ONZAPIN ODT ORODISPERSIBLE TABLET 10 MG [SIN13958P]

Product Info

ONZAPIN ODT ORODISPERSIBLE TABLET 10 MG

[SIN13958P]

4.1 Therapeutic indications
Olanzapine is indicated for the acute and maintenance treatment of schizophrenia and other psychoses where positive symptoms (e.g. delusions, hallucinations, disordered thinking, hostility, suspiciousness) and/or negative symptoms (e.g. flattened affect, emotional and social withdrawal, poverty of speech) are prominent. Olanzapine also alleviates the secondary affective symptoms commonly associated with schizophrenia and related disorders.

Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.

Olanzapine is indicated for the short- term treatment of acute manic episode associated with Bipolar I Disorder.

Olanzapine is indicated for preventing recurrence of manic, mixed or depressive episodes in Bipolar I Disorder (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.2 Posology and method of administration
Schizophrenia: The recommended starting dose for olanzapine is 10 mg/day.

Manic episode: The starting dose is 15 mg as a single daily dose in monotherapy or 10 mg daily in combination therapy (See section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Preventing recurrence in bipolar disorder: The recommended starting dose is 10 mg/day. For patients who have been receiving olanzapine for treatment of manic episode, 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 optimisation 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 5–20 mg/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 regards for meals as absorption is not affected by food. Gradual tapering of the dose should be considered when discontinuing olanzapine.

Method of administration: Orodispersible tablet should be placed in the mouth, where it will be rapidly dispersed in saliva, so it can be easily swallowed. Removal of the intact orodispersible tablet from the mouth is difficult. Since the orodispersible tablet is fragile, it should be taken immediately on opening the blister. Alternatively, it may be dispersed in a full glass of water or other suitable beverage (orange juice, apple juice, milk or coffee) immediately before administration.

Olanzapine orodispersible tablet is bioequivalent to olanzapine conventional tablets, with a similar rate and extent of absorption. It has the same dosage and frequency of administration as olanzapine conventional tablets. Olanzapine orodispersible tablets may be used as an alternative to olanzapine conventional tablets.

Paediatric population: Olanzapine is not recommended for use in children and adolescents below 18 years of age due to a lack of data on safety and efficacy. A greater magnitude of weight gain, lipid and prolactin alterations has been reported in short-term studies of adolescent patients than in studies of adult patients (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Elderly patients: A lower starting dose (5 mg/day) is not routinely indicated but should be considered for those 65 and over when clinical factors warrant (see also section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Patients with renal and/or hepatic impairment: A lower starting dose (5 mg) should be considered for such patients. In cases of moderate hepatic insufficiency (cirrhosis, Child-Pugh Class A or B), the starting dose should be 5 mg and only increased with caution.

Smokers: The starting dose and dose range need not be routinely altered for non-smokers relative to smokers. The metabolism of olanzapine may be induced by smoking. Clinical monitoring is recommended and an increase of olanzapine dose may be considered if necessary (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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. Dose escalation, when indicated, should be conservative in such patients. (See also section 4.5 and section 5.2. – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients. Patients with known risk for narrow-angle glaucoma.