Source: Health Products Regulatory Authority (ZA) Revision Year: 2023 Publisher: Ranbaxy Pharmaceuticals (Pty) Ltd, 14 Lautre Road, Stormill Ext. 1, Roodepoort 1724, South Africa
Category and class: A 2.8 Analgesic combinations
Pharmacotherapeutic group: Anilides, Paracetamol combinations
ATC Code: N02BE51
CODOXOL has analgesic, antipyretic and antihistaminic properties.
Paracetamol is an effective, well-documented analgesic preparation.
Codeine is a proven analgesic medicine, which has a suggested central action.
Doxylamine succinate is an ethanolamine type antihistamine with mild sedative, anti-allergic and anti-emetic properties. Because of its sedative action, it reduces the psychic tension component of tension headache and other somatic pain/tension states.
Caffeine has a mild stimulant effect on the cerebral cortex and relieves fatigue.
Doxylamine succinate is readily absorbed from the gastrointestinal tract. Following oral administration the effects start within 15 to 30 minutes and peak within one hour. In humans 60 – 80 % of doxylamine given has been recovered in urine at 24 hours post-dose.
The bioavailabilities of paracetamol and codeine phosphate when given as the combination are similar to those when they are given separately.
Codeine is mainly metabolized by glucuronidation to codeine-6-glucuronide. Minor routes of metabolism include Odemethylation leading to morphine, N-demethylation to norcodeine and both O-and N-demethylation to normorphine.
Morphine and norcodeine are further transformed to glucuronide conjugates. Unchanged codeine and its metabolites are mainly excreted by urinary route within 48 hours (84,4 ± 15,9 %).
The O-demethylation of codeine to morphine is catalyzed by the cytochrome P450 isozyme 2D6 (CYP2D6) which shows genetic polymorphism that may affect the efficacy and toxicity of codeine.
Genetic polymorphism in CYP2D6 leads to ultra-rapid, extensive and poor metaboliser phenotypes.
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