Midodrine

Generic Name: Midodrine hydrochloride

Dosage Form: tablet
Midodrine Hydrochloride Tablets

Rx only

WARNING

Because Midodrine hydrochloride tablets can cause marked elevation of supine blood pressure, it should be used in patients whose lives are considerably impaired despite standard clinical care. The indication for use of Midodrine hydrochloride tablets in the treatment of symptomatic orthostatic hypotension is based primarily on a change in a surrogate marker of effectiveness, an increase in systolic blood pressure measured one minute after standing, a surrogate marker considered likely to correspond to a clinical benefit. At present, however, clinical benefits of Midodrine hydrochloride tablets, principally improved ability to carry out activities of daily living, have not been verified.

Midodrine Description

Midodrine hydrochloride is a vasopressor/antihypotensive agent. Midodrine hydrochloride is an odorless, white, crystalline powder, soluble in water and sparingly soluble in methanol having a pKa of 7.8 (0.3% aqueous solution), a pH of 3.5 to 5.5 (5% aqueous solution) and a melting range of 200°C to 203°C. It is chemically described as: (1) Acetamide, 2-amino-N-[2-(2,5-dimethoxyphenyl)-2-hydroxyethyl]-monohydrochloride, (±)-; or (2) (±)-2-amino-N-(ß-hydroxy-2,5-dimethoxyphenethyl)acetamide monohydrochloride. Midodrine Hydrochloride’s molecular formula is C12H18N2O4HCl, its molecular weight is 290.7 and its structural formula is:

Each tablet for oral administration contains 2.5 mg, 5 mg or 10 mg of Midodrine hydrochloride and the following inactive ingredients: pregelatinized starch, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate. In addition, the 5 mg tablets contain FD&C yellow No. 6 aluminum lake and FD&C red No. 40 aluminum lake and the 10 mg tablets contain FD&C blue No. 2 aluminum lake.

Midodrine - Clinical Pharmacology

Mechanism of Action

Midodrine hydrochloride forms an active metabolite, desglyMidodrine, that is an alpha1-agonist and exerts its actions via activation of the alpha-adrenergic receptors of the arteriolar and venous vasculature, producing an increase in vascular tone and elevation of blood pressure. DesglyMidodrine does not stimulate cardiac beta-adrenergic receptors. DesglyMidodrine diffuses poorly across the blood-brain barrier and is therefore not associated with effects on the central nervous system.

Administration of Midodrine hydrochloride results in a rise in standing, sitting and supine systolic and diastolic blood pressure in patients with orthostatic hypotension of various etiologies. Standing systolic blood pressure is elevated by approximately 15 mmHg to 30 mmHg at 1 hour after a 10 mg dose of Midodrine, with some effect persisting for 2 to 3 hours. Midodrine hydrochloride has no clinically significant effect on standing or supine pulse rates in patients with autonomic failure.

Pharmacokinetics

Midodrine hydrochloride is a prodrug, i.e., the therapeutic effect of orally administered Midodrine is due to the major metabolite desglyMidodrine, formed by deglycination of Midodrine. After oral administration, Midodrine hydrochloride is rapidly absorbed. The plasma levels of the prodrug peak after about half an hour and decline with a half-life of approximately 25 minutes, while the metabolite reaches peak blood concentrations about 1 to 2 hours after a dose of Midodrine and has a half-life of about 3 to 4 hours. The absolute bioavailability of Midodrine (measured as desglyMidodrine) is 93%. The bioavailability of desglyMidodrine is not affected by food. Approximately the same amount of desglyMidodrine is formed after intravenous and oral administration of Midodrine. Neither Midodrine nor desglyMidodrine is bound to plasma proteins to any significant extent.

Metabolism and Excretion

Thorough metabolic studies have not been conducted, but it appears that deglycination of Midodrine to desglyMidodrine takes place in many tissues and both compounds are metabolized in part by the liver. Neither Midodrine nor desglyMidodrine is a substrate for monoamine oxidase. Renal elimination of Midodrine is insignificant. The renal clearance of desglyMidodrine is of the order of 385 mL/minute, most, about 80%, by active renal secretion. The actual mechanism of active secretion has not been studied, but it is possible that it occurs by the base-secreting pathway responsible for the secretion of several other drugs that are bases (see also Potential for Drug Interactions).

Clinical Studies

Midodrine has been studied in 3 principal controlled trials, one of 3-weeks duration and 2 of 1 to 2 days duration. All studies were randomized, double-blind and parallel-design trials in patients with orthostatic hypotension of any etiology and supine-to-standing fall of systolic blood pressure of at least 15 mmHg accompanied by at least moderate dizziness/lightheadedness.

Patients with pre-existing sustained supine hypertension above 180/110 mmHg were routinely excluded. In a 3-week study in 170 patients, most previously untreated with Midodrine, the Midodrine-treated patients (10 mg t.i.d., with the last dose not later than 6 P.M.) had significantly higher (by about 20 mmHg) 1-minute standing systolic pressure 1 hour after dosing (blood pressures were not measured at other times) for all 3 weeks. After week 1, Midodrine-treated patients had small improvements in dizziness/ lightheadedness/unsteadiness scores and global evaluations, but these effects were made difficult to interpret by a high early drop-out rate (about 25% vs 5% on placebo). Supine and sitting blood pressure rose 16/8 mmHg and 20/10 mmHg, respectively, on average.

In a 2-day study, after open-label Midodrine, known Midodrine responders received Midodrine 10 mg or placebo at 0, 3 and 6 hours. One-minute standing systolic blood pressures were increased 1 hour after each dose by about 15 mmHg and 3 hours after each dose by about 12 mmHg; 3-minute standing pressures were increased also at 1, but not 3, hours after dosing. There were increases in standing time seen intermittently 1 hour after dosing, but not at 3 hours.

In a 1-day, dose-response trial, single doses of 0 mg, 2.5 mg, 10 mg and 20 mg of Midodrine were given to 25 patients. The 10 mg and 20 mg doses produced increases in standing 1-minute systolic pressure of about 30 mmHg at 1 hour; the increase was sustained in part for 2 hours after 10 mg and 4 hours after 20 mg. Supine systolic pressure was ≥200 mmHg in 22% of patients on 10 mg and 45% of patients on 20 mg; elevated pressures often lasted 6 hours or more.

Special Populations

A study with 16 patients undergoing hemodialysis demonstrated that Midodrine hydrochloride is removed by dialysis.

Indications and Usage for Midodrine

Midodrine hydrochloride tablets are indicated for the treatment of symptomatic orthostatic hypotension (OH). Because Midodrine hydrochloride tablets can cause marked elevation of supine blood pressure (BP>200 mmHg systolic), it should be used in patients whose lives are considerably impaired despite standard clinical care, including non-pharmacologic treatment (such as support stockings), fluid expansion and lifestyle alterations. The indication is based on Midodrine hydrochloride tablet's effect on increases in 1-minute standing systolic blood pressure, a surrogate marker considered likely to correspond to a clinical benefit. At present, however, clinical benefits of Midodrine hydrochloride tablets, principally improved ability to perform life activities, have not been established. Further clinical trials are underway to verify and describe the clinical benefits of Midodrine hydrochloride tablets.

