Dumax
Generic Name
Duloxetine
Manufacturer
Apex Pharma Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| dumax 60 mg tablet | ৳ 50.00 | ৳ 200.00 |
Description
Overview of the medicine
Dumax 60 mg tablet contains Duloxetine, a serotonin and norepinephrine reuptake inhibitor (SNRI) used to treat major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain, fibromyalgia, and chronic musculoskeletal pain.
Uses & Indications
Dosage
Adults
For MDD/GAD: Initially 20-30 mg twice daily, or 60 mg once daily. Max 120 mg/day. For DPNP/FM/CMP: 60 mg once daily. Some patients may start with 30 mg once daily for 1 week to allow adjustment.
Elderly
Similar to adults, but use with caution. Consider a lower starting dose and slower titration due to increased sensitivity and potential for adverse effects.
Renal_impairment
Avoid in severe renal impairment (CrCl <30 mL/min). For moderate impairment (CrCl 30-60 mL/min), consider reducing the dose or frequency, e.g., 30 mg once daily.
How to Take
Take orally with or without food. Swallow the tablet whole; do not crush, chew, or open the capsule contents, as this may affect the enteric coating and lead to early release of the drug.
Mechanism of Action
Duloxetine selectively inhibits the reuptake of serotonin (5-HT) and norepinephrine (NE) in the central nervous system, leading to increased extracellular levels of these neurotransmitters in the synaptic cleft, thereby enhancing their neurotransmission.
Pharmacokinetics
Onset
Antidepressant effects may take 2-4 weeks. Pain relief may be observed earlier (within 1-2 weeks).
Excretion
Primarily via urine (approximately 70%) and feces (approximately 20%) as inactive metabolites.
Half life
Approximately 12 hours (range 8-17 hours).
Absorption
Well absorbed orally. Absolute bioavailability is 50%. Peak plasma concentrations (Tmax) occur 6 hours post-dose. Food delays Tmax by 3 hours and decreases Cmax by 11%.
Metabolism
Extensively metabolized in the liver by CYP1A2 and CYP2D6. Major metabolites are inactive.
Side Effects
Contraindications
- Hypersensitivity to duloxetine or any component of the formulation.
- Concomitant use with Monoamine Oxidase Inhibitors (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 or end-stage liver disease.
Drug Interactions
MAOIs
Concomitant use can lead to serious, sometimes fatal, reactions including serotonin syndrome.
Anticoagulants/Antiplatelets (e.g., warfarin, NSAIDs)
Increased risk of bleeding due to duloxetine's effect on platelet aggregation.
Drugs that increase gastric pH (e.g., antacids, PPIs)
May lead to premature degradation of duloxetine due to the enteric coating.
CYP2D6 Inhibitors (e.g., paroxetine, fluoxetine, quinidine)
Can increase duloxetine exposure.
CYP1A2 Inhibitors (e.g., fluvoxamine, cimetidine, quinolone antibiotics)
Can significantly increase duloxetine plasma concentrations.
Other Serotonergic Drugs (e.g., SSRIs, SNRIs, triptans, tramadol, St. John's Wort)
Increased risk of serotonin syndrome.
Storage
Store below 30°C (86°F) in a dry place, protected from light and moisture. Keep out of reach of children. Do not freeze.
Overdose
Symptoms of overdose include somnolence, coma, serotonin syndrome, seizures, vomiting, and tachycardia. Treatment involves supportive and symptomatic measures. Gastric lavage and activated charcoal may be considered. There is no specific antidote.
Pregnancy & Lactation
Pregnancy Category C. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonates exposed to SNRIs in the third trimester have developed complications. Duloxetine is excreted into human milk; consider the developmental and health benefits of breastfeeding along with the mother's clinical need for duloxetine and any potential adverse effects on the breastfed infant.
Side Effects
Contraindications
- Hypersensitivity to duloxetine or any component of the formulation.
- Concomitant use with Monoamine Oxidase Inhibitors (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 or end-stage liver disease.
Drug Interactions
MAOIs
Concomitant use can lead to serious, sometimes fatal, reactions including serotonin syndrome.
Anticoagulants/Antiplatelets (e.g., warfarin, NSAIDs)
Increased risk of bleeding due to duloxetine's effect on platelet aggregation.
Drugs that increase gastric pH (e.g., antacids, PPIs)
May lead to premature degradation of duloxetine due to the enteric coating.
CYP2D6 Inhibitors (e.g., paroxetine, fluoxetine, quinidine)
Can increase duloxetine exposure.
CYP1A2 Inhibitors (e.g., fluvoxamine, cimetidine, quinolone antibiotics)
Can significantly increase duloxetine plasma concentrations.
Other Serotonergic Drugs (e.g., SSRIs, SNRIs, triptans, tramadol, St. John's Wort)
Increased risk of serotonin syndrome.
Storage
Store below 30°C (86°F) in a dry place, protected from light and moisture. Keep out of reach of children. Do not freeze.
Overdose
Symptoms of overdose include somnolence, coma, serotonin syndrome, seizures, vomiting, and tachycardia. Treatment involves supportive and symptomatic measures. Gastric lavage and activated charcoal may be considered. There is no specific antidote.
Pregnancy & Lactation
Pregnancy Category C. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonates exposed to SNRIs in the third trimester have developed complications. Duloxetine is excreted into human milk; consider the developmental and health benefits of breastfeeding along with the mother's clinical need for duloxetine and any potential adverse effects on the breastfed infant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months from the date of manufacture when stored under recommended conditions.
Availability
Pharmacies, hospitals, clinics
Approval Status
FDA approved, also approved by local drug authorities (e.g., DGDA)
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Duloxetine has undergone extensive clinical trials demonstrating its efficacy and safety for its approved indications, including placebo-controlled, randomized studies across diverse patient populations. Post-marketing surveillance continues to monitor its long-term effects.
Lab Monitoring
- Liver function tests (LFTs) periodically, especially in patients with pre-existing liver disease or those consuming substantial amounts of alcohol.
- Blood pressure monitoring, as duloxetine can cause an increase in blood pressure.
- Serum sodium levels (especially in elderly patients or those taking diuretics) due to risk of hyponatremia.
Doctor Notes
- Thoroughly assess patients for bipolar disorder before initiating duloxetine, as it may precipitate a manic or hypomanic episode.
- Monitor blood pressure regularly, especially in patients with pre-existing hypertension.
- Educate patients on the importance of gradual discontinuation to minimize withdrawal symptoms.
- Consider liver function tests periodically, particularly in patients with hepatic impairment or significant alcohol consumption.
- Counsel about the black box warning regarding suicidal thoughts and behaviors, especially in pediatric and young adult patients.
Patient Guidelines
- Take Dumax 60 mg exactly as prescribed by your doctor.
- Do not stop taking this medicine abruptly without consulting your doctor, as it can cause withdrawal symptoms.
- Report any new or worsening symptoms of depression, suicidal thoughts, or unusual changes in mood or behavior to your doctor immediately.
- Avoid alcohol consumption while taking this medication.
- Be cautious when driving or operating machinery until you know how this medicine affects you, as it may cause dizziness or drowsiness.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your 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
Duloxetine may cause dizziness, drowsiness, or blurred vision. Patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that duloxetine therapy does not adversely affect their ability to engage in such activities.
Lifestyle Advice
- Maintain a healthy and balanced diet.
- Engage in regular physical activity as advised by your doctor.
- Practice stress management techniques such as meditation or yoga.
- Ensure adequate sleep hygiene.
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