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Wednesday, July 25, 2012

Anafranil

Generic Name: Clomipramine Hydrochloride
Class: Tricyclics and Other Norepinephrine-reuptake Inhibitors
VA Class: CN601
Chemical Name: 3-Chloro-10,11-dihydro-N,N-dimethyl -5H-dibenz[b,f]azepine-5-propanamine monohydrochloride
Molecular Formula: C₁₉H₂₃ClN₂•HCl
CAS Number: 17321-77-6

Suicidality

Antidepressants may increase risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (18–24 years of age) with major depressive disorder and other psychiatric disorders; balance this risk with clinical need.^d ^e Clomipramine is not approved for use in pediatric patients except patients with obsessive-compulsive disorder.¹ (See Pediatric Use under Cautions.)

In pooled data analyses, risk of suicidality was not increased in adults >24 years of age and apparently was reduced in adults ≥65 years of age with antidepressant therapy compared with placebo.^d ^e

Depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide.^d ^e ^f

Appropriately monitor and closely observe all patients who are started on clomipramine therapy for clinical worsening, suicidality, or unusual changes in behavior; involve family members and/or caregivers in this process.^d ^e ^f (See Worsening of Depression and Suicidality Risk under Cautions.)

Introduction

Tricyclic antidepressant (TCA);¹ ² ³ ²³⁵ pharmacologic profile resembles that of other TCAs,²³⁵ ²³⁸ SSRIs, and trazodone.² ³ ⁴ ²¹² ²¹³ ²¹⁴ ²²⁰ ²²¹

Uses for Anafranil

Obsessive-Compulsive Disorder (OCD)

Among the drugs of choice for the management of OCD.⁶⁹ ²⁸⁹ ²⁹³ ²⁹⁶ ²⁹⁷

Reduces but does not completely eliminate obsessions and compulsions.⁹⁶ ²⁷¹ ²⁹² ³⁰⁰

Panic Disorder

Has been used effectively for the management of panic disorder† with or without agoraphobia†.² ³ ⁴ ¹⁰⁴ ¹⁰⁵ ¹⁰⁶ ¹⁰⁷ ¹⁰⁸ ¹⁰⁹ ¹¹⁰ ¹¹⁶ ³⁴⁷

Major Depressive Disorder

Has been used effectively for the management of major depressive disorder†.² ³ ²⁵⁴ ²⁵⁵ ²⁵⁶ ²⁵⁷ ²⁵⁸ ²⁵⁹ ²⁶⁰ ²⁶⁷ ²⁷⁷ ²⁷⁸ ²⁸² ²⁸⁸

Despite comparable efficacy,² ³ ²⁵⁵ ²⁵⁶ ²⁵⁷ ²⁵⁸ ²⁶⁰ ²⁷⁷ ²⁸² ²⁸³ the adverse effect profile (e.g., anticholinergic effects) of clomipramine may limit its usefulness relative to other antidepressants (e.g., TCAs, SSRIs).² ²⁵⁷ ²⁵⁸ ²⁷⁷ ²⁸² ²⁸³ ²⁸⁸ ²⁸⁹

Effective antidepressant when obsessive manifestations accompany episode of major depressive disorder.²⁸⁸

Chronic Pain

Has been used for the management of chronic pain† (e.g., central pain, idiopathic pain disorder, tension headache, diabetic peripheral neuropathy, cancer pain) alone or as adjunct to conventional analgesics.² ³ ⁵² ¹¹¹ ¹¹² ¹¹³ ¹¹⁴ ¹¹⁵ ¹¹⁸ ¹¹⁹ ¹²⁰ ¹²¹ ¹²² ¹²³ ¹²⁴ ¹²⁵ ³⁴³ ³⁴⁴

Cataplexy and Associated Narcolepsy

Has been used for the symptomatic management of cataplexy† in a limited number of patients with cataplexy† and associated narcolepsy†.³ ¹³² ¹³³ ²⁷⁹

Autistic Disorder

Has been used for the management of repetitive and obsessive-compulsive behaviors and hyperactivity associated with autistic disorder†;¹³⁴ ¹³⁵ ¹⁴¹ ²⁸⁵ ²⁸⁶ does not treat core symptoms of autistic disorder.^b

Trichotillomania

Has been used for the management of trichotillomania† (an urge to pull out one’s hair) in a limited number of patients with the disorder;³ ¹³⁶ ¹³⁷ ¹³⁸ ¹³⁹ relapse reported in some patients receiving long-term therapy.¹⁴⁰

Onychophagia

Has been used for the management of severe onychophagia† (nail biting) without a history of OCD.¹⁴²

Associated with relatively high dropout rate because of adverse effects and drug intolerance; not considered first-line therapy in most patients with onychophagia.¹⁴² ³⁴¹

Eating Disorders

Has been used for the management of anorexia nervosa† in a limited number of patients with the disorder.²²⁹ ²³⁰ ²³¹

Initial therapeutic effects (e.g., improved eating behavior, weight gain) not sustained with long-term therapy (e.g., ≥8 weeks).²²⁹ ²³⁰ ²³¹ ²³⁴

Avoid use in underweight individuals and in those exhibiting suicidal ideation.²⁸⁸ ³⁴¹

Premature Ejaculation

Has been used for the management of premature ejaculation†.³ ¹²⁸ ¹²⁹ ¹³⁰ ¹³¹

Premenstrual Syndrome

Has been used for the management of premenstrual syndrome†.²⁶¹ ²⁶² ²⁶³ ²⁶⁴

Anafranil Dosage and Administration

General

Allow at least 2 weeks to elapse between discontinuance of therapy with an MAO inhibitor and initiation of clomipramine and vice versa.¹ Also allow at least 5 weeks to elapse when switching from fluoxetine.¹

Monitor for possible worsening of depression, suicidality, or unusual changes in behavior, especially at the beginning of therapy or during periods of dosage adjustments.^d ^e ^f (See Worsening of Depression and Suicidality Risk under Cautions.)

Sustained therapy may be required;² ⁴ ³³ ⁷⁸ ⁸⁰ ⁸¹ ⁸² ¹⁴⁸ ³⁴¹ use lowest effective dosage and monitor periodically for need for continued therapy.¹ ²⁹⁹

Avoid abrupt discontinuance of therapy.¹ ² ⁷⁸ ¹⁴⁸ ³⁰¹ To avoid withdrawal reactions, taper dosage gradually (e.g., over a period of approximately 2 weeks).¹ ² ⁷⁸ ¹⁴⁸ ³⁰¹

Panic Disorder†

Transient increase in the number and intensity of panic attacks may occur during initial therapy with the drug.⁴ ¹⁰⁴ ¹⁰⁵ ¹⁰⁶ ²⁸⁸

Administration

Oral Administration

Administer orally; initially, in divided doses with meals to lessen adverse GI effects.¹ After initial dosage titration, the total daily dose may be given once daily at bedtime¹ ² ⁴ ²⁷¹ to minimize adverse effects (e.g., sedation) during waking hours¹ ² and enhance patient compliance.²

Also has been administered IM† or IV†, but a parenteral dosage form is not commercially available in the US.⁴ ²⁷²

Dosage

Available as clomipramine hydrochloride; dosage is expressed in terms of the salt.¹

Individualize dosage carefully according to individual requirements and response.¹

Allow 2–3 weeks to elapse between any further dosage adjustments after the initial dosage titration period for achievement of steady-state plasma concentrations.¹

Pediatric Patients

OCD

Oral

Children >10 years of age: initially, 25 mg daily.¹ Gradually increase dosage, as tolerated, during the first 2 weeks of therapy up to a maximum of 3 mg/kg or 100 mg daily, whichever is lower.¹ ² ²⁴² Titrate dosage carefully.¹ If necessary, dosages may be increased gradually during the next several weeks up to a maximum of 3 mg/kg or 200 mg daily (whichever is lower).¹ ² ³ ⁴ ⁶⁶ ⁶⁷

Optimum duration not established; ¹ ⁷⁸ ²⁷¹ some clinicians recommend that therapy be continued in responding patients at the minimally effective dosage for at least 18 months before attempting to discontinue.¹ ²⁷¹ ²⁹⁹

Adults

OCD

Oral

Initially, 25 mg daily.¹ Gradually increase dosage, as tolerated, during the first 2 weeks of therapy to approximately 100 mg daily.¹ If necessary, dosages may be increased gradually during the next several weeks up to a maximum of 250 mg daily.¹ ² ³ ⁴ ⁶⁶ ⁶⁷

Panic Disorder†

Oral

Usual dosage: ≤50 mg daily (range: 12.5–150 mg daily);² ⁴ ¹⁰⁴ ¹⁰⁵ ¹⁰⁶ ¹⁰⁷ ¹⁰⁸ ¹¹⁰ ¹¹⁶ ²⁷² patients with agoraphobia may require higher dosage.⁴ ¹⁰⁴ ¹⁰⁵ ¹⁰⁶

Major Depressive Disorder†

Oral

100–250 mg daily.² ²⁷² ²⁷⁷ ²⁷⁸ ²⁸⁸

Chronic Pain†

Oral

100–250 mg daily.² ¹¹⁵ ²⁷² ²⁸⁸

Cataplexy and Associated Narcolepsy†

Oral

25–200 mg daily.¹³² ¹³³ ²⁷² ²⁷⁹

Prescribing Limits

Pediatric Patients

OCD

Oral

Maximum 3 mg/kg or 200 mg daily, whichever is lower.¹ ² ³ ⁴ ⁶⁶ ⁶⁷

Adults

OCD

Oral

Maximum 250 mg daily.¹ ² ³ ⁴ ⁶⁶ ⁶⁷

Panic Disorder†

Oral

Maximum 200 mg daily.² ⁴ ¹⁰⁴ ¹⁰⁵ ¹⁰⁶ ¹⁰⁷ ¹⁰⁸ ¹¹⁰ ¹¹⁶ ²⁷²

Special Populations

Geriatric Patients

Manufacturer makes no specific recommendation for dosage adjustment¹ ⁴¹ ²⁴⁰ but lower clomipramine hydrochloride dosages are recommended by some clinicians at least during initial therapy.² ⁴ ²⁷² ²⁸²

Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and potential for concomitant disease and drug therapy.¹

Cautions for Anafranil

Contraindications

Concurrent or recent (i.e., within 2 weeks) therapy with an MAO inhibitor.¹ (See Specific Drugs under Interactions.)

