Prolert
Generic Name
Fluoxetine
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| prolert 20 mg suspension | ৳ 60.00 | N/A |
Description
Overview of the medicine
Prolert 20 mg Suspension contains Fluoxetine, an antidepressant medication used to treat major depressive disorder, obsessive-compulsive disorder, bulimia nervosa, and panic disorder.
Uses & Indications
Dosage
Adults
Initial: 20 mg once daily, usually in the morning. May be increased after several weeks to a maximum of 80 mg/day, depending on condition and response.
Elderly
Lower initial doses (e.g., 10 mg/day) may be considered, with gradual titration. Maximum dose typically 60 mg/day.
Renal_impairment
No dosage adjustment needed for mild to moderate renal impairment. Use with caution in severe renal impairment.
Hepatic_impairment
Reduce dose or frequency (e.g., 10 mg daily or 20 mg every other day) due to reduced metabolism.
How to Take
Take orally, usually once daily in the morning, with or without food. Shake the suspension well before use. Use a measuring device for accurate dosing.
Mechanism of Action
Fluoxetine selectively inhibits the reuptake of serotonin (5-HT) in the central nervous system, thereby increasing the concentration of serotonin in the synaptic cleft and enhancing serotonergic neurotransmission.
Pharmacokinetics
Onset
Clinical effects may take 2-4 weeks to become apparent, although some patients may experience initial improvements earlier.
Excretion
Primarily excreted by the kidneys (about 60% as metabolites).
Half life
Fluoxetine: 2-3 days; Norfluoxetine (active metabolite): 7-9 days
Absorption
Well absorbed orally, bioavailability about 70%. Food does not affect systemic bioavailability but may delay absorption slightly.
Metabolism
Extensively metabolized in the liver, primarily by CYP2D6, to norfluoxetine, an equally potent but longer-acting active metabolite.
Side Effects
Contraindications
- Hypersensitivity to Fluoxetine or any component of the formulation
- Concomitant use with MAOIs (Monoamine Oxidase Inhibitors) or within 14 days of discontinuing MAOI treatment
- Concomitant use with Pimozide or Thioridazine
- History of QT prolongation or congenital long QT syndrome
Drug Interactions
MAOIs
Risk of serious, sometimes fatal, reactions (serotonin syndrome).
Tramadol
Increased risk of seizures and serotonin syndrome.
Triptans
Risk of serotonin syndrome.
Warfarin
Increased bleeding risk due to enhanced anticoagulant effect.
NSAIDs/Aspirin
Increased risk of bleeding, especially gastrointestinal.
St. John's Wort
Increased risk of serotonin syndrome.
Pimozide/Thioridazine
Increased plasma levels, risk of QT prolongation and arrhythmias.
Tricyclic Antidepressants (TCAs)
Increased plasma levels of TCAs, risk of toxicity.
Storage
Store at controlled room temperature (20-25°C), away from moisture and direct light. Do not freeze. Keep out of reach of children.
Overdose
Symptoms: Nausea, vomiting, seizures, cardiovascular dysfunction (ranging from asymptomatic arrhythmias to cardiac arrest), CNS depression, and coma. Management: Establish and maintain an airway, ensure adequate oxygenation and ventilation. Monitor cardiac and vital signs. Activated charcoal may be useful. Symptomatic and supportive treatment is recommended. There is no specific antidote.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonates exposed to SSRIs in late pregnancy have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Excreted into breast milk; caution advised. Consult a doctor.
Side Effects
Contraindications
- Hypersensitivity to Fluoxetine or any component of the formulation
- Concomitant use with MAOIs (Monoamine Oxidase Inhibitors) or within 14 days of discontinuing MAOI treatment
- Concomitant use with Pimozide or Thioridazine
- History of QT prolongation or congenital long QT syndrome
Drug Interactions
MAOIs
Risk of serious, sometimes fatal, reactions (serotonin syndrome).
Tramadol
Increased risk of seizures and serotonin syndrome.
Triptans
Risk of serotonin syndrome.
Warfarin
Increased bleeding risk due to enhanced anticoagulant effect.
NSAIDs/Aspirin
Increased risk of bleeding, especially gastrointestinal.
St. John's Wort
Increased risk of serotonin syndrome.
Pimozide/Thioridazine
Increased plasma levels, risk of QT prolongation and arrhythmias.
Tricyclic Antidepressants (TCAs)
Increased plasma levels of TCAs, risk of toxicity.
Storage
Store at controlled room temperature (20-25°C), away from moisture and direct light. Do not freeze. Keep out of reach of children.
Overdose
Symptoms: Nausea, vomiting, seizures, cardiovascular dysfunction (ranging from asymptomatic arrhythmias to cardiac arrest), CNS depression, and coma. Management: Establish and maintain an airway, ensure adequate oxygenation and ventilation. Monitor cardiac and vital signs. Activated charcoal may be useful. Symptomatic and supportive treatment is recommended. There is no specific antidote.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonates exposed to SSRIs in late pregnancy have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Excreted into breast milk; caution advised. Consult a doctor.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Usually 24 to 36 months from manufacturing date, check product label.
Availability
Pharmacies, hospitals, clinics
Approval Status
Approved by regulatory authorities worldwide
Patent Status
Patent expired
WHO Essential Medicine
YesClinical Trials
Numerous clinical trials have established the efficacy and safety of fluoxetine for its approved indications, including studies in pediatric and adult populations.
Lab Monitoring
- No specific routine lab monitoring required. Monitor clinical symptoms and side effects. For patients with diabetes, blood glucose levels may need monitoring.
- Electrolytes (e.g., sodium) if hyponatremia is suspected.
Doctor Notes
- Counsel patients about delayed onset of action and potential for initial anxiety/agitation.
- Monitor for serotonin syndrome, especially when co-administered with other serotonergic agents.
- Assess for bipolar disorder before initiating therapy, as SSRIs can induce mania/hypomania in susceptible individuals.
Patient Guidelines
- Take as directed by your doctor.
- Do not stop taking this medicine abruptly; sudden discontinuation can lead to withdrawal symptoms. Consult your doctor for tapering.
- Report any unusual mood changes, worsening depression, or suicidal thoughts to your doctor immediately.
- Avoid alcohol while taking this medicine.
- It may take several weeks for the full antidepressant effect to be noticed.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double dose.
Driving Precautions
May cause dizziness, drowsiness, or blurred vision. Patients should be advised to exercise caution when driving or operating hazardous machinery until they are reasonably certain that Fluoxetine does not adversely affect their ability to engage in such activities.
Lifestyle Advice
- Regular exercise and a balanced diet can complement the treatment.
- Practice stress-reduction techniques like meditation or yoga.
- Maintain a regular sleep schedule.
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