After initiation of treatment, Midodrine hydrochloride tablets should be continued only for patients who report significant symptomatic improvement.

Contraindications

Midodrine hydrochloride is contraindicated in patients with severe organic heart disease, acute renal disease, urinary retention, pheochromocytoma or thyrotoxicosis. Midodrine hydrochloride should not be used in patients with persistent and excessive supine hypertension.

Warnings

Supine Hypertension

The most potentially serious adverse reaction associated with Midodrine hydrochloride therapy is marked elevation of supine arterial blood pressure (supine hypertension). Systolic pressure of about 200 mmHg was seen overall in about 13.4% of patients given 10 mg of Midodrine hydrochloride. Systolic elevations of this degree were most likely to be observed in patients with relatively elevated pre-treatment systolic blood pressures (mean 170 mmHg). There is no experience in patients with initial supine systolic pressure above 180 mmHg, as those patients were excluded from the clinical trials. Use of Midodrine hydrochloride in such patients is not recommended. Sitting blood pressures were also elevated by Midodrine hydrochloride therapy. It is essential to monitor supine and sitting blood pressures in patients maintained on Midodrine hydrochloride.

Precautions

General

The potential for supine and sitting hypertension should be evaluated at the beginning of Midodrine hydrochloride therapy. Supine hypertension can often be controlled by preventing the patient from becoming fully supine, i.e., sleeping with the head of the bed elevated. The patient should be cautioned to report symptoms of supine hypertension immediately. Symptoms may include cardiac awareness, pounding in the ears, headache, blurred vision, etc.

The patient should be advised to discontinue the medication immediately if supine hypertension persists. Blood pressure should be monitored carefully when Midodrine hydrochloride is used concomitantly with other agents that cause vasoconstriction, such as phenylephrine, ephedrine, dihydroergotamine, phenylpropanolamine or pseudoephedrine.

A slight slowing of the heart rate may occur after administration of Midodrine hydrochloride, primarily due to vagal reflex. Caution should be exercised when Midodrine hydrochloride is used concomitantly with cardiac glycosides (such as digitalis), psychopharmacologic agents, beta blockers or other agents that directly or indirectly reduce heart rate. Patients who experience any signs or symptoms suggesting bradycardia (pulse slowing, increased dizziness, syncope, cardiac awareness) should be advised to discontinue Midodrine hydrochloride and should be re-evaluated.

Midodrine hydrochloride should be used cautiously in patients with urinary retention problems, as desglyMidodrine acts on the alpha-adrenergic receptors of the bladder neck.

Midodrine hydrochloride should be used with caution in orthostatic hypotensive patients who are also diabetic, as well as those with a history of visual problems who are also taking fludrocortisone acetate, which is known to cause an increase in intraocular pressure and glaucoma.

Midodrine hydrochloride use has not been studied in patients with renal impairment. Because desglyMidodrine is eliminated via the kidneys and higher blood levels would be expected in such patients, Midodrine hydrochloride should be used with caution in patients with renal impairment, with a starting dose of 2.5 mg (see DOSAGE AND ADMINISTRATION). Renal function should be assessed prior to initial use of Midodrine hydrochloride.

Midodrine hydrochloride use has not been studied in patients with hepatic impairment. Midodrine hydrochloride should be used with caution in patients with hepatic impairment, as the liver has a role in the metabolism of Midodrine.

Information for Patients

Patients should be told that certain agents in over-the-counter products, such as cold remedies and diet aids, can elevate blood pressure and therefore, should be used cautiously with Midodrine hydrochloride, as they may enhance or potentiate the pressor effects of Midodrine hydrochloride (see Drug Interactions). Patients should also be made aware of the possibility of supine hypertension. They should be told to avoid taking their dose if they are to be supine for any length of time, i.e., they should take their last daily dose of Midodrine hydrochloride 3 to 4 hours before bedtime to minimize nighttime supine hypertension.

Laboratory Tests

Since desglyMidodrine is eliminated by the kidneys and the liver has a role in its metabolism, evaluation of the patient should include assessment of renal and hepatic function prior to initiating therapy and subsequently, as appropriate.

Drug Interactions

When administered concomitantly with Midodrine hydrochloride, cardiac glycosides may enhance or precipitate bradycardia, A.V. block or arrhythmia.

The use of drugs that stimulate alpha-adrenergic receptors (e.g., phenylephrine, pseudoephedrine, ephedrine, phenylpropanolamine or dihydroergotamine) may enhance or potentiate the pressor effects of Midodrine hydrochloride. Therefore, caution should be used when Midodrine hydrochloride is administered concomitantly with agents that cause vasoconstriction.

Midodrine hydrochloride has been used in patients concomitantly treated with salt-retaining steroid therapy (i.e., fludrocortisone acetate), with or without salt supplementation. The potential for supine hypertension should be carefully monitored in these patients and may be minimized by either reducing the dose of fludrocortisone acetate or decreasing the salt intake prior to initiation of treatment with Midodrine hydrochloride. Alpha-adrenergic blocking agents, such as prazosin, terazosin and doxazosin, can antagonize the effects of Midodrine hydrochloride.

Potential for Drug Interactions

It appears possible, although there is no supporting experimental evidence, that the high renal clearance of desglyMidodrine (a base) is due to active tubular secretion by the base-secreting system also responsible for the secretion of such drugs as metformin, cimetidine, ranitidine, procainamide, triamterene, flecainide and quinidine. Thus there may be a potential for drug-drug interaction with these drugs.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies have been conducted in rats and mice at dosages of 3 to 4 times the maximum recommended daily human dose on a mg/m2 basis, with no indication of carcinogenic effects related to Midodrine hydrochloride. Studies investigating the mutagenic potential of Midodrine hydrochloride revealed no evidence of mutagenicity. Other than the dominant lethal assay in male mice, where no impairment of fertility was observed, there have been no studies on the effects of Midodrine hydrochloride on fertility.

Pregnancy

Pregnancy Category C:

Midodrine hydrochloride increased the rate of embryo resorption, reduced fetal body weight in rats and rabbits and decreased fetal survival in rabbits when given in doses 13 (rat) and 7 (rabbit) times the maximum human dose based on body surface area (mg/m2). There are no adequate and well-controlled studies in pregnant women. Midodrine hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. No teratogenic effects have been observed in studies in rats and rabbits.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Midodrine hydrochloride is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Adverse Reactions

The most frequent adverse reactions seen in controlled trials were supine and sitting hypertension; paresthesia and pruritus, mainly of the scalp; goosebumps; chills; urinary urge; urinary retention and urinary frequency.