During the acute recovery phase following MI.¹

Known hypersensitivity to clomipramine or other TCAs.¹

Warnings/Precautions

Warnings

Seizures

Risk of seizure; use with caution in patients with a history of seizures or other predisposing factors (e.g., brain damage of various etiology, alcoholism, concurrent use of other drugs that lower the seizure threshold).¹

Risk may be dose related.¹ (See Prescribing Limits under Dosage and Administration.)

Worsening of Depression and Suicidality Risk

Possible worsening of depression and/or emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior in both adult and pediatric patients, whether or not they are taking antidepressants; may persist until clinically important remission occurs.^d ^e ^f ^g However, suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide.^d ^e ^f

Appropriately monitor and closely observe patients receiving clomipramine for any reason, particularly during initiation of therapy (i.e., the first few months) and during periods of dosage adjustments.^d ^e ^f (See Boxed Warning and also see Pediatric Use under Cautions.)

Anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and/or mania may be precursors to emerging suicidality.^e ^f Consider changing or discontinuing therapy in patients whose depression is persistently worse or in those with emerging suicidality or symptoms that might be precursors to worsening depression or suicidality, particularly if severe, abrupt in onset, or not part of patient’s presenting symptoms.^d ^e ^f (See General under Dosage and Administration and also see Withdrawal Reactions under Cautions.)

Prescribe in smallest quantity consistent with good patient management to reduce risk of overdosage.¹ ^e

Observe these precautions for patients with psychiatric (e.g., major depressive disorder, OCD) or nonpsychiatric disorders.^e

Bipolar Disorder

May unmask bipolar disorder.^e (See Activation of Mania or Hypomania under Cautions.) Clomipramine is not approved for use in treating bipolar depression.¹

Screen for risk of bipolar disorder by obtaining detailed psychiatric history (e.g., family history of suicide, bipolar disorder, depression) prior to initiating therapy.^e

General Precautions

Cardiovascular Effects

Modest orthostatic decreases in BP,¹ ¹⁹³ modest tachycardia,¹ and/or ECG abnormalities (e.g., VPCs, ST-T wave changes, intraventricular conduction abnormalities) reported; use with caution in patients with known cardiovascular disease.¹

Titrate dosage carefully.¹

Neuropsychiatric Effects

Variety of neuropsychiatric manifestations (e.g., delusions, hallucinations, psychotic episodes, confusion, paranoia) reported.¹ ³ ¹⁵⁵ ¹⁵⁶ ²³⁸

May precipitate an acute psychotic episode in patients with unrecognized schizophrenia.¹ ³ ¹⁵⁵ ¹⁵⁶ ²⁹⁵

Activation of Mania or Hypomania

Risk of activation of mania or hypomania in patients with affective disorder.¹ ³ ¹⁵⁵ ¹⁵⁶ ²⁹⁵ (See Bipolar Disorder under Cautions.)

Anticholinergic Effects

Use with caution in patients for whom excess anticholinergic activity could be harmful (e.g., history of urinary retention, increased intraocular pressure, angle-closure glaucoma).¹

Interactions

More than 30 cases of hyperthermia reported,¹ most cases occurring in patients receiving clomipramine in combination with other drugs (e.g., antipsychotic agents).¹ ¹⁵⁷ ¹⁹⁹ When clomipramine and an antipsychotic agent were used concomitantly, the cases sometimes were considered to be examples of neuroleptic malignant syndrome (NMS).¹ ¹⁵⁷ ¹⁹⁹

Hepatic Effects

Potentially clinically important elevations (e.g., >3 times ULN) in serum ALT¹ ⁶⁵ and AST¹ concentrations;¹ severe hepatic injury and/or death rarely reported.¹

Possible cross hepatotoxicity (e.g., elevated values on hepatic function tests, abdominal pain) involving different TCAs including clomipramine.²⁰⁷ (See Hepatic Impairment under Cautions.)

Hematologic Effects

Bone marrow depression¹ ²²⁷ (e.g., leukopenia,¹ agranulocytosis,¹ ³ ¹⁶² ¹⁶⁴ ¹⁶⁵ ¹⁶⁶ thrombocytopenia,¹ anemia,¹ pancytopenia)¹ ³ ¹⁶³ rarely reported.¹ ²²⁷

Obtain leukocyte and differential blood cell counts if fever and sore throat occur during therapy.¹

Sexual Dysfunction

Relatively high risk of sexual dysfunction¹ ³ ¹⁸⁰ (e.g., libido change,¹ ⁶⁵ ¹⁸⁹ ²⁵¹ ejaculatory failure,¹ ⁶⁵ ¹⁸⁰ ¹⁸⁸ ²⁵¹ impotence¹ ⁶⁵ ¹⁸⁹ ²⁴⁵ ²⁷⁰ ) in male patients with OCD.¹

Normal sexual functioning usually returns within a few days after discontinuing therapy.² ³ ¹⁸⁰

Weight Changes

Possible weight gain¹ ²⁴² ²⁴⁵ ²⁴⁷ ²⁴⁹ or weight loss.¹

Withdrawal Reactions

Withdrawal reactions (e.g., dizziness, nausea, vomiting, headache, malaise, sleep disturbance, hyperthermia, sweating, irritability, seizures, worsening of psychiatric status) reported following abrupt discontinuance of therapy.¹ ² ⁷⁸ ¹⁴⁸ ³⁰¹

To avoid withdrawal reactions, taper dosage gradually and monitor patients carefully.¹ ² ⁷⁸ ¹⁴⁸ ³⁰¹

Electroconvulsive Therapy (ECT)

Possible increased ECT risks; limit to patients for whom concomitant use is essential.¹

Elective Surgery

Discontinue therapy for as long as is clinically feasible prior to surgery and advise the anesthetist of such action.¹

Thyroid Disease

Use with caution in hyperthyroid patients or patients receiving thyroid agents because of the possibility of cardiac toxicity.¹ ¹

Adrenal Medulla Tumors

Use with caution in patients with tumors of the adrenal medulla, in whom hypertensive crises may be provoked.¹

Specific Populations

Pregnancy

Category C.¹

Possible withdrawal symptoms (e.g., jitteriness,¹ ⁷¹ ¹⁵² ¹⁵⁸ tremor,¹ ⁷¹ ¹⁵³ ¹⁵⁴ seizures¹ ³ ¹⁵² ¹⁵³ ) in neonates whose mothers received clomipramine throughout pregnancy;¹ avoid use during late pregnancy whenever possible.¹⁵³

Lactation

Distributed into milk;¹ ⁴ ²² ⁵⁵ ⁶⁰ ⁶² ⁷¹ ¹⁵⁰ discontinue nursing or the drug.¹ ⁶² ¹⁴⁹ ¹⁵⁰ ¹⁵¹

Pediatric Use

Safety and efficacy for OCD not established in children <10 years of age.¹

Potential risks associated with long-term use (e.g., effects on growth, development, or maturation) not systematically evaluated in children and adolescents.¹

Adverse effects in children and adolescents >10 years of age generally similar to those in adults.¹

FDA warns that a greater risk of suicidal thinking or behavior (suicidality) occurred during first few months of antidepressant treatment (4%) compared with placebo (2%) in children and adolescents with major depressive disorder, OCD, or other psychiatric disorders based on pooled analyses of 24 short-term placebo-controlled trials of 9 antidepressant drugs (SSRIs and others).^e However, a more recent meta-analysis of 27 placebo-controlled trials of 9 antidepressants (SSRIs and others) in patients <19 years of age with major depressive disorder, OCD, or non-OCD anxiety disorders suggests that the benefits of antidepressant therapy in treating these conditions may outweigh the risks of suicidal behavior or suicidal ideation.^g No suicides occurred in these pediatric trials.^e ^g

Carefully consider these findings when assessing potential benefits and risks of clomipramine in a child or adolescent for any clinical use.^d ^e ^f ^g (See Worsening of Depression and Suicidality Risk under Cautions.)

