Product Information:

OLANZAGET 6mg + 25mg Capsules contain a fixed-dose combination of:

1. Olanzapine 6mg – an atypical antipsychotic that modulates dopamine (D₂) and serotonin (5-HT₂A) receptors
2. Fluoxetine 25mg – a selective serotonin reuptake inhibitor (SSRI) antidepressant

This formulation is used for the treatment of bipolar I disorder (depressive episodes) and treatment-resistant depression (TRD) in adults. The combination enhances efficacy by targeting both dopaminergic and serotonergic pathways simultaneously.

⚠️ Important Note: This combination is equivalent to Symbyax®, approved specifically for bipolar depression and TRD. It must be prescribed and monitored by a qualified psychiatrist.

Uses of (OLANZAGET 6MG + 25MG CAPSULES):

1. Acute treatment of depressive episodes associated with bipolar I disorder
2. Management of major depressive disorder not responding to standard antidepressants (TRD)
3. Off-label: Severe depression with mixed or psychotic features

Key Benefits of (OLANZAGET 6MG + 25MG CAPSULES):

1. Superior efficacy compared to monotherapy in bipolar depression
2. Reduces risk of mood switching (mania) when treating bipolar depression
3. Once-daily dosing improves treatment adherence
4. Addresses both depressive and residual psychotic symptoms

How To Use (OLANZAGET 6MG + 25MG CAPSULES):

1. Take one capsule once daily, preferably in the evening (due to olanzapine-induced sedation).
2. Swallow whole with water—can be taken with or without food.
3. Do not discontinue abruptly—taper gradually under medical supervision to avoid relapse or withdrawal.
4. Therapeutic response may take 2–6 weeks; full benefit up to 8–12 weeks.

When Not to Use (OLANZAGET 6MG + 25MG CAPSULES):

Do not use if you have:

1. Hypersensitivity to olanzapine, fluoxetine, or any excipients
2. Concurrent or recent (within 14 days) use of MAO inhibitors
3. Uncontrolled narrow-angle glaucoma
4. History of neuroleptic malignant syndrome (NMS) or serotonin syndrome
5. Known QT interval prolongation or arrhythmias

Side Effects of (OLANZAGET 6MG + 25MG CAPSULES):

Common:

1. Sedation, dizziness, dry mouth
2. Increased appetite and weight gain
3. Nausea, insomnia, fatigue
4. Constipation, tremor, restlessness

Serious (require immediate medical attention):

1. Serotonin syndrome: Agitation, confusion, rapid heart rate, high fever, muscle rigidity
2. Neuroleptic malignant syndrome (NMS): Hyperthermia, altered mental status, muscle stiffness
3. Metabolic disturbances: Hyperglycemia, dyslipidemia, significant weight gain
4. Suicidal ideation (especially in patients <25 years during early treatment)
5. Hyponatremia, seizures, or abnormal bleeding (fluoxetine-related)

Discontinue and seek emergency care if severe reactions occur.

Dosage: (OLANZAGET 6MG + 25MG CAPSULES):

1. Starting dose: One capsule (6mg olanzapine + 25mg fluoxetine) once daily
2. May be increased based on clinical response (e.g., to 12mg/50mg)
3. Elderly or hepatic impairment: Use lower starting doses; monitor closely
4. Maximum recommended dose: Typically 12mg olanzapine + 50mg fluoxetine per day
5. Not approved for children <18 years

Who It’s For (OLANZAGET 6MG + 25MG CAPSULES):

Adults diagnosed with bipolar I depression or treatment-resistant major depressive disorder, under ongoing psychiatric supervision.

Warnings & Precautions:

1. Black Box Warning: Antidepressants increase the risk of suicidal thoughts in children, adolescents, and young adults (<25 years)
2. Monitor weight, fasting glucose, and lipid profile at baseline and periodically
3. Avoid alcohol—enhances CNS depression
4. May impair cognitive/motor function—avoid driving until effects are known
5. Screen thoroughly for bipolar disorder before initiating antidepressant therapy

Drug Interactions:

1. MAO inhibitors: Contraindicated—risk of life-threatening serotonin syndrome
2. Other serotonergic drugs (triptans, tramadol, St. John’s wort): ↑ Serotonin syndrome risk
3. Warfarin: Fluoxetine may ↑ INR—monitor closely
4. CNS depressants (benzodiazepines, opioids): ↑ Sedation and respiratory depression
5. Carbamazepine: May ↓ olanzapine levels
6. Always inform your psychiatrist about all medications and supplements.

Additional Information:

Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children. Do not use after the expiration date. Available by prescription only in Pakistan.