The frequency of these events in a 3-week placebo-controlled trial is shown in the following table:

Adverse Events

* Includes hyperesthesia and scalp paresthesia † Includes dysuria (1), increased urinary frequency (2), impaired urination (1), urinary retention (5), urinary urgency (2) ‡ Includes scalp pruritus § Includes patients who experienced an increase in supine hypertension ¶ Includes abdominal pain and pain increase
	Placebo n=88		Midodrine n=82
Event	# of reports	% of patients	# of reports	% of patients
Total # of reports	22		77
Paresthesia*	4	4.5	15	18.3
Piloerection	0	0	11	13.4
Dysuria†	0	0	11	13.4
Pruritus‡	2	2.3	10	12.2
Supine hypertension§	0	0	6	7.3
Chills	0	0	4	4.9
Pain¶	0	0	4	4.9
Rash	1	1.1	2	2.4

Less frequent adverse reactions were headache; feeling of pressure/fullness in the head; vasodilation/flushing face; confusion/thinking abnormality; dry mouth; nervousness/anxiety and rash. Other adverse reactions that occurred rarely were visual field defect; dizziness; skin hyperesthesia; insomnia; somnolence; erythema multiforme; canker sore; dry skin; dysuria; impaired urination; asthenia; backache; pyrosis; nausea; gastrointestinal distress; flatulence and leg cramps.

The most potentially serious adverse reaction associated with Midodrine hydrochloride therapy is supine hypertension. The feelings of paresthesia, pruritus, piloerection and chills are pilomotor reactions associated with the action of Midodrine on the alpha-adrenergic receptors of the hair follicles. Feelings of urinary urgency, retention and frequency are associated with the action of Midodrine on the alpha-receptors of the bladder neck.

Overdosage

Symptoms of overdose could include hypertension, piloerection (goosebumps), a sensation of coldness and urinary retention. There are 2 reported cases of overdosage with Midodrine hydrochloride, both in young males. One patient ingested Midodrine hydrochloride drops, 250 mg, experienced systolic blood pressure greater than 200 mmHg, was treated with an IV injection of 20 mg of phentolamine and was discharged the same night without any complaints.

The other patient ingested 205 mg of Midodrine hydrochloride (41 5-mg tablets) and was found lethargic and unable to talk, unresponsive to voice but responsive to painful stimuli, hypertensive and bradycardic. Gastric lavage was performed and the patient recovered fully by the next day without sequelae. The single doses that would be associated with symptoms of overdosage or would be potentially life-threatening are unknown. The oral LD50 is approximately 30 mg/kg to 50 mg/kg in rats, 675 mg/kg in mice and 125 mg/kg to 160 mg/kg in dogs.

DesglyMidodrine is dialyzable.

Recommended general treatment, based on the pharmacology of the drug, includes induced emesis and administration of alpha-sympatholytic drugs (e.g., phentolamine).

Midodrine Dosage and Administration

The recommended dose of Midodrine hydrochloride tablets is 10 mg, 3 times daily. Dosing should take place during the daytime hours when the patient needs to be upright, pursuing the activities of daily living. A suggested dosing schedule of approximately 4-hour intervals is as follows: shortly before or upon arising in the morning, midday and late afternoon (not later than 6 P.M.). Doses may be given in 3-hour intervals, if required, to control symptoms, but not more frequently.

Single doses as high as 20 mg have been given to patients, but severe and persistent systolic supine hypertension occurs at a high rate (about 45%) at this dose. In order to reduce the potential for supine hypertension during sleep, Midodrine hydrochloride tablets should not be given after the evening meal or less than 4 hours before bedtime. Total daily doses greater than 30 mg have been tolerated by some patients, but their safety and usefulness have not been studied systematically or established. Because of the risk of supine hypertension, Midodrine hydrochloride tablets should be continued only in patients who appear to attain symptomatic improvement during initial treatment.

The supine and standing blood pressure should be monitored regularly and the administration of Midodrine hydrochloride tablets should be stopped if supine blood pressure increases excessively.

Because desglyMidodrine is excreted renally, dosing in patients with abnormal renal function should be cautious; although this has not been systematically studied, it is recommended that treatment of these patients be initiated using 2.5 mg doses.

Dosing in children has not been adequately studied.

Blood levels of Midodrine and desglyMidodrine were similar when comparing levels in patients 65 or older vs. younger than 65 and when comparing males vs. females, suggesting dose modifications for these groups are not necessary.

How is Midodrine Supplied

Midodrine Hydrochloride Tablets, for oral administration, are available as:

2.5 mg: White, round, flat-faced, bevelled edge, debossed “E“ over “40” on one side and bisected on the other side and supplied as:

NDC 0185-0040-01 bottles of 100

NDC 0185-0040-05 bottles of 500

5 mg: Reddish-orange, round, flat-faced, bevelled edge, debossed “E“ over “43” on one side and bisected on the other side and supplied as:

NDC 0185-0043-01 bottles of 100

NDC 0185-0043-05 bottles of 500

10 mg: Blue-grey, round, flat-faced, bevelled edge, debossed, “E“ over “149” on one side and bisected on the other side and supplied as:

NDC 0185-0149-01 bottles of 100

NDC 0185-0149-05 bottles of 500

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required.

To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Sandoz Inc.

Princeton, NJ 08540

OS8009

Rev. 11/11

MF0040REV11/11

MG #18357

Midodrine Hydrochloride Tablets, 2.5 mg - Label

NDC 0185-0040-01

Midodrine Hydrochloride Tablets

2.5 mg

Rx only

100 Tablets

Sandoz

Midodrine Hydrochloride Tablets, 5 mg - Label

NDC 0185-0043-01

Midodrine Hydrochloride Tablets

5 mg

Rx only

100 Tablets

Sandoz

Midodrine Hydrochloride Tablets, 10 mg - Label

NDC 0185-0149-01

Midodrine Hydrochloride Tablets

10 mg

Rx only

100 Tablets

Sandoz

Midodrine HCL  Midodrine hydrochloride  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0185-0040 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Midodrine HYDROCHLORIDE (Midodrine) Midodrine HYDROCHLORIDE 2.5 mg

Inactive Ingredients Ingredient Name Strength COLLOIDAL SILICON DIOXIDE   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE

Product Characteristics Color WHITE Score 2 pieces Shape ROUND Size 7mm Flavor Imprint Code E;40 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0185-0040-05 500 TABLET In 1 BOTTLE None 2 0185-0040-01 100 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076514	09/11/2003

Midodrine HCL  Midodrine hydrochloride  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0185-0043 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Midodrine HYDROCHLORIDE (Midodrine) Midodrine HYDROCHLORIDE 5 mg

Inactive Ingredients Ingredient Name Strength COLLOIDAL SILICON DIOXIDE   FD&C RED NO. 40   FD&C YELLOW NO. 6   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE

Product Characteristics Color ORANGE, RED Score 2 pieces Shape ROUND Size 7mm Flavor Imprint Code E;43 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0185-0043-05 500 TABLET In 1 BOTTLE None 2 0185-0043-01 100 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076514	09/11/2003

Midodrine HCL  Midodrine hydrochloride  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0185-0149 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Midodrine HYDROCHLORIDE (Midodrine) Midodrine HYDROCHLORIDE 10 mg

Inactive Ingredients Ingredient Name Strength COLLOIDAL SILICON DIOXIDE   FD&C BLUE NO. 2   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE

Product Characteristics Color GRAY, BLUE Score 2 pieces Shape ROUND Size 7mm Flavor Imprint Code E;149 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0185-0149-05 500 TABLET In 1 BOTTLE None 2 0185-0149-01 100 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076514	07/02/2002

Labeler - Eon Labs, Inc. (012656273)

Revised: 12/2011Eon Labs, Inc.