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.¹

In pooled data analyses, a reduced risk of suicidality was observed in adults ≥65 years of age with antidepressant therapy compared with placebo.^d ^e (See Boxed Warning and also see Worsening of Depression and Suicidality Risk under Cautions.)

Possible increased sensitivity to anticholinergic (e.g., dry mouth, constipation, vision disturbance), cardiovascular, orthostatic hypotension, and sedative effects of TCAs.

Hepatic Impairment

Use with caution in patients with clinically important hepatic disease; periodically monitor hepatic enzyme concentrations.¹

Renal Impairment

Use with caution in patients with clinically important renal impairment.¹

Common Adverse Effects

Adverse GI (e.g., dry mouth, constipation, nausea, dyspepsia, anorexia, increased appetite), nervous system (e.g., somnolence, tremor, dizziness, nervousness, fatigue, myoclonus), or genitourinary (e.g., changed libido, ejaculatory failure, impotence, micturition disorder) effects; sweating; weight gain; visual changes.¹ ² ³⁵ ⁶⁵ ²⁴²

Interactions for Anafranil

Extensively metabolized in the liver by various CYP isoenzymes (e.g., CYP1A2,³⁴⁶ CYP2C,⁷³ CYP2D6,⁷² ⁷³ CYP3A4).^c

Drugs Affecting Hepatic Microsomal Enzymes

Inhibitors of CYP2D6 and/or 1A2: Potential pharmacokinetic interaction (increased plasma clomipramine concentrations).^a Monitor plasma clomipramine concentrations whenever a CYP2D6 inhibitor is added or discontinued and adjust dosages as needed.^a

Drugs Associated with Serotonin Syndrome

Potential pharmacologic (serotonin syndrome) interaction with serotonergic agents.¹ ¹⁷⁵ ³⁰² ³⁰³ Avoid such use whenever clinically possible.¹ ³⁰² ³⁰³

Drugs Affecting the Seizure Threshold

Use caution with concurrent administration of clomipramine and drugs (e.g., other antidepressants, antipsychotic agents) that lower the seizure threshold.¹

Protein-bound Drugs

Potential for clomipramine to displace or to be displaced by other protein-bound drugs.¹ Observe patients for adverse effects.¹ ²

Specific Drugs

Drug	Interaction	Comments
Alcohol	Potential for increased CNS effects of alcohol¹ Limited data suggest that demethylation of clomipramine may be reduced with chronic alcohol consumption⁵⁵ ⁶⁰ ⁶³ ⁶⁴	Advise patients of risks of such concomitant use¹
Alprazolam	Adverse effects resembling serotonin syndrome¹⁷⁴ ¹⁷⁸
Antiarrhythmics: class 1C (e.g., flecainide, propafenone)	Potential for decreased clomipramine metabolism^a	Monitor for TCA toxicity^a
Anticholinergic agents	Potential for additive anticholinergic effects¹ ² ^c	Use with caution; dosage adjustment may be needed¹ ² ^c
Antipsychotic agents (e.g., phenothiazines)	Hyperthermia and adverse effects resembling NMS¹ ¹⁵⁷ ¹⁹⁹ Potential for decreased clomipramine metabolism^c	Dosage adjustment may be needed^c
Barbiturates (e.g., phenobarbital)	May be additive with or may potentiate CNS effects¹ ¹⁵⁹ Possible decreased plasma clomipramine concentrations¹ ¹⁵⁹ Increased plasma phenobarbital concentrations reported¹	Advise patients of risks associated with such concomitant use¹
Cimetidine	Potential increased plasma clomipramine concentrations¹ ¹⁵⁹ ^c	Use with caution; dosage adjustment may be needed^c
CNS depressants (e.g., alcohol, sedatives, hypnotics)	Potentiates effects of CNS depressants¹ ^c	Use with caution^c
Digoxin	Possible altered protein binding of clomipramine or digoxin¹ ²	Monitor for adverse effects¹ ²
Haloperidol	Potential for increased plasma clomipramine concentrations¹ ²	Use with caution; dosage adjustment may be needed^c
Hypotensive agents (e.g., clonidine, guanethidine)	May antagonize antihypertensive effects¹ ² ¹⁵⁹	Monitor BP^c
Levodopa	May interfere with levodopa absorption^c	Monitor levodopa dosage carefully^c
Lithium	Adverse effects resembling serotonin syndrome¹⁷⁴ ¹⁷⁸
MAO inhibitors (e.g., phenelzine)	Potentially life-threatening serotonin syndrome¹ ² ¹⁵⁹ ¹⁶⁰ Status epilepticus reported with concomitant phenelzine use² ³ ¹⁶¹	Concomitant use contraindicated¹ ^c Allow at least 14 days to elapse when switching to or from these drugs¹ ^c
Methylphenidate	Possible increased plasma clomipramine concentrations¹ ¹⁵⁹
Oral contraceptives	No evidence of interference with clomipramine therapeutic effects¹⁵⁹
Phenytoin	Possible decreased plasma clomipramine concentrations¹ ¹⁵⁹
SSRIs (e.g., fluoxetine, fluvoxamine)	Possible serotonin syndrome^c Potential decreased clomipramine metabolism and increased plasma concentrations^a ^c Possible seizures with concomitant fluoxetine use¹⁷⁰ Severalfold elevation of plasma clomipramine concentration with concomitant fluvoxamine use¹⁷¹	Use with caution;^c monitor for TCA toxicity^a Allow at least 5 weeks to elapse when switching from fluoxetine^a ^c
Smoking	Possible decreased plasma clomipramine concentrations¹ ² ⁴¹ ⁵⁵ ⁶⁰
Sympathomimetic agents (e.g., amphetamines, epinephrine, isoproterenol, norepinephrine, phenylephrine)	Increased vasopressor, cardiac effects^c	Use with caution; dosage adjustment may be required^c
Thyroid agents (e.g., levothyroxine, liothyronine)	May accelerate the onset of therapeutic effects of TCA^c Possible cardiac arrhythmias^c	Use with caution^c
Valproic acid	Possible elevated serum clomipramine concentrations; may precipitate seizures in predisposed individuals²⁹⁸
Warfarin	Possible altered protein binding of clomipramine or warfarin¹ ²	Monitor for adverse effects¹ ²

Anafranil Pharmacokinetics

Absorption

Bioavailability

Well absorbed following oral administration,² ³ ⁴ ⁵ ¹⁰ ⁵⁵ with peak plasma concentrations usually attained within 2–6 hours (mean: 4.7 hours).¹ ¹⁰ ¹¹ ¹² ²⁵ ²⁹

Oral bioavailability is about 50% because of extensive first-pass metabolism.¹ ² ²⁵ ⁵⁵

Onset

Therapeutic response in OCD generally occurs within 2–6 weeks, with maximal effects after 3–4 months.³³ ⁶⁶ ⁹⁹ ¹⁰³

Food

Food does not appear to substantially affect bioavailability from capsules.¹ ²⁹

Special Populations

In geriatric patients, plasma concentrations of clomipramine and its major active metabolite (desmethylclomipramine) are substantially higher than those in younger adults (18–40 years of age).¹ ⁴¹ ⁶⁰

In children <15 years of age, plasma concentration-dose ratios of clomipramine are substantially lower than those of adults.¹ ⁴³

In smokers, steady-state plasma clomipramine concentrations are substantially lower than in nonsmokers;¹ ⁴¹ ⁵⁵ ⁶⁰ smoking appears to have less effect on plasma concentrations of desmethylclomipramine.⁶⁰

Distribution

Extent

Clomipramine and desmethylclomipramine widely distributed in body tissues, with moderate to high concentrations occurring in organs such as the lungs, adrenals, kidneys, heart, and brain.¹ ³ ⁵ ¹⁰ ⁵³

Crosses the blood-brain barrier; desmethylclomipramine concentration in CSF is about 2.6 times higher than in plasma.¹

Crosses the placenta and distributes into milk.¹ ⁴ ²² ⁵⁵ ⁶⁰ ⁶² ⁷¹

Plasma Protein Binding

Approximately 97–98%, principally to albumin and possibly to α₁-acid glycoprotein (α₁-AGP).¹ ² ⁴ ²⁹ ⁵⁵ ⁵⁶

Elimination

Metabolism

Extensively metabolized to active metabolites¹ ² ³ ⁴ ⁵ ¹⁹ ²⁰ ⁵⁵ ⁶¹ ⁷² ⁷³ by various CYP isoenzymes (e.g., CYP1A2,³⁴⁶ CYP2C,⁷³ CYP2D6,⁷² ⁷³ CYP3A4).^c

Exhibits nonlinear pharmacokinetics at dosages >150 mg daily.¹ ⁸ Metabolism of clomipramine and desmethylclomipramine may be capacity limited (saturable).¹ ⁸ ⁵⁵

Elimination Route

Clomipramine and metabolites excreted in urine and in feces (via biliary elimination).¹ ⁴ ⁵ ¹¹ ²¹ ²⁹ ⁵⁵ ⁷³

Half-life

Elimination half-lives of clomipramine and desmethylclomipramine are approximately 32 hours (range: 19–37 hours) and 69 hours (range: 54–77 hours), respectively, after a 150-mg oral dose.¹ ²

Elimination half-lives may be considerably prolonged at dosages near upper limit of recommended dosage range (i.e., 200–250 mg daily).¹ ⁸

Special Populations

Effects of renal and hepatic impairment on the disposition of clomipramine have not been fully elucidated.¹ ⁶⁰

Hemodialysis, peritoneal dialysis, forced diuresis, and/or exchange transfu

Tuesday, July 24, 2012

Triavil

Generic Name: amitriptyline and perphenazine (a mee TRIP ti leen and per FEN a zeen)

Brand Names: Etrafon Forte, Triavil

What is Triavil (amitriptyline and perphenazine)?

