Balamine DM oral drops

Name: Balamine DM oral drops

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.

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.

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.

Dosage and Administration

AGE DOSE * FREQUENCY *
Balamine DM Oral Drops
For Oral Use Only
1-3 months 1/4 dropperful (1/4 mL) q.i.d.
3-6 months 1/2 dropperful (1/2 mL) q.i.d.
6-9 months 3/4 dropperful (3/4 mL) q.i.d.
9-18 months 1 dropperful (1 mL) q.i.d.
Balamine DM Syrup
18 months-6 years 1/2 teaspoonful
(2.5 mL)
q.i.d.
adults and children
6 years and over
1 teaspoonful
(5 mL)
q.i.d.
* In mild cases or in particularly sensitive patients, less frequent or reduced doses may be adequate.

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

Manufactured by:

Elge, Inc.

Rosenberg, Tx. 77471

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