BROMFED DM Syrup (2021)

Βιβλιογραφική αναφορά

Συγγραφείς

Morton Grove Pharmaceuticals, Inc.

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1. Description

Bromfed DM Cough Syrup is a clear, light pink syrup with a butterscotch flavor. Each 5 mL (1 teaspoonful) contains: Brompheniramine Maleate, USP 2 mg Pseudoephedrine Hydrochloride, USP 30 mg Dextromethorphan ...

2. Clinical Pharmacology

Brompheniramine maleate is a histamine antagonist, specifically an H1-receptor-blocking agent belonging to the alkylamine class of antihistamines. Antihistamines appear to compete with histamine ...

3. Indications and Usage

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

4. Contraindications

Hypersensitivity to any of the ingredients. Do not use in the newborn, in premature infants, in nursing mothers, or in patients with severe hypertension or severe coronary artery disease. Do not use dextromethorphan ...

5. Warnings

Especially in infants and small children, antihistamines in overdosage may cause hallucinations, convulsions, and death. Antihistamines may diminish mental alertness. In the young child, they may produce ...

6.1. General

Because of its antihistamine component, Bromfed DM Cough Syrup should be used with caution in patients with a history of bronchial asthma, narrow angle glaucoma, gastrointestinal obstruction, or urinary ...

6.2. Information for Patients

Patients should be warned about engaging in activities requiring mental alertness, such as driving a car or operating dangerous machinery.

6.4. Drug Interactions

Monoamine oxidase (MAO) inhibitors Hyperpyrexia, hypotension, and death have been reported coincident with the coadministration of MAO inhibitors and products containing dextromethorphan. In addition, ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

Animal studies of Bromfed DM Cough Syrup to assess the carcinogenic and mutagenic potential or the effect on fertility have not been performed.

6.7. Pregnancy

Teratogenic Effects Pregnancy Category C Animal reproduction studies have not been conducted with Bromfed DM Cough Syrup. It is also not known whether Bromfed DM Cough Syrup can cause fetal harm ...

6.9. Nursing Mothers

Because of the higher risk of intolerance of antihistamines in small infants generally, and in newborns and prematures in particular, Bromfed DM Cough Syrup is contraindicated in nursing mothers.

6.10. Pediatric Use

Safety and effectiveness in pediatric patients below the age of 6 months have not been established (see DOSAGE AND ADMINISTRATION).

6.11. Geriatric Use

Clinical studies of Bromfed DM Cough Syrup did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, antihistamines are ...

7. Adverse Reactions

The most frequent adverse reactions to Bromfed DM Cough Syrup are: sedation; dryness of mouth, nose and throat; thickening of bronchial secretions; dizziness. Other adverse reactions may include: Dermatologic: ...

9. Overdosage

Signs and Symptoms Central nervous system effects from overdosage of brompheniramine may vary from depression to stimulation, especially in children. Anticholinergic effects may be noted. Toxic doses of ...

10. Dosage and Administration

Adults and pediatric patients 12 years of age and over: 10 mL (2 teaspoonfuls) every 4 hours. Children 6 to under 12 years of age: 5 mL (1 teaspoonful) every 4 hours. Children 2 to under 6 years of age: ...

11. How Supplied

Bromfed DM Cough Syrup is a clear, light pink-colored, butterscotch-flavored syrup containing in each 5 mL (1 teaspoonful) brompheniramine maleate 2 mg, pseudoephedrine hydrochloride 30 mg and dextromethorphan ...

12. Storage and Handling

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP TIGHTLY CLOSED Dispense in a tight, light-resistant container as defined in the USP.