Amitriptyline is in a group of drugs called tricyclic antidepressants. Amitriptyline affects chemicals in the brain that may become unbalanced.

Perphenazine is in a group of drugs called phenothiazines (feen-oh-THYE-a-zeens). Perphenazine affects chemicals in the brain that may become unbalanced and cause anxiety.

The combination of amitriptyline and perphenazine is used to treat depression, anxiety, and agitation.

Amitriptyline and perphenazine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Triavil (amitriptyline and perphenazine)?

You should not take this medication if you are allergic to amitriptyline (Elavil, Vanatrip, Limbitrol) or perphenazine (Trilafon), or if you have liver damage, a weak immune system, a blood cell disorder (such as anemia), or if you have recently had a heart attack. Do not use amitriptyline and perphenazine 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.

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Video: Treatment for Depression

Treatments for depression are getting better everyday and there are things you can start doing right away.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. Do not drink alcohol. Amitriptyline and perphenazine can increase the effects of alcohol, which could be dangerous.

What should I discuss with my healthcare provider before taking Triavil (amitriptyline and perphenazine)?

You should not use this medication if you are allergic to amitriptyline (Elavil, Vanatrip, Limbitrol) or perphenazine (Trilafon), or if you have:

liver damage;

a blood cell disorder (such as anemia);

a weak immune system (bone marrow depression); or

if you have recently had a heart attack.

Do not use amitriptyline and perphenazine 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. Serious, life threatening side effects can occur if you use amitriptyline and perphenazine before the MAO inhibitor has cleared from your body.

To make sure you can safely take amitriptyline and perphenazine, tell your doctor if you have any of these other conditions:

kidney or liver disease;

heart disease, or a history of heart attack or stroke;

pheochromocytoma (adrenal gland tumor);

epilepsy or other seizure disorder;

a thyroid disorder;

asthma, emphysema, or other breathing disorder;

glaucoma;

problems with urination;

bipolar disorder (manic-depression), schizophrenia or other mental illness;

history of drug or alcohol addiction;

history of suicidal thoughts or behavior; or

history of breast cancer.

You may have thoughts about suicide while taking an antidepressant, especially if you are younger than 24 years old. Tell your doctor if you have worsening depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Taking antipsychotic medication during the last 3 months of pregnancy may cause problems in the newborn, such as withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles. However, you may have withdrawal symptoms or other problems if you stop taking your medicine during pregnancy. If you become pregnant while taking amitriptyline and perphenazine, do not stop taking it without your doctor's advice. Amitriptyline and perphenazine may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medication to anyone under 18 years old without medical advice.

How should I take Triavil (amitriptyline and perphenazine)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

It may take up to 4 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 4 weeks of treatment.

To be sure this medication is not causing harmful effects, your blood may need to be tested often. Your kidney or liver function may also need to be tested. Visit your doctor regularly.

If you need surgery, tell the surgeon ahead of time that you are using amitriptyline and perphenazine. You may need to stop using the medicine for a short time. Do not stop using amitriptyline and perphenazine suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using amitriptyline and perphenazine. Store at room temperature away from moisture and heat.

What happens if I miss a dose?

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 amitriptyline and perphenazine can be fatal.

Overdose symptoms may include uneven heartbeats, extreme drowsiness, confusion, agitation, hallucinations, vomiting, feeling hot or cold, sweating, muscle stiffness, feeling light-headed, fainting, seizure (convulsions), or coma.

What should I avoid while taking Triavil (amitriptyline and perphenazine)?

Do not drink alcohol. This medication can increase the effects of alcohol, which could be dangerous. Amitriptyline and perphenazine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid exposure to sunlight or tanning beds. Perphenazine can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Triavil (amitriptyline and perphenazine) 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. Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. Call your doctor at once if you have a serious side effect such as:

restless muscle movements in your eyes, tongue, jaw, or neck;

tremor (uncontrolled shaking);

fever, stiff muscles, confusion, sweating, fast or uneven heartbeats;

feeling like you might pass out;

seizures (convulsions);

slow heart rate, chest pain or heavy feeling;

easy bruising or bleeding;

jaundice (yellowing of your skin or eyes);

painful or difficult urination; or

urinating less than usual or not at all.

Less serious side effects may include:

feeling dizzy, drowsy, or tired;

strange dreams or nightmares;

sleep problems (insomnia);

dry mouth, loss of appetite;

nausea, vomiting, diarrhea, constipation;

blurred vision;

breast changes; or

decreased sex drive, impotence, or difficulty having an orgasm.

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 Triavil (amitriptyline and perphenazine)?

Before taking amitriptyline and perphenazine, tell your doctor if you have used an "SSRI" antidepressant in the past 5 weeks, such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), or sertraline (Zoloft).

Cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures or anxiety can add to sleepiness caused by amitriptyline and perphenazine. Tell your doctor if you regularly use any of these medicines, or any other antidepressant.

The following drugs can interact with amitriptyline and perphenazine. Tell your doctor if you are using any of these:

atropine (Atreza, Lomotil, Sal-Tropine, and others);

cimetidine (Tagamet);

a heart rhythm medication such as quinidine (Quin-G), procainamide (Pronestyl), disopyramide (Norpace), flecaininde (Tambocor), mexiletine (Mexitil), or propafenone, (Rythmol).

This list is not complete and other drugs may interact with amitriptyline and perphenazine. 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 Triavil resources

Triavil Use in Pregnancy & Breastfeeding
Drug Images
Triavil Drug Interactions
Triavil Support Group
1 Review for Triavil - Add your own review/rating

Compare Triavil with other medications

Agitation
Anxiety
Depression

Where can I get more information?

Your pharmacist can provide more information about amitriptyline and perphenazine.

Monday, July 23, 2012

Fosamax Once Weekly 70 mg Tablet

FOSAMAX Once Weekly 70 mg Tablets

Alendronic acid as alendronate sodium trihydrate

Read all of this leaflet carefully before you start taking this medicine, even if this is a repeat prescription.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

It is particularly important to understand the information in section 3. HOW TO TAKE FOSAMAX, before taking this medicine.

In this leaflet:

1. What FOSAMAX is and what it is used for

2. Before you take FOSAMAX

3. How to take FOSAMAX

4. Possible side effects

5 How to store FOSAMAX

6. Further information

What Fosamax Is And What It Is Used For

What is FOSAMAX?

Fosamax belongs to a group of non-hormonal medicines called bisphosphonates. FOSAMAX prevents the loss of bone that occurs in women after they have been through the menopause, and helps to rebuild bone. It reduces the risk of spine and hip fractures.

What is FOSAMAX used for?

Your doctor has prescribed Fosamax to treat your osteoporosis. FOSAMAX reduces the risk of spine and hip fractures.

FOSAMAX is a once weekly treatment.

What is osteoporosis?

Osteoporosis is a thinning and weakening of the bones. It is common in women after the menopause. At the menopause, the ovaries stop producing the female hormone, oestrogen, which helps to keep a woman’s skeleton healthy. As a result, bone loss occurs and bones become weaker. The earlier a woman reaches the menopause, the greater the risk of osteoporosis.

Early on, osteoporosis usually has no symptoms. If left untreated, however, it can result in broken bones. Although these usually hurt, breaks in the bones of the spine may go unnoticed until they cause height loss. Broken bones can happen during normal, everyday activity, such as lifting, or from minor injury that would not generally break normal bone. Broken bones usually occur at the hip, spine, or wrist and can lead not only to pain but also to considerable problems like stooped posture (‘dowager’s hump’) and loss of mobility.

How can osteoporosis be treated?

Osteoporosis can be treated and it is never too late to begin treatment. FOSAMAX not only prevents the loss of bone but actually helps to rebuild bone you may have lost and reduces the risk of bones breaking in the spine and hip.

As well as your treatment with FOSAMAX, your doctor may suggest you make changes to your lifestyle to help your condition, such as:

Stopping smoking: Smoking appears to increase the rate at which you lose bone and, therefore, may increase your risk of broken bones.

Exercise: Like muscles, bones need exercise to stay strong and healthy. Consult your doctor before you begin any exercise programme.

Eating a balanced diet: Your doctor can advise you about your diet or whether you should take any dietary supplements (especially calcium and Vitamin D).

