Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ESCITALOPRAM OXALATE
Generic Health Sdn. Bhd.
ESCITALOPRAM OXALATE
30tablet Tablets
Jubilant Generics Limited
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ LUPILOPRAM TABLETS Escitalopram oxalate (10mg and 20mg) 1 WHAT IS IN THIS LEAFLET 1. What Lupilopram Tablets is used for 2. How Lupilopram Tablets works 3. Before you take Lupilopram Tablets 4. How to take Lupilopram Tablets 5. While you are using Lupilopram Tablets 6. Side Effects 7. Storage and Disposal of Lupilopram Tablets 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 1. WHAT LUPILOPRAM TABLETS IS USED FOR Lupilopram Tablets is used to treat depression (major depressive episodes) and anxiety disorders [such as panic disorder with or without agoraphobia (fear of leaving home, entering shops or fear of being at open and public places), social anxiety disorder (fear or avoidance of social situations) and obsessive- compulsive disorder (persistent, obsessive thoughts that make you carry out repetitive behaviour)]. 2. HOW LUPILOPRAM TABLETS WORKS Lupilopram Tablets 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. 3. BEFORE YOU TAKE LUPILOPRAM TABLETS _WHEN YOU MUST NOT TAKE IT _ Do not take: if you are allergic (hypersensitive) to escitalopram or any of the other ingredients of Lupilopram Tablets. If you take other medicines that belong to a group called monoamine oxidase (MAO) inhibitors, including selegiline (used in the treatment of Parkinson´s disease), moclobemide (used in the treatment of depression) and linezolid (an antibiotic). Taking Lupilopram with MAO inhibitors may cause serious and sometimes fatal reactions with features resembling serotonin syndrome such as high fever, agitation, confusion, trembling and abrupt contractions of muscles. If you feel like this, contact your doctor. If you are born with or have had an episode of abnorma Baca dokumen lengkap
For the use of a registered medical practitioner or a hospital or a laboratory only LUPILOPRAM TABLETS 10 MG & 20 MG PRODUCT NAME: Lupilopram Tablets 10 mg Lupilopram Tablets 20 mg NAME AND STRENGTH OF ACTIVE INGREDIENT: Each film-coated tablet contains: Escitalopram Oxalate equivalent to Escitalopram 10 mg Escitalopram Oxalate equivalent to Escitalopram 20 mg PRODUCT DESCRIPTION: ESCITALOPRAM TABLETS 10 MG White, oval shaped, biconvex, film-coated tablets, with scoreline on one side, debossed with ‘B’ on left side of scoreline and ‘3’ on right side of scoreline and plain on the other side. ESCITALOPRAM TABLETS 20 MG White, oval shaped, biconvex, film-coated tablets, with scoreline on one side, debossed with ‘B4’ on side of scoreline and plain on the other side. PHARMACODYNAMICS / PHARMACOKINETICS: Pharmacodynamic Properties Pharmacotherapeutic groups: anti-depressants, selective serotonin reuptake inhibitors ATC-code: N06AB10 MECHANISM OF ACTION 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-HT 1A , 5-HT 2 , DA D 1 and D 2 receptors, α 1 -, α 2 -, β-adrenoceptors, histamine H 1 , 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 (V d , 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. BIOTRANSFORMATIO Baca dokumen lengkap