Olzap 10 Tablet

Generic Name: Olanzapine

Strength: 10 mg

Manufacturer: Opsonin Pharma Ltd.

Indications:

• Schizophrenia

• Mania

• Bipolar disorder

• Agitation

Pharmacology:

• Olzap (Olanzapine) is an atypical antipsychotic agent.

• It has affinities for serotonin 5HT2A/2C, 5HT3, 5HT6; dopamine D1, D2, D3, D4, D5; cholinergic muscarinic receptors M1-M5; α1 adrenergic; and histamine H1 receptors.

• The mechanism of action of Olanzapine, like other drugs effective in schizophrenia, is unknown. However, it's proposed that its efficacy is mediated through a combination of dopamine and serotonin type 2 (5HT2) antagonism.

• Olanzapine is well absorbed after oral administration, reaching peak plasma concentrations within 5 to 8 hours. Food does not affect absorption.

• Olanzapine is not mutagenic, clastogenic, or carcinogenic.

Dosage and Administration:

• Schizophrenia, Combination Therapy for Mania, Bipolar Disorder: The initial dose is 5-10 mg once daily. The daily dosage may be adjusted based on individual clinical status within the range of 5-20 mg daily. Doses greater than 10 mg daily should only be considered after reassessment. The maximum dose is 20 mg daily.

• Monotherapy for Mania: The initial dose is 15 mg once daily. The daily dosage may be adjusted based on individual clinical status within the range of 5-20 mg daily. Doses greater than 15 mg should only be considered after reassessment. The maximum dose is 20 mg daily.

• Olanzapine can be given without regard to meals. Gradual tapering of the dose should be considered when discontinuing Olanzapine.

Contraindications:

• Olanzapine is contraindicated in patients with a known hypersensitivity to any ingredient of the product and in patients with a known risk for narrow-angle glaucoma.

Side Effects:

• Very common undesirable effects are somnolence and weight gain.

• Other possible side effects include increased appetite, elevated glucose levels, elevated triglyceride levels, dizziness, akathisia, Parkinson's disease, dyskinesia, orthostatic hypotension, mild and transient anticholinergic effects (including constipation and dry mouth), asthenia, edema, and photosensitivity reaction.

Pregnancy and Lactation:

• Olanzapine should be used in pregnancy only if the potential benefits justify the potential risk to the fetus. Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during treatment with Olanzapine.

• Patients should not breastfeed if they are taking Olanzapine.

Drug Interactions:

• Olanzapine may antagonize the effects of levodopa and dopamine agonists.

• Drugs that induce CYP1A2 or glucuronyl transferase enzymes (e.g., omeprazole and rifampicin) may increase Olzap clearance.

• Inhibitors of CYP1A2 may potentially inhibit Olzap elimination.

• Carbamazepine may increase the clearance of Olzap.

• Caution should be taken when Olzap is administered with centrally acting drugs and alcohol.