Before You Take Fosamax

Do not take FOSAMAX

(1) if you are allergic (hypersensitive) to alendronate sodium trihydrate or any of the other ingredients

(2) if you have certain problems with your gullet (oesophagus - the tube that connects your mouth with your stomach) such as narrowing or difficulty swallowing

(3) if you cannot stand or sit upright for at least 30 minutes

(4) if your doctor has told you that you have low blood calcium

If you think any of these apply to you, do not take the tablets. Talk to your doctor first and follow the advice given.

Take special care with FOSAMAX

It is important to tell your doctor before taking FOSAMAX if:

you suffer from kidney problems

you have any allergies

you have any swallowing or digestive problems

your doctor has told you that you have Barrett's oesophagus (a condition associated with changes in the cells that line the lower oesophagus)

you have low blood calcium levels

you have gum disease

you have a planned dental extraction

A dental examination should be considered before you start treatment with FOSAMAX if you have any of the conditions below.

you have cancer

you are undergoing chemotherapy or radiotherapy

you are taking steroids

you don’t receive routine dental care

you have gum disease

Appropriate preventive dental care, as recommended by the dentist, should be followed during treatment.

Irritation, inflammation or ulceration of the gullet (oesophagus – the tube that connects your mouth with your stomach) often with symptoms of chest pain, heartburn, or difficulty or pain upon swallowing may occur, especially if patients do not drink a full glass of water and/or if they lie down less than 30 minutes after taking FOSAMAX. These side effects may worsen if patients continue to take FOSAMAX after developing these symptoms.

Taking other medicines

It is likely that calcium supplements, antacids, and some oral medicines will interfere with the absorption of FOSAMAX if taken at the same time. Therefore, it is important that you follow the advice given in section 3. HOW TO TAKE FOSAMAX.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking FOSAMAX with food and drink

It is likely that food and beverages (including mineral water) will make FOSAMAX less effective if taken at the same time. Therefore, it is important that you follow the advice given in section 3. HOW TO TAKE FOSAMAX.

Children and adolescents

FOSAMAX should not be given to children and adolescents.

Pregnancy and breast-feeding

FOSAMAX is only intended for use in postmenopausal women. You should not take FOSAMAX if you are or think you may be pregnant, or if you are breast-feeding.

Driving and using machines

There have been side effects (including blurred vision, dizziness and severe bone, muscle or joint pain) reported with FOSAMAX that may affect your ability to drive or operate machinery. Individual responses to FOSAMAX may vary (See POSSIBLE SIDE EFFECTS.)

Important information about some of the ingredients of FOSAMAX

FOSAMAX contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How To Take Fosamax

Take one FOSAMAX tablet once a week.

Follow these instructions carefully to make sure you will benefit from FOSAMAX.

1) Choose the day of the week that best fits your schedule. Every week, take one FOSAMAX tablet on your chosen day.

It is very important to follow instructions 2), 3), 4) and 5) to help the FOSAMAX tablet reach your stomach quickly and help reduce the chance of irritating your gullet (oesophagus - the tube that connects your mouth with your stomach).

2) After getting up for the day and before taking any food, drink, or other medicine, swallow your FOSAMAX tablet whole with a full glass of water only (not mineral water) (not less than 200 ml or 7 fl. oz.).

Do not take with mineral water (still or sparkling).

Do not take with coffee or tea.

Do not take with juice or milk.

Do not crush or chew the tablet or allow it to dissolve in your mouth.

3) Do not lie down — stay fully upright (sitting, standing or walking) — for at least 30 minutes after swallowing the tablet. Do not lie down until after your first food of the day.

4) Do not take FOSAMAX at bedtime or before getting up for the day.

5) If you develop difficulty or pain upon swallowing, chest pain, or new or worsening heartburn, stop taking FOSAMAX and contact your doctor.

6) After swallowing your FOSAMAX tablet, wait at least 30 minutes before taking your first food, drink, or other medicine of the day, including antacids, calcium supplements and vitamins. FOSAMAX is effective only if taken when your stomach is empty.

If you take more FOSAMAX than you should

If you take too many tablets by mistake, drink a full glass of milk and contact your doctor immediately. Do not make yourself vomit, and do not lie down.

If you forget to take FOSAMAX

If you miss a dose, just take one tablet on the morning after you remember. Do not take two tablets on the same day. Return to taking one tablet once a week, as originally scheduled on your chosen day.

If you stop taking FOSAMAX

It is important that you continue taking FOSAMAX for as long as your doctor prescribes the medicine. FOSAMAX can treat your osteoporosis only if you continue to take the tablets.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible Side Effects

Like all medicines, FOSAMAX can cause side effects, although not everybody gets them.

The following terms are used to describe how often side effects have been reported.

Very Common (occurring in at least 1 of 10 patients treated)

Common (occurring in at least 1 of 100 and less than 1 of 10 patients treated)

Uncommon (occurring in at least 1 of 1000 and less than 1 of 100 patients treated)

Rare (occurring in at least 1 of 10000 and less than 1 of 1000 patients treated)

Very rare (occurring in less than 1 of 10,000 patients treated)

Common:

heartburn; difficulty swallowing; pain upon swallowing; ulceration of the gullet (oesophagus - the tube that connects your mouth with your stomach) which can cause chest pain, heartburn or difficulty or pain upon swallowing

bone, muscle and/or joint pain

abdominal pain; uncomfortable feeling in the stomach or belching after eating; constipation; full or bloated feeling in the stomach; diarrhoea; flatulence;

headache

Uncommon:

nausea; vomiting

irritation or inflammation of the gullet (oesophagus – the tube that connects your mouth with your stomach) or stomach

black or tar-like stools

rash; itching; redness of the skin

Rare:

allergic reactions such as hives; swelling of the face, lips, tongue and/or throat, possibly causing difficulty breathing or swallowing

symptoms of low blood calcium levels including muscle cramps or spasms and/or tingling sensation in the fingers or around the mouth

stomach or peptic ulcers (sometimes severe or with bleeding)

narrowing of the gullet (oesophagus – the tube that connects your mouth with your stomach)

jaw problems associated with delayed healing and infection, often following tooth extraction

blurred vision, pain or redness in the eye

rash made worse by sunlight

severe bone, muscle and/or joint pain

mouth ulcers when the tablets have been chewed or sucked

transient flu-like symptoms, such as aching muscles, generally feeling unwell and sometimes with fever usually at the start of treatment

Very rare:

severe skin reactions

During post-marketing experience the following side effects have been reported (frequency unknown):

dizziness, changed sense of taste

hair loss

joint swelling, fracture of the thigh bone in patients on long-term treatment with FOSAMAX.

Thigh pain, weakness or discomfort may be an early indication of a possible fracture of the thigh bone

tiredness, swelling in the hands or legs

Laboratory test findings:

Very common: mild and transient decreases in blood calcium and phosphate levels, generally within the normal range.

Tell your doctor or pharmacist promptly about these or any other unusual symptoms.

It will help if you make a note of what you experienced, when it started and how long it lasted.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How To Store Fosamax

Keep out of the reach and sight of children.

Do not use FOSAMAX after the expiry date which is stated on the carton and the wallet after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions. Do not remove the tablets from the blister pack until you are ready to take the medicine.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information

What FOSAMAX contains

Active substance

The active substance is alendronate sodium trihydrate. Each tablet contains 70 mg alendronic acid as alendronate sodium trihydrate.

Other ingredients

Microcrystalline cellulose (E460), lactose anhydrous, croscarmellose sodium and magnesium stearate (E572).

What FOSAMAX looks like and contents of the pack

FOSAMAX tablets are available as oval, white tablets marked with an outline of a bone image on one side and ‘31’ on the other.

The tablets are supplied in wallets with sealed aluminium blisters in cartons in the following pack sizes

2 tablets (1 wallet containing 2 tablets in aluminium blisters).

4 tablets (1 wallet containing 4 tablets in aluminium blisters).

8 tablets (2 wallets each containing 4 tablets in aluminium blisters).

12 tablets (3 wallets each containing 4 tablets in aluminium blisters).

40 tablets (10 wallets each containing 4 tablets in aluminium blisters).

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation Holder is

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon

Hertfordshire

EN11 9BU

United Kingdom

The manufacturer is

Merck Sharp & Dohme (Italia) SpA

Via Emilia 21

27100 Pavia

Italy

This medicinal product is authorized in the Member States of the EEA under the following names:

Austria: FOSAMAX einmal wöchentlich 70mg Tabletten

Belgium: FOSAMAX 70 mg Hebdomadaire, comprimés

Denmark: Fosamax Ugetablet

Finland: FOSAMAX 70 mg tabletit

France: FOSAMAX 70 mg comprimé

Germany: FOSAMAX einmal wöchentlich 70 mg Tabletten

Greece: FOSAMAX 70 mg εβδομαδιαίο δισκίο

Iceland: Fosamax vikutafla 70 mg

Ireland: Fosamax Once Weekly 70 mg Tablets

Italy: FOSAMAX 70 mg compresse

Luxembourg: FOSAMAX 70 mg Hebdomadaire, comprimés

Netherlands: FOSAMAX 70 mg één tablet per week

Norway: FOSAMAX 70 mg

Portugal: FOSAMAX 70 mg

Spain: FOSAMAX Semanal 70 mg comprimidos

Sweden: FOSAMAX Veckotablett 70 mg

UK: FOSAMAX Once Weekly 70 mg Tablets

This leaflet was last approved in February 2010

HOW CAN YOU OBTAIN MORE INFORMATION ABOUT ‘FOSAMAX’?

