Pays: Malaisie
Langue: anglais
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ESCITALOPRAM OXALATE
HOVID BERHAD
ESCITALOPRAM OXALATE
30 Tablets; 10 Tablets; 100 Tablets
HOVID BERHAD
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ HOVID-ESCITALOPRAM TABLET _ _ Escitalopram (as oxalate) (10mg, 20mg) Page no. WHAT IS IN THIS LEAFLET 1. What hovid-Escitalopram is used for 2. How hovid-Escitalopram works 3. Before you use hovid-Escitalopram 4. How to use hovid-Escitalopram 5. While you are using it 6. Side effects 7. Storage and Disposal of hovid- Escitalopram 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT HOVID-ESCITALOPRAM IS USED FOR hovid-Escitalopram contains escitalopram and is used to treat: • depression • panic disorder with or without agoraphobia (fear of public or open spaces) • social anxiety disorder/social phobia (fear or avoidance of social situations) • obsessive-compulsive disorder (OCD) (persistent, obsessive thoughts that make you carry out repetitive behaviour) HOW HOVID-ESCITALOPRAM WORKS hovid-Escitalopram contains the active substance escitalopram. hovid- Escitalopram belongs to a group of antidepressants called selective serotonin reuptake inhibitors (SSRIs). These medicines act on the serotonin- system in the brain by increasing the serotonin level. Disturbances in the serotonin-system are considered an important factor in the development of depression and related diseases. BEFORE YOU USE HOVID- ESCITALOPRAM _- When you must not use it _ Do not take: • if you are allergic to escitalopram or any of the other ingredients of this medicine (listed in section _Product Description_ ). • If you take other medicines which belong to a group called monoamine oxidase inhibitors (MAOIs) (see subsection _Taking _ _other medicines_ ). Taking hovid- Escitalopram with a MAOI may cause a serious, sometimes fatal, reaction with features resembling serotonin syndrome (see section Side effects). • at the same time as taking pimozide (used in the treatment of mental disorders or nervous system disorders) • _- Before you start to use it _ Please tell your doctor if you have any other condition or illness, Lire le document complet
HOVID-ESCITALOPRAM TABLET VIESC01-var4 DESCRIPTION hovid-Escitalopram Tablet 10mg: Oval, white film-coated tablet, shallow convex and scored on one face hovid-Escitalopram Tablet 20mg: Oval, white film-coated tablet, shallow convex with ‘H’, ‘D’ and break bar embossed on one face COMPOSITION hovid-Escitalopram Tablet 10mg: Escitalopram oxalate 12.775mg equivalent to Escitalopram 10mg hovid-Escitalopram Tablet 20mg: Escitalopram oxalate 25.55mg equivalent to Escitalopram 20mg PHARMACODYNAMICS Escitalopram is a selective inhibitor of serotonin (5-HT) re-uptake with high affinity for the primary binding site. It also binds to an allosteric site on the serotonin transporter, with a 1000 fold lower affinity. Escitalopram has no or low affinity for a number of receptors including 5-HT1A, 5-HT2, DA D1 and D2 receptors, α1-, α2-, β-adrenoceptors, histamine H1, muscarine cholinergic, benzodiazepine, and opioid receptors. The inhibition of 5-HT re-uptake is the only likely mechanism of action explaining the pharmacological and clinical effects of escitalopram. PHARMACOKINETICS ABSORPTION Absorption is almost complete and independent of food intake. (Mean time to maximum concentration (mean T max ) is 4 hours after multiple dosing). As with racemic citalopram, the absolute bioavailability of escitalopram is expected to be about 80%. DISTRIBUTION The apparent volume of distribution (Vd,β/F) after oral administration is about 12 to 26 L/kg. The plasma protein binding is below 80% for escitalopram and its main metabolites. METABOLISM Escitalopram is metabolised in the liver to the demethylated and didemethylated metabolites. Both of these are pharmacologically active. Alternatively, the nitrogen may be oxidised to form the N-oxide metabolite. Both parent substance and metabolites are partly excreted as glucuronides. After multiple dosing the mean concentrations of the demethyl and didemethyl metabolites are usually 28-31% and <5%, respectively, of the escitalopram concentration. Biotransformation of escitalopram to Lire le document complet