More Midodrine resources

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

• Midodrine MedFacts Consumer Leaflet (Wolters Kluwer)


• midodrine Concise Consumer Information (Cerner Multum)


• midodrine Advanced Consumer (Micromedex) - Includes Dosage Information


• Midodrine Hydrochloride Monograph (AHFS DI)

Compare Midodrine with other medications

• Dysautonomia
• Hypotension
• Postural Orthostatic Tachycardia Syndrome

Terbutaline Sulfate

Class: Selective beta-2-Adrenergic Agonists
VA Class: RE103
CAS Number: 23031-32-5

Special Alerts:

[Posted 02/17/2011] ISSUE: FDA notified healthcare professionals that injectable terbutaline should not be used in pregnant women for prevention or prolonged treatment (beyond 48-72 hours) of preterm labor in either the hospital or outpatient setting because of the potential for serious maternal heart problems and death. In addition, oral terbutaline should not be used for prevention or any treatment of preterm labor because it has not been shown to be effective and has similar safety concerns.

Death and serious adverse reactions, including increased heart rate, transient hyperglycemia, hypokalemia, cardiac arrhythmias, pulmonary edema, and myocardial ischemia have been reported after prolonged administration of oral or injectable terbutaline to pregnant women.

BACKGROUND: Terbutaline is approved to prevent and treat bronchospasm (narrowing of airways) associated with asthma, bronchitis, and emphysema. The drug is sometimes used off-label (an unapproved use) for acute obstetric uses, including treating preterm labor and treating uterine hyperstimulation. Terbutaline has also been used off-label over longer periods of time in an attempt to prevent recurrent preterm labor.

The decision to require the addition of a Boxed Warning and Contraindication is based on new safety information reviewed by the FDA, specifically postmarketing safety reports of terbutaline used for obstetrical indications (see Data Summary in Drug Safety Communication) as well as data from the medical literature. These label changes are consistent with statements from the American College of Obstetricians and Gynecologists (ACOG).

A Data Summary is provided in the Drug Safety Communication

RECOMMENDATION: Based on FDA review, FDA has concluded that the risk of serious adverse events outweighs any potential benefit to pregnant women receiving prolonged treatment with terbutaline injection (beyond 48-72 hours), or acute or prolonged treatment with oral terbutaline. FDA is requiring the addition of a new Boxed Warning and Contraindication to the terbutaline drug labels to warn healthcare professionals about these risks.

Healthcare professional and patients should follow the recommendations in the “Additional Information for Healthcare Professionals/Patients” sections of the Drug Safety Communication. For more information visit the FDA website at: and .

Introduction

Bronchodilator; relatively selective, short-acting β₂-adrenergic agonist.^{a b c}

Uses for Terbutaline Sulfate

Bronchospasm in Asthma

Symptomatic management or prevention of bronchospasm in patients with reversible, obstructive airway disease (e.g., asthma).^{a b}

Current asthma management guidelines suggest use of oral β₂-adrenergic agonist therapy principally in patients unable to use inhaled bronchodilators (e.g., young children).^d Oral administration associated with slower onset of action and increased incidence of adverse effects.^{167 183 d}

Sub-Q terbutaline generally used for relief of acute exacerbations of asthma in hospitalized patients.^j No proven advantage of sub-Q administration compared with oral inhalation (no longer commercially available in US). ^j

Bronchospasm in COPD

Symptomatic management of reversible bronchospasm associated with chronic bronchitis and emphysema.^{a b c}

Inhaled β₂-adrenergic agonists preferred over oral β₂-adrenergic agonist therapy for treatment of COPD;^{h i} long-acting inhaled bronchodilators more effective and convenient than short-acting agents.^h Oral β₂-adrenergic agonist use associated with slower onset of action and increased incidence of adverse effects compared with inhaled therapy.^{h i}

Role of oral β₂-adrenergic agonists in treatment of COPD limited.

Antenatal Use in Preterm Labor

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.

Acute IV† and sub-Q therapy in selected women to inhibit uterine contractions in preterm labor† (tocolysis) and prolong gestation when beneficial.^{108 109 110 111 115 116 117 118 119 120 121 122 123 124 125 126 188 e}

Manufacturers state that terbutaline should not be used for tocolysis.^{a b} However, available data suggest that acute sub-Q β-adrenergic agonist treatment may forestall labor for 48 hours,^{108 111 119 120 121 122 123 124 126} providing time for patients to be transferred to other (e.g., tertiary-care) facilities and/or receive other agents (e.g., corticosteroids) to increase fetal maturation (e.g., lung maturation).^{124 125 126 188 189 e} Any other potential benefits of such drugs in prolonging pregnancy are unclear.^{124 125 126 188 189}

American College of Obstetricians and Gynecologists (ACOG) states that because of limited comparative studies, there is no clear first-line tocolytic agent.¹⁸⁸

Maintenance therapy with sub-Q infusion or oral β-adrenergic agonists, including terbutaline, in women with arrested preterm labor not shown to decrease risk of preterm birth.^{124 125 f g} Current evidence considered inadequate to support use of sub-Q infusion or oral maintenance therapy.^{188 f g} FDA states that safety and efficacy of sub-Q infusion maintenance therapy not adequately demonstrated and that such therapy is potentially dangerous.¹⁶¹ (See Preterm Labor under Cautions.)

Tocolytic therapy in general may be contraindicated by certain maternal or fetal conditions (e.g., advanced cervical dilation, acute fetal distress other than intrauterine resuscitation, placental insufficiency, chorioamnionitis, eclampsia or severe preeclampsia, fetal demise [singleton], lethal congenital or chromosomal abnormalities, fetal maturity, maternal hemodynamic instability, placental abruption, intrauterine infection), and specifically, β-adrenergic agonist therapy may be contraindicated by other conditions (e.g., maternal cardiac rhythm disturbances or certain other cardiac diseases, poorly controlled diabetes mellitus, thyrotoxicosis, hypertension).^{124 188}

Terbutaline Sulfate Dosage and Administration

Administration

Administer orally or sub-Q.^{a b}

Has been administered IV† to inhibit uterine contractions in preterm labor† (tocolysis).^{109 117 124 e} Administration of sub-Q injection preparation by other routes (e.g., IV) or methods not recommended by manufacturer.^a (See Preterm Labor under Cautions.)

Oral Administration

Administer orally 3 times daily during waking hours, at approximately 6-hour intervals,.^b

Sub-Q Administration

For solution and drug compatibility information, see Compatibility under Stability.

Inject into lateral deltoid area.^a

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.

