condoms) while using Thiotepa.

LAB TESTS, including liver function, kidney function, and white blood cell counts, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.

Thiotepa is not recommended for use in CHILDREN. Safety and effectiveness have not been confirmed.

PREGNANCY and BREAST-FEEDING: Thiotepa has been shown to cause harm to the fetus. Avoid becoming pregnant while taking Thiotepa. If you think you may be pregnant, discuss with your doctor the benefits and risks of using Thiotepa during pregnancy. It is unknown if Thiotepa is excreted in breast milk. Do not breast-feed while taking Thiotepa.

Possible side effects of Thiotepa:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Blurred vision; dizziness; hair loss; headache; loss of appetite; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black stools; change in the color of urine; chills, fever, or sore throat; cough; irregular or absent menstrual periods; nosebleed; pain at the injection site; unusual bruising or bleeding; unusual tiredness or weakness; urination problems.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Thiotepa side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Thiotepa:

Thiotepa is usually handled and stored by a health care provider. If you are using Thiotepa at home, store Thiotepa as directed by your pharmacist or health care provider. Keep Thiotepa out of the reach of children and away from pets.

General information:

If you have any questions about Thiotepa, please talk with your doctor, pharmacist, or other health care provider.

Thiotepa is to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Thiotepa. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Thiotepa resources

Thiotepa Side Effects (in more detail)
Thiotepa Use in Pregnancy & Breastfeeding
Thiotepa Drug Interactions
Thiotepa Support Group
0 Reviews for Thiotepa - Add your own review/rating

Thiotepa Prescribing Information (FDA)

Thiotepa Professional Patient Advice (Wolters Kluwer)

thiotepa Concise Consumer Information (Cerner Multum)

thiotepa Injection Advanced Consumer (Micromedex) - Includes Dosage Information

Compare Thiotepa with other medications

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J-Tan D Chewable Tablets

Pronunciation: BROME-fen-IR-a-meen/FEN-il-EF-rin
Generic Name: Brompheniramine/Phenylephrine
Brand Name: Examples include J-Tan D and Vazotab

J-Tan D Chewable Tablets are used for:

Relieving symptoms of sinus congestion, pressure, runny nose, and sneezing caused by colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.

J-Tan D Chewable Tablets are an antihistamine and decongestant combination. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The decongestant promotes sinus and nasal drainage, which relieves congestion and pressure.

Do NOT use J-Tan D Chewable Tablets if:

you are allergic to any ingredient in J-Tan D Chewable Tablets

you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems

you are taking sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using J-Tan D Chewable Tablets:

Some medical conditions may interact with J-Tan D Chewable Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have a fast, slow, or irregular heartbeat

if you have phenylketonuria, trouble urinating, or trouble sleeping

if you have a history of adrenal gland problems (eg, adrenal gland tumor); asthma; a blockage of your bladder, stomach, or intestines; blood vessel problems; diabetes; an enlarged prostate or other prostate problems; or glaucoma or increased pressure in the eye

if you have a history of heart problems, high blood pressure, lung problems (eg, emphysema), seizures, sleep apnea, stroke, thyroid problems, or ulcers

Some MEDICINES MAY INTERACT with J-Tan D Chewable Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased

Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, MAOIs (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of J-Tan D Chewable Tablets's side effects

Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by J-Tan D Chewable Tablets

Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by J-Tan D Chewable Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if J-Tan D Chewable Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use J-Tan D Chewable Tablets:

Use J-Tan D Chewable Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take J-Tan D Chewable Tablets by mouth with or without food.

Chew J-Tan D Chewable Tablets well before swallowing.

If you miss a dose of J-Tan D Chewable Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use J-Tan D Chewable Tablets.

Important safety information:

J-Tan D Chewable Tablets may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use J-Tan D Chewable Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using J-Tan D Chewable Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

Do not take diet or appetite control medicines while you are taking J-Tan D Chewable Tablets without checking with your doctor.

