País: Austràlia
Idioma: anglès
Font: Department of Health (Therapeutic Goods Administration)
olanzapine, Quantity: 2.5 mg
Strides Pharma Science Pty Ltd
Olanzapine
Tablet, uncoated
Excipient Ingredients: hyprolose; magnesium stearate; lactose monohydrate; crospovidone
Oral
30
(S4) Prescription Only Medicine
Olanzapine is indicated for the treatment of schizophrenia and related psychoses. ,Olanzapine alone or in combination with lithium or valproate is indicated for the short-term treatment of acute manic episodes associated with Bipolar I Disorder. ,Olanzapine is indicated for preventing recurrence of manic, mixed or depressive episodes in Bipolar I Disorder.
Visual Identification: Yellow coloured, circular, biconvex uncoated tablets, debossed with "C" on one side and "45" on the other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2011-11-15
OZIN™ 2.5, 5, 7.5 & 10 CONSUMER MEDICINE INFORMATION Olanzapine tablets WHAT IS IN THIS LEAFLET This leaflet answers some common questions people ask about OZIN. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor will have weighed the risks of you taking OZIN 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 THE MEDICINE. You may need to read it again. WHAT OZIN IS USED FOR OZIN belongs to a group of medicines called antipsychotics. It helps to correct chemical imbalances in the brain, which may cause mental illness. OZIN is used to treat symptoms of schizophrenia and related psychoses. Schizophrenia is a mental illness with disturbances in thinking, feelings and behaviour. OZIN 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 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 for another reason. ALWAYS ASK YOUR DOCTOR IF YOU NEED MORE INFORMATION. This medicine is available only with a doctor’s prescription. OZIN 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: IF YOU HAVE HAD AN ALLERGIC REACTION TO OZIN OR TO ANY OF THE INGREDIENTS LISTED Llegiu el document complet
Page 1 of 17 PRODUCT INFORMATION OZIN TM 2.5, 5, 7.5 & 10 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 tablets contain either 2.5 mg, 5 mg, 7.5 mg or 10 mg of olanzapine. INACTIVE: lactose, crospovidone, hydroxypropylcellulose & magnesium stearate._ _ 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 m 1 -m 5 ; 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 producing catalepsy, an effect indicative of motor side-effects. Unlike some other antipsychotic agents, olanzapine increased responding in an ‘anxiolytic’ test. Page 2 of 17 In a single 10 mg oral dose Positron Emission Tomography (PET) study in healthy volunteers, olanzapine produced higher receptor oc Llegiu el document complet