Available as terbutaline sulfate; dosage expressed in terms of sulfate salt.^{a b}

Pediatric Patients

Bronchospasm

Asthma

Oral

Children or adolescents 12–15 years of age: 2.5 mg 3 times daily. Do not exceed 7.5 mg in 24-hour period.^{b b}

Sub-Q

Hospitalized children ≤12 years of age† with acute asthma exacerbation: 0.01 mg/kg has been given every 20 minutes for a total of 3 doses, then every 2–6 hours as needed.^j

Children or adolescents ≥12 years of age: 0.25 mg recommended by manufacturer.^a Repeat dose (0.25 mg) if substantial clinical improvement does not occur ≤15–30 minutes.^a If no response, consider other measures. ^a Manufacturer recommends total dosage of ≤0.5 mg within a 4-hour period.^a

Hospitalized children or adolescents >12 years of age with asthma exacerbation: 0.25 mg every 20 minutes for a total of 3 doses suggested by some clinicians.^j

Adults

Bronchospasm

Asthma

Oral

5 mg 3 times daily, given approximately every 6 hours.^b If disturbing adverse effects occur, reduce dosage to 2.5 mg 3 times daily.^b Do not exceed 15 mg in 24-hour period.^b

Sub-Q

0.25 mg recommended by manufacturer.^a Repeat dose (0.25 mg) if substantial clinical improvement does not occur ≤15–30 minutes.^a If no response, consider other measures.^a Manufacturer recommends total dosage of ≤0.5 mg within 4-hour period.^a

Hospitalized adults with asthma exacerbation: 0.25 mg every 20 minutes for a total of 3 doses suggested by some clinicians.^j

COPD

Oral

5 mg 3 times daily, given approximately every 6 hours.^b If disturbing adverse effects occur, reduce dosage to 2.5 mg 3 times daily.^b

Sub-Q

0.25 mg recommended by manufacturer.^a Repeat dose (0.25 mg) if substantial clinical improvement does not occur ≤15–30 minutes.^a If no response, consider other measures.^a Manufacturer recommends total dosage of ≤0.5 mg within 4-hour period.^a

Preterm Labor†

Sub-Q

0.25 mg every 0.3–3 hours has been recommended.¹⁸⁸

Prolongs gestation for about 48 hours.^e

Temporarily discontinue if pulse rate is >120 bpm.¹⁸⁸

Prescribing Limits

Pediatric Patients

Bronchospasm

Asthma

Oral

Children 12–15 years of age: Maximum 7.5 mg daily.^b

Sub-Q

Children ≥12 years of age: Maximum: 0.5 mg within 4-hour period.^a

Adults

Bronchospasm

Asthma

Oral

Maximum 15 mg daily.^b

Sub-Q

Maximum 0.5 mg within 4-hour period.^a

COPD

Oral

Maximum 15 mg daily.^b

Sub-Q

Maximum 0.5 mg within 4-hour period.^a

Special Populations

Geriatric Patients

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

Cautions for Terbutaline Sulfate

Contraindications

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.

Known hypersensitivity to sympathomimetic agents or any ingredient in formulation.^{a b}

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.

Acute or Worsening Asthma

Failure to respond to a previously effective dosage of terbutaline may indicate seriously worsening asthma.^{a b d} Reevaluate asthma therapy, giving special consideration to possible need for anti-inflammatory treatment (e.g., corticosteroids).^{a b d} Use of β-adrenergic agents alone not adequate to control mild to severe persistent asthma symptoms.^{d j}

Cardiovascular Effects

Possible clinically important cardiovascular effects, including changes in BP, heart rate, and ECG (e.g., flattening of the T wave, prolongation of the QT_c interval, ST-segment depression).^{a b}

Cautious use recommended in patients with cardiovascular disorders, including ischemic heart disease, coronary insufficiency, cardiac arrhythmias, and hypertension.^{a b} May require drug discontinuance.^{a b}

Nervous System Effects

Possible CNS stimulation (e.g., nervousness, tremor).^{a b c d} Seizures reported rarely; did not recur following drug discontinuance.^{a b}

Cautious use recommended in patients with seizure disorders and those unusually responsive to sympathomimetic amines.^{a b}

Sensitivity Reactions

Immediate hypersensitivity reactions and exacerbations of bronchospasm reported.^{a b}

General Precautions

Preterm Labor

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.

Potentially serious adverse effects, including transient hyperglycemia, usually transient hypokalemia, increased heart rate, cardiac arrhythmias, pulmonary edema, and myocardial ischemia, have occurred during preterm labor†.^{124 a b e g} In addition, increased fetal heart rate and neonatal hypoglycemia reported.^{a b e}

Not recommended by manufacturer for management of preterm labor because of risk of such effects.^{a b} Maintenance sub-Q infusion therapy considered potentially dangerous, particularly on an outpatient basis.¹⁶¹

Endocrine and Metabolic Effects

Large IV† doses may aggravate preexisting diabetes and ketoacidosis.^{a b}

Use with caution in patients with diabetes mellitus or hyperthyroidism.^{a b}

Possible hypokalemia;^{a b} may increase risk of cardiovascular effects.^{a b} Hypokalemia usually transient, not requiring supplementation.^{a b}

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 B.^{a b} Restrict use for relief of bronchospasm during labor to women in whom benefits clearly outweigh risks.^{a b} (See Preterm Labor under Cautions.)

Lactation

Distributed into milk, but in amounts generally considered insufficient to affect nursing infants.^c Administer to nursing women only if potential benefits to woman outweigh possible risk to infant.^{a b}

Pediatric Use

Safety and efficacy not established in children <12 years of age.^{a b}

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.^a (See Geriatric Patients under Dosage and Administration.)

Common Adverse Effects

Oral: Nervousness,^b tremor,^b headache,^b somnolence,^b palpitations,^b dizziness,^b tachycardia,^b nausea.^b

Sub-Q: Nervousness,^a drowsiness,^a tremor,^a headache,^a palpitations.^a

Interactions for Terbutaline Sulfate

Specific Drugs

Drug	Interaction	Comments
Antidepressants, tricyclic	Potentiation of vascular effectsa b	Extreme caution recommended with concomitant therapy or in patients receiving terbutaline ≤2 weeks after discontinuance of tricyclic antidepressantsa b
β-Adrenergic blocking agents	Potential antagonism of pulmonary effects resulting in severe bronchospasm in asthmatic patientsa b	If concomitant therapy required, consider cautious use of cardioselective β-adrenergic blocking agentsa b
Diuretics, potassium depleting	Potential for decreased serum potassium concentrations and/or ECG changes, especially when recommended β-adrenergic agonist dosage exceededa b	Use concomitantly with cautiona b
MAO inhibitors	Potentiation of vascular effectsa b	Extreme caution recommended with concomitant therapy or in patients receiving terbutaline ≤2 weeks after discontinuance of MAO inhibitorsa b
Sympathomimetic agents	Potential for additive adverse cardiovascular effectsa b c	Concomitant use not recommendeda b Does not preclude use of an inhaled adrenergic agonist bronchodilator to relieve acute bronchospasm during long-term oral terbutaline therapyb

Terbutaline Sulfate Pharmacokinetics

Absorption

Bioavailability

Oral: About 30-50%.^b

Sub-Q: Well absorbed.^c

Onset

Sub-Q, patients with COPD: Measurable changes in expiratory flow rate occur ≤5 minutes.^a Clinically important bronchodilation occurs ≤15 minutes.^a Peak effects occur ≤30–60 minutes.^a

Oral, patients with COPD: Measurable changes in pulmonary flow rate usually occur ≤30 minutes.^b Substantial clinical improvement in pulmonary function occurs ≤1–2 hours.^b Peak effects occur ≤2–3 hours.^b

Duration

Sub-Q: 1.5–4 hours.^a Duration of clinical improvement similar to equivalent doses (mg for mg) of epinephrine.^a

Oral: ≤8 hours.^b

Distribution

Extent

Crosses placenta^{a b e g} and distributes into milk.^c (See Preterm Labor under Cautions.)

