Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ARIPIPRAZOLE
UNIMED SDN BHD
ARIPIPRAZOLE
100tablet Tablets; 30tablets Tablets
Indoco Remedies Limited
ARIAN TABLETS Aripiprazole (10mg, 15mg, 20mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What ARIAN is used for 2. How ARIAN works 3. Before you use ARIAN 4. How to use ARIAN 5. While you are using it 6. Side effects 7. Storage and Disposal of ARIAN 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT ARIAN IS USED FOR ARIAN is one of a group of medicines called antipsychotics. It is used to treat schizophrenia and related manic disorders in patients who suffer from a disease characterized by symptoms such as hearing, seeing or sensing things which are not there, suspiciousness, mistaken beliefs, incoherent speech and behavior and emotional flatness. People with this conditions may also feel depressed, guilty, anxious or tense. HOW ARIAN WORKS ARIAN works by acting on various receptors in the brain, particularly dopamine receptors and serotonin (5HT) receptors. Dopamine and serotonin are natural compounds called neurotransmitters, and are involved in transmitting messages between brain cells. Psychotic illness is considered to be caused by disturbances in the activity of neurotransmitters (mainly dopamine) in the brain. Aripiprazole is thought to work mainly by stabilising the dopamine activity in the brain. BEFORE YOU USE ARIAN - _When you must not use it _ _ _ DO NOT TAKE ARIAN: If you are allergic (hypersensitive) to ARIAN or any of the other ingredients of ARIAN. _ _ _Pregnancy and lactation _ Pregnancy Ask your doctor or pharmacist for advice before taking any medicine. Be sure to tell your doctor immediately if you are pregnant, think you may be pregnant, or if you are planning to become pregnant. Breastfeeding Ask your doctor or pharmacist for advice before taking any medicine. If you are taking ARIAN, you should not breast-feed. _-Before you start use it _ TELL YOUR DOCTOR IF YOU SUFFER FROM : High blood sugar (characterized by symptoms such as excessive thirst, passing of large amounts of urine, increase in appetite, feel Baca dokumen lengkap
ARIAN 10 MG TABLETS (ARIPIPRAZOLE 10 MG TABLETS) ARIAN 15 MG TABLETS (ARIPIPRAZOLE 15 MG TABLETS) ARIAN 20 MG TABLETS (ARIPIPRAZOLE 20 MG TABLETS) DESCRIPTION AND COMPOSITION: _ARIAN 10 MG TABLETS: _ White, uncoated, oval shaped beveled edged tablets. Each uncoated tablet contains 10 mg of Aripiprazole. _ARIAN 15 MG TABLETS: _ White, uncoated, round, biconvex, beveled edged tablets. Each uncoated tablet contains 15 mg of Aripiprazole. _ARIAN 20 MG TABLETS: _ White, uncoated, round, biconvex tablets. Each uncoated tablet contains 20 mg Aripiprazole. PHARMACODYNAMICS Aripiprazole is a psychotropic drug intended for the treatment of schizophrenia and related manic disorders. Aripiprazole exhibits high affinity for dopamine D2 and D3, serotonin 5.HT1A and 5.HT2A receptors, moderate affinity for dopamine D4, serotonin 5.HT2C and 5.HT7, alpha 1.adrenergic and histamine HI receptors and moderate affinity for the serotonin reuptake site. Aripiprazole has no appreciable affinity for cholinergic muscarinic receptors. The exact mechanism of action of aripiprazole is unknown. However, it has been proposed that the efficacy of aripiprazole is medicated through a combination of partial agonist activity at D2 and 5.HT1A receptors and antagonist activity at 5-HT2A receptors. PHARMACOKINETICS Aripiprazole is well absorbed after administration of the tablet, with peak plasma concentrations occurring within 3 hours to 5 hours; the absolute oral bioavailability of the tablet formulation is 87%. ARIAN tablets can be administered with or without food. At therapeutic concentrations, Aripiprazole and its major metabolite are greater than 99% bound to serum proteins, primarily to albumin. In healthy human volunteers administered 0.5 mg/day to 30 mg/day Aripiprazole for 14 days, there was dose-dependent D2 receptor occupancy indicating brain penetration of Aripiprazole in humans. Aripiprazole is metabolized primarily by three biotrasformation pathways: dehydrogenation, hydroxylation, and N-dealkylation. Based on in vitro studies, CYP3A4 a Baca dokumen lengkap