This leaflet gives you the most important patient information about ‘Fosamax’. If you have any questions after you have read it, ask your doctor or pharmacist, who will give you further information.

For more information about osteoporosis, contact (in UK)_The National Osteoporosis Society, Camerton, Bath BA2 0PJ. Telephone (01761) 471771; Fax (01761) 471104; Helpline 0845 4500230 or (in RoI) The Irish Osteoporosis Society, 33 Pearse Street, Dublin 2, Telephone (01) 6774267.

The National Osteoporosis Society and the Irish Osteoporosis Society are independent charities not connected with Merck Sharp & Dohme Limited.

denotes registered trademark of

Merck Sharp & Dohme Corp.

a division of Merck & Co., Inc.

Whitehouse Station

USA

PIL.FSM70.10.UK.3231 – II-027

Triaminic Multi-Sympton

Generic Name: chlorpheniramine, dextromethorphan, and pseudoephedrine (klor feh NEER a meen, dex tro meh THOR fan, and soo doe eh FEH drin)

Brand Names: AccuHist PDX Drops, Atuss DS, Children's NyQuil, Creomulsion Cough/Cold/Allergy, Creomulsion Pediatric, Dicel DM, Dicel DM Chewables, Entre-S, Esocor P, Kidcare Cough and Cold, M-End DM, Mesehist DM, Neutrahist PDX Drops, Nyquil Child Cough and Cold, Pediatric Cough & Cold Medicine, Rescon-DM, Robitussin Pediatric Night Relief, Robitussin PM Cough & Cold, Triaminic Cold and Cough, Triaminic Multi-Sympton, Triaminic Night Time, Triaminic Softchew Cold and Cough, Triaminic-D Multi-Symptom Cold, Vicks 44M Pediatric, Vicks Pediatric Formula 44M

What is Triaminic Multi-Sympton (chlorpheniramine, dextromethorphan, and pseudoephedrine)?

Chlorpheniramine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

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

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

The combination of chlorpheniramine, dextromethorphan, and pseudoephedrine is used to treat runny or stuffy nose, sneezing, itching, watery eyes, cough, and sinus congestion caused by allergies, the common cold, or the flu.

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

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

What is the most important information I should know about Triaminic Multi-Sympton (chlorpheniramine, dextromethorphan, and pseudoephedrine)?

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not use a cough or cold 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 taking this medicine if you have heart disease, high blood pressure, kidney disease, diabetes, glaucoma, a thyroid disorder, emphysema or bronchitis, an enlarged prostate, or urination problems.

Do not use cold or cough medicine without your doctor's advice if you are pregnant or breast-feeding. Ask a doctor or pharmacist before using any other cold, cough, or allergy medicine. Chlorpheniramine, dextromethorphan, and pseudoephedrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an antihistamine, cough suppressant, or decongestant. Do not take this medicine for longer than 7 days in a row. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

What should I discuss with my healthcare provider before taking Triaminic Multi-Sympton (chlorpheniramine, dextromethorphan, and pseudoephedrine)?

Do not use a cough or cold 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 this medicine if you have:

heart disease or high blood pressure;

kidney disease;

diabetes;

glaucoma;

a thyroid disorder;

emphysema or chronic bronchitis;

an enlarged prostate; or

problems with urination.

FDA pregnancy category C. It is not known whether chlorpheniramine, dextromethorphan, and pseudoephedrine will harm an unborn baby. Do not use this medication without medical advice if you are pregnant. Chlorpheniramine, dextromethorphan, and pseudoephedrine may pass into breast milk and may harm a nursing baby. Do not use cold or cough medicine without medical advice if you are breast-feeding a baby.

Artificially sweetened liquid cough or 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 Triaminic Multi-Sympton (chlorpheniramine, dextromethorphan, and pseudoephedrine)?

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. Cough or cold medicine is usually taken only for a short time until your symptoms clear up.

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.

The chewable tablet should be chewed before you swallow it.

Shake the oral suspension well just before you measure a dose. Do not take this medicine for longer than 7 days in a row. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

This medication can cause unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.

If you need surgery, tell the surgeon ahead of time if you have taken a cough or cold medicine within the past few days. Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Since cough or cold 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.

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

What should I avoid while taking Triaminic Multi-Sympton (chlorpheniramine, dextromethorphan, and pseudoephedrine)?

This medication may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Chlorpheniramine can decrease sweating and you may be more prone to heat stroke.

Drinking alcohol can increase certain side effects of this medication.

Avoid taking this medication if you also take diet pills, caffeine pills, or other stimulants (such as ADHD medications). Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Ask a doctor or pharmacist before using any other cold, cough, or allergy medicine. Chlorpheniramine, dextromethorphan, and pseudoephedrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an antihistamine, cough suppressant, or decongestant.

Triaminic Multi-Sympton (chlorpheniramine, dextromethorphan, and pseudoephedrine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using this medicine and call your doctor at once if you have a serious side effect such as:

fast, pounding, or uneven heartbeats;

slow, shallow breathing;

confusion, hallucinations, unusual thoughts or behavior;

severe dizziness, anxiety, restless feeling, or nervousness;

urinating less than usual or not at all;

easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or

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

Less serious side effects may include:

dry mouth, nose, or throat;

mild stomach pain, constipation;

blurred vision;

dizziness, drowsiness, mild headache;

sleep problems (insomnia);

feeling restless or excited (especially in children);

problems with memory or concentration; or

flushing (warmth, redness, or tingly feeling).

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 Triaminic Multi-Sympton (chlorpheniramine, dextromethorphan, and pseudoephedrine)?

Before using this medicine, tell your doctor if you regularly use other medicines that make you sleepy (such as sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by chlorpheniramine, dextromethorphan, and pseudoephedrine.

Ask a doctor or pharmacist if it is safe for you to use chlorpheniramine, dextromethorphan, and pseudoephedrine if you are also using any of the following drugs:

glycopyrrolate (Robinul);

mepenzolate (Cantil);

atropine (Atreza, Sal-Tropine), belladonna (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm Scop);

bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);

bronchodilators such as ipratropium (Atrovent) or tiotropium (Spiriva);

a diuretic (water pill), or blood pressure medicine;

irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Hyomax), or propantheline (Pro Banthine); or

salicylates such as aspirin, Backache Relief Extra Strength, Novasal, Nuprin Backache Caplet, Doan's Pills Extra Strength, Pepto-Bismol, Tricosal, and others.

This list is not complete and other drugs may interact with chlorpheniramine, dextromethorphan, and pseudoephedrine. 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 Triaminic Multi-Sympton resources

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

AccuHist PDX Drops MedFacts Consumer Leaflet (Wolters Kluwer)

AccuHist PDX Drops Prescribing Information (FDA)

Dicel DM Chewables Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Entre-S Prescribing Information (FDA)

Compare Triaminic Multi-Sympton with other medications

Cough and Nasal Congestion

Where can I get more information?

Your pharmacist can provide more information about chlorpheniramine, dextromethorphan, and pseudoephedrine.

See also: Triaminic Multi-Sympton side effects (in more detail)

Sunday, July 22, 2012

Milkhouse CHG Teat Tip

Generic Name: chlorhexidine gluconate and didecyldimethylammonium chloride liquid

Dosage Form: FOR ANIMAL USE ONLY
CHG Teat Dip

TEAT DIPPING is an important part of a MASTITIS CONTROL PLAN:

1. Dip teats immediately after milking.

2. Use good milking and environmental

    management procedures.

3. Use properly functioning milking equipment.

4. Treat every quarter of every cow at dry off.

5. Identify and treat or manage clinical cases

    promptly.

6. Cull chronically infected cows.

TEAT DIPPING IN COLD WEATHER:

When the temperature falls below 10 degrees F, or when wind chill is significant,

special precautions should be taken to avoid chapped and frozen teats.

1. Teats should be dry before turning cows out into cold weather.

2. When teats are dipped after milking, allow 30 seconds contact, and blot

    off any excess teat dip with a single service towel.

3. Warm the teat dip to reduce drying time.

4. Provide windbreaks in outside areas for cows.

5. Monitor fresh cows with swollen udders and teats since they are more

    susceptible to chapped and frozen teats.

DIRECTIONS FOR USE:

- DO NOT DILUTE.

- Dip teats immediately after milking as a routine part of milking

procedures.

- Dip to THOROUGHLY COVER at least the lower one-third of the teat

(preferably to the base of the udder), IMMEDIATELY after every milking.

TAKE TIME

OBSERVE

LABEL DIRECTIONS
- Empty and clean dip cups after each milking, or during milking, if they

become contaminated.