Elimination

Metabolism

Partially metabolized in liver, principally to inactive sulfate conjugate.^{a b}

Elimination Route

Following sub-Q administration, excreted principally as unchanged drug (60%) in urine.^{a b}

Half-life

Sub-Q administration: Mean 5.7 hours.^a

Oral single-dose administration in patients with asthma: Approximately 3.4 hours.^b

Stability

Storage

Oral

Tablets

15–30°C.^b Protect from light.^b

Parenteral

Solution for Injection

20–25°C.^a Protect from light by storing in original carton until use.^a

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution Compatibility^HID

Compatible
Dextrose 5% in water
Sodium chloride 0.45 or 0.9%

Drug Compatibility

Admixture CompatibilityHID

Compatible
Aminophylline
Incompatible
Bleomycin sulfate

ActionsActions

• 
  

  Stimulates β-adrenergic receptors of sympathetic nervous system with little or no effect on α-adrenergic receptors.^{a b c}

  
  


• 
  

  Less selective than relatively selective β₂-agonists (e.g., albuterol).^c

  
  


• 
  

  No apparent preferential β₂-adrenergic effect following sub-Q administration in controlled clinical studies.^a

  
  


• 
  

  Stimulates the production of cyclic adenosine-3′,5′-monophosphate (cAMP), which mediates numerous cellular responses, including bronchial smooth muscle relaxation and inhibition of release of mediators from mast cells in airways.^{a b}

  
  


• 
  

  Decreases resistance of airways.^{a b}

  
  


• 
  

  Relaxes uterine smooth muscle and inhibits uterine contractions.^{108 109 110 111 115 116 117 118 119 120 121 122 123 124 125 126 188 a c g} (See Antenatal Use in Preterm Labor under Uses and see Preterm Labor under Cautions.)

  
  

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.

• 
  

  Importance of understanding proper storage and administration techniques.^{a b}

  
  


• 
  

  Importance of adherence to dosing schedules, including not exceeding the recommended dose or frequency of use unless otherwise instructed by clinician.^{a b}

  
  


• 
  

  If decreased effectiveness occurs and/or symptoms become worse, contact clinician immediately; do not increase dose or frequency of administration.^b

  
  


• 
  

  Importance of using inhaled or other anti-asthma agents only as directed by clinician.^b

  
  


• 
  

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

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription (e.g., inhaled drugs, other anti-asthma agents) and OTC drugs.^{a b}

  
  


• 
  

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

  
  

Preparations

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

Terbutaline Sulfate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets	2.5 mg	Terbutaline Sulfate Tablets	Global, Lannett
		5 mg	Terbutaline Sulfate Tablets	Global, Lannett
Parenteral	Injection, for subcutaneous use only	1 mg/mL	Terbutaline Sulfate Injection	Abraxis, Bedford, Sicor

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.

Brethine 2.5MG Tablets (AAIPHARMA): 90/$45.99 or 270/$119.97

Terbutaline Sulfate 1MG/ML Solution (APP PHARMACEUTICAL): 1/$13.99 or 3/$19.97

Terbutaline Sulfate 2.5MG Tablets (GLOBAL PHARMACEUTICAL CORP): 90/$44.99 or 270/$125.98

Terbutaline Sulfate 5MG Tablets (GLOBAL PHARMACEUTICAL CORP): 90/$47.99 or 270/$125.98

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 17, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

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101. Joseph X, Whitehurst VE, Bloom S et al. Enhancement of cardiotoxic effects of beta-adrenergic bronchodilators by aminophylline in experimental animals. Fundam Appl Toxicol. 1981; 1:443-7. [PubMed 6136445]

102. Anon. Interactions between methyl xanthines and beta adrenergic agonists. FDA Drug Bull. 1981; 11:19-20. [PubMed 6119269]

103. Kelly HW. Controversies in asthma therapy with theophylline and the β₂-adrenergic agonists. Clin Pharm. 1984; 3:386-95. [IDIS 187701] [PubMed 6147224]

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107. Geigy. Brethine (terbutaline sulfate) injection prescribing information. Summit, NJ; 1995 Dec.

108. Beall MH, Edgar BW, Paul RH et al. A comparison of ritodrine, terbutaline, and magnesium sulfate for the suppression of preterm labor. Am J Obstet Gynecol. 1985; 153:854-9. [IDIS 211026] [PubMed 4073155]

109. Kosasa TS, Busse R, Wahl N et al. Long-term tocolysis with combined intravenous terbutaline and magnesium sulfate: a 10-year study of 1000 patients. Obstet Gynecol. 1994; 84:369-73. [IDIS 334072] [PubMed 8058233]

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113. Schreyer P, Caspi E, Snir E et al. Metabolic effects of intramuscular and oral administration of ritodrine in pregnancy. Obstet Gynecol. 1981; 57:730-3. [IDIS 133043] [PubMed 7231825]

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123. Perry KG Jr, Morrison JC, Rust OA et al. Incidence of adverse cardiopulmonary effects with low-dose continuous terbutaline infusion. Am J Obstet Gynecol. 1995; 173:1273-7. [IDIS 355651] [PubMed 7485336]

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125. Macones GA, Berlin M, Berlin JA. Efficacy of oral beta-agonist maintenance therapy in preterm labor: a meta-analysis. Obstet Gynecol. 1995; 85:313-7. [IDIS 341822] [PubMed 7824252]

126. King JF, Grant A, Keirse MJ et al. Beta-mimetics in preterm labour: an overview of the randomized controlled trials. Br J Obstet Gynaecol. 1988; 95:211-22. [IDIS 305430] [PubMed 2897207]

127. Canadian Preterm Labor Investigators Group. Treatment of preterm labor the beta-adrenergic agonist ritodrine. N Engl J Med. 1992; 327:308-12. [IDIS 299344] [PubMed 1620169]

128. Wilkins IA, Lynch L, Mehalek KE et al. Efficacy and side effects of magnesium sulfate and ritodrine as tocolytic agents. Am J Obstet Gynecol. 1988; 159:685-9. [IDIS 246807] [PubMed 3048103]

129. Astra USA, Inc. Yutopar (ritodrine hydrochloride) injection prescribing information dated April 1995. In: Physicians’ desk reference. 51st ed. Montvale, NJ; Medical Economics Company Inc; 1997:566-7.

130. CibaGeneva. Brethine (terbutaline sulfate) tablets prescribing information. In: Physicians’ desk reference. 50th ed. Montvale, NJ: Medical Economics Company Inc; 1997:831.2.

131. Meyer JM, Wenzel CL, Kradjan WA. Salmeterol: a novel, long-acting beta 2-agonist. Ann Pharmacother. 1993; 27:1478-87. [IDIS 323106] [PubMed 7905757]

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134. Lipworth BJ. Risks versus benefits of inhaled β₂-agonists in the management of asthma. Drug Safety. 1992; 7:54-70. [PubMed 1346963]

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136. Anon. Warnings from the CSM. Int Pharm J. 1991; 5:247-8.

