FLUOXETINE-TEVA 20 MG CAPSULES

TEVA PHARMACEUTICAL INDUSTRIES LTD (ISRAEL)🇸🇬 Health Sciences Authority

Approval Date: Jun 5, 2003
Approval ID: 3ad15fef4ae05272
Company: TEVA PHARMACEUTICAL INDUSTRIES LTD (ISRAEL)
Type: Therapeutic

Approval Details

Approval Id: 3ad15fef4ae05272
Drug Name: FLUOXETINE-TEVA 20 MG CAPSULES
Product Name: FLUOXETINE-TEVA 20 MG CAPSULES
Approval Number: SIN12311P
Approval Date: 2003-06-05
Registrant: TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.
Licence Holder: TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: CAPSULE
Dosage: Dosage and Administration Because of the long elimination half-lives of the parent drug and its major active metabolite, changes in dose will not be fully reflected in plasma levels for several weeks. Therefore, monitoring of plasma levels may not be a good indicator for dose adjustments of fluoxetine. Treatment of Depression Initial Therapy The recommended dose is 20 mg/day administered in the morning. A dose increase may be considered after several weeks if no clinical improvement is observed. Doses above 20 mg/day should be administered on a b.i.d. schedule (i.e., morning and noon) and should not exceed a maximum dose of 80 mg/day. The full antidepressant effect may be delayed until 4 weeks of treatment or longer. As with many other medications, a lower or less frequent dosage should be used in patients with hepatic impairment. A lower or less frequent dosage should also be considered for the elderly and for patients with concurrent disease or on multiple medications. Dosage adjustments for renal impairment are not routinely necessary. Maintenance/Long-Term Treatment Optimal duration of fluoxetine therapy remains speculative. Acute episodes of depression generally require several months or longer of sustained pharmacologic therapy; whether the dose of antidepressant needed to induce remission is identical to the dose needed to maintain or sustain mental tranquillity is unknown. Treatment of Obsessive-Compulsive Disorder (OCD) Initial Therapy The initial recommended dose is 20 mg once daily administered in the morning. The dose may be then gradually increased up to 60 mg daily after several weeks of non- satisfactory response to the initial dose. The maximum daily dosage should not exceed 80 mg. As with the use of Fluoxetine in depression, a lower or less frequent dosage should be used in patients with renal hepatic impairment. A lower or less frequent dosage should also be considered for the elderly (see Use in the Elderly under Warnings, – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information), and for patients with concurrent disease or on multiple medications. Dosage adjustments for renal impairment are not routinely necessary. Maintenance/Continuation Therapy While there are no systematic studies that answer the question for how long to continue fluoxetine, OCD is a chronic condition and it is reasonable to consider continuation for a responding patient. Although the efficacy of fluoxetine after 13 weeks has not been documented in controlled trials, patients have been continued in therapy under double-blind conditions for up to an additional 6 months without loss of benefit. However, dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for treatment. Treatment of Binge-Eating and Vomiting Behaviors in Bulimia Nervosa. (Reduction of Binge-Eating and Purging Activity) Initial Therapy A dose of 60 mg/day is recommended, administered in the morning. For some patients it may be advisable to titrate up to this target dose over several days. Fluoxetine doses above 60 mg/day have not been systematically studied in patients with bulimia. As with the use of fluoxetine in depression and OCD, a lower or less frequent dosage should be used in patients with hepatic impairment. A lower or less frequent dosage should also be considered for the elderly, and for patients with concurrent disease or on multiple concomitant medications. Dosage adjustments for renal impairment are not routinely necessary. Maintenance/Continuation Therapy While there are no systematic studies that answer the question of how long to continue fluoxetine, bulimia is a chronic condition and it is reasonable to consider continuation for a responding patient. Although the efficacy of fluoxetine after 16 weeks has not been documented in controlled trials, some patients have been continued in therapy under double-blind conditions for up to an additional 6 months without loss of benefit. However, patients should be periodically reassessed to determine the need for continued treatment.
Route Of Administration: ORAL
Indication Info: Indications <ul> <li>For the treatment of depression. The effectiveness of fluoxetine in long-term use (i.e. for more than 5 to 6 weeks) has not been evaluated in controlled trials. Therefore, the physician who decides to use fluoxetine for long periods should periodically reevaluate the long-term usefulness for the individual patient.</li> <li>Fluoxetine is also indicated in the treatment of obsessive-compulsive disorder (OCD). Effectiveness in long-term use, i.e. for more than 13 weeks, has not been established. (see Dosage and Administration).</li> <li>Fluoxetine is also indicated for the treatment of binge-eating and vomiting behaviors in bulimia nervosa.</li> </ul>
Contraindications: Contraindications Patients with known hypersensitivity to any ingredient of the preparation. There have been reports of serious, sometimes fatal, reactions in patients receiving fluoxetine in combination with a monoamine oxidase (MAO) inhibitor, and in patients who have recently discontinued fluoxetine and are then started on an MAO inhibitor. Therefore, fluoxetine should not be used concurrently with a MAO inhibitor. Transfer from MAO-Inhibitor Therapy to Fluoxetine Therapy. A lapse of 14 days should be allowed between the discontinuation of a MAO-inhibitor and the institution of fluoxetine. Transfer from Fluoxetine Therapy to MAO-Inhibitor Therapy. Since fluoxetine and its major metabolite have very long elimination half-lives, at least 5 weeks should be allowed after discontinuing fluoxetine before starting a MAO inhibitor.
Atc Code: N06AB03
Atc Item Name: fluoxetine
Pharma Manufacturer Name: TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

Active Ingredients

FLUOXETINE ( as HCl)

20 mg

FLUOXETINE (AS HCL)

20 MG

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Jun 5, 2003

Approval ID

3ad15fef4ae05272

Type

Therapeutic

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