Alacol DM Syrup (Ballay)

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DESCRIPTION

Antihistamine/Nasal Decongestant/Antitussive syrup for oral administration. An alcohol-free, sugar-free, black raspberry flavored syrup. Each teaspoonful (5 mL) contains: Dextromethorphan HBr. 10 mg; Phenylephrine HCl, 5mg; Brompheniramine Maleate, 2 mg.

INACTIVE INGREDIENTS

Propylene Glycol, Sodium Saccharin, Glycerin, Sorbitol, Purified Water, Raspberry Flavor, FD&C Red#40, and FD&C Blue#1

CLINICAL PHARMACOLOGY

Dextromethorphan Hydrobromide 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. Phenylephrine HCl is a sympathomimetic drug which is readily absorbed from the gastrointestinal tract and produces nasal vasoconstriction (decongestion). Phenylephrine effects its vasoconstrictor activity by releasing noradrenaline from sympathetic nerve endings and from direct stimulation of (alpha)-adreno receptors in blood vessels. Brompheniramine Maleate is a histamine antagonist, specifically an H ₁ -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 (vasodilatation, increased vascular permeability, increased mucous secretion) of nasal tissue. Brompheniramine is well absorbed from the gastrointestinal tract, with peak plasma concentration after a 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 sight of metabolic transformation.

INDICATIONS

ALACOL DM is indicated for the 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 newborns, in premature infants, in nursing mothers, in patients with severe hypertension or severe coronary artery disease, or in those receiving MAO inhibitors. Antihistamines should not be used to treat lower respiratory tract conditions including asthma.

WARNINGS

A persistent cough may be a sign of a serious condition. If cough persists for more than one week, tends to recur or is accompanied by fever, rash, or persistent headache, consult a physician. Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a physician. Especially in infants and small children, antihistamines in overdosage may cause hallucinations, convulsions, and death. Antihistamines may diminish mental alertness. In young children they may produce excitation.

PRECAUTIONS

General - Because of its antihistamine component, ALACOL DM should be used with caution in patients with a history of bronchial asthma, narrow-angle glaucoma, gastrointestinal obstruction, urinary bladder neck obstruction. Because of its sympathomimetic component, ALACOL DM should be used with caution in patients with diabetes, hypertension, heart disease, 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.

Drug Interactions:    Antihistamines have additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, antianxiety agents, etc.). MAO inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines. MAO inhibitors may enhance the effect of phenylephrine. Sympathomimetics may reduce the effects of antihypertensive drugs.

Carcinogenesis, Mutagenesis, Impairment of Fertility - Animal studies of ALACOL DM to assess carcinogenic and mutagenic potential, or the effect on fertility have not been performed.

Usage in Pregnancy-Pregnancy Category C. Teratogenic Effects - Animal reproduction studies have not been conducted with ALACOL DM. It is also not known whether ALACOL DM can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ALACOL DM should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Reproduction studies of brompheniramine maleate in rats and mice at doses up to 16 times the maximum human dose have revealed no evidence of impaired fertility or harm 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, ALACOL DM is contraindicated in nursing mothers.

ADVERSE REACTIONS

The most frequent adverse reactions to ALACOL DM include sedation, dryness of mouth, nose and throat, thickening of bronchial secretions, and dizziness. Other adverse reactions may include: Dermatologic - Urticaria, drug rash, photosensitivity, and pruritus. Cardiovascular System - Hypotension, hypertension, cardiac arrhythmias. Central Nervous System - disturbed coordination, tremor, irritability, insomnia, visual disturbance, weakness, nervousness, convulsions, headache, euphoria and dysphoria. G.U. System - Urinary frequency, difficult urination. G.I. System - Epigastric discomfort, anorexia, nausea, vomiting, diarrhea, or constipation. Respiratory System - Tightness of chest and wheezing, shortness of breath. Hematologic System - Hemolytic anemia, thrombocytopenia, agranulocytosis.

OVERDOSAGE

Signs and Symptoms - Dextromethorphan in toxic doses will cause drowsiness, ataxia, nystagmus, opisthotonos, and convulsive seizures. Overdosage of phenylephrine may be associated with tachycardia, hypertension, and cardiac arrhythmias. The effect on the central nervous system of an overdosage of brompheniramine may vary from depression to stimulation, especially in children. Anticholinergic effects may also occur. Treatment - Induce emesis if patient is alert and is seen by a physician 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 HCl 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.

DOSAGE AND ADMINISTRATION

Adults and Children over 12 years - 2 teaspoonsful (10 mL) every 4 hours. Children 6 to 12 years - 1 teaspoonful (5 mL) every 4 hours. Children 2 to 6 years - ½ teaspoonful (2.5 mL) every 4 hours. Children under 2 years - as directed by a physician. Do not exceed 6 doses during a 24 hour period.

HOW SUPPLIED

NDC 63162-507-16 16 oz (473 mL) bottles, and NDC 63162-507-20 20 mL sample bottles.

Store between 59°-86°F (15°-30°C)

Dispense in tight, light resistant containers as defined by the USP.

KEEP THIS AND ALL MEDICATIONS OUT OF

THE REACH OF CHILDREN.

Rx Only

Manufactured in USA for

BALLAY PHARMACEUTICALS, INC.

Wimberley, TX 78676

REV 11/01

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