137. Spitzer WO, Sussa S, Ernst P et al. The use of β-agonists and the risk of death and near death from asthma. N Engl J Med. 1992; 326:501-6. [IDIS 291894] [PubMed 1346340]

138. Palmer JBD, Jenkins MM. β₂-agonists in asthma. Lancet. 1991; 337:43. [IDIS 275815] [PubMed 1670660]

139. Dahl R. β₂-agonists in asthma. Lancet. 1991; 337:43. [IDIS 275815] [PubMed 1670660]

140. Löfdahl CG, Svedmyr N. Beta agonists—friends or foes? Eur Respir J. 1991; 4:1161-5. Editorial.

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142. Wanner A. Is the routine use of inhaled β-adrenergic agonists appropriate in asthma treatment? Yes. Am J Respir Crit Care Med. 1995; 151:597-9. [IDIS 344522] [PubMed 7881643]

143. Sears MR. Is the routine use of inhaled β-adrenergic agonists appropriate in asthma treatment? No. Am J Respir Crit Care Med. 1995; 151:600-1. [IDIS 344523] [PubMed 7881644]

144. Lai CKW, Twentyman OP, Holgate ST. The effect of an increase in inhaled allergen dose after rimiterol hydrobromide on the occurrence and magnitude of the late asthmatic response and the asssociated change in nonspecific bronchial responsiveness. Am Rev Respir Dis. 1989; 140:917-23. [IDIS 310468] [PubMed 2572192]

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147. Cockcroft DW, McParland CP, Britto SA et al. Regular inhaled salbutamol and airway responsiveness to allergen. Lancet. 1993; 342:833-7. [IDIS 320479] [PubMed 8104272]

148. Mullen ML, Mullen B, Carey M. The association between β-agonist use and death from asthma: a meta-analytic integration of case-control studies. JAMA. 1993; 270:1842-5. [IDIS 320909] [PubMed 8105113]

149. Reviewers’ comments (personal observations) on Salmeterol Xinafoate 12:12.

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151. Devoy MAB, Fuller RW, Palmer JBD. Are there any detrimental effects of the use of inhaled long-acting β₂-agonists in the treatment of asthma? Chest. 1995; 107:1116-24.

152. McFadden ER Jr. Perspectives in β₂-agonist therapy: vox clamantis in deserto vel lux in tenebris? J Allergy Clin Immunol. 1995; 95:641-51.

153. Crane J, Burgess C, Pearce N et al. Asthma deaths in New Zealand. BMJ. 1992; 304:1307. [IDIS 296806] [PubMed 1606438]

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155. Löfdahl CG, Svedmyr N. Beta agonists—friends or foes? Eur Respir J. 1991; 4:1161-5. Editorial.

156. Sisson MC. Preventing preterm labor. Is trebutaline our best option? AWHONN Lifelines. 1997; 1:42-6.

157. Allbert JR, Johnson C, Roberts WE et al. Tocolysis for recurrent preterm labor using a continuous subcutaneous infusion pump. J Reprod Med. 1994; 39:614-8. [IDIS 334689] [PubMed 7996525]

158. Moise KJ, Sala DJ, Zurawin RK et al. Continuous subcutaneous terbutaline pump therapy for premature labor: safety and efficacy. South Med J. 1992; 85:255-60. [IDIS 293256] [PubMed 1546349]

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178. D’Alonzo GE, Nathan RA, Henochow

terbinafine

Generic Name: terbinafine (ter BIN na feen)

Brand Names: LamISIL

What is terbinafine?

Terbinafine is an antifungal antibiotic.

Terbinafine is used to treat infections caused by fungus that affect the fingernails or toenails. Terbinafine oral granules are used to treat a fungal infection of scalp hair follicles in children who are at least 4 years old.

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

What is the most important information I should know about terbinafine?

Before using terbinafine, tell your doctor if you have liver or kidney disease, or an autoimmune disorder such as lupus or psoriasis.

Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Terbinafine will not treat a viral infection such as the common cold or flu. Some people taking terbinafine have developed severe liver damage leading to liver transplant or death. It is not clear whether terbinafine actually caused the liver damage in these patients. In most cases, the patient had a serious medical condition before taking terbinafine.

Call your doctor at once if you have symptoms of liver damage, such as nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). These events can occur whether or not you have ever had liver problems before.

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

It may take several months for your nails to return to their normal appearance after your treatment with terbinafine.

What should I discuss with my healthcare provider before taking terbinafine?

You should not use this medication if you are allergic to terbinafine.

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

• liver disease;


• kidney disease;


• 
  

  a history of depression; or

  
  


• 
  

  an autoimmune disorder such as lupus or psoriasis.

  
  

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Terbinafine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take terbinafine?

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.

Take the terbinafine tablet with a full glass (8 ounces) of water.

Terbinafine granules should be sprinkled into a spoonful of pudding or mashed potatoes (do not mix with applesauce, fruit juice, or other acidic foods). Swallow this mixture right away without chewing. Do not save the mixture for later use.

The terbinafine granule mixture should be taken with a meal.

Terbinafine is usually taken for 6 to 12 weeks.

Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Terbinafine will not treat a viral infection such as the common cold or flu.

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

It may take several months for your nails to return to their normal appearance after your treatment with terbinafine.

Store at room temperature away from moisture, heat, and light.

Keep the terbinafine oral granules in their sealed packet until you are ready to use.

See also: Terbinafine dosage (in more detail)

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.

Overdose symptoms may include dizziness, stomach pain, nausea, vomiting, skin rash, or urinating more than usual.

What should I avoid while taking terbinafine?

Avoid coffee, tea, cola, energy drinks or other sources of caffeine while taking this medication. Avoid exposure to sunlight or tanning beds. Lamivudine can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Terbinafine 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.

Some people taking terbinafine have developed severe liver damage leading to liver transplant or death. It is not clear whether terbinafine actually caused the liver damage in these patients. In most cases, the patient had a serious medical condition before taking terbinafine.

Call your doctor at once if you have symptoms of liver damage, such as nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). These events can occur whether or not you have ever had liver problems before.

Stop taking terbinafine and call your doctor at once if you have a serious side effect such as:

• 
  

  fever, chills, body aches, flu symptoms, sores in your mouth and throat;

  
  


• 
  

  joint pain or swelling, swollen glands, patchy skin color, or a butterfly-shaped skin rash over your cheeks and nose;

  
  


• 
  

  changes in mood or behavior;

  
  


• 
  

  weight loss due to taste changes;

  
  


• 
  

  raised, silvery flaking of the skin; or

  
  


• 
  

  severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

  
  

Less serious side effects may include:

• 
  

  upset stomach, gas, diarrhea, mild nausea or stomach pain;

  
  


• 
  

  headache;

  
  


• 
  

  mild skin rash or itching; 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.

Terbinafine Dosing Information

Usual Adult Dose for Onychomycosis -- Fingernail:

Tablets: 250 mg orally once a day for 6 weeks

The optimal clinical effect is observed some months after mycological cure and completion of treatment. This is related to the time required for outgrowth of healthy nail.

Usual Adult Dose for Onychomycosis -- Toenail:

Tablets: 250 mg orally once a day for 12 weeks

The optimal clinical effect is observed some months after mycological cure and completion of treatment. This is related to the time required for outgrowth of healthy nail.

