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pseudoephedrine hydrochloride, dextromethorphan hydrobromide and brompheniramine maleate

Dosage Form: syrup
Bromdex D™ Syrup

Antitussive/Nasal Decongestant/Antihistamine

Sugar Free • Alcohol Free

Bromdex D Description

Bromdex D™ Syrup is a purple-colored, berry/vanilla-flavored syrup available for oral administration. Each teaspoonful (5 mL) contains:

Pseudoephedrine Hydrochloride, USP ................................. 50 mg

Dextromethorphan Hydrobromide, USP .............................. 30 mg

Brompheniramine Maleate, USP............................................. 3 mg

INACTIVE INGREDIENTS: Sodium Benzoate, Citric Acid, Saccharin Sodium, Sorbitol Solution, Glycerin, FD&C Red No. 40, FD&C Blue No. 1, Berry/Vanilla Flavor, Purified Water.

Pseudoephedrine Hydrochloride, USP is a nasal decongestant with the chemical name Benzenemethanol, α-[1-(methylamino)ethyl]-,[S-(R*,R*)-, hydrochloride. Its structure is as follows:

Dextromethorphan Hydrobromide, USP is an antitussive with the chemical name 3-Methoxy-17-methyl-9α, 13α, 14α –morphinan. Its structure is as follows:

Brompheniramine Maleate is an antihistamine with the chemical name: 2-Pyridinepropanamine, γ-(4-bromophenyl)-N,N-dimethyl-, (±)-, (Z)-2-butenedioate. Its structure is as follows:

Bromdex D - Clinical Pharmacology

Pseudoephedrine

Pseudoephedrine acts on sympathetic nerve endings and also on smooth muscle, making it useful as a nasal decongestant. The nasal decongestant effect is mediated by the action of pseudoephedrine on α-sympathetic receptors, producing vasoconstriction of the dilated nasal arterioles. Following oral administration, effects are noted within 30 minutes with peak activity occurring at approximately one hour.

Dextromethorphan

Dextromethorphan acts centrally to elevate the threshold for coughing. It has no analgesic or addictive properties. The onset of antitussive action occurs in 15 to 30 minutes after administration and is of long duration.

Brompheniramine Maleate

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 for receptor sites on effector cells. Brompheniramine also has anticholinergic (drying) and sedative effects. Among the antihistaminic effects, it antagonizes the allergic response (vasodilation, increased vascular permeability, increased mucus secretion) of nasal tissue. Brompheniramine is well absorbed from the gastrointestinal tract, with peak plasma concentration after single, oral dose of 4 mg reached in 5 hours; urinary excretion is the major route of elimination, mostly as products of biodegradation; the liver is assumed to be the main site of metabolic transformation.

Indications and Usage for Bromdex D

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

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 in patients receiving monoamine oxidase (MAOI) inhibitors (or for 14 days after stopping MAOI therapy) (see Drug Interactions). Antihistamines should not be used to treat lower respiratory tract conditions including asthma.

Warnings

Do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a doctor. If symptoms do not improve within 7 days or are accompanied by a fever, consult a doctor. Do not take this product if you have heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, a breathing problem such as emphysema, or chronic bronchitis, or difficulty in urination due to enlargement of the prostate gland, unless directed by your doctor. Especially in infants and small children, antihistamines in overdosage may cause hallucinations, convulsions, and death. Antihistamines may diminish mental alertness. May cause excitability especially in children. May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution when driving a motor vehicle or operating machinery.

Precautions

General

Because of its antihistamine component, Bromdex D™ Syrup should be used with caution in patients with a history of bronchial asthma, narrow angle glaucoma, gastrointestinal obstruction, or urinary bladder neck obstruction. Because of its sympathomimetic component, Bromdex D™ Syrup should be used with caution in patients with diabetes, hypertension, heart disease, or thyroid disease.

Information for Patients

Patients should be warned about engaging in activities requiring mental alertness, such as driving a car or operating dangerous machinery. Pseudoephedrine is banned and tested for by the U.S. Olympic Committee (USOC) and the National Collegiate Athletic Association (NCAA).

Drug Interactions

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Concomitant administration of this medication in conjunction with an MAOI may cause hyperpyrexia, hypotension, or death. MAOI's also prolong and intensify the anticholinergic (drying) effects of antihistamines and may enhance the effect of pseudoephedrine. Concomitant administration of this medication and MAOI's should be avoided (see CONTRAINDICATIONS).

Central Nervous System (CNS depressants)

Antihistamines have additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, antianxiety agents, etc.).

