DESCRIPTION

ZEPHREX is a white film coated, oval-shaped tablet with a bisect on one side and Sanofi with 460 below the name on the other side.

Each tablet contains:

Pseudoephedrine HCl ............................... 60 mg

Guaifenesin ............................................. 400 mg

CLINICAL PHARMACOLOGY

Pseudoephedrine hydrochloride acts on alpha-adrenergic receptors in the mucosa of the respiratory tract producing vasoconstriction. Pseudoephedrine HCl shrinks swollen nasal mucous membranes, reduces tissue hyperemia, edema, nasal congestion and increases nasal airway patency. Guaifenesin enhances the flow of respiratory tract fluid (RTF). The enhanced flow of less viscid secretions lubricates irritated respiratory tract membranes, promotes ciliary action and facilitates the removal of inspissated mucus. As a result, sinus and bronchial drainage is improved and dry nonproductive coughs become more productive and less frequent.

INDICATIONS

ZEPHREX is indicated for the relief of nasal congestion due to the common cold, hay fever or other upper respiratory allergies and nasal congestion associated with sinusitis. To promote nasal or sinus drainage; for the relief of eustachian tube congestion; for adjunctive therapy in serious otitis media; for the symptomatic relief of respiratory conditions characterized by dry nonproductive cough and in the presence of tenacious mucus and/or mucous plugs in the respiratory tract.

CONTRAINDICATIONS

ZEPHREX is contraindicated in patients with a known hypersensitivity to any of its ingredients. Also contraindicated in patients with severe hypertension, severe coronary artery disease and patients on MAO inhibitor therapy. Should not be used in prostatic hypertrophy.

WARNINGS

Considerable caution should be exercised in patients with hypertension, diabetes mellitus, ischemic heart disease, hyperthyroidism and prostatic hypertrophy.

PRECAUTIONS

Hypertensive patients should use ZEPHREX only with medical advice, as they may experience a change in blood pressure due to added vasoconstriction.

Excessive Use --May cause systemic effects (nervousness, dizziness, or sleeplessness) which are more likely in infants and in the elderly. Habituation and toxic psychosis have followed long-term usage. Excessive dosage may also cause nausea and vomiting.

Usage in Elderly --Patients 60 years and older are more likely to experience adverse reactions to sympathomimetics. Overdose may cause hallucinations, convulsions, CNS depression and death. Demonstrate safe use of a short-acting sympathomimetic before use of a sustained action formulation in elderly patients.

Usage in Pregnancy --(Category C) it is not known whether ZEPHREX can cause fetal harm or affect reproduction capacity. Give only when clearly needed.

Usage in Lactation -- ZEPHREX is contraindicated in the nursing mother because of the higher than usual risks to infants from sympathomimetic agents.

Persistent Cough --May indicate a serious condition. If cough persists for more than one week, tends to recur or is accompanied by a high fever, rash or persistent headache, consult a physician.

Laboratory Test Interactions --Guaifenesin has been reported to interfere with clinical laboratory determinations of urinary 5-hydroxyindolacetic acid (5-HIAA) and vanillymandelic acid (VMA).

Pediatric Use --Safety and effectiveness of ZEPHREX in children below the age of 6 has not been established.

DRUG INTERACTIONS

MAO Inhibitors and beta adrenergic blockers increase effects of sympathomimetics. Sympathomimetics may reduce the antihypertensive effects of methyldopa, mecamylamine, reserpine and veratrum alkaloids.

ADVERSE REACTIONS

Adverse reactions include nausea, cardiac palpitations, increased irritability or excitement, headache, dizziness and tachycardia.

OVERDOSAGE

Treatment of overdosage should provide symptomatic care. If the amount ingested is considered dangerous or excessive, induce vomiting with ipecac syrup unless the patient is convulsing, comatose, or has lost the gag reflex, in which case, perform gastric lavage using a large bore tube. If indicated, follow with activated charcoal and a saline cathartic.

DOSAGE AND ADMINISTRATION

Adults--1 tablet every 6 hours. Children 6 to 12 years--1/2 tablet every 6 hours.

HOW SUPPLIED

100's NDC 0024-2624-01

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN

Rx only

Store at controlled room temperature.

DISPENSE IN TIGHT, LIGHT RESISTANT CONTAINERS AS DEFINED BY THE USP/NF.

HPG12787-01-0999SS

26249691