국가: 말레이시아
언어: 영어
출처: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DIAZEPAM
IDAMAN PHARMA MANUFACTURING SDN BHD
DIAZEPAM
30 Tablets; 1000 Tablets
IDAMAN PHARMA MANUFACTURING SDN BHD
IDAMAN PHARMA DIAZEPAM TABLET 10MG Diazepam 10mg 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Idaman Pharma Diazepam Tablet 10mg is used for 2. How Idaman Pharma Diazepam Tablet 10mg works 3. Before you use Idaman Pharma Diazepam Tablet 10mg 4. How to use Idaman Pharma Diazepam Tablet 10mg 5. While you are using it 6. Side Effects 7. Storage and Disposal of Idaman Pharma Diazepam Tablet 10mg 8. Product Description 9. Product Registration Holder & Manufacturer 10. Date of Revision WHAT IDAMAN PHARMA DIAZEPAM TABLET 10MG IS USED FOR Idaman Pharma Diazepam Tablet 10mg is used to: • Relieve anxiety in short - term (2-4 weeks). • Help to relax muscles during muscle spasm. • An adjunct to certain seizures. • Treat acute alcohol withdrawal symptoms. • Relieve anxiety and tension before operative procedures. • As oral premedication for the nervous dental patient. HOW IDAMAN PHARMA DIAZEPAM TABLET 10MG WORKS Idaman Pharma Diazepam Tablet 10mg belongs to a group of medicines called benzodiazepines. It is thought to work by acting on chemicals in the brain as a tranquilizer. BEFORE YOU USE IDAMAN PHARMA DIAZEPAM TABLET 10MG _- When you must not use it _ Do not take Idaman Pharma Diazepam Tablet 10mg and tell your doctor if: • You are allergic to diazepam or to other benzodiazepine medicines or to any of the other ingredients in your tablets (see section PRODUCT DESCRIPTION ). • You have acute-close angle glaucoma (high pressure in the eye) • You have myasthenia gravis (a condition which causes muscles to weaken and tire easily) • You have severe breathing problems (severe obstructive disease) • You have severe liver dysfunction • You have sleep apnea syndrome. _ _ _- Before you start to use Idaman Pharma _ _Diazepam Tablet 10mg _ Get advice from your doctor or pharmacist if: • You are elderly or suffer severe weakness • You have arteriosclerosis (thickening or hardening of blood vessels) • You have liver or kidney problems • You have breathing difficulty 전체 문서 읽기
IDAMAN PHARMA MANUFACTURING IDAMAN PHARMA DIAZEPAM TABLET 10MG PRODUCT DESCRIPTION Clean, dry, uniform, round, flat, bevel edged tablets and scored on one side. Colour: Blue. Each tablet contains Diazepam 10mg Source of lactose: Bovine ROUTE OF ADMINISTRATION Oral PHARMACODYNAMICS Diazepam is a benzodiazepine tranquilliser with anticonvulsant, sedative, muscle relaxant and amnesic properties. Benzodiazepines, such as diazepam, bind to receptors in various regions of the brain and spinal cord. This binding increases the inhibitory effects of gamma-aminobutyric acid (GABA). GABAs functions include CNS involvement in sleep induction. Also involved in the control of hypnosis, memory, anxiety, epilepsy and neuronal excitability. PHARMACOKINETICS ABSORPTION Diazepam is readily and completely absorbed from the GI tract. Peak plasma concentrations occurring within about 30-90 minutes of oral administration, a steady plasma concentration is reached after 5-6 days and is directly related to dose. DISTRIBUTION Diazepam crosses the blood-brain barrier and is highly lipid soluble, this causes the initial effects to decrease rapidly as it is redistributed into fat deposits and tissues Diazepam is very extensively bound to plasma proteins (98-99%). Diazepam and its metabolites also enters breast milk and crosses the placenta freely, this may lead to accumulation in the infant or foetus. BIOTRANSFORMATION Diazepam is extensively metabolised in the liver and, in addition to desmethyldiazepam, its active metabolites include oxazepam and temazepam. Diazepam has a biphasic half-life with an initial rapid distribution phase followed by a prolonged terminal elimination phase of 1 or 2 days; its action is further prolonged by the even longer half-life of 2-5 days of its principle active metabolite, desmethyldiazepam (nordiazepam), the relative proportion of which increases in the body on long-term administration. The plasma half-life of diazepam is prolonged in neonates, in the elderly, and in patients with kidney or liver disease. ELI 전체 문서 읽기