Loxetine
Generic Name
Fluoxetine
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| loxetine 20 mg tablet | ৳ 8.00 | ৳ 80.00 |
Description
Overview of the medicine
Loxetine 20 mg Tablet contains Fluoxetine, a selective serotonin reuptake inhibitor (SSRI) antidepressant. It is primarily used to treat major depressive disorder, obsessive-compulsive disorder, panic disorder, and bulimia nervosa. It works by helping to restore the balance of a certain natural substance (serotonin) in the brain, which can improve mood, sleep, appetite, and energy level.
Uses & Indications
Dosage
Adults
For Major Depressive Disorder, the typical starting dose is 20 mg once daily, usually in the morning. The dose may be increased after several weeks to a maximum of 80 mg/day, depending on response and tolerability.
Elderly
Lower starting doses and slower titration may be considered due to potentially altered metabolism and increased sensitivity (e.g., 10 mg/day initially).
Renal_impairment
No specific dosage adjustment is generally recommended for mild to moderate renal impairment. Use with caution in severe impairment, and dose reduction may be considered.
How to Take
Take Loxetine 20 mg Tablet orally with or without food, usually once daily in the morning. Swallow the tablet whole with water; do not crush, chew, or break it.
Mechanism of Action
Fluoxetine selectively inhibits the reuptake of serotonin by presynaptic neurons in the central nervous system, thereby potentiating serotonergic activity. It has little or no effect on norepinephrine or dopamine reuptake. This leads to an increase in serotonin concentration in the synaptic cleft, enhancing neurotransmission.
Pharmacokinetics
Onset
Antidepressant effects may take 2-4 weeks to become noticeable. Anxiolytic effects may appear earlier.
Excretion
Primarily excreted in the urine as metabolites (about 60%). Small amounts are excreted in feces.
Half life
Fluoxetine has a half-life of 2-4 days, and its active metabolite, norfluoxetine, has a much longer half-life of 7-16 days.
Absorption
Well absorbed from the gastrointestinal tract, with peak plasma concentrations reached in 6-8 hours. Bioavailability is not significantly affected by food.
Metabolism
Extensively metabolized in the liver by the CYP2D6 enzyme system to its principal active metabolite, norfluoxetine, and other inactive metabolites.
Side Effects
Contraindications
- Hypersensitivity to fluoxetine or any excipients in 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
Warfarin
Increased risk of bleeding due to inhibition of CYP2C9/2D6, leading to elevated warfarin levels. Monitor INR closely.
NSAIDs/Aspirin
Increased risk of bleeding, particularly gastrointestinal bleeding, due to effects on platelet function.
Tramadol, Triptans
Increased risk of serotonin syndrome due to additive serotonergic effects.
Tricyclic Antidepressants (TCAs)
May increase plasma concentrations of TCAs, requiring dosage adjustments and monitoring for adverse effects.
MAOIs (Monoamine Oxidase Inhibitors)
Risk of serious, sometimes fatal, serotonin syndrome (hyperthermia, rigidity, myoclonus, autonomic instability, mental status changes).
Storage
Store in a cool, dry place below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include nausea, vomiting, seizures, cardiovascular dysfunction (ranging from asymptomatic arrhythmias to cardiac arrest), and CNS depression. Treatment is supportive; establish and maintain an airway, monitor cardiac and vital signs, and administer activated charcoal. 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. Small amounts are excreted in breast milk; caution is advised during breastfeeding, and potential risks/benefits should be discussed with a doctor.
Side Effects
Contraindications
- Hypersensitivity to fluoxetine or any excipients in 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
Warfarin
Increased risk of bleeding due to inhibition of CYP2C9/2D6, leading to elevated warfarin levels. Monitor INR closely.
NSAIDs/Aspirin
Increased risk of bleeding, particularly gastrointestinal bleeding, due to effects on platelet function.
Tramadol, Triptans
Increased risk of serotonin syndrome due to additive serotonergic effects.
Tricyclic Antidepressants (TCAs)
May increase plasma concentrations of TCAs, requiring dosage adjustments and monitoring for adverse effects.
MAOIs (Monoamine Oxidase Inhibitors)
Risk of serious, sometimes fatal, serotonin syndrome (hyperthermia, rigidity, myoclonus, autonomic instability, mental status changes).
Storage
Store in a cool, dry place below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include nausea, vomiting, seizures, cardiovascular dysfunction (ranging from asymptomatic arrhythmias to cardiac arrest), and CNS depression. Treatment is supportive; establish and maintain an airway, monitor cardiac and vital signs, and administer activated charcoal. 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. Small amounts are excreted in breast milk; caution is advised during breastfeeding, and potential risks/benefits should be discussed with a doctor.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months from the manufacturing date, consult packaging for exact date.
Availability
Pharmacies, hospitals, online pharmacies
Approval Status
Approved by major regulatory bodies (e.g., FDA, DGDA)
Patent Status
Generic available (Patent expired)
WHO Essential Medicine
YesClinical Trials
Numerous randomized, placebo-controlled clinical trials have demonstrated fluoxetine's efficacy in treating major depressive disorder, OCD, bulimia nervosa, panic disorder, and PMDD. These trials have also evaluated its long-term safety and tolerability.
Lab Monitoring
- Liver function tests (baseline and if clinically indicated)
- Electrolytes (especially sodium, if hyponatremia is suspected or in at-risk patients)
- ECG (in patients with cardiac risk factors or concomitant medications known to prolong QT interval)
Doctor Notes
- Prior to initiating fluoxetine, assess patients for a history of bipolar disorder or mania, as SSRIs can precipitate a manic episode.
- Closely monitor patients for the emergence or worsening of suicidal ideation and unusual behavioral changes, especially during initial treatment and dose adjustments.
- Educate patients on the importance of adherence and the dangers of abrupt discontinuation due to potential withdrawal symptoms (e.g., dizziness, paresthesia, anxiety).
- Caution with concomitant use of other serotonergic agents to avoid serotonin syndrome. Provide clear instructions on signs and symptoms of serotonin syndrome.
- Consider baseline and periodic ECGs in patients with known cardiac conditions or those taking other QT-prolonging drugs.
Patient Guidelines
- Do not stop taking this medicine suddenly without consulting your doctor, as withdrawal symptoms may occur.
- It may take several weeks for the full antidepressant effect to be felt, so continue treatment as prescribed.
- Avoid driving or operating machinery until you know how this medicine affects you, as it may cause drowsiness or dizziness.
- Inform your doctor about all other medications, herbal products, and supplements you are taking to prevent potential drug interactions.
- Report any unusual changes in mood or behavior, especially suicidal thoughts, to your doctor immediately.
Missed Dose Advice
If you miss a dose of Loxetine, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Loxetine 20 mg Tablet may cause drowsiness, dizziness, or blurred vision. Patients should be cautious when driving or operating heavy machinery until they are certain that this medicine does not adversely affect their ability to perform such tasks.
Lifestyle Advice
- Regular exercise and a balanced diet can support mental well-being.
- Practice stress-reduction techniques like meditation, deep breathing exercises, or yoga.
- Maintain a regular sleep schedule to help manage mood and energy levels.
- Avoid excessive alcohol consumption as it can interfere with treatment and worsen side effects.
- Engage in social activities and hobbies to improve mood.
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