- Do not pour used dip back into original container.

- KEEP FROM FREEZING

- Keep container closed to prevent contamination.

- Store container in an upright position.

FIRST-AID

EYES: If contact with eyes occurs, flush with plenty of cool water for 15

minutes. Consult a physician.

INTERNAL: May be harmful if swallowed. If ingested, drink large amounts of

water or milk. DO NOT induce vomiting. Get medical attention immediately.

FOR ASSISTANCE WITH MEDICAL

EMERGENCY CONTACT:

CHEM-TEL, 1-800-255-3924

MILKHOUSE BRAND

CHG Teat Dip

A SANITIZING TEAT DIP

An Aid in Reducing the Spread of

Organisms Which May Cause Mastitis.

ACTIVE INGREDIENTS:

Chlorhexidine Digluconate......................................0.35%

Didecyl Dimethyl Ammonium Chloride.....................0.20%

Excellent skin conditioning properties.

KEEP OUT OF THE REACH OF CHILDREN

CAUTION

NET CONTENTS: 1 U.S. FL. GALLON (3.78 LITERS)

STEARNS PACKAGING CORPORATION

4200 Sycamore Avenue - Madison, Wisconsin 53714

MILKHOUSE BRAND CHG TEAT DIP
chlorhexidine gluconate, didecyldimethylammonium chloride liquid

Product Information
Product Type	OTC ANIMAL DRUG	NDC Product Code (Source)	60282-1080
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE)	CHLORHEXIDINE GLUCONATE	0.35 L in 100 L
DIDECYLDIMETHYLAMMONIUM CHLORIDE (DIDECYLDIMETHYLAMMONIUM)	DIDECYLDIMETHYLAMMONIUM CHLORIDE	0.2 L in 100 L

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	60282-1080-1	3.78 L In 1 BOTTLE, PLASTIC	None
2	60282-1080-2	18.93 L In 1 PAIL	None
3	60282-1080-3	56.78 L In 1 DRUM	None
4	60282-1080-4	208.2 L In 1 DRUM	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/02/1985

Labeler - Stearns Packaging Corporation (006069256)

Registrant - Stearns Packaging Corporation (006069256)

Establishment
Name	Address	ID/FEI	Operations
Stearns Packaging Corporation		006069256	manufacture

Revised: 09/2010Stearns Packaging Corporation

CitraNatal 90 DHA

Generic Name: prenatal multivitamins (PRE nay tal VYE ta mins)

Brand Names: Advance Care Plus, Bright Beginnings, Cavan Folate, Cavan One, Cavan-Heme OB, Cenogen Ultra, CitraNatal Rx, Co Natal FA, Complete Natal DHA, Complete-RF, CompleteNate, Concept OB, Docosavit, Dualvit OB, Duet, Edge OB, Elite OB 400, Femecal OB, Folbecal, Folcaps Care One, Folivan-OB, Foltabs, Gesticare, Icar Prenatal, Icare Prenatal Rx, Inatal Advance, Infanate DHA, Kolnatal DHA, Lactocal-F, Marnatal-F, Maternity, Maxinate, Mission Prenatal, Multi-Nate 30, Multinatal Plus, Nata 29 Prenatal, Natachew, Natafort, Natelle, Neevo, Nestabs, Nexa Select with DHA, Novanatal, NovaStart, O-Cal Prenatal, OB Complete, OB Natal One, Ob-20, Obtrex DHA, OptiNate, Paire OB Plus DHA, PNV Select, PNV-Total, PR Natal 400, Pre-H-Cal, Precare, PreferaOB, Premesis Rx, PrenaCare, PrenaFirst, PrenaPlus, Prenatabs OBN, Prenatabs Rx, Prenatal 1 Plus 1, Prenatal Elite, Prenatal Multivitamins, Prenatal Plus, Prenatal S, Prenatal-U, Prenate Advanced Formula, Prenate DHA, Prenate Elite, Prenavite FC, PreNexa, PreQue 10, Previte Rx, PrimaCare, Pruet DHA, RE OB Plus DHA, Renate, RightStep, Rovin-NV, Se-Care, Se-Natal One, Se-Plete DHA, Se-Tan DHA, Select-OB, Seton ET, Strongstart, Stuart Prenatal with Beta Carotene, Tandem OB, Taron-BC, Tri Rx, TriAdvance, TriCare, Trimesis Rx, Trinate, Triveen-PRx RNF, UltimateCare Advance, Ultra-Natal, Vemavite PRX 2, VeNatal FA, Verotin-BY, Verotin-GR, Vinacal OR, Vinatal Forte, Vinate Advanced (New Formula), Vinate AZ, Vinate Care, Vinate Good Start, Vinate II (New Formula), Vinate III, Vinate One, Vitafol-OB, VitaNatal OB plus DHA, Vitaphil, Vitaphil Aide, Vitaphil Plus DHA, Vitaspire, Viva DHA, Vol-Nate, Vol-Plus, Vol-Tab Rx, Vynatal F.A., Zatean-CH, Zatean-PN

What are CitraNatal 90 DHA (prenatal multivitamins)?

There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.

Prenatal vitamins are a combination of many different vitamins that are normally found in foods and other natural sources.

Prenatal vitamins are used to provide the additional vitamins needed during pregnancy. Minerals may also be contained in prenatal multivitamins.

Prenatal vitamins may also be used for purposes not listed in this medication guide.

What is the most important information I should know about prenatal vitamins?

There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.

Never take more than the recommended dose of a multivitamin. Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects and can also harm your unborn baby. Certain minerals contained in a prenatal multivitamin may also cause serious overdose symptoms or harm to the baby if you take too much.

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.

Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the multivitamin.

What should I discuss with my healthcare provider before taking prenatal vitamins?

Many vitamins can cause serious or life-threatening side effects if taken in large doses. Do not take more of this medication than directed on the label or prescribed by your doctor.

Before taking prenatal vitamins, tell your doctor about all of your medical conditions.

You may need to continue taking prenatal vitamins if you breast-feed your baby. Ask your doctor about taking this medication while breast-feeding.

How should I take prenatal vitamins?

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.

Never take more than the recommended dose of prenatal vitamins.

Take your prenatal vitamin with a full glass of water.

Swallow the regular tablet or capsule whole. Do not break, chew, crush, or open it.

The chewable tablet must be chewed or allowed to dissolve in your mouth before swallowing. You may also allow the chewable tablet to dissolve in drinking water, fruit juice, or infant formula (but not milk or other dairy products). Drink this mixture right away.

Use prenatal vitamins regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat. Keep prenatal vitamins in their original container. Storing vitamins in a glass container can ruin the medication.

What happens if I miss a dose?

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?

What should I avoid while taking prenatal vitamins?

Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Avoid the regular use of salt substitutes in your diet if your multivitamin contains potassium. If you are on a low-salt diet, ask your doctor before taking a vitamin or mineral supplement.

Prenatal vitamins 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.

When taken as directed, prenatal vitamins are not expected to cause serious side effects. Less serious side effects may include:

upset stomach;

headache; or

unusual or unpleasant taste in your mouth.

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 prenatal vitamins?

Vitamin and mineral supplements can interact with certain medications, or affect how medications work in your body. Before taking a prenatal vitamin, tell your doctor if you also use:

diuretics (water pills);

heart or blood pressure medications;

tretinoin (Vesanoid);

isotretinoin (Accutane, Amnesteen, Clavaris, Sotret);

trimethoprim and sulfamethoxazole (Cotrim, Bactrim, Gantanol, Gantrisin, Septra, TMP/SMX); or

an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Cataflam, Voltaren), indomethacin (Indocin), meloxicam (Mobic), and others.

This list is not complete and other drugs may interact with prenatal vitamins. 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 CitraNatal 90 DHA resources

CitraNatal 90 DHA Side Effects (in more detail)
CitraNatal 90 DHA Use in Pregnancy & Breastfeeding
CitraNatal 90 DHA Drug Interactions
CitraNatal 90 DHA Support Group
1 Review for CitraNatal 90 DHA - Add your own review/rating

CitraNatal 90 DHA MedFacts Consumer Leaflet (Wolters Kluwer)

Cal-Nate MedFacts Consumer Leaflet (Wolters Kluwer)

CareNatal DHA MedFacts Consumer Leaflet (Wolters Kluwer)

CitraNatal Assure Prescribing Information (FDA)

CitraNatal Harmony Prescribing Information (FDA)

Concept DHA Prescribing Information (FDA)

Docosavit Prescribing Information (FDA)

Duet DHA with Ferrazone MedFacts Consumer Leaflet (Wolters Kluwer)

Folbecal MedFacts Consumer Leaflet (Wolters Kluwer)

Folcal DHA Prescribing Information (FDA)

Folcaps Care One Prescribing Information (FDA)

Gesticare DHA Prescribing Information (FDA)

Gesticare DHA MedFacts Consumer Leaflet (Wolters Kluwer)

Inatal Advance Prescribing Information (FDA)

Inatal Ultra Prescribing Information (FDA)

Multi-Nate DHA Prescribing Information (FDA)

Multi-Nate DHA Extra Prescribing Information (FDA)

