Primace
Generic Name
Fluoxetine
Manufacturer
Acme Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| primace 125 mg capsule | ৳ 2.50 | ৳ 25.00 |
Description
Overview of the medicine
Primace 125 mg capsule contains Fluoxetine, a selective serotonin reuptake inhibitor (SSRI) used for the treatment of various psychiatric disorders, including major depressive disorder, obsessive-compulsive disorder, and bulimia nervosa. This high strength formulation is typically used for specific extended-release or once-weekly dosing regimens, or under strict specialist supervision for severe conditions.
Uses & Indications
Dosage
Adults
The 125 mg strength of Fluoxetine is typically reserved for once-weekly dosing in specific extended-release formulations or for severe, treatment-resistant conditions under strict specialist supervision, where the daily dose may sometimes be escalated beyond standard maximums. Standard daily dosing usually ranges from 20-60 mg, with a maximum of 80 mg/day for some conditions. Always follow your doctor's specific instructions.
Elderly
A lower starting dose (e.g., 10 mg daily) is recommended for elderly patients, with gradual titration based on response and tolerability. The 125 mg strength is generally not suitable for initial therapy in this population.
Renal_impairment
No dose adjustment is usually required for mild to moderate renal impairment. Caution is advised in severe renal impairment, and dose reduction may be considered, especially if co-existing hepatic impairment.
How to Take
Take the capsule orally, with or without food, usually once daily in the morning. If taking for PMDD, it may be prescribed for daily use or intermittent use (e.g., during the luteal phase). Do not crush or chew the capsule.
Mechanism of Action
Fluoxetine selectively inhibits the reuptake of serotonin (5-HT) into presynaptic neurons in the central nervous system, thereby increasing the concentration of serotonin in the synaptic cleft. This increased serotonin availability is believed to modulate mood, emotion, and behavior.
Pharmacokinetics
Onset
Antidepressant effects usually observed within 2-4 weeks, though some patients may experience benefits earlier.
Excretion
Primarily excreted in the urine as metabolites.
Half life
Fluoxetine: 2-4 days; Active metabolite (norfluoxetine): 4-16 days. This long half-life allows for once-daily or once-weekly dosing.
Absorption
Well absorbed orally; peak plasma concentrations reached in 6-8 hours. Food does not significantly affect absorption.
Metabolism
Extensively metabolized in the liver by cytochrome P450 enzymes (primarily CYP2D6 and CYP3A4) to its active metabolite, norfluoxetine, and other inactive metabolites.
Side Effects
Contraindications
- Hypersensitivity to fluoxetine or any component of the formulation.
- Concomitant use with Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of discontinuing an MAOI, due to the risk of serotonin syndrome.
- Concomitant use with thioridazine or pimozide.
Drug Interactions
MAOIs
Concomitant use is contraindicated due to the risk of potentially fatal serotonin syndrome.
Warfarin
Increased risk of bleeding due to fluoxetine's displacement of warfarin from protein binding sites. Monitor INR closely.
Tramadol, Triptans
Increased risk of serotonin syndrome.
CYP2D6 metabolized drugs (e.g., tricyclic antidepressants, risperidone)
Fluoxetine is a potent CYP2D6 inhibitor, potentially increasing plasma levels and adverse effects of co-administered drugs.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include nausea, vomiting, seizures, sinus tachycardia, and signs of CNS excitation. Management should involve supportive and symptomatic treatment, maintaining a patent airway, and monitoring cardiac and vital signs. Activated charcoal may be considered. 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. Fluoxetine is excreted in breast milk; therefore, caution should be exercised when administered to a nursing mother. Consult your doctor.
Side Effects
Contraindications
- Hypersensitivity to fluoxetine or any component of the formulation.
- Concomitant use with Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of discontinuing an MAOI, due to the risk of serotonin syndrome.
- Concomitant use with thioridazine or pimozide.
Drug Interactions
MAOIs
Concomitant use is contraindicated due to the risk of potentially fatal serotonin syndrome.
Warfarin
Increased risk of bleeding due to fluoxetine's displacement of warfarin from protein binding sites. Monitor INR closely.
Tramadol, Triptans
Increased risk of serotonin syndrome.
CYP2D6 metabolized drugs (e.g., tricyclic antidepressants, risperidone)
Fluoxetine is a potent CYP2D6 inhibitor, potentially increasing plasma levels and adverse effects of co-administered drugs.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include nausea, vomiting, seizures, sinus tachycardia, and signs of CNS excitation. Management should involve supportive and symptomatic treatment, maintaining a patent airway, and monitoring cardiac and vital signs. Activated charcoal may be considered. 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. Fluoxetine is excreted in breast milk; therefore, caution should be exercised when administered to a nursing mother. Consult your doctor.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months from the date of manufacture.
Availability
Pharmacies, Hospitals
Approval Status
Approved (Generic)
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Fluoxetine has undergone extensive clinical trials demonstrating its efficacy and safety across various indications, including major depressive disorder, OCD, and bulimia nervosa. Ongoing research continues to explore its use in other conditions and its long-term effects.
Lab Monitoring
- Monitor renal and hepatic function periodically, especially in patients with pre-existing impairment.
- Monitor serum sodium in patients at risk for hyponatremia (e.g., elderly, those on diuretics).
Doctor Notes
- Carefully monitor patients for clinical worsening, suicidality, or unusual changes in behavior, particularly during the initial few months of therapy or when the dose is changed.
- Educate patients and caregivers about the symptoms of serotonin syndrome and the need for immediate medical attention if they occur.
Patient Guidelines
- Take this medicine exactly as prescribed by your doctor.
- Do not stop taking Fluoxetine suddenly, as it can lead to withdrawal symptoms. Any dose reduction should be gradual and under medical supervision.
- Report any unusual mood changes, agitation, or suicidal thoughts to your doctor immediately.
- Be patient; the full therapeutic effects may take several weeks to appear.
Missed Dose Advice
If you miss a dose, take it as soon as you remember, unless it is almost time for your next scheduled dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
Fluoxetine may cause dizziness, drowsiness, or blurred vision, especially at the beginning of treatment or after dose changes. Avoid driving or operating heavy machinery until you know how this medicine affects you.
Lifestyle Advice
- Avoid consuming alcohol while taking this medicine, as it can worsen side effects.
- Maintain a regular sleep schedule and engage in light to moderate exercise to support mental well-being.
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