Daxetin
Generic Name
Duloxetine
Manufacturer
Example Pharma Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| daxetin 60 mg tablet | ৳ 50.00 | ৳ 200.00 |
Description
Overview of the medicine
Daxetin 60 mg tablet contains Duloxetine, a serotonin-norepinephrine reuptake inhibitor (SNRI) used to treat major depressive disorder, generalized anxiety disorder, neuropathic pain associated with diabetic peripheral neuropathy, fibromyalgia, and chronic musculoskeletal pain.
Uses & Indications
Dosage
Adults
Major Depressive Disorder/GAD: Initial 20-30 mg once daily, may increase to 60 mg once daily. Max 120 mg/day for MDD. DPNP/Fibromyalgia/Chronic Musculoskeletal Pain: 60 mg once daily (maintenance dose after initial lower doses).
Elderly
No specific dose adjustment for mild to moderate renal/hepatic impairment. Start with lower doses (e.g., 20 mg once daily) and titrate carefully, especially with severe organ impairment.
Renal_impairment
Not recommended for patients with end-stage renal disease (CrCl <30 mL/min) or severe renal impairment.
How to Take
Take orally with or without food. Swallow the tablet whole; do not chew, crush, or open.
Mechanism of Action
Duloxetine is a potent inhibitor of neuronal reuptake of both serotonin and norepinephrine. It has a weak inhibitory effect on dopamine reuptake. It increases the concentrations of serotonin and norepinephrine in the central nervous system, which is thought to be responsible for its antidepressant, anxiolytic, and pain-relieving effects.
Pharmacokinetics
Onset
Antidepressant effects may begin within 1-2 weeks, full effect in 4 weeks. Pain relief may start earlier.
Excretion
Primarily excreted in urine (approximately 70%) and feces (approximately 20%) as inactive metabolites.
Half life
Approximately 12 hours (range 8-17 hours).
Absorption
Well absorbed orally, reaching peak plasma concentrations 6-10 hours post-dose due to delayed-release formulation.
Metabolism
Extensively metabolized in the liver by CYP1A2 and CYP2D6.
Side Effects
Contraindications
- Hypersensitivity to duloxetine or any excipients
- Concomitant use with MAOIs or within 14 days of discontinuing an MAOI
- Uncontrolled narrow-angle glaucoma
- Severe renal impairment (CrCl <30 mL/min) or end-stage renal disease
- Severe hepatic impairment
Drug Interactions
Monoamine Oxidase Inhibitors (MAOIs)
Risk of serotonin syndrome (hyperthermia, rigidity, myoclonus, autonomic instability, mental status changes).
CNS Depressants (e.g., alcohol, benzodiazepines)
Enhanced CNS depressant effect.
CYP1A2 Inhibitors (e.g., fluvoxamine, ciprofloxacin)
Increased duloxetine plasma levels.
CYP2D6 Inhibitors (e.g., quinidine, fluoxetine, paroxetine)
Moderate increase in duloxetine levels.
Serotonergic Drugs (e.g., SSRIs, triptans, fentanyl, tramadol, tryptophan)
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 somnolence, coma, serotonin syndrome, seizures, vomiting, and tachycardia. Treatment is supportive; maintain airway, monitor cardiac and vital signs. Activated charcoal may be considered. There is no specific antidote.
Pregnancy & Lactation
Pregnancy Category C. Use only if potential benefit justifies potential risk to the fetus. Not recommended during breastfeeding as duloxetine is excreted in breast milk.
Side Effects
Contraindications
- Hypersensitivity to duloxetine or any excipients
- Concomitant use with MAOIs or within 14 days of discontinuing an MAOI
- Uncontrolled narrow-angle glaucoma
- Severe renal impairment (CrCl <30 mL/min) or end-stage renal disease
- Severe hepatic impairment
Drug Interactions
Monoamine Oxidase Inhibitors (MAOIs)
Risk of serotonin syndrome (hyperthermia, rigidity, myoclonus, autonomic instability, mental status changes).
CNS Depressants (e.g., alcohol, benzodiazepines)
Enhanced CNS depressant effect.
CYP1A2 Inhibitors (e.g., fluvoxamine, ciprofloxacin)
Increased duloxetine plasma levels.
CYP2D6 Inhibitors (e.g., quinidine, fluoxetine, paroxetine)
Moderate increase in duloxetine levels.
Serotonergic Drugs (e.g., SSRIs, triptans, fentanyl, tramadol, tryptophan)
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 somnolence, coma, serotonin syndrome, seizures, vomiting, and tachycardia. Treatment is supportive; maintain airway, monitor cardiac and vital signs. Activated charcoal may be considered. There is no specific antidote.
Pregnancy & Lactation
Pregnancy Category C. Use only if potential benefit justifies potential risk to the fetus. Not recommended during breastfeeding as duloxetine is excreted in breast milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months
Availability
Pharmacies, hospitals, and licensed drug stores
Approval Status
Approved by regulatory authorities (e.g., FDA, DGDA)
Patent Status
Patent expired; generic versions available
Clinical Trials
Duloxetine has undergone extensive clinical trials demonstrating its efficacy and safety for approved indications. Ongoing post-marketing surveillance and studies continue to gather data.
Lab Monitoring
- Liver function tests (baseline and periodically, especially in patients with pre-existing liver disease or those on other hepatotoxic drugs)
- Blood pressure (periodically)
- Renal function (in patients with kidney impairment)
Doctor Notes
- Emphasize slow titration up and down to minimize side effects and withdrawal symptoms.
- Monitor for signs of serotonin syndrome, especially when co-administered with other serotonergic agents.
- Assess liver function periodically, particularly in patients with pre-existing hepatic impairment or alcohol abuse.
- Educate patients about the black box warning regarding suicidality.
Patient Guidelines
- Do not stop taking this medicine abruptly; consult your doctor for gradual dose reduction.
- Report any suicidal thoughts or unusual behavior changes to your doctor immediately.
- Avoid alcohol while on this medication.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it is almost time for the next dose, 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
May cause dizziness or drowsiness. Avoid driving or operating heavy machinery until you know how this medicine affects you.
Lifestyle Advice
- Maintain a healthy diet and regular exercise.
- Practice stress-reduction techniques like meditation or yoga.
- Ensure adequate sleep.
- Limit caffeine intake.
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