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Olanzapin

Olanzapine
Film-coated tablets 30 x 5 mg; 30 x 10 mg

ATC N05A H03
Prescription-only medicine
Reimburse by Health Insurance Fund

POSOLOGY AND METHOD OF ADMINISTRATION

Adults

Schizophrenia

The recommended starting dose for olanzapine is 10mg/day.

Manic Episode

The starting dose is 15mg as a single daily dose in monotherapy or 10mg daily in combination therapy.

Preventing recurrence in bipolar disorder: The recommended starting dose is 10mg/day.

For patients who have been receiving olanzapine for the treatment of manic episodes, continue therapy for preventing recurrence at the same dose. If a new manic, mixed, or depressive episode occurs, olanzapine treatment should be continued (with dose optimization as needed), with supplementary therapy to treat mood symptoms, as clinically indicated.

During treatment for schizophrenia, manic episode, and recurrence prevention in bipolar disorder, daily dosage may subsequently be adjusted on the basis of individual clinical status within the range of 5-20mg/day. An increase to a dose greater than the recommended starting dose is advised only after appropriate clinical reassessment and should generally occur at intervals of not less than 24 hours.

Olanzapine can be given without regard for meals, as absorption is not affected by food. Gradual tapering of the dose should be considered when discontinuing olanzapine. There is no experience for the use of olanzapine at children.

Elderly: A lower starting dose (5mg/day) is not routinely indicated but should be considered for those 65 and over when clinical factors warrant.
Renal and/or hepatic impairment: A lower starting dose (5mg) should be considered for such patients. In cases of moderate hepatic insufficiency (cirrhosis, Child-Pugh class A or B), the starting dose should be 5mg and only increased with caution.

Gender: The starting dose and dose range need not be routinely altered for female patients relative to male patients.

Smokers: The starting dose and dose range need not be routinely altered for non-smokers relative to smokers.
When more than one factor is present which might result in slower metabolism (female gender, geriatric age, non-smoking status), consideration should be given to decreasing the starting dose (5 mg daily). Dose escalation, when indicated, should be conservative in such patients.

Medicine’s information on this web page is only a short description of its characteristics. Do not take them as recommendations for self-treatment of your health condition.

You must inform your physician and pharmacist and follow their recommendations before you use the medicine for treatment. Always read carefully the patient information leaflet.

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COMPOSITION

Each film-coated tablet contains 5 mg olanzapine.
Each film-coated tablet contains 10 mg olanzapine.

THERAPEUTIC INDICATIONS

Olanzapine is indicated for the treatment of schizophrenia.
Olanzapine is effective in maintaining clinical improvement during continuation therapy in patients who have shown an initial treatment response.
Olanzapine is indicated for the treatment of moderate to a severe manic episode.
At patients with bipolar disorder whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence.

CONTRAINDICATIONS

Olanzapine is contraindicated at:

– Patients with hypersensitivity to the active substance or to any of the excipients;
– Patients with a known risk for narrow-angle glaucoma.


PACKAGING

Box of 30 film-coated tablets of 5 mg (3 blisters x 10 tablets)
Box of 30 film-coated tablets of 10 mg (3 blisters x 10 tablets)

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