Cophylac (Normethadone – p-Hydroxyephedrine)

COPHYLAC®

Hoechst Marion Roussel

Normethadone – p-Hydroxyephedrine HCl Compound

Antitussive

Indications And Clinical Uses: The treatment of cough associated with inflamed mucosa, which does not respond to products of lesser potency.

Cophylac Expectorant is indicated to facilitate expectoration and control cough associated with inflamed mucosa and tenacious sputum which does not respond to products of lesser potency.

Contra-Indications: Do not administer to patients receiving MAO inhibitors. Cophylac Expectorant is contraindicated in pertussis and other conditions predisposing to nausea and vomiting.

Precautions: Before prescribing medication to suppress or modify cough, it is important to ascertain that the underlying cause of the cough is identified, that modification of the cough does not increase the risk of clinical or physiologic complications, and that appropriate therapy for the primary disease is provided.

In young children the respiratory centre is especially susceptible to the depressant action of narcotic cough suppressants. Benefit to risk ratio should be carefully considered especially in children with respiratory embarrassment, e.g., croup. Estimation of dosage relative to the child’s age and weight is of great importance.

Pregnancy: Since normethadone crosses the placental barrier, its use in pregnancy is not recommended.

As normethadone may inhibit peristalsis, patients with chronic constipation should be given Cophylac only after weighing the potential therapeutic benefit against the hazards involved.

Contains normethadone. May be habit forming.

Symptoms And Treatment Of Overdose: Symptoms: An overdose of 4 mL taken within 4 to 5 hours has produced transient nausea, cold sweat, and tachycardia in one reported case. Should 33% or more of one bottle be ingested, paralysis of the respiratory centre may result.

Treatment: Naloxone HCl.

Dosage And Administration: Adults and children over 14 years, 15 drops twice daily; children 3 to 14 years, 5 to 10 drops twice daily; children under 3 years, 2 to 5 drops twice daily.

Drops are dispensed by inverting the drop dispensing bottle. May be taken plain, with sugar or in any beverage, preferably after breakfast and at bedtime. Cophylac Expectorant should not be taken more than twice a day and never on an empty stomach.

Availability And Storage: Cophylac: Each mL of sugar-free solution contains: normethadone HCl 10 mg (1%) and p-hydroxyephedrine HCl 20 mg (2%). Nonmedicinal ingredients: citric acid anhydrous granular, glycerin, lemon oil, methylparaben and purified water. Energy: 3.3 kJ (0.8 kcal). Tartrazine-free. Dispensing bottles of 15 mL.

Cophylac Expectorant: Each mL of sugar-free solution contains: normethadone HCl 10 mg (1%), p-hydroxyephedrine HCl 20 mg (2%) and emetine HCl 1.3 mg (0.13%). Nonmedicinal ingredients: citric acid anhydrous granular, glycerin, lemon oil, methylparaben and purified water. Energy: 3.3 kJ (0.8 kcal). Tartrazine-free. Dispensing bottles of 15 mL.

COPHYLAC® Hoechst Marion Roussel Normethadone – p-Hydroxyephedrine HCl Compound Antitussive

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