Страна: Австралия
Език: английски
Източник: Department of Health (Therapeutic Goods Administration)
Olanzapine
Aurobindo Pharma Australia Pty Ltd
Olanzapine
OZIN ODT TM 5, 10, 15 & 20 CONSUMER MEDICINE INFORMATION Olanzapine orally disintegrating tablets WHAT IS IN THIS LEAFLET This leaflet answers some common questions people ask about OZIN ODT. It does not contain all the available information. It does not take the place of talking with your doctor or pharmacist. All medicines have risks and benefits. Your doctor will have weighed the risks of you taking OZIN ODT against the benefits they expect it will have for you.. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THIS MEDICINE. You may need to read it again. WHAT OZIN ODT IS USED FOR OZIN ODT belongs to a group of medicines called antipsychotics. It helps to correct chemical imbalances in the brain, which may cause mental illness. OZIN ODT is used to treat symptoms of schizophrenia and related psychoses. Schizophrenia is a mental illness with disturbances in thinking, feelings and behaviour. OZIN ODT alone, or in combination with lithium or valproate, is used for the short-term treatment of acute manic episodes associated with Bipolar I Disorder. OZIN ODT is also a mood stabiliser that prevents further occurrences of the disabling high and low (depressed) extremes of mood associated with Bipolar I Disorder. Bipolar I Disorder is a mental illness with symptoms such as feeling "high", having excessive amounts of energy, needing much less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability. Your doctor may have prescribed OZIN ODT for another reason. ALWAYS ASK YOUR DOCTOR IF YOU NEED MORE INFORMATION. This medicine is available only with a doctor's prescription. OZIN ODT is not recommended for use in children under the age of 18 years as there is not enough information on its effects in this age group. BEFORE YOU TAKE IT _ _ TELL YOUR DOCTOR IF YOU HAVE ANY OF THE FOLLOWING CONDITIONS OR IF YOU HAVE EVER EXPERIENCED ANY OF THESE CONDITIONS. _WHEN YOU MUST NOT TAKE IT: _ _ _ DO NOT TAKE OZIN ODT: IF YOU HAVE HAD AN Прочетете целия документ
Page 1 of 18 PRODUCT INFORMATION OZIN ODT TM 5, 10, 15 & 20 ORALLY DISINTEGRATING TABLETS NAME OF THE MEDICINE Active ingredient Olanzapine Chemical name 2-Methyl-4-(4-methylpiperazin-1-yl)-10_H_-thieno[2,3- _b_][1,5]benzodiazepine Molecular formula C 17 H 20 N 4 S Molecular weight 312.4 CAS number 132539-06-1 Chemical structure: DESCRIPTION Olanzapine is a yellow, crystalline powder. It is practically insoluble in water, freely soluble in methylene chloride, slightly soluble in ethanol (96 per cent). OZIN ODT is available as orally disintegrating tablets containing 5 mg, 10 mg, 15 mg & 20 mg olanzapine. OZIN ODT orally disintegrating tablets contain the following inactive ingredients: mannitol, polacrilin potassium, crospovidone, microcrystalline cellulose, aspartame, colloidal anhydrous silica, sodium stearyl fumarate and the proprietary ingredient, artificial pineapple FL SD #883. PHARMACOLOGY PHARMACODYNAMICS Olanzapine is an atypical antipsychotic, antimanic and mood stabilising agent that demonstrates a broad pharmacological profile across a number of receptor systems. In preclinical studies, olanzapine exhibited a range of receptor affinities (Ki; < 100 nmol) for serotonin 5HT 2A/2C , 5HT 3 , 5HT 6 ; dopamine D 1 , D 2 , D 3 , D 4 , D 5 ; cholinergic muscarinic receptors m1- m5; α 1 adrenergic; and histamine H 1 receptors. Animal behavioural studies with olanzapine indicated 5HT, dopamine and cholinergic antagonism, consistent with the receptor binding profile. Olanzapine demonstrated a greater _in-vitro _affinity for serotonin 5HT 2 than dopamine D 2 receptors and in _in-vivo _models, greater 5HT 2 than D 2 activity. Electrophysiological studies demonstrated that olanzapine selectively reduced the firing of mesolimbic (A10) dopaminergic neurons, while having little effect on the striatal (A9) pathways involved in motor function. Olanzapine reduced a conditioned avoidance response, a test indicative of antipsychotic activity, at doses below those Page 2 of 18 producing catalepsy, an effect indicative of m Прочетете целия документ