Codeine is an alkaloid obtained from opium or prepared from morphine by methylation and occurs as white crystals. Codeine effloresces slowly in dry air and is effected by light. The chemical name of codeine phosphate is 7,8-Didehydro-4,5alpha-epoxy-3-methoxy-17-methylmorphinan-6alpha-ol phosphate (1:1)(salt) hemihydrate and has the empirical formula of C18H21NO3·H3PO4·1/2H20. Its molecular weight is 406.4.

Each soluble tablet contains 30 mg (0.074 mmol) or 60 mg (0.15 mmol) of codeine phosphate. These tablets also contain lactose and sucrose.

Soluble tablets of codeine phosphate are freely soluble in water. They are intended for the preparation of solutions for parenteral administration. These tablets are not sterile. Codeine phosphate is an analgesic.

INDICATIONS

Codeine phosphate is an analgesic indicated for the relief of mild to moderate pain.

DOSAGE AND ADMINISTRATION

For Analgesia: Dosage should be adjusted according to the severity of the pain and the response of the patient.

Adults: 15 to 60 mg every 4 to 6 hours (usual adult dose, 30 mg).

Children: 1 Year of Age and Older - 0.5 mg/kg of b.d. weight or 15 mg/m2 of b.d. surface every 4 to 6 hours.

Soluble tablets codeine phosphate are administered subcutaneously or intramuscularly.

Solutions for injection should be prepared with sterile water and filtered through a 0.22 membrane filter.

Note: Do not use the solution if it is more than slightly discolored or contains a precipitate.

PATIENT INFORMATION

Codeine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, s.c. as driving a car or operating machinery. Codeine in combination with other narcotic analgesics, phenothiazines, sedative hypnotics, and alcohol has additive depressant effects.