Each film-coated tablet contains: Olanzapine 10 mg.
Antipsychotic.
Pharmacology: Pharmacokinetics: Olanzapine is well absorbed from the gastrointestinal tract after oral. Olanzapine is about 93% bound to plasma proteins. It is extensively metabolized in the liver, primarily by direct glucuronidation and by oxidation mediated through the cytochrome P450 isoenzymes CYP1A2 and to lesser extent, CYP2D6. The 2 major metabolites 10-N-glucoronide and 4A-N-desmetyhlolanzapine appear to be inactive. About 57% of a dose is excreted in the urine, mainly as metabolites, and about 30% appears in the faeces. The mean plasma elimination half-life has been variously reported to be about 30 to 38 hours; half-lives tend to be longer in female than in male patients. Olanzapine distributed into breast milk.
Olanzapine is a thianodiazepine atypical antipsychotic. It is used for the management of schizophrenia and for the treatment of moderate to severe mania associated with bipolar disorder.
Schizophrenia combination therapy for mania, preventing recurrence in bipolar disorder in adults over 18 years old, 10 mg daily maybe adjusted to range of 5-20 mg daily. Doses greater than 15 mg only after reassessment. Maximum of 20 mg daily or as prescribed by the physician.
Olanzapine may affect the performance of skilled tasks such as driving.
Withdrawal symptoms, including sweating, tremor, anxiety and nausea and vomiting have occurred rarely when olanzapine has been stopped abruptly, a gradual reduction may be appropriate when stopping olanzapine.
The most frequent adverse effects with olanzapine are somnolence and weight gain, hyperprolactinaemia is also common, but usually asymptomatic. Increased appetite, dizziness, elevated plasma glucose; orthostatic hypotension and mild transient antimuscarinic effects such as constipation and dry mouth are also relatively common.
The central effects of other CNS depressants, including alcohol may be enhanced by olanzapine. Olanzapine may antagonize the effects of dopaminergics. Neutropenia may be more common when olanzapine is with valproate. There is a theoretical risk of QT prolongation when olanzapine is given with other drugs that are known to cause this effect.
The metabolism of olanzapine is mediated to some extent by the cytochrome P450 isoenzyme CYPIA2. Use with drugs that inhibit, induce or act as a substrate to this isoenzyme may affect plasma concentrations of olanzapine and a dose adjustment of olanzapine may be required. The CYPIA2 inhibitor fluvoxamine significantly inhibits the metabolism of olanzapine. The clearance of olanzapine is increased by tobacco, smoking and carbamazepine.
Store at temperatures not exceeding 30°C. Should be protected from light and moisture.
N05AH03 - olanzapine ; Belongs to the class of diazepines, oxazepines and thiazepines antipsychotics
Olanzapro FC tab 10 mg
30's