Product Information:

OLANZAGET 3mg + 25mg Capsules contain a fixed-dose combination of:

1. Olanzapine 3mg – an atypical antipsychotic that modulates dopamine and serotonin receptors
2. Fluoxetine 25mg – a selective serotonin reuptake inhibitor (SSRI) antidepressant

This combination is used to treat treatment-resistant depression and bipolar I disorder (depressive episodes), leveraging dual neurotransmitter modulation for enhanced efficacy.

⚠️ Important Note: This combination mirrors the formulation of Symbyax® (olanzapine/fluoxetine), approved for specific psychiatric indications. Use only under strict psychiatric supervision.

Uses of (OLANZAGET 3MG + 25MG CAPSULES):

1. Bipolar I Disorder: Acute treatment of depressive episodes
2. Treatment-Resistant Depression (TRD): In patients who have not responded to antidepressant monotherapy
3. Off-label: Severe depression with psychotic features

Key Benefits of (OLANZAGET 3MG + 25MG CAPSULES):

1. Dual-action therapy targets both dopaminergic and serotonergic pathways
2. More effective than either agent alone in bipolar depression and TRD
3. Reduces relapse risk in bipolar disorder when used appropriately
4. Once-daily dosing improves adherence

How To Use (OLANZAGET 3MG + 25MG CAPSULES):

1. Take one capsule once daily, preferably in the evening (due to olanzapine’s sedative effect).
2. Swallow whole with water—can be taken with or without food.
3. Do not stop abruptly—taper under medical supervision to avoid withdrawal or relapse.
4. Full therapeutic effect may take 2–6 weeks.

When Not to Use (OLANZAGET 3MG + 25MG CAPSULES):

Do not use if you have:

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

Side Effects of (OLANZAGET 3MG + 25MG CAPSULES):

Common:

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

Serious (require immediate medical attention):

1. Serotonin syndrome: Agitation, hallucinations, rapid heart rate, high fever, muscle rigidity
2. Neuroleptic malignant syndrome (NMS): High fever, confusion, muscle stiffness, autonomic instability
3. Metabolic effects: Hyperglycemia, dyslipidemia, significant weight gain
4. Suicidal thoughts (especially in young adults during early treatment)
5. Hyponatremia (low sodium), seizures, abnormal bleeding (fluoxetine-related)

Discontinue and seek emergency care if severe reactions occur.

Dosage: (OLANZAGET 3MG + 25MG CAPSULES):

1. Starting dose: One capsule (3mg olanzapine + 25mg fluoxetine) once daily
2. May be increased based on response and tolerability (e.g., to 6mg/25mg or 12mg/50mg formulations)
3. Elderly or hepatic impairment: Start with lower doses; monitor closely
4. Not for children <18 years unless specifically indicated

Who It’s For (OLANZAGET 3MG + 25MG CAPSULES):

Adults diagnosed with bipolar I depression or major depressive disorder unresponsive to standard antidepressants, under ongoing psychiatric care.

Warnings & Precautions:

1. Black Box Warning: Antidepressants increase risk of suicidal thinking in children, adolescents, and young adults
2. Monitor for weight, blood glucose, and lipid levels regularly
3. Avoid alcohol—increases CNS depression
4. May impair judgment—avoid driving or operating machinery until response is known
5. Screen for bipolar disorder before starting antidepressants to avoid mania induction

Drug Interactions:

1. MAO inhibitors: Contraindicated—risk of serotonin syndrome
2. Other SSRIs, SNRIs, triptans: ↑ Serotonin syndrome risk
3. Anticoagulants (warfarin): Fluoxetine may ↑ INR
4. CNS depressants (benzodiazepines, opioids): ↑ Sedation
5. Carbamazepine: May reduce 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.