BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE
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brompheniramine maleate,
pseudoephedrine hydrochloride and
dextromethorphan hydrobromide liquid
River's Edge Pharmaceuticals, LLC
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BPM Mal/PSE HCl/DM HBr 4/20/20mg/5 mLDESCRIPTION
BPM Mal/PSE HCl/DM HBr 4/20/20mg/5 mL is an antihistamine, decongestant, and antitussive available for oral administration as a clear liquid. Each 5 mL(1 teaspoonful) of cotton candy flavored liquid contains:Brompheniramine Maleate .............................4 mg
Pseudoephedrine Hydrochloride ..................20 mg
Dextromethorphan Hydrobromide................20 mg
Inactive Ingredients: Glycerin, Propylene Glycol, Sorbitol, Citric Acid, Sodium Citrate, Sodium Saccharin, Cotton Candy Flavor, Purified Water.
Brompheniramine Maleate is an antihistamine having the chemical name, 2-Pyridinepropanamine, g -(4- bromophenyl)-N, N-dimethyl-, (±)-,(Z)-2-butenedioate (1:1).
Pseudoephedrine Hydrochloride is a sympathomimetic amine commonly used as a decongestant having the chemical name, Benzenemethanol, a-[1-(methylamino) ethyl]-, [S-(R*,R*)-, hydrochloride which is a naturally occurring dextrorotatory stereoisomer of ephedrine.
Dextromethorphan Hydrobromide is chemically named as 3-Methoxy-17-methyl-9a, 13a, 14a-morphinan hydrobromide which naturally occurs as white crystals and is sparingly soluble in water and freely soluble in alcohol.
CLINICAL PHARMACOLOGY
Antihistamine, decongestant, and antitussive actions.Brompheniramine Maleate
Brompheniramine Maleate is a histamine antagonist, specifically a H1-receptor-blocking agent belonging to the alkylamine class of antihistamines. Antihistamines appear to compete with histamine for receptor sites on effector cells. Brompheniramine Maleate 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.
Pseudoephedrine Hydrochloride
Pseudoephedrine Hydrochloride is an oral sympathomimetic amine which 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
Dextromethorphan Hydrobromide is a nonnarcotic antitussive with effectiveness equal to codeine. It acts in the medulla oblongata to elevate the cough threshold. Dextromethorphan Hydrobromide does not produce analgesia or induce tolerance, and has minimal potential for addiction. The onset of antitussive action occurs in 15 to 30 minutes after administration and is of long duration.
At usual doses, it will not depress respiration nor inhibit ciliary activity. Dextromethorphan Hydrobromide 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
BPM Mal/PSE HCl/DM HBr 4/20/20mg/5 mL is indicated for symptomatic 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. Do not use in newborn infants, premature infants, in nursing mothers, in patients with severe hypertension, severe coronary artery disease, ischemic heart disease, or in those receiving monoamine oxidase (MAO) inhibitors. Antihistamines are contraindicated in patients with narrow-angle glaucoma, urinary retention, peptic ulcer, and during an asthma attack. Antihistamines should not be used to treat lower respiratory tract conditions including asthma.WARNINGS
Do not exceed the recommended dosage. Patients with persistent cough such as occur with smoking, asthma, emphysema, or where cough is accompanied by excessive secretions should not take this product. A persistent cough may be a sign of a serious condition. If the cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor. Use caution when giving to children or patients with chronic pulmonary disease, shortness of breath, difficulty in breathing, asthma, emphysema, high blood pressure, heart disease, diabetes, thyroid disease, or difficulty in urination due to enlargement of the prostate gland unless directed by a physician. Antihistamines may impair mental and physical abilities required for the performance of potentially hazardous tasks, such as driving a car or operating machinery, and may impair mental alertness in children. Antihistamines may cause hyperexcitability, especially in children. At doses higher than the recommended dose, nervousness, dizziness, or sleeplessness may occur. Especially in infants and small children, antihistamines in overdosage may cause hallucinations, convulsions, and death. If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a doctor. Administration of Dextromethorphan Hydrobromide may be accompanied by histamine release and should be used with caution in atopic children.If a hypertensive crisis occurs, these drugs should be discontinued immediately and therapy to lower blood pressure should be instituted immediately. Fever should be managed by means of external cooling.
PRECAUTIONS
GeneralBefore prescribing medication to suppress or modify cough, it is important to ascertain that the underlying cause of cough is identified, that modification of cough does not increase the risk of clinical or physiologic complications, and that appropriate therapy for the primary disease is provided. Because of its antihistamine component, BPM Mal/PSE HCl/DM HBr 4/20/20mg/5 mL 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, BPM Mal/PSE HCl/DM HBr 4/20/20mg/5 mL 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 and motor coordination, such as driving a car or operating machinery. Patients should be cautioned to get up slowly from a lying or sitting position and to lie down if nausea occurs. Alcohol or other sedative drugs may enhance the drowsiness caused by antihistamines.
Drug Interactions
MAO inhibitors prolong and intensify the anticholinergic effects of antihistamines. Antihistamines may have additive effects with alcohol and other CNS depressants, e.g., hypnotics, sedatives, tranquilizers, antianxiety agents.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Animal studies of BPM Mal/PSE HCl/DM HBr 4/20/20mg/5 mL to assess the carcinogenic and mutagenic potential to the effect on fertility have not been performed.
