- Approval Id
- 0f3db1b992565d02
- Drug Name
- OLANCOR FC TABLETS 10MG
- Product Name
- OLANCOR FC TABLETS 10MG
- Approval Number
- SIN14639P
- Approval Date
- 2014-09-29
- Registrant
- PHARMAKOE PTE. LTD.
- Licence Holder
- PHARMAKOE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>4.2. Posology and method of administration</strong><br>
<strong>Schizophrenia:</strong> The recommended starting dose for olanzapine is 10 mg/day.</p>
<p><strong>Manic episode:</strong> The starting dose is 15 mg as a single daily dose in monotherapy or 10 mg daily in combination therapy. (See Section 5.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>)</p>
<p><strong>Preventing recurrence in bipolar disorder:</strong> The recommended starting dose is 10mg/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.</p>
<p>During treatment for both 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.</p>
<p><strong>Children:</strong> Olanzapine has not been studied in subjects under 18 years of age.</p>
<p><strong>Elderly patients:</strong> A lower starting dose (5 mg/day) is not routinely indicated but should be considered for those 65 and over when clinical factors warrant.</p>
<p><strong>Patients with renal and/or hepatic impairment:</strong> 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.</p>
<p><strong>Gender:</strong> The starting dose and dose range need not be routinely altered for female patients relative to male patients.</p>
<p><strong>Smokers:</strong> The starting dose and dose range need not be routinely altered for non-smoking patients relative to smoking patients.</p>
<p>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, Interaction with Other Medicaments and Other Forms of Interaction, and Section 5.2, Pharmacokinetic properties – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>)</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>Therapeutic indications</strong><br>
Olanzapine is indicated for the acute and maintenance treatment of schizophrenia and other psychoses where positive symptoms (e.g., delusions, hallucinations, disordered thinking, hostility, and 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.</p>
<p>Olanzapine is effective in maintaining the clinical improvement during continuing therapy in patients who have shown initial treatment response.</p>
<p>Olanzapine is indicated for short-term treatment of acute manic episode associated with Bipolar I Disorder.</p>
<p>Olanzapine is indicated for preventing recurrence of manic, mixed or depressive episodes in Bipolar I Disorder.</p>
- Contraindications
- <p><strong>4.3. Contraindications</strong><br>
Hypersensitivity to olanzapine or any of the excipients. Patients with known risk for narrow-angle glaucoma.</p>
- Atc Code
- N05AH03
- Atc Item Name
- olanzapine
- Pharma Manufacturer Name
- PHARMAKOE PTE. LTD.