J-Tan D Chewable Tablets has brompheniramine and phenylephrine in it. Before you start any new medicine, check the label to see if it has brompheniramine or phenylephrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.

Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.

If your symptoms do not get better within 5 to 7 days or if they get worse, check with your doctor.

J-Tan D Chewable Tablets may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to J-Tan D Chewable Tablets. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.

J-Tan D Chewable Tablets may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking J-Tan D Chewable Tablets for a few days before the tests.

Some of these products contain phenylalanine. If you must have a diet that is low in phenylalanine, ask your pharmacist if it is in your product.

Tell your doctor or dentist that you take J-Tan D Chewable Tablets before you receive any medical or dental care, emergency care, or surgery.

Use J-Tan D Chewable Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, dizziness, drowsiness, dry mouth, excitability, low blood pressure, and trouble urinating.

Caution is advised when using J-Tan D Chewable Tablets in CHILDREN; they may be more sensitive to its effects, especially excitability.

J-Tan D Chewable Tablets should not be used in CHILDREN younger than 6 years old without first checking with the child's doctor; safety and effectiveness in these children have not been confirmed.

Different brands of J-Tan D Chewable Tablets may have different dosing instructions for CHILDREN. Use J-Tan D Chewable Tablets as directed by your doctor. If you are unsure of the dose to give a child, check with your doctor or pharmacist.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using J-Tan D Chewable Tablets while you are pregnant. Do not take J-Tan D Chewable Tablets in the third trimester of pregnancy. J-Tan D Chewable Tablets are found in breast milk. Do not breast-feed while taking J-Tan D Chewable Tablets.

Possible side effects of J-Tan D Chewable Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; dry mouth; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; confusion; decreased coordination; difficulty urinating or inability to urinate; fainting; fast or irregular heartbeat; hallucinations; mood or mental changes; persistent trouble sleeping; restlessness; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; tremor; wheezing.

See also: J-Tan D side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; ringing in the ears; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular breathing; unusually fast, slow, or irregular heartbeat.

Proper storage of J-Tan D Chewable Tablets:

Store J-Tan D Chewable Tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep J-Tan D Chewable Tablets out of the reach of children and away from pets.

General information:

If you have any questions about J-Tan D Chewable Tablets, please talk with your doctor, pharmacist, or other health care provider.

J-Tan D Chewable Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about J-Tan D Chewable Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More J-Tan D resources

J-Tan D Side Effects (in more detail)
J-Tan D Use in Pregnancy & Breastfeeding
J-Tan D Drug Interactions
J-Tan D Support Group
0 Reviews for J-Tan D - Add your own review/rating

Compare J-Tan D with other medications

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Nasal Congestion
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Monday, March 12, 2012

Theraflu Warming Severe Cold Daytime

Generic Name: acetaminophen, dextromethorphan, and phenylephrine (a SEET a MIN of fen, DEX troe me THOR fan, and FEN il EFF rin)

Brand Names: Comtrex Cold & Cough, Daytime, Flu & Severe Cold & Cough Daytime Powder, Mapap Cold Formula, Theraflu Daytime Severe Cold & Cough, Theraflu Multi-Symptom Severe Cold, Theraflu Nighttime Severe Cold & Cough, Theraflu Warming Relief Daytime Multi-Symptom Cold, Theraflu Warming Severe Cold Daytime, Tylenol Children's Plus Cold & Cough, Tylenol Cold Multi-Symptom Daytime

What is Theraflu Warming Severe Cold Daytime (acetaminophen, dextromethorphan, and phenylephrine)?

Acetaminophen is a pain reliever and fever reducer.

Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex.

Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of acetaminophen, dextromethorphan, and phenylephrine is used to treat headache, fever, body aches, cough, stuffy nose, and sinus congestion caused by allergies, the common cold, or the flu.

This medicine will not treat a cough that is caused by smoking, asthma, or emphysema.

Acetaminophen, dextromethorphan, and phenylephrine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about this medicine?

