Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Dr-reddy
DRL CITALOPRAM 20 (film-coated tablet) DRL CITALOPRAM 40 (film-coated tablet) SCHEDULING STATUS: S5 PROPRIETARY NAME (and dosage form): DRL CITALOPRAM 20 (film-coated tablet) DRL CITALOPRAM 40 (film-coated tablet) COMPOSITION DRL CITALOPRAM 20: Each film-coated tablet contains citalopram hydrobromide equivalent to citalopram 20 mg DRL CITALOPRAM 40: Each film-coated tablet contains citalopram hydrobromide equivalent to citalopram 40 mg Sugar free PHARMACOLOGICAL CLASSIFICATION A 1.2 Psychoanaleptics (antidepressants) PHARMACOLOGICAL ACTION Citalopram is a bicyclic phthalane derivative with antidepressant effect. Its effect is linked to the selective inhibition of specific serotonin (5-HT) reuptake.Citalopram, primarily through its (S)-enantiomer, blocks 5-HT reuptake, leading to potentiation of serotonergic activity in the central nervous system (CNS). Neither citalopram nor its metabolites have an effect on noradrenaline, dopamine and GABA reuptake. Citalopram has little or no antidopaminergic, antiadrenergic, antiserotonergic, antihistaminergic or anticholinergic properties. Pharmacokinetics Oral bioavailability is about 80%with maximum plasma levels being reached in 4 hours (range 1 - 6 hours). Volume of distribution is about 14 L/kg (range 9 - 17 L/kg). Time to reach steady state concentration is 1 - 2 weeks. Protein binding is about 80%. Elimination half-life is 36 hours (range 28 - 42 hours). Citalopram undergoes hepatic metabolism primarily involving the cytochrome P 450 (CYP3A4) and 2C19 (CYP2C19) isoenzymes and to a small extent cytochrome P 450 2D6 (CYP2D6) isoenzymes. The metabolites inhibit the reuptake of serotonin but are less potent than the parent molecule. Citalopram is mainly excreted via the liver with the remainder via the kidneys (approximately 20% of which 12% is unch Read the complete document