Stresin
Generic Name
Fluoxetine
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| stresin 20 mg dr capsule | ৳ 8.00 | ৳ 80.00 |
Description
Overview of the medicine
Fluoxetine is an antidepressant belonging to the Selective Serotonin Reuptake Inhibitor (SSRI) class. It is used to treat major depressive disorder, obsessive-compulsive disorder (OCD), panic disorder, bulimia nervosa, and premenstrual dysphoric disorder (PMDD). The delayed-release formulation allows for once-daily dosing.
Uses & Indications
Dosage
Adults
Major Depressive Disorder: Initially 20 mg once daily. May increase to 40-60 mg daily after several weeks if no clinical improvement. Maximum 80 mg/day. DR capsules are typically dosed once daily.
Elderly
Lower initial doses (e.g., 10 mg/day) may be considered, with careful titration and monitoring for adverse effects.
Renal_impairment
No dosage adjustment necessary for mild to moderate renal impairment. Caution is advised in severe impairment (eGFR <10 mL/min).
How to Take
Take orally once daily, with or without food. Swallow the delayed-release capsule whole; do not chew, crush, or open. Consistent timing of administration is recommended.
Mechanism of Action
Fluoxetine selectively inhibits the reuptake of serotonin (5-HT) in the central nervous system, leading to increased concentrations of serotonin in the synaptic cleft. This potentiation of serotonergic activity is believed to be responsible for its antidepressant and anxiolytic effects.
Pharmacokinetics
Onset
Antidepressant effects typically begin within 2-4 weeks of continuous treatment, though some patients may experience improvement earlier.
Excretion
Mainly excreted by the kidneys (approximately 80%) as inactive metabolites, with a small portion excreted in feces (approximately 15%).
Half life
Fluoxetine: 2-4 days; Norfluoxetine (active metabolite): 7-16 days. Due to long half-lives, steady-state plasma concentrations are achieved after several weeks.
Absorption
Well absorbed orally. Peak plasma concentrations achieved in 6-8 hours for delayed-release capsules. Bioavailability is approximately 70%.
Metabolism
Extensively metabolized in the liver, primarily by CYP2D6, to its major active metabolite, norfluoxetine. Also metabolized by CYP2C9 and CYP3A4.
Side Effects
Contraindications
- Hypersensitivity to fluoxetine or any component of the formulation.
- Concomitant use of Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of discontinuing an MAOI. A washout period of at least 5 weeks is required before starting an MAOI after stopping fluoxetine.
- Concomitant use of thioridazine or pimozide.
Drug Interactions
Tricyclic Antidepressants (TCAs)
May increase plasma concentrations of TCAs.
Warfarin and other anticoagulants
Increased bleeding risk due to fluoxetine's effect on platelet aggregation.
Monoamine Oxidase Inhibitors (MAOIs)
Risk of serious, sometimes fatal, serotonin syndrome.
Drugs metabolized by CYP2D6 (e.g., Pimozide, Thioridazine)
Fluoxetine is a potent CYP2D6 inhibitor, potentially increasing levels of co-administered drugs.
Serotonergic drugs (e.g., Triptans, Tramadol, other SSRIs)
Increased risk of serotonin syndrome.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include nausea, vomiting, seizures, somnolence, tachycardia, and ECG changes (e.g., QT prolongation). Management is primarily supportive, including maintaining an adequate airway, oxygenation, and ventilation. Activated charcoal may be considered. There is no specific antidote.
Pregnancy & Lactation
Pregnancy Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. Consult your doctor. Lactation: Fluoxetine and its active metabolite are excreted in breast milk. Caution should be exercised when fluoxetine is administered to a nursing mother.
Side Effects
Contraindications
- Hypersensitivity to fluoxetine or any component of the formulation.
- Concomitant use of Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of discontinuing an MAOI. A washout period of at least 5 weeks is required before starting an MAOI after stopping fluoxetine.
- Concomitant use of thioridazine or pimozide.
Drug Interactions
Tricyclic Antidepressants (TCAs)
May increase plasma concentrations of TCAs.
Warfarin and other anticoagulants
Increased bleeding risk due to fluoxetine's effect on platelet aggregation.
Monoamine Oxidase Inhibitors (MAOIs)
Risk of serious, sometimes fatal, serotonin syndrome.
Drugs metabolized by CYP2D6 (e.g., Pimozide, Thioridazine)
Fluoxetine is a potent CYP2D6 inhibitor, potentially increasing levels of co-administered drugs.
Serotonergic drugs (e.g., Triptans, Tramadol, other SSRIs)
Increased risk of serotonin syndrome.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include nausea, vomiting, seizures, somnolence, tachycardia, and ECG changes (e.g., QT prolongation). Management is primarily supportive, including maintaining an adequate airway, oxygenation, and ventilation. Activated charcoal may be considered. There is no specific antidote.
Pregnancy & Lactation
Pregnancy Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. Consult your doctor. Lactation: Fluoxetine and its active metabolite are excreted in breast milk. Caution should be exercised when fluoxetine is administered to a nursing mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the date of manufacture.
Availability
Pharmacies, Hospitals
Approval Status
Approved by regulatory authorities
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have established the efficacy and safety of fluoxetine in various psychiatric conditions. Ongoing research continues to explore its full therapeutic potential and optimize treatment strategies.
Lab Monitoring
- Serum sodium levels (especially in elderly patients or those on diuretics, due to risk of hyponatremia).
- Liver function tests (periodically, especially in patients with pre-existing hepatic impairment).
Doctor Notes
- Counsel patients on the delayed onset of therapeutic effects and the importance of adherence to prevent discontinuation syndrome.
- Monitor for emergent suicidal ideation, especially in pediatric and young adult patients, and manage proactively.
- Be aware of potential drug interactions, particularly with other serotonergic agents and CYP2D6 substrates.
- Assess for serotonin syndrome, especially during initiation or dose escalation, or when co-administered with other serotonergic drugs.
Patient Guidelines
- Take this medicine exactly as prescribed by your doctor. Do not stop taking it suddenly, as this can lead to withdrawal symptoms.
- It may take several weeks for you to feel the full benefits of this medicine. Continue taking it even if you don't feel immediate improvement.
- Report any new or worsening symptoms, especially changes in mood, behavior, or suicidal thoughts, to your doctor immediately.
- Avoid alcohol while taking fluoxetine.
Missed Dose Advice
If a dose is missed, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and resume your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Fluoxetine may cause dizziness, drowsiness, or blurred vision. Do not drive or operate machinery until you know how this medicine affects you.
Lifestyle Advice
- Engage in regular physical activity to help manage mood and energy levels.
- Maintain a balanced diet and adequate sleep hygiene.
- Seek support from family, friends, or a mental health professional.
- Practice stress-reduction techniques such as mindfulness or meditation.
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