Riik: Malaisia
keel: inglise
Allikas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ZOLPIDEM TARTRATE
MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.
ZOLPIDEM TARTRATE
1000Tablet Tablets; 100Tablet Tablets
MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1 ANPRO-ZOLPIDEM TABLETS 10MG Zolpidem Tartrate (10mg) WHAT IS IN THIS LEAFLET 1. What Anpro-Zolpidem Tablets 10mg is used for 2. How Anpro-Zolpidem Tablets 10mg works 3. Before you take Anpro- Zolpidem Tablets 10mg 4. How to take Anpro-Zolpidem Tablets 10mg 5. While you are taking Anpro- Zolpidem Tablets 10mg 6. Side Effects 7. Storage and Disposal of Anpro-Zolpidem Tablets 10mg 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT ANPRO-ZOLPIDEM TABLETS 10MG IS USED FOR It is indicated in the treatment of sleep disorders in occasional insomnia (difficulty falling and/ or staying sleep) and transient (impermanent) insomnia. HOW ANPRO-ZOLPIDEM TABLETS 10MG WORKS? Zolpidem Tartrate is the active ingredient of Anpro-Zolpidem Tablets 10mg. It has similar sedative properties to benzodiazepine medicines. Zolpidem Tartrate belongs to a group of medicines called imidazopyridine hypnotics. It works by acting on your brain to help you sleep. BEFORE YOU TAKE ANPRO-ZOLPIDEM TABLETS 10MG _-When you must not take it _ If you are allergic (hypersensitive) to Zolpidem Tartrate or any other ingredients of Anpro-Zolpidem Tablets 10mg in the formulation. If you have acute and/or severe breathing problems. If you have severe, acute or chronic liver problem because of the risk of encephalopathy (disorder or disease of the brain). If you have sleep apnea (stop breathing for short periods at night). If you have severe muscle weakness problem (myasthenia gravis). - _Before you start to take it _ You must tell your doctor if: You have allergies to any medicine which you have taken previously to treat your current condition. You are pregnant, trying to conceive or breast-feeding. You are dependent on alcohol or other medicines. You have insomnia. You are suffering from major depression. You are elderly or suffering from kidney or liver impairment, which exposed to accumulation risk upon taking Zolpidem Lugege kogu dokumenti
7179-03 ANPRO-ZOLPIDEM TABLETS 10MG NAME AND STRENGTH OF ACTIVE INGREDIENT(S): Each tablet contains: Zolpidem Tartrate………………………………………………10mg PRODUCT DESCRIPTION: A yellow, oblong tablet of size 10 x 4mm. PHARMACODYNAMICS: Pharmacologically, zolpidem binds selectively to the omega-1 subclass (or BZ1) of benzodiazepine receptors in the brain without binding to peripheral benzodiazepine receptors. This has been corroborated by the observation that zolpidem has little or no muscle relaxant properties. Zolpidem has been shown to reduce sleep latency (time to fall asleep), decrease the number of awakenings, and to increase total sleep time. While REM sleep is not significantly decreased, the onset of REM is delayed. The REM/non-REM ratio is not significantly altered. Slow wave (stage 3 and 4) sleep time is increased. This more closely resembles natural sleep than does hypnosis induced by the benzodiazepines; this may result in fewer adverse reactions related to disturbance of normal sleep patterns. PHARMACOKINETICS: _Absorption _ Zolpidem is rapidly absorbed from the gastrointestinal tract after oral doses, peak plasma concentrations occuring within 3 hours. Bioavailability, Oral, tablets: 70% Effect of food : decreased systemic exposure (decreased Cmax and AUC; increased Tmax) _Distribution _ Zolpidem is about 92% bound to plasma proteins. The distribution volume in adults is 0.54L/kg. Zolpidem is distributed into breast milk. _Metabolism _ Liver, extensive Zolpidem undergoes first-pass metabolism. It is metabolised mainly by the cytochrome P450 isoenzyme CYP3A4; _Elimination _ Zolpidem has an elimination half-life of about 2.5 hours. The inactive metabolites of zolpidem are excreted in the urine and faeces. Zolpidem is not dialysable. _Populations at risk _ In patients with renal insufficiency, whether dialysed or not, a moderate decrease in clearance is observed. Other kinetic parameters remain unchanged. In patients with hepatic insufficiency, the bioavailability of zolpi Lugege kogu dokumenti