Dextac
Generic Name
dextac-60-mg-capsule
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| dextac 60 mg capsule | ৳ 16.00 | ৳ 96.00 |
Description
Overview of the medicine
Dextac 60 mg Capsule contains Duloxetine, a serotonin-norepinephrine reuptake inhibitor (SNRI) used to treat major depressive disorder, generalized anxiety disorder, neuropathic pain, fibromyalgia, and chronic musculoskeletal pain. It helps improve mood and reduce pain sensations by increasing certain natural substances in the brain.
Uses & Indications
Dosage
Adults
For MDD/GAD: Initially 20-30 mg once daily, may increase to 60 mg once daily. Max 120 mg/day for some indications. For DPNP/FM/CMP: 60 mg once daily. For chronic low back or osteoarthritis pain: 60 mg once daily.
Elderly
Similar to adults, but cautious titration recommended due to potential decreased clearance. Initiate at a lower dose if necessary.
Renal_impairment
Severe renal impairment (CrCl <30 mL/min): Not recommended. Moderate renal impairment (CrCl 30-80 mL/min): Use with caution, consider lower starting dose.
How to Take
Take orally, with or without food. Swallow the capsule whole; do not chew, crush, or open the capsule contents, as this can affect its extended-release properties.
Mechanism of Action
Duloxetine selectively inhibits the reuptake of serotonin and norepinephrine, leading to increased neurotransmitter concentrations in the synaptic cleft. This enhancement of neurotransmission is believed to be responsible for its antidepressant, anxiolytic, and analgesic effects.
Pharmacokinetics
Onset
Symptomatic relief for depression and anxiety may begin in 1-2 weeks, with full therapeutic effects often observed after 4-6 weeks of consistent treatment.
Excretion
Primarily excreted in urine (approximately 70%) and feces (approximately 20%) as inactive metabolites. Less than 1% of the administered dose is excreted as unchanged duloxetine.
Half life
The elimination half-life of duloxetine is approximately 12 hours (range 8 to 17 hours).
Absorption
Well absorbed orally; peak plasma concentrations typically occur 6 hours post-dose. Absolute oral bioavailability ranges from 32% to 80% (mean 50%).
Metabolism
Extensively metabolized in the liver by the cytochrome P450 isoenzymes CYP1A2 and CYP2D6 to multiple inactive metabolites.
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 hepatic impairment or end-stage renal disease (CrCl <30 mL/min).
- Concomitant use with thioridazine.
Drug Interactions
MAOIs
Concomitant use is contraindicated due to increased risk of serotonin syndrome.
Warfarin
Potential for increased bleeding, monitor INR.
Thioridazine
Contraindicated due to risk of serious ventricular arrhythmias and sudden death.
SSRIs/SNRIs/Tricyclic Antidepressants
Increased risk of serotonin syndrome.
CYP1A2 Inhibitors (e.g., Fluvoxamine, Ciprofloxacin)
Can significantly increase duloxetine plasma levels.
CYP2D6 Inhibitors (e.g., Quinidine, Fluoxetine, Paroxetine)
Can increase duloxetine exposure.
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 may include somnolence, coma, serotonin syndrome, seizures, vomiting, and tachycardia. There is no specific antidote. Management should consist of supportive care, including monitoring of vital signs and cardiac rhythm. Gastric lavage and activated charcoal may be considered.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Duloxetine is excreted in human milk; therefore, breastfeeding is not recommended during treatment.
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 hepatic impairment or end-stage renal disease (CrCl <30 mL/min).
- Concomitant use with thioridazine.
Drug Interactions
MAOIs
Concomitant use is contraindicated due to increased risk of serotonin syndrome.
Warfarin
Potential for increased bleeding, monitor INR.
Thioridazine
Contraindicated due to risk of serious ventricular arrhythmias and sudden death.
SSRIs/SNRIs/Tricyclic Antidepressants
Increased risk of serotonin syndrome.
CYP1A2 Inhibitors (e.g., Fluvoxamine, Ciprofloxacin)
Can significantly increase duloxetine plasma levels.
CYP2D6 Inhibitors (e.g., Quinidine, Fluoxetine, Paroxetine)
Can increase duloxetine exposure.
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 may include somnolence, coma, serotonin syndrome, seizures, vomiting, and tachycardia. There is no specific antidote. Management should consist of supportive care, including monitoring of vital signs and cardiac rhythm. Gastric lavage and activated charcoal may be considered.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Duloxetine is excreted in human milk; therefore, breastfeeding is not recommended during treatment.
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 by FDA and DGDA
Patent Status
Generic available
Clinical Trials
Duloxetine has undergone extensive clinical trials demonstrating its efficacy and safety across its approved indications. These trials have shown significant improvements in symptoms compared to placebo. Ongoing research includes studies on its long-term effects and potential new uses.
Lab Monitoring
- Liver function tests (LFTs) periodically, especially in patients with pre-existing liver disease or heavy alcohol consumption.
- Blood pressure monitoring regularly.
- Renal function tests in patients with kidney impairment.
- Serum sodium levels in patients at risk of hyponatremia.
Doctor Notes
- Counsel patients regarding the importance of adherence to treatment and potential for withdrawal symptoms if discontinued abruptly. Emphasize gradual tapering under medical supervision.
- Monitor blood pressure and heart rate regularly, especially in patients with pre-existing cardiovascular conditions.
- Assess liver function periodically, particularly in patients with a history of liver disease or alcohol abuse.
- Educate patients and caregivers about the black box warning regarding the increased risk of suicidal thoughts and behaviors, and instruct them to report any concerning changes immediately.
Patient Guidelines
- Take Dextac exactly as prescribed by your doctor; do not alter the dose or stop abruptly without consultation.
- Be aware of the potential for increased suicidal thoughts or behavioral changes, especially at the start of treatment; report any concerns to your doctor.
- Avoid alcohol consumption while taking this medication.
- Inform your doctor and pharmacist about all other medications, supplements, and herbal products you are taking.
- Do not chew, crush, or open the capsule.
- If you experience any new or worsening symptoms, contact your doctor immediately.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. However, 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
Dextac may cause dizziness, drowsiness, or blurred vision, which could impair your ability to drive or operate machinery. Exercise caution and avoid such activities until you know how this medicine affects you.
Lifestyle Advice
- Engage in regular physical activity, which can help improve mood and reduce pain.
- Maintain a balanced and healthy diet.
- Practice stress-reduction techniques such as meditation, yoga, or deep breathing exercises.
- Ensure adequate sleep and maintain a consistent sleep schedule.
- Avoid smoking.
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