Antihypertensive drugs

Sympathomimetics may reduce the effects of antihypertensive drugs.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Animal studies of Bromdex D™ Syrup to assess the carcinogenic and mutagenic potential or the effect on fertility have not been performed.

Pregnancy

Teratogenic Effects

Pregnancy: Category C

Animal reproduction studies have not been conducted with Bromdex D™ Syrup. It is also not known whether Bromdex D™ Syrup can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This product should be administered to a pregnant woman only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Because of the higher risk of intolerance of antihistamines in small infants generally, and in newborns and prematures in particular, Bromdex D™ Syrup is contraindicated in nursing mothers.

Pediatric Use

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

Adverse Reactions

The most frequent adverse reactions to Bromdex D™ Syrup are: sedation; dryness of mouth, nose and throat; thickening of bronchial secretions; dizziness. Other adverse reactions may include:

Dermatologic: Urticaria, drug rash, photosensitivity, pruritus.

Cardiovascular: Hypotension, hypertension, cardiac arrhythmias, palpitations.

CNS: Disturbed coordination, tremor, irritability, insomnia, visual disturbances, weakness, nervousness, convulsions, headache, euphoria, and dysphoria.

Urinary System: Urinary frequency, difficult urination.

Gastrointestinal System: Epigastric discomfort, anorexia, nausea, vomiting, diarrhea, constipation.

Respiratory System: Tightness of chest and wheezing, shortness of breath.

Hematologic System: Hemolytic anemia, thrombocytopenia, agranulocytosis.

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 pseudoephedrine may result in CNS stimulation, tachycardia, hypertension, and cardiac arrhythmias; signs of CNS depression may occasionally be seen. Dextromethorphan in toxic doses will cause drowsiness, ataxia, nystagmus, opisthotonos, and convulsive seizures.

Toxic Doses

Data suggest that individuals may respond in an unexpected manner to apparently small amounts of a particular drug. A 2½-year-old child survived the ingestion of 21 mg/kg of dextromethorphan exhibiting only ataxia, drowsiness, and fever, but seizures have been reported in 2 children following the ingestion of 13–17 mg/kg. Another 2½-year-old child survived a dose of 300–900 mg of brompheniramine, The toxic dose of pseudoephedrine should be less than that of ephedrine, which is estimated to be 50 mg/kg.

Treatment

Induce emesis if patient is alert and is seen prior to 6 hours following ingestion. Precautions against aspiration must be taken, especially in infants and small children, Gastric lavage may be carried out, although in some instances tracheostomy may be necessary prior to lavage. Naloxone hydrochloride 0.005 mg/kg intravenously may be of value in reversing the CNS depression that may occur from an overdose of dextromethorphan, CNS stimulants may counter CNS depression. Should CNS hyperactivity or convulsive seizures occur, intravenous short-acting barbiturates may be indicated. Hypertensive responses and/or tachycardia should be treated appropriately. Oxygen, intravenous fluids, and other supportive measures should be employed as indicated.

Bromdex D Dosage and Administration

Adults and Children 12 years of age or older: 1 teaspoonful every 6 hours. Children 6 to 12 years of age: ½ teaspoonful every 6 hours. Do not exceed four doses in a 24-hour period. This product is not indicated for use in children under 6 years of age. (see PRECAUTIONS, Pediatric Use.)

How is Bromdex D Supplied

Bromdex D™ Syrup is a purple-colored, berry/vanilla-flavored, sugar-free, alcohol-free syrup supplied in 16 fl. oz. bottles, NDC 51991-637-16.

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

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature. Protect from freezing.

Warning: Keep this and all medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

Rx Only

Manufactured by: Tri-Med Laboratories, Inc., Somerset, NJ 08873

Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487

Iss. 5/09

PRINCIPAL DISPLAY PANEL - Syrup Label

Breckenridge

Pharmaceutical, Inc.

NDC 51991-637-16

Bromdex D™

Syrup

Antitussive/Nasal Decongestant/

Antihistamine

Sugar Free

Alcohol Free

Description: Each 5 mL (one teaspoonful) for oral

administration contains:

Pseudoephedrine HCl ..................................50 mg

Dextromethorphan HBr.................................30 mg

Brompheniramine Maleate .............................3 mg

INACTIVE INGREDIENTS: Sodium Benzoate,

Citric Acid, Saccharin Sodium, Sorbitol Solution,

Glycerin, FD&C Red No. 40, FD&C Blue No. 1,

Berry/Vanilla Flavor, Purified Water.