País: Malasia
Idioma: inglés
Fuente: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SERTRALINE HYDROCHLORIDE
UNIMED SDN BHD
SERTRALINE HYDROCHLORIDE
100 Tablet Tablets; 28Tablet Tablets
Aurobindo Pharma Limited (Unit III),
AURASERT TABLETS Sertraline Tablets (50mg, 100mg) 1 _Consumer Medication Information Leaflet (RiMUP)_ WHAT IS IN THIS LEAFLET 1. What Aurasert is used for 2. How Aurasert works 3. Before you use Aurasert 4. How to use Aurasert 5. While you are using it 6. Side effects 7. Storage and Disposal of Aurasert 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT AURASERT IS USED FOR • For the treatment of symptoms of depressive illness including accompanying symptoms of anxiety. It is also indicated in preventing relapse of the initial episode of depression or recurrence of further depressive episodes including accompanying symptoms of anxiety. • In the treatment of obsessions (persistent, obsessive thoughts) and compulsions (uncontrollable, repetitive behavior) in patients with obsessive compulsive disorder (OCD). • For the treatment of panic disorder with or without agoraphobia (fear of public or open spaces). HOW AURASERT WORKS Aurasert contains the active ingredient Sertraline and is one of a group of medicines called Selective Serotonin Re- uptake Inhibitors (SSRIs); Serotonin is one of the chemicals in your brain which helps control your mood. Sertraline blocks the reabsorption of serotonin by the nerve cells, thereby increasing the amount of serotonin in your brain. BEFORE YOU USE AURASERT - _When you must not use it _ Do not take sertraline if: • You are allergic to sertraline or any of the other ingredients of this medicine (see section PRODUCT DESCRIPTION ). • You are taking or have recently taken medicines called monoamine oxidase inhibitors (MAOIs, including selegiline and moclobemide) or MAOI like drugs (such as linezolid). • Aurasert should not be used concomitantly to patients taking monoamine oxidase inhibitors, while switching from an MAOI to sertraline or vice-versa, a washout period of at least 14 days should elapse. • Do not take Aurasert if you are currently taking pimozide. Taking Sertaline with a MAOI may cause a serious, fatal reaction wit Leer el documento completo
D3 PACKAGE INSERT Aurasert 50 (Sertraline Tablets 50mg) Aurasert 100 (Sertraline Tablets 100mg) DESCRIPTION AND COMPOSITION: AURASERT 50 White coloured, biconvex, capsule shaped, film coated tablets debossed with 'A' on one side and with a score line in between '8' and '1' on the other side. Each film-coated tablet contains: Sertraline hydrochloride equivalent to sertraline 50mg AURASERT 100 White coloured, biconvex, capsule shaped film coated tablets debossed with 'A' on one side and '82' on the other side. Each film-coated tablet contains: Sertraline hydrochloride equivalent to sertraline 100mg PHARMACODYNAMICS: Sertraline is a potent and selective inhibitor of neuronal serotonin (5-HT) reuptake. It has only a weak effect on Neuronal uptake of nor-epinephrine and dopamine. Sertraline's inhibition of serotonin reuptake enhances serotonergic transmission. _In vitro _studies have shown that sertraline has no significant affinity for adrenergic, muscarinic, cholinergic, gamma aminobutyric acid (GABA), dopaminergic, serotonergic (5HT1A, 5HT1B, 5HT2) histaminergic or benzodiazepine receptors. PHARMACOKINETICS The gastrointestinal absorption of sertraline is slow but consistent. Sertraline undergoes extensive first pass metabolism in the liver. The bioavailability is slightly increased if sertraline is taken with food. Mean peak plasma concentrations of about 20-55 mcg/l occur between 4.5-8.4 hours after administration of a single 100mg dose. Sertraline is approximately 98% bound to plasma proteins. Both sertraline and its metabolites are extensively distributed into tissues. The metabolite n-desmethylsertraline exhibits only about 1/8 of its activity. It does not contribute to the antidepressant activity or toxicity of the parent compound. Both sertraline and its metabolite undergo oxidative deamination and subsequent reduction, hydroxylation and glucuronide conjugation. Only 0.2% of the unchanged drug is excreted through the kidneys. The elimination half-life of sertraline is 24 to 26 hours. The pharmacokinetics of Leer el documento completo