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. Do not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, coronary artery disease, or overactive thyroid. Avoid drinking alcohol. It may increase your risk of liver damage while you are taking acetaminophen. Do not use this medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

What should I discuss with my healthcare provider before taking this medicine?

Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen. Do not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, coronary artery disease, or overactive thyroid. Do not use this medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Ask a doctor or pharmacist if it is safe for you to take acetaminophen, dextromethorphan, and phenylephrine if you have:

liver disease, cirrhosis, or a history of alcoholism;

diabetes;

glaucoma;

diabetes;

epilepsy or other seizure disorder;

enlarged prostate or urination problems;

pheochromocytoma (an adrenal gland tumor); or

cough with mucus, or cough caused by emphysema or chronic bronchitis.

It is not known whether acetaminophen, dextromethorphan, and phenylephrine will harm an unborn baby. Do not use this medicine without a doctor's advice if you are pregnant. Acetaminophen, dextromethorphan, and phenylephrine may pass into breast milk and may harm a nursing baby. Decongestants may also slow breast milk production. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

Artificially sweetened cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.

How should I take this medicine?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. This medicine is usually taken only for a short time until your symptoms clear up.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children.

Measure liquid medicine with a special dose measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose measuring device, ask your pharmacist for one.

Dissolve one packet of the powder in at least 4 ounces of water. Stir this mixture and drink all of it right away.

Do not take for longer than 7 days in a row. Stop taking the medicine and call your doctor if you still have a fever after 3 days of use, you still have pain after 7 days (or 5 days if treating a child), if your symptoms get worse, or if you have a skin rash, ongoing headache, or any redness or swelling.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken this medicine within the past few days. Store at room temperature away from moisture and heat. Do not allow liquid medicine to freeze.

What happens if I miss a dose?

Since this medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose symptoms may also include severe forms of some of the side effects listed in this medication guide.

What should I avoid while taking this medicine?

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP. This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid drinking alcohol. It may increase your risk of liver damage while you are taking acetaminophen.

This medicine side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. chest pain, fast, slow, or uneven heart rate; Stop using this medication and call your doctor at once if you have any of these serious side effects:

chest pain, fast, slow, or uneven heart rate;

severe dizziness, feeling like you might pass out;

mood changes, confusion, hallucinations;

tremor, seizure (convulsions);

fever;

urinating less than usual or not at all;

nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of your skin or eyes); or

nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, chest pain, uneven heartbeats, seizure).

Less serious side effects may include:

dizziness, weakness;

mild headache;

mild nausea, diarrhea, upset stomach;

dry mouth, nose, or throat;

feeling nervous, restless, irritable, or anxious; or

sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect this medicine?

Ask a doctor or pharmacist if it is safe for you to take this medicine if you are also using any of the following drugs:

leflunomide (Arava);

tapentadol (Nucynta);

an antibiotic, antifungal medicine, sulfa drug, or tuberculosis medicine;

an antidepressant;

birth control pills or hormone replacement therapy;

blood pressure medication;

cancer medicine;

cholesterol-lowering medications such as Lipitor, Niaspan, Zocor, Vytorin, and others;

gout or arthritis medications (including gold injections);

HIV/AIDS medication;

medicines to treat psychiatric disorders;

migraine headache medicine;

an NSAID such as Advil, Aleve, Arthrotec, Cataflam, Celebrex, Indocin, Motrin, Naprosyn, Treximet, Voltaren, others; or

seizure medication.

This list is not complete and other drugs may interact with acetaminophen, dextromethorphan, and phenylephrine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Theraflu Warming Severe Cold Daytime resources

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Compare Theraflu Warming Severe Cold Daytime with other medications

Cold Symptoms
Cough
Cough and Nasal Congestion
Nasal Congestion
Pain/Fever
Sinus Symptoms
Tonsillitis/Pharyngitis

Where can I get more information?

Your pharmacist can provide more information about acetaminophen, dextromethorphan, and phenylephrine.