Država: Malezija
Jezik: engleski
Izvor: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
OLANZAPINE
LABORATORIES TORRENT (MALAYSIA) SDN. BHD.
OLANZAPINE
30tablet Tablets; 100tablet Tablets; 10tablet Tablets
TORRENT PHARMACEUTICALS LTD.
TOLANZ TABLET _ _ Olanzapine (5 mg, 10 mg) _ _ _ _ 1 _ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What is Tolanz used for 2. How Tolanz works 3. Before you use Tolanz 4. How to use Tolanz 5. While you are using it 6. Side effects 7. Storage and Disposal of Tolanz 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT TOLANZ IS USED FOR Olanzapine belongs to a group of medicines called antipsychotics and is used to treat the following conditions: • Schizophrenia, a disease with symptoms such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn. People with this disease may also feel depressed, anxious or tense. • Maintaining the clinical improvement during continuation therapy in people who have shown an initial treatment response. • Moderate to severe manic episodes, a condition with symptoms of excitement or euphoria. Tolanz has been shown to prevent recurrence of these symptoms in individual with bipolar disorder whose manic episode has responded to Tolanz treatment. HOW TOLANZ WORKS Olanzapine acts on a receptors named as serotonin receptors and by this it exhibits antipsychotic properties. BEFORE YOU USE TOLANZ - _When you must not use it _ Do not take Tolanz: • If you are allergic (hypersensitive) to olanzapine or any of the other ingredients of Tolanz. An allergic reaction may be recognized as a rash, itching, a swollen face, swollen lips or shortness of breath. If this has happened to you, tell your doctor. • If you have been previously diagnosed with eye problems such as certain kinds of glaucoma (increased pressure in the eye). _Pregnancy and lactation_ _ _ If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. You should not be given this medicine when breast-feeding, as small amounts of Tolanz can pass into breast milk. Ask your doctor or pharmacist for Pročitajte cijeli dokument
xxxxxxxx-xxxx For the use of a Registered Medical Practitioner or a Hospital or a Laboratory only. NAME AND STRENGTH OF ACTIVE SUBSTANCE(S) TOLANZ TABLET 5 MG Each uncoated tablet contains Olanzapine USP 5 mg TOLANZ TABLET 10 MG Each uncoated tablet contains Olanzapine USP 10 mg DOSAGE FORM Uncoated Tablets PRODUCT DESCRIPTION TOLANZ TABLET 5 MG Yellow colored, round, biconvex uncoated tablets debossed with “5” on one side and “67” on other side. TOLANZ TABLET 10 MG Yellow colored, round, biconvex uncoated tablets debossed with “10” on one side and “169” on other side. CLINICAL PHARMACOLOGY PHARMACODYNAMICS Olanzapine is an antipsychotic agent that demonstrates a broad pharmacologic profile across a number of receptor systems. Olanzapine exhibited a range of receptor affinities (Ki; < 100 nM) for serotonin 5 HT2A/2C, 5 HT3, 5HT6; dopamine D1, D2, D3, D4, D5; cholinergic muscarinic. It is reported that olanzapine reduced a conditioned avoidance response, a test indicative of antipsychotic activity, at doses below those producing catalepsy, an effect indicative of motor side-effects. Unlike some other antipsychotic agents, olanzapine increases responding in an “anxiolytic” test. Olanzapine produced a higher 5-HT2 A than dopamine D2 receptor occupancy. In addition, olanzapine-responsive patients had lower striatal D2 occupancy than some other antipsychotic and risperidone-responsive patients, while being comparable to clozapineresponsive patients. It is reported that olanzapine was associated with statistically significantly greater improvements in negative as well as positive symptoms. PHARMACOKINETICS Olanzapine is well absorbed after oral administration reaching peak plasma concentrations within 5 to 8 hours. The absorption is not affected by food. Olanzapine is metabolized in the liver by conjugative and oxidative pathways. The major circulating metabolite is the 10-N-glucuronide which does not pass the blood brain barrier. Cytochromes P450- CYP1A2 and P450-CYP2D6 contribute to the formation Pročitajte cijeli dokument