DESCRIPTION

Antihistamine/Decongestant/Antitussive for oral use

ACTIVE INGREDIENTS

INACTIVE INGREDIENTS

BALAMINE DM ORAL DROPS

Citric acid, D&C Red No. 33, FD&C Blue No. 1, glycerin, sodium benzoate, sodium citrate, sorbitol, purified water, flavoring and other ingredients.

BALAMINE DM SYRUP

Citric acid, D&C Red No. 33, FD&C Blue No. 1, glycerin, menthol, povidone, purified water, sodium benzoate, sodium citrate, sorbitol, and flavoring.

Carbinoxamine maleate (2-[p-Chloro-(alpha)-[2-(dimethylamino) ethoxyl] benzyl]pyridine maleate) is one of the ethanolamine class of H ₁ antihistamines. Pseudoephedrine hydrochloride (Benzenemethanol,(alpha)-[1-(methylamino) ethyl]-,[S-R*,R*)]-, hydrochloride) is the hydrochloride of pseudoephedrine, a naturally occurring dextrorotatory stereoisomer of ephedrine. Dextromethorphan Hydrobromide (Morphinan, 3-methoxy-17-methyl-, (9(alpha), 13(alpha), 14(alpha))-, hydrobromide, monohydrate) is the hydrobromide of d-form racemethorphan.

CLINICAL PHARMACOLOGY

Antihistaminic, decongestant and antitussive actions.

Carbinoxamine maleate possesses H ₁ antihistaminic activity and mild anticholinergic and sedative effects. Serum half-life for carbinoxamine is estimated to be 10 to 20 hours. Virtually no intact drug is excreted in the urine.

Pseudoephedrine hydrochloride is an oral sympathomimetic amine that acts as a decongestant to respiratory tract mucous membranes. While its vasoconstrictor action is similar to that of ephedrine, pseudoephedrine has less pressor effect in normotensive adults. Serum half-life for pseudoephedrine is 6 to 8 hours. Acidic urine is associated with faster elimination of the drug. About one-half of the administered dose is excreted in the urine.

Dextromethorphan hydrobromide is a nonnarcotic antitussive with effectiveness equal to codeine. It acts in the medulla oblongata to elevate the cough threshold. Dextromethorphan does not produce analgesia or induce tolerance, and has no potential for addiction. At usual doses, it will not depress respiration or inhibit ciliary activity. Dextromethorphan is rapidly metabolized with trace amounts of the parent compound in blood and urine. About one-half of the administered dose is excreted in the urine as conjugated metabolites.

INDICATIONS AND USAGE

For relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.

CONTRAINDICATIONS

Patients with hypersensitivity or idiosyncrasy to any of its ingredients. Sympathomimetic amines are contraindicated in patients with severe hypertension, severe coronary artery disease and patients on monoamine oxidase (MAO) inhibitor therapy. Antihistamines are contraindicated in patients with narrow-angle glaucoma, urinary retention, peptic ulcer and during an asthma attack. Dextromethorphan should not be used in patients receiving a monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping the MAOI drug.

WARNINGS

Sympathomimetic amines should be used judiciously and sparingly in patients with hypertension, diabetes, ischemic heart disease, hyperthyroidism, increased intraocular pressure or prostatic hypertrophy. See CONTRAINDICATIONS . Sympathomimetic amines may produce CNS stimulation with convulsions or cardiovascular collapse with accompanying hypotension. The elderly (60 years and older) are more likely to exhibit adverse reactions. Antihistamines may cause excitability, especially in children. At doses higher than the recommended dose, nervousness, dizziness, or sleeplessness may occur. Do not exceed recommended dosage. Administration of dextromethorphan may be accompanied by histamine release and should be used with caution in atopic children.

PRECAUTIONS

General

Before prescribing medication to suppress or modify cough, identify and provide therapy for the underlying cause of cough and take caution that modification of cough does not increase the risk of clinical or physiologic complications. Dextromethorphan should be used with caution in sedated or debilitated patients and in patients confined to supine positions.

Use with caution in patients with hypertension, heart disease, asthma, hyperthyroidism, increased intraocular pressure, diabetes mellitus and prostatic hypertrophy.

