Prescription Drugs

CLINICAL PHARMACOLOGY Pseudoephedrine hydrochloride is an (alpha)-adrenergic receptor agonist (sympathomimetic) which produces vasoconstriction by stimulating (alpha)-receptors within the mucosa of the respiratory tract. Clinically, pseudoephedrine shrinks swollen mucous membranes, reduces tissue hyperemia, edema, and nasal congestion, and increases nasal airway patency. Guaifenesin promotes lower respiratory tract drainage by thinning bronchial secretions, lubricates irritated respiratory tract membranes through increased mucous flow, and facilitates removal of viscous, inspissated mucus. As a result of these drugs, sinus and bronchial drainage is improved, and dry, nonproductive coughs become more productive and less frequent.

DESCRIPTION Each Entex PSE (pseudoephedrine and guaifenesin) yellow coated, scored, long-acting tablet for oral administration contains pseudoephedrine hydrochloride 120 mg guaifenesin 600 mg in a special base to provide a prolonged therapeutic effect. This product contains ingredients of the following therapeutic classes: decongestant and expectorant. Pseudoephedrine hydrochloride is a decongestant having the chemical name, benzenemethanol,(alpha)-[1-(methylamino)ethyl]-[ S -( R*, R* ) ]-, hydrochloride. Guaifenesin is an expectorant having the chemical name, 1,2-propanediol, 3-(2-methoxyphenoxy)-. Inactive Ingredients: Each tablet contains compressible sugar, D&C Yellow No. 10 Aluminum Lake, dioctyl sodium sulfosuccinate, FD&C Yellow No. 6 Aluminum Lake, hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycol, purified water, silicon dioxide, sodium citrate, stearic acid, and titanium dioxide.

INDICATIONS Entex PSE (pseudoephedrine and guaifenesin) tablets are 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 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. DOSAGE AND ADMINISTRATION Adults and adolescents 12 years of age and older: one tablet twice daily (every 12 hours). Children 6 to under 12 years: one-half ( 1 / 2 ) tablet twice daily (every 12 hours). Entex PSE (pseudoephedrine and guaifenesin) tablets are not recommended for pediatric patients under 6 years of age. Tablets may be broken in half for ease of administration without affecting release of medication but should not be crushed or chewed prior to swallowing. HOW SUPPLIED Entex PSE (pseudoephedrine and guaifenesin) tablets are coated yellow, scored and coded with "Entex PSE (pseudoephedrine and guaifenesin) " on one side and "032 032" on the scored side. NDC 51479-032-01 bottles of 100 Store at controlled room temperature (59°-77°F or 15°-25°C). Dispense in tight, light-resistant containers as defined in USP. Rx only. Manufactured by WelPharm, Inc. Irvine, CA 92614 Manufactured for DURA Pharmaceuticals, Inc. San Diego, CA 92121

PATIENT INFORMATION 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.

OVERDOSE Symptoms: Overdose may cause hallucinations, convulsions, CNS depression, cardiovascular collapse and death. Treatment: 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. Since the effects of Entex PSE (pseudoephedrine and guaifenesin) tablets may last up to 12 hours, treatment should be continued for at least that length of time. CONTRAINDICATIONS Entex PSE (pseudoephedrine and guaifenesin) tablets are contraindicated in patients with a known hypersensitivity to any of its ingredients, in nursing mothers, or in patients with severe hypertension, severe coronary artery disease, prostatic hypertrophy, or in patients on MAO inhibitor therapy.

SIDE EFFECTS Gastrointestinal: nausea and vomiting. Central Nervous System: nervousness, dizziness, sleeplessness, lightheadedness, tremor, hallucinations, convulsions, CNS depression, fear, anxiety, headache, increased irritability or excitement. Cardiovascular: palpitations, tachycardia, cardiovascular collapse and death. General: weakness. Respiratory: respiratory difficulties. DRUG INTERACTIONS MAO inhibitors and beta adrenergic blockers increase effects of sympathomimetics. Sympathomimetics may reduce the antihypertensive effects if methyldopa, guanethidine, mecamylamine, reserpine and veratrum alkaloids.

WARNINGS Sympathomimetic amines should be used with caution in patients with hypertension, diabetes mellitus, heart disease, peripheral vascular disease, increased intraocular pressure, hyperthyroidism, or prostatic hypertrophy. PRECAUTIONS General: Hypertensive patients should use Entex PSE (pseudoephedrine and guaifenesin) tablets only with medical advice, as they may experience a change in blood pressure due to added vasoconstriction. Information for Patients: 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. Drug Interactions: MAO inhibitors and beta adrenergic blockers increase effects of sympathomimetics. Sympathomimetics may reduce the antihypertensive effects if methyldopa, guanethidine, mecamylamine, reserpine and veratrum alkaloids. Drug/Laboratory Test Interactions: Guaifenesin has been reported to interfere with clinical laboratory determinations of urinary 5-hydroxyindoleacetic acid (5-HIAA) and urinary vanillylmandelic acid (VMA). Pregnancy: Pregnancy Category C. Animal reproduction studies have not been conducted with Entex PSE (pseudoephedrine and guaifenesin) tablets. It is also not known whether Entex PSE (pseudoephedrine and guaifenesin) tablets can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Entex PSE (pseudoephedrine and guaifenesin) tablets should be given to a pregnant woman only if clearly needed. Nursing Mothers: Entex PSE (pseudoephedrine and guaifenesin) tablets are contraindicated in the nursing mother because of the higher than usual risks to infants from sympathomimetic agents. 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. Pediatric Use: Safety and effectiveness of Entex PSE (pseudoephedrine and guaifenesin) tablets in pediatric patients below the age of 6 have not been established.