Phenergan (Promethazine HCl – Potassium Guaiacolsulfonate – Codeine Phosphate)

PHENERGAN® EXPECTORANT with Codeine

Novartis Consumer Health

Promethazine HCl – Potassium Guaiacolsulfonate – Codeine Phosphate

Cough Therapy

Indications And Clinical Uses: For symptomatic relief of coughs due to colds and minor upper respiratory tract infections. To facilitate expectoration and control cough associated with inflamed mucosa and tenacious sputum which does not respond to products of lesser potency.

Contra-Indications: Sensitivity to any of the components, patients receiving MAO inhibitors. Not recommended for children below 2 years of age.

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.

Children: 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.

Not to be administered to children under 2 years of age.

Pregnancy: Since codeine crosses the placental barrier, the use of Phenergan Expectorant with Codeine in pregnancy is not recommended.

As codeine may inhibit peristalsis, patients with chronic constipation should be given Phenergan Expectorant with Codeine only after weighing the potential therapeutic benefit against the hazards involved.

Preparations containing codeine may be habit forming.

Use products with caution in patients with hypertension, glaucoma, hyperthyroidism, cardiac or peripheral vascular disease or diabetes mellitus.

Occupational Hazards: Patients should be cautioned not to operate vehicles or hazardous machinery until their response to the drug has been determined. Since the depressant effects of antihistamines are additive to those of other drugs affecting the CNS, patients should be cautioned against drinking alcoholic beverages or taking hypnotics, sedatives, psychotherapeutic agents or other drugs with CNS depressant effects during antihistaminic therapy.

See also guaifenesin monograph.

Adverse Reactions: Dryness of the mouth, blurring of vision, dizziness or mild stimulation and insomnia may occur. Very rare cases of leukopenia and only one case of agranulocytosis following prolonged therapy with promethazine at high dosages have been reported.

Dosage: Adults: 5 to 10 mL every 4 to 6 hours, or as prescribed. Children (over 2 years of age): 2.5 to 5 mL every 4 to 6 hours, or as prescribed.

Availability And Storage: Each 5 mL of brown syrup contains: promethazine HCl 5.65 mg, potassium guaiacolsulfonate 40 mg and codeine phosphate 10 mg. Energy: 67.1 kJ (16.0 kcal)/5 mL. Alcohol: 7.5% v/v. Sucrose: 3.6 g/5 mL. Tartrazine-free. Bottles of 500 mL.

PHENERGAN® EXPECTORANT with Codeine Novartis Consumer Health Promethazine HCl – Potassium Guaiacolsulfonate – Codeine Phosphate Cough Therapy

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