Information for Patients:    Avoid alcohol and other CNS depressants while taking these products. Patients sensitive to antihistamines may experience moderate to severe drowsiness. Patients sensitive to sympathomimetic amines may note mild CNS stimulation. While taking these products, exercise care in driving or operating appliances, machinery, etc.

Drug Interactions:    Antihistamines may enhance the effects of tricyclic antidepressants, barbiturates, alcohol, and other CNS depressants. MAO inhibitors prolong and intensify the anticholinergic effects of antihistamines.

Sympathomimetic amines may reduce the antihypertensive effects of reserpine, veratrum alkaloids, methyldopa and mecamylamine. Effects of sympathomimetics are increased with MAO inhibitors and beta-adrenergic blockers. The cough-suppressant action of dextromethorphan and narcotic antitussives are additive. Dextromethorphan is contraindicated with monoamine oxidase inhibitors (MAOI). See CONRAINDICATIONS section.

Pregnancy Category C:    Animal reproduction studies have not been conducted with Balamine DM. It is also not known whether these products can cause fetal harm when administered to a pregnant woman or affect reproduction capacity. Give to pregnant women only if clearly needed.

Nursing Mothers:    It is not known whether the drugs in Balamine DM are excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue the product, taking into account the importance of the drug to the mother.

ADVERSE REACTIONS

Antihistamines: Sedation, dizziness, diplopia, vomiting, diarrhea, dry mouth, headache, nervousness, nausea, anorexia, heartburn, weakness, polyuria and dysuria and, rarely, excitability in children. Urinary retention may occur in patients with prostatic hypertrophy.

Sympathomimetic Amines: Convulsions, CNS stimulation, cardiac arrhythmias, respiratory difficulty, increased heart rate or blood pressure, hallucinations, tremors, nervousness, insomnia, weakness, pallor and dysuria.

Dextromethorphan: Drowsiness, dizziness, and GI disturbance.

OVERDOSAGE

No information is available as to specific results of an overdose of these products. The signs, symptoms and treatment described below are those of H ₁ antihistamine, ephedrine and dextromethorphan overdose.

Symptoms:    Should antihistamine effects predominate, central action constitutes the greatest danger. In the small child, predominant symptoms are excitation, hallucination, ataxia, incoordination, tremors, flushed face and fever.

Convulsions, fixed and dilated pupils, coma and death may occur in severe cases. In the adult, fever and flushing are uncommon; excitement leading to convulsions and postictal depression is often preceded by drowsiness and coma. Respiration is usually not seriously depressed; blood pressure is usually stable.

Should sympathomimetic symptoms predominate, central effects include restlessness, dizziness, tremor, hyperactive reflexes, talkativeness, irritability and insomnia. Cardiovascular and renal effects include difficulty in micturition, headache, flushing, palpitation, cardiac arrhythmias, hypertension with subsequent hypotension and circulatory collapse. Gastrointestinal effects include dry mouth, metallic taste, anorexia, nausea, vomiting, diarrhea, and abdominal cramps.

Dextromethorphan may cause respiratory depression with a large overdose.

Treatment:    a) Evacuate stomach as condition warrants. Activated charcoal may be useful. b) Maintain a non-stimulating environment. c) Monitor cardiovascular status. d) Do not give stimulants. e) Reduce fever with cool sponging. f) Treat respiratory depression with naloxone if dextromethorphan toxicity is suspected. g) Use sedatives or anticonvulsants to control CNS excitation and convulsions. h) Physostigmine may reverse anticholinergic symptoms. i) Ammonium chloride may acidify the urine to increase urinary excretion of pseudoephedrine. j) Further care is

symptomatic and supportive.

DOSAGE AND ADMINISTRATION

HOW SUPPLIED

Balamine DM Oral Drops, grape flavored, in 30 mL bottles, with calibrated droppers, NDC 63162-509-30.

Balamine DM Syrup, grape flavored, in 16 fl. oz. (1-pint) bottles, NDC 63162-508-16.

Dispense in USP tight, light-resistant container. Avoid exposure to excessive heat.

Rx ONLY

Revised 12/01

BALLAY

Manufactured for: Ballay Pharmaceuticals, Inc.

Wimberley, Tx. 78676