Teratogenic Effects – Pregnancy Category C
Animal reproduction studies have not been conducted with BPM Mal/PSE HCl/DM HBr 4/20/20mg/5 mL. It is also not known whether BPM Mal/PSE HCl/DM HBr 4/20/20mg/5 mL can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. BPM Mal/PSE HCl/DM HBr 4/20/20mg/5 mL should be given to a pregnant woman only if clearly needed.
Nursing Mothers
Because of the higher risk of intolerance of antihistamines in small infants generally, and in newborns and prematures in particular, BPM Mal/PSE HCl/DM HBr 4/20/20mg/5 mL is contraindicated in nursing mothers.
Pediatric Use
Consult a physician for use in children under 2 years of age.
Geriatric Use
The elderly (60 years of age or older) are more likely to exhibit adverse reactions. Caution should be taken when prescribing this drug to the elderly.
ADVERSE REACTIONS
The most frequent adverse reactions to BPM Mal/PSE HCl/DM HBr 4/20/20mg/5 mL include sedation; dryness of mouth, nose, and throat; thickening of bronchial secretions; dizziness. Other adverse reactions may include:General: urinary, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of mouth, nose, and throat.
Cardiovascular System: hypotension, headache, palpitations, tachycardia, extra systoles.
Dermatologic: urticaria, drug rash, photosensitivity, and pruritus.
Central Nervous System: sedation, sleepiness, dizziness, disturbed coordination, fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesias, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, hysteria, neuritis, convulsions.
Gastrointestinal: epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation.
Genitourinary: urinary frequency, difficult urination, urinary retention, early mensea.
Respiratory: thickening of bronchial secretions, tightness of chest and wheezing, nasal stuffiness.
Hematologic System: hemolytic anemia, thrombocytopenia, agranulocytosis.
OVERDOSAGE
Signs and Symptoms
Overdosage of Pseudoephedrine Hydrochloride may be associated with central nervous system stimulation, tachycardia, hypertension, and cardiac arrhythmias. Dextromethorphan Hydrobromide in toxic doses will cause drowsiness, ataxia, nystagmus, opisthotonos and convulsive seizures. Central nervous system effects from overdosage of Brompheniramine Maleate may vary from depression to stimulation, especially in children. Anticholinergic effects may also occur.
Toxic Doses
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 tracheotomy may be necessary prior to lavage. Naloxone 0.005 mg/kg intravenously may be of value in reversing CNS depression that may occur from an overdose of Dextromethorphan Hydrobromide. 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.
DOSAGE AND ADMINISTRATION*
Adults and children over 12 years of age:1 - 2 teaspoonfuls (5 - 10 mL) every 4 to 6 hours, not to exceed 8 teaspoons in 24 hours.
Children 6 to under 12 years of age:
1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 4 teaspoons in 24 hours.
Children 2 to under 6 years of age:
1/2 teaspoonful (2.5 mL) every 4 to 6 hours, not to exceed 2 teaspoons in 24 hours.
Consult a physician for dosage and administration for children under 2 years of age.
*In mild cases or in particularly sensitive patients, less frequent or reduced doses may be appropriate and adequate.
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.
HOW SUPPLIED
BPM Mal/PSE HCl/DM HBr 4/20/20mg/5 mL is an alcohol free, clear, cotton candy flavored liquid available in 16 fl oz (473 mL) bottles, NDC 68032-460-16.Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.
Store at controlled room temperature,15° - 30°C (59° - 86°F). Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.
Rx Only
Manufactured for:
River’s Edge Pharmaceuticals
Suwanee, GA 30024
Iss. 11/09 460-10
304799-002A NDC# 460-16
PACKAGING
(LABEL)NDC 68032-460-16
BPM Mal/PSE HCl/DM HBr 4/20/20mg/5 mL Liquid
Rx Only
Brompheniramine Maleate .............................4 mg/5 mL
Pseudoephedrine Hydrochloride ..................20 mg/5 mL
Dextromethorphan Hydrobromide................20 mg/5 mL
Antihistamine-decongestant-antitussive
Each teaspoonful (5 mL) contains:
Brompheniramine Maleate .............................4 mg
Pseudoephedrine Hydrochloride ..................20 mg
Dextromethorphan Hydrobromide................20 mg
Rx Only
16 fl oz (473 mL)
DOSAGE AND ADMINISTRATION*
Adults and children over 12 years of age:
1 - 2 teaspoonfuls (5 - 10 mL) every 4 to 6 hours, not to exceed 8 teaspoons in 24 hours.
Children 6 to under 12 years of age:
1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 4 teaspoons in 24 hours.
Children 2 to under 6 years of age:
1/2 teaspoonful (2.5 mL) every 4 to 6 hours, not to exceed 2 teaspoons in 24 hours.
Consult a physician for dosage and administration for children under 2 years of age.
*In mild cases or in particularly sensitive patients, less frequent or reduced doses may be appropriate and adequate.
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.
Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.
Store at controlled room temperature,15° - 30°C (59° - 86°F). Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.
Rx Only
Manufactured for:
River’s Edge Pharmaceuticals
Suwanee, GA 30024
Iss. 11/09 460-10
304799-002A NDC# 460-16
| BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE
brompheniramine maleate, pseudoephedrine hydrochloride, dextromethorphan hydrobromide liquid |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| unapproved drug other | 01/18/2010 | 01/31/2012 | |
| Labeler - River's Edge Pharmaceuticals, LLC (133879135) |