Maa: Etelä-Afrikka
Kieli: englanti
Lähde: South African Health Products Regulatory Authority (SAHPRA)
Dr-reddy
CITRAZ 5 (film-coated tablets) CITRAZ 10 (film-coated tablets) CITRAZ 20 (film-coated tablets) SCHEDULING STATUS: S5 PROPRIETARY NAME (and dosage form): CITRAZ 5 (film-coated tablets) CITRAZ 10 (film-coated tablets) CITRAZ 20 (film-coated tablets) COMPOSITION CITRAZ 5: Each film-coated tablet contains escitalopram oxalate equivalent to escitalopram 5 mg CITRAZ 10: Each film-coated tablet contains escitalopram oxalate equivalent to escitalopram 10 mg CITRAZ 20: Each film-coated tablet contains escitalopram oxalate equivalent to escitalopram 20 mg PHARMACOLOGICAL CLASSIFICATION A 1.2 Psychoanaleptics (antidepressants) PHARMACOLOGICAL ACTION Mechanism of action Escitalopram is a selective inhibitor of serotonin (5-HT)-uptake. Escitalopram has minimal effect on noradrenaline (NA), dopamine (DA) and gamma aminobutyric acid (GABA) uptake. Escitalopram has no or very low affinity for a series of receptors including 5-HT 1A , 5-HT 2 , DA, D 1 and D 2 receptors, alpha 1 -, alpha 2 -, beta-adrenoceptors, histamine H 1 , muscarine cholinergic, benzodiazepine and opioid receptors. Pharmacokinetic properties Absorption Absorption is independent of food intake (mean T max is 4 hours after multiple dosing). Distribution The apparent volume of distribution (V d, â /F) after oral administration is about 12 to 26 L/kg. The plasma protein binding of escitalopram is approximately 55%. Biotransformation Escitalopram is metabolised in the liver to the demethylated and didemethylated metabolites. Alternatively, the nitrogen may be oxidised to form the N-oxide metabolite. Both parent substance and metabolites are partly excreted as glucuronides. Unchanged escitalopram is the predominant compound in plasma. After multiple dosing the mean concentrations of the demethyl- and didemethyl metabolites are usually 28 - 31% and <5% of Lue koko asiakirja