Usual Adult Dose for Tinea Capitis:

Oral granules: 250 mg orally once a day for 6 weeks

Some evidence suggests that a longer duration of therapy (e.g., 6 to 8 weeks) or higher dosage may be necessary when tinea capitis is caused by Microsporum canis.

Usual Adult Dose for Cutaneous Candidiasis:

Tablets: 250 mg orally once a day for 2 to 4 weeks

Usual Adult Dose for Tinea Corporis:

Tablets: 250 mg orally once a day for 2 to 4 weeks

Usual Adult Dose for Tinea Cruris:

Tablets: 250 mg orally once a day for 2 to 4 weeks

Usual Adult Dose for Tinea Pedis:

Tablets: 250 mg orally once a day for 2 to 6 weeks

Usual Pediatric Dose for Tinea Capitis:

Oral granules:
4 years or older:
Less than 25 kg: 125 mg orally once a day
25 to 35 kg: 187.5 mg orally once a day
Greater than 35 kg: 250 mg orally once a day

Duration: 6 weeks

Some evidence suggests that a longer duration of therapy (e.g., 6 to 8 weeks) or higher dosage may be necessary when tinea capitis is caused by Microsporum canis.

What other drugs will affect terbinafine?

Before taking terbinafine, tell your doctor if you are taking any of the following medicines:

• 
  

  cimetidine (Tagamet, Tagamet HB);

  
  


• 
  

  cyclosporine (Gengraf, Neoral, Sandimmune);

  
  


• 
  

  rifampin (Rifater, Rifadin, Rimactane, Rifamate);

  
  


• 
  

  another antifungal medicine, such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), miconazole (Oravig), or voriconazole (Vfend);

  
  


• 
  

  a blood thinner such as warfarin (Coumadin, Jantoven);

  
  


• 
  

  a heart rhythm medication such as amiodarone (Cordarone, Pacerone), propafenone (Rythmol) or flecainide (Tambocor);

  
  


• 
  

  an "SSRI" antidepressant such as fluoxetine (Prozac), fluvoxamine (Luvox), or paroxetine (Paxil);

  
  


• 
  

  a tricyclic antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), desipramine (Norpramin), imipramine (Janimine, Tofranil), and others;

  
  


• 
  

  an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate); or

  
  


• 
  

  a beta-blocker such as betaxolol (Kerlone), carvedilol (Coreg), labetalol (Normodyne), metoprolol (Dutoprol, Lopressor, Toprol), pindolol (Visken), propranolol (Inderal), or timolol (Blocadren).

  
  

This list is not complete and other drugs may interact with terbinafine. 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 terbinafine resources

• Terbinafine Dosage
• Terbinafine Use in Pregnancy & Breastfeeding
• Drug Images
• Terbinafine Drug Interactions
• Terbinafine Support Group
• 45 Reviews for Terbinafine - Add your own review/rating

• terbinafine Advanced Consumer (Micromedex) - Includes Dosage Information


• Terbinafine Prescribing Information (FDA)


• Terbinafine MedFacts Consumer Leaflet (Wolters Kluwer)


• Terbinafine Professional Patient Advice (Wolters Kluwer)


• Lamisil Prescribing Information (FDA)


• Lamisil Monograph (AHFS DI)


• Lamisil Consumer Overview

Compare terbinafine with other medications

• Cutaneous Candidiasis
• Onychomycosis, Fingernail
• Onychomycosis, Toenail
• Tinea Capitis
• Tinea Corporis
• Tinea Cruris
• Tinea Pedis

Where can I get more information?

• Your pharmacist can provide more information about terbinafine.

Gamma-aminobutyric acid reuptake inhibitors

A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Gamma-Aminobutyric acid (GABA) reuptake inhibitors are analogs of gamma-Aminobutyric acid that bind to gamma-aminobutyric acid transporters and inhibit GABA reuptake. This increases extracellular levels of GABA and enhances GABA mediated synaptic activity in the brain.

Gamma-Aminobutyric acid reuptake inhibitors are used as anticonvulsant agents to treat epilepsy.

See also

Medical conditions associated with gamma-aminobutyric acid reuptake inhibitors:

• Seizures

Drug List:

Gabitril

Tusso-ZR Liquid

Pronunciation: kar-bay-ta-PEN-tane/gwye-FEN-e-sin
Generic Name: Carbetapentane/Guaifenesin
Brand Name: Examples include Oratuss and Tusso-ZR

Tusso-ZR Liquid is used for:

Relieving unproductive cough and reducing mucus in the chest due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Tusso-ZR Liquid is a cough suppressant and expectorant combination. The cough suppressant works in the brain to help decrease the cough reflex. The expectorant works by thinning mucus (phlegm) in the lungs, making it less sticky and easier to cough up. This makes coughs more productive.

Do NOT use Tusso-ZR Liquid if:

• you are allergic to any ingredient in Tusso-ZR Liquid


• you are taking or have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) with the last 14 days

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

Before using Tusso-ZR Liquid:

Some medical conditions may interact with Tusso-ZR Liquid. 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 chronic cough due to smoking, asthma, chronic bronchitis, or emphysema, or if your cough produces large amounts of mucus


• if you have a history of heart problems, high blood pressure, prostate problems, an overactive thyroid, diabetes, or glaucoma

Some MEDICINES MAY INTERACT with Tusso-ZR Liquid. Tell your health care provider if you are taking any other medicines, especially any of the following:

• MAOIs (eg, phenelzine) because they may increase the risk of Tusso-ZR Liquid's side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tusso-ZR Liquid 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 Tusso-ZR Liquid:

Use Tusso-ZR Liquid as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Tusso-ZR Liquid by mouth with or without food.


• Drinking extra fluids while you are taking Tusso-ZR Liquid is recommended. Check with your doctor for instructions.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• If you miss a dose of Tusso-ZR Liquid and you are taking it regularly, 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 Tusso-ZR Liquid.

Important safety information:

• Tusso-ZR Liquid may cause drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Tusso-ZR Liquid with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Tusso-ZR Liquid; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Do not use Tusso-ZR Liquid for a cough with a lot of mucous. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.


• If cough persists for more than 1 week or is accompanied by a fever, contact your health care provider. A persistent cough could be a sign of a serious condition.


• Tusso-ZR Liquid may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Tusso-ZR Liquid.


• Caution is advised when using Tusso-ZR Liquid in CHILDREN; they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tusso-ZR Liquid while you are pregnant. It is not known if Tusso-ZR Liquid is found in breast milk. If you are or will be breast-feeding while you use Tusso-ZR Liquid, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Tusso-ZR Liquid:

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:

Drowsiness; dry mouth, nose, or throat; upset stomach.

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).

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: Tusso-ZR 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 restlessness; seizures; severe agitation.

Proper storage of Tusso-ZR Liquid:

Store Tusso-ZR Liquid at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tusso-ZR Liquid out of the reach of children and away from pets.

General information:

• If you have any questions about Tusso-ZR Liquid, please talk with your doctor, pharmacist, or other health care provider.


• Tusso-ZR Liquid 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 Tusso-ZR Liquid. 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

Copyright © 2012 Wolters Kluwer Health, Inc.

More Tusso-ZR resources

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

Compare Tusso-ZR with other medications

• Cough