MultiNatal Plus MedFacts Consumer Leaflet (Wolters Kluwer)

Natelle One Prescribing Information (FDA)

Neevo Caplets MedFacts Consumer Leaflet (Wolters Kluwer)

Neevo DHA MedFacts Consumer Leaflet (Wolters Kluwer)

OB Complete 400 MedFacts Consumer Leaflet (Wolters Kluwer)

Paire OB Plus DHA Prescribing Information (FDA)

PreNexa MedFacts Consumer Leaflet (Wolters Kluwer)

PreNexa Prescribing Information (FDA)

PreferaOB Prescribing Information (FDA)

Prenatal Plus Prescribing Information (FDA)

Prenatal Plus Iron Prescribing Information (FDA)

Prenate Elite Prescribing Information (FDA)

Prenate Elite MedFacts Consumer Leaflet (Wolters Kluwer)

Prenate Elite tablets

Prenate Essential Prescribing Information (FDA)

PrimaCare Advantage MedFacts Consumer Leaflet (Wolters Kluwer)

PrimaCare ONE capsules

PrimaCare One MedFacts Consumer Leaflet (Wolters Kluwer)

Renate DHA Prescribing Information (FDA)

Se-Natal 19 Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Se-Natal 19 Prescribing Information (FDA)

Tandem DHA Prescribing Information (FDA)

Tandem OB Prescribing Information (FDA)

TriAdvance Prescribing Information (FDA)

Triveen-One MedFacts Consumer Leaflet (Wolters Kluwer)

Triveen-PRx RNF Prescribing Information (FDA)

UltimateCare ONE NF Prescribing Information (FDA)

Ultra NatalCare MedFacts Consumer Leaflet (Wolters Kluwer)

Vinate AZ Prescribing Information (FDA)

Vitafol-One MedFacts Consumer Leaflet (Wolters Kluwer)

Zatean-CH Prescribing Information (FDA)

Compare CitraNatal 90 DHA with other medications

Vitamin/Mineral Supplementation during Pregnancy/Lactation

Where can I get more information?

Your pharmacist can provide more information about prenatal vitamins.

See also: CitraNatal 90 DHA side effects (in more detail)

Gonal-f RFF Subcutaneous

Generic Name: follitropin alfa (Subcutaneous route)

fol-i-TROE-pin AL-fa

Commonly used brand name(s)

In the U.S.

Gonal-F

Gonal-F RFF

Available Dosage Forms:

Powder for Solution

Solution

Therapeutic Class: Female Reproductive Agent

Pharmacologic Class: Human Follicle Stimulating Hormone

Uses For Gonal-F RFF

Follitropin alfa is a hormone identical to follicle-stimulating hormone (FSH) produced by the pituitary gland. FSH helps to develop eggs in the ovaries.

Follitropin alfa is used as a fertility medicine to develop eggs in women who have not been able to become pregnant because of problems in ovulation. Also, many women wanting to become pregnant will use this medicine while enrolled in a fertility program (assisted reproductive technology [ART]) that uses procedures such as in vitro fertilization (IVF) or embryo transfer (ET). Follitropin alfa may be used with other medicines for these purposes.

Follitropin alfa is also used as a fertility medicine to help men with low sperm counts produce more sperms. Treatment with human chorionic gonadotropin should come before treatment with follitropin alfa. This pretreatment elevates the amount of testosterone to the correct level. Treatment with human chorionic gonadotropin should continue as long as follitropin alfa is being used.

Some patients may be treated with another hormone called gonadotropin-releasing hormone agonist (GnRHa) before starting treatment with follitropin alfa. GnRHa reduces the amount of FSH released from the pituitary gland. This is done so that the doctor can replace their FSH with follitropin alfa in the proper amounts each day to achieve fertility.

This medicine is available only with your doctor's prescription.

Before Using Gonal-F RFF

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of follitropin alfa

This section provides information on the proper use of a number of products that contain follitropin alfa. It may not be specific to Gonal-F RFF. Please read with care.

To make using follitropin alfa as safe and reliable as possible, you should understand how and when to use this medicine and what effects may be expected. A paper with information for the patient will be given to you with your filled prescription and will provide many details concerning the use of follitropin alfa. Read this paper carefully and ask your health care professional for any additional information or explanation.

Sometimes follitropin alfa can be given by injection at home. If you are using this medicine at home:

Understand and use the proper method of safely preparing the medicine if you are going to prepare your own medicine.

Wash yours hands with soap and water and use a clean work area to prepare your injection.

Make sure you clearly understand and carefully follow your doctor's instructions on how to give yourself an injection, including using the proper needle and syringe.

Do not inject more or less of the medicine than your doctor ordered.

Remember to move the site of injection to different areas to prevent skin problems from developing.

Throw away needles, syringes, bottles, and unused medicine after the injection in a safe manner.

Tell your doctor when you use the last dose of follitropin alfa. Follitropin alfa often requires that another hormone called human chorionic gonadotropin (hCG) be given as a single dose the day after the last dose of follitropin alfa is given. Your doctor will give you this medicine or arrange for you to get this medicine at the right time.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For injection dosage form:
- For treatment of female infertility:
  - Adults—75 international units (IU) injected under the skin once a day for approximately fourteen days. The dose may be increased at weekly intervals by 37.5 IU, up to a total dose of 300 IU once a day. Using follitropin alfa for longer than fourteen days may be needed, but only if directed by your doctor. Report when you receive your last dose of follitropin alfa because you may be given an injection of hCG twenty-four hours later. If abdominal pain occurs with the use of follitropin alfa, report it to your doctor immediately, discontinue treatment, do not receive the dose of hCG, and avoid sexual intercourse.
- For use with assisted reproductive technology (ART) procedures:
  - Adults—150 international units (IU) injected under the skin once a day for five days beginning on Day 2 or Day 3 of your menstrual cycle. After five days, your dose may be increased by 75 to 150 IU every three to five days, up to a total dose of 450 IU once a day, for up to five more days. Some patients may start treatment at a dose of 225 IU once a day. Using follitropin alfa for longer than ten days may be needed, but only if directed by your doctor. Report when you receive your last dose of follitropin alfa because you may be given an injection of hCG twenty-four hours later.
- For treatment of male infertility
  - Adults— 150 international units (IU) injected under the skin three times a week in conjunction with 1000 USP Units of human chorionic gonadotropin (hCG) three times a week. Your dose may be increased up to 300 IU three times a week, and the treatment may last up to eighteen months.

Missed Dose

Call your doctor or pharmacist for instructions.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Gonal-F RFF

It is very important that your doctor check your progress often at regular visits to make sure that the medicine is working properly and to check for unwanted effects. Your doctor will probably want to follow the developing eggs inside the ovaries by doing an ultrasound examination and measuring hormones in your blood stream. After you no longer receive follitropin alfa, your progress still must be checked for at least 2 weeks.

If your doctor has asked you to record your basal body temperatures (BBTs) daily, make sure that you do this every day. Using a BBT record or some other method, your doctor will help you decide when you are most fertile and when ovulation occurs. It is important that sexual intercourse take place around the time when you are most fertile to give you the best chance of becoming pregnant. Follow your doctor's directions carefully.

If abdominal pain occurs with use of follitropin alfa, discontinue treatment and report the problem to your doctor immediately. Do not receive the injection of human chorionic gonadotropin (hCG) and avoid sexual intercourse.

This medicine may cause some people to become dizzy. If this side effect occurs, do not drive, use machines, or do anything else that could be dangerous if you are not alert while you are using follitropin alfa and for 24 hours after you stop using it.

Gonal-F RFF Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Stop taking this medicine and get emergency help immediately if any of the following effects occur:

Abdominal pain (severe), nausea, vomiting, and weight gain (rapid)

Check with your doctor as soon as possible if any of the following side effects occur:

More commonFor patients treated for female infertility or patients pretreated with a gonadotropin-releasing hormone agonist (GnRHa) undergoing assisted reproduction technologies (ART)

Abdominal bloating

diarrhea

flu or cold-like symptoms, such as body aches or pain, coughing, fever, headache, loss of voice, runny nose, and unusual tiredness or weakness

nausea

passing of gas

vaginal bleeding between menstrual periods

For patients treated for female infertility

Acne

breast pain or tenderness

mood swings

Less commonFor patients treated for female infertility or patients pretreated with GnRHa undergoing ART

Dizziness

painful menstrual periods

redness, pain, or swelling at injection site

sleepiness

vaginal bleeding unrelated to menstrual periods (heavy)

white vaginal discharge

For patients treated for female infertility

Fainting

light-headedness

migraine headache

nervousness

stomach discomfort

For patients treated pretreated with a GnRHa undergoing ART

Fast, racing heartbeat

itching of skin

loss of appetite

thirst (unusual)

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

Abdominal pain (severe), nausea, vomiting, and weight gain (rapid)

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Gonal-F RFF Subcutaneous side effects (in more detail)

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More Gonal-F RFF Subcutaneous resources

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

Compare Gonal-F RFF Subcutaneous with other medications

Follicle Stimulation
Hypogonadism, Male
Ovulation Induction