Quartuss DM

phenylephrine hydrochloride, dextromethorphan hydrobromide and chlorpheniramine maleate

Dosage Form: oral liquid
Quartuss™ DM Drops

Nasal Decongestant/Antitussive/Antihistamine

Quartuss DM Description

Each dropperful (1 mL) contains:

Dextromethorphan HBr.................................................................................................................... 3 mg

Phenylephrine HCl........................................................................................................................ 1.5 mg

Chlorpheniramine Maleate .............................................................................................................. 1 mg

	Dextromethorphan hydrobromide is an antitussive having the chemical name, Morphinan, 3-methoxy-17-methyl-, (9α,13α, 14α)-, hydrobromide, monohydrate with the following structure:		Phenylephrine Hydrochloride is a nasal decongestant having the chemical name, Benzenemethanol, 3-hydroxy-α-[(methylamino)methyl]-, hydrochloride (R)-. (–)-m-Hydroxy-α-[methylamino) methyl]benzyl alcohol hydrochloride, with the following structure:
Molecular formula: C18H25NO•HBr•H2O	M.W.=370.32	Molecular formula: C9H13NO2•HCl	M.W.=203.67
			Chlorpheniramine Maleate is an antihistamine having the chemical name, 2-Pyridinepropanamine, γ-(4-chlorophenyl)-N,N-dimethyl-, (Z)-2-butenedioate (1:1). 2-[p-Chloro-α-[2-(dimethylamino)ethyl]benzyl]pyridine maleate (1:1). with the following structure:
Molecular formula: C16H19ClN2•C4H4O4        M.W.=390.86

INACTIVE INGREDIENTS

Sodium Benzoate, Citric Acid, Sorbitol Solution, Glycerin, FD&C Red No. 40, Bubblegum Flavor, Purified Water.

Quartuss DM - Clinical Pharmacology

Dextromethorphan HBr

Dextromethorphan HBr is a nonopioid antitussive agent. It suppresses the cough reflex by a direct action on the cough center in the medulla of the brain. Dextromethorphan HBr has no significant analgesic or sedative properties. It does not depress respiration or predispose an individual to addiction with usual doses. In therapeutic dosage, Dextromethorphan HBr does not inhibit ciliary activity. The onset of action is typically within 30 minutes and the duration of action can be up to 6 hours. Dextromethorphan HBr is rapidly and extensively metabolized by the liver. It is primarily excreted in the kidneys as unchanged dextromethorphan and demethylated metabolites including dextrorphan, an active metabolite.

Phenylephrine Hydrochloride

Phenylephrine HCl, a nasal decongestant, is a potent postsynaptic alpha-receptor agonist with little effect on the beta receptors of the heart. Phenylephrine HCl has no effect on the beta-adrenergic receptors of the bronchi or peripheral blood vessels. A direct action at receptors accounts for the greater part of its effects, only a small part being due to its ability to release norepinephrine. Therapeutic doses of Phenylephrine HCl may cause vasoconstriction. It increases resistance and, to a lesser extent, decreases capacitance of blood vessels. Total peripheral resistance is increased, resulting in increased systolic and diastolic blood pressure. Pulmonary arterial pressure is usually increased, and renal blood flow is usually decreased. Local vasoconstriction and hemostasis occur following infiltration of Phenylephrine HCl into tissues. The main effect of Phenylephrine HCl on the heart is bradycardia; it produces a positive inotropic effect on the myocardium in doses greater than those usually used therapeutically. Rarely, the drug may increase the irritability of the heart which can cause arrhythmias. Cardiac output is decreased slightly. Phenylephrine HCl increases the work of the heart by increasing peripheral arterial resistance. Phenylephrine HCl has a mild central stimulant effect. Following oral administration of Phenylephrine HCl, constriction of blood vessels in the nasal mucosa relieves nasal congestion associated with allergy or head colds. This may occur within 15 or 20 minutes and may persist for up to 4 hours.

Chlorpheniramine Maleate

Chlorpheniramine Maleate possesses H1 antihistaminic activity and mild anticholinergic and sedative effects.

INDICATIONS

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

Contraindications

Quartuss™ DM Drops is contraindicated in patients hypersensitive to any of its ingredients. It is also contraindicated in patients with severe hypertension or severe coronary artery disease, or in those receiving monoamine oxidase (MAO) inhibitors (or for 14 days after stopping MAOI therapy). Antihistamines should not be used to treat lower respiratory tract conditions including asthma.

Warnings

Do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor. If symptoms do not improve within 7 days or are accompanied by a fever, consult a doctor. Sympathomimetic amines should be used with caution in patients with hypertension, ischemic heart disease, diabetes mellitus, increased intraocular pressure, hyperthyroidism, or prostatic hypertrophy. Sympathomimetics may produce central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension. Do no exceed recommended dosage.

Precautions

General

Before prescribing this medication to suppress or modify cough, identify and provide therapy for the underlying cause of the cough. Avoid alcohol and other CNS depressants while taking this product. Patients sensitive to antihistamines may experience moderate to severe drowsiness.

Information For Patients

Patients should be warned about engaging in activities requiring mental alertness, such as driving 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 HCl. Sympathomimetics may reduce the effects of antihypertensive drugs.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

No data is currently available on long term potential for carcinogenesis, mutagenesis, or impairment of fertility in animals or humans.

Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with this product. It is not known whether this product can cause fetal harm when administered to a pregnant woman or affect reproduction capacity. Give to pregnant women only if clearly needed. Administration of Phenylephrine HCl to patients in late pregnancy or labor may cause fetal anoxia or bradycardia by increasing contractility of the uterus and decreasing uterine blood flow.

Nursing Mothers

Some sympathomimetics are excreted in breast milk. Use of this product by nursing mothers is not recommended.

Adverse Reactions

Dextromethorphan HBr

Adverse effects with Dextromethorphan HBr are rare, but nausea and/or other gastrointestinal disturbances, headache, slight dizziness and drowsiness sometimes occur.

Phenylephrine HCl

Hyperreactive individuals may display ephedrine-like reactions such as tachycardia, palpitations, headache, dizziness, or nausea. Sympathomimetics have been associated with certain untoward reactions including fear, anxiety, nervousness, restlessness, tremor, weakness, pallor, respiratory difficulty, dysuria, insomnia, hallucinations, convulsions, CNS depression, arrhythmias, and cardiovascular collapse with hypotension.

Chlorpheniramine Maleate

Antihistamines may cause sedation, dizziness, diplopia, vomiting, diarrhea, dry mouth, headache, nervousness, nausea, anorexia, heartburn, weakness, polyuria and; rarely, excitability in children.

Overdosage

Signs and Symptoms

Overdosage with dextromethorphan HBr may produce CNS excitement and metal confusion. Overdosage with sympathomimetic amines can cause hypertension, headache, convulsions, cerebral hemorrhage and vomiting may occur. Headache may be a symptom of hypertension. Bradycardia may also be seen early in Phenylephrine HCl overdosage through stimulation of baroreceptors. Excessive CNS stimulation may result in excitement, tremor, restlessness, and insomnia. Other effects may include pallor, mydriasis, hyperglycemia, and urinary retention. Severe overdosage may cause tachypnea or hyperpnea, hallucinations, convulsions, or delirium, but in some individuals, there may be CNS depression. Arrhythmias (including ventricular fibrillation) may lead to hypotension and circulatory collapse. Severe hypokalemia can occur, probably due to a compartmental shift rather that a depletion of potassium. Should antihistamine effects predominate, central action constitutes the greatest danger. In the small child, symptoms include excitation, hallucination, ataxia, uncoordination, tremors, flushed face and fever. Convulsions, fixed and dilated pupils, coma and death may occur in severe cases. In the adult, fever and flushing are uncommon, excitement leading to convulsions and postictal depression is often preceded by drowsiness and coma. Respiration is usually not seriously depressed; blood pressure is usually stable.

Treatment

The patient should be induced to vomit, even if emesis has occurred spontaneously. Pharmacologic vomiting by the administration of ipecac syrup is a preferred method, however, vomiting should not be induced in patients with impaired consciousness. Precautions against aspiration must be taken, especially in infants, children and comatose patients. Following emesis, any drug remaining in the stomach may be absorbed by activated charcoal administered as a slurry with water. Treatment of the signs and symptoms of overdosage is symptomatic and supportive.

Quartuss DM Dosage and Administration

Consult physician for dosing. Dosing is based on weight and month of age of child. May be repeated every 4-6 hours if required for relief. Not to exceed 4 doses in 24 hours. In mild cases or in particularly sensitive patients less frequent or reduced doses may be adequate.

How is Quartuss DM Supplied

Quartuss™ DM Drops is supplied as an alcohol free, sugar free, bubblegum flavored liquid, in bottles of 1 fl. oz. (30 mL), NDC 51991-537-03, with a calibrated (1 mL) dropper.

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.

Storage

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

Pharmacist: Dispense in original container.

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

Rx ONLY

Distributed by:

Breckenridge Pharmaceutical, Inc.

Boca Raton, FL 33487

Manufactured by:

Tri-Med Laboratories, Inc.

Somerset, NJ 08873

Iss. 6/07

PRINCIPAL DISPLAY PANEL - 30 mL Box

Breckenridge

Pharmaceutical, Inc

NDC 51991-537-03

Quartuss™ DM

Drops

Antitussive/Nasal Decongestant/Antihistamine

•Sugar Free •Alcohol Free

Each 1 mL contains:

Phenylephrine Hydrochloride ...........1.5 mg

Chlorpheniramine Maleate ..................1 mg

Dextromethorphan HBr .......................3 mg

Inactive Ingredients: Sodium Benzoate, Citric Acid,

Sorbitol Solution, Glycerin, FD & C Red No.40, Artificial

Bubblegum Flavor, Purified Water.

Rx ONLY

Net Contents: 1 fl. oz. (30 mL)

With Calibrated Dropper

Quartuss DM  phenylephrine hydrochloride, dextromethorphan hydrobromide and chlorpheniramine maleate  liquid

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 51991-537 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride 1.5 mg  in 1 mL Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide 3 mg  in 1 mL Chlorpheniramine Maleate (Chlorpheniramine) Chlorpheniramine Maleate 1 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength sodium benzoate   citric acid monohydrate   sorbitol   glycerin   FD&C Red No. 40   water

Product Characteristics Color RED (Clear) Score      Shape Size Flavor BUBBLE GUM Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 51991-537-03 30 mL In 1 BOTTLE, DROPPER None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		10/01/2007	12/31/2011

Labeler - Breckenridge Pharmaceutical, Inc. (150554335)

Establishment
Name	Address	ID/FEI	Operations
Trimed		182050567	MANUFACTURE

Revised: 10/2010Breckenridge Pharmaceutical, Inc.

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