Stresin
Generic Name
Duloxetine
Manufacturer
Healthcare Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| stresin 30 mg dr capsule | ৳ 12.00 | ৳ 120.00 |
Description
Overview of the medicine
Stresin 30 mg DR Capsule is a serotonin-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
Major Depressive Disorder/Generalized Anxiety Disorder: 60 mg once daily. Diabetic Peripheral Neuropathic Pain/Fibromyalgia/Chronic Pain: Initiate with 30 mg once daily for 1 week, then increase to 60 mg once daily. Maximum 120 mg/day.
Elderly
Similar to adults, but cautious titration may be considered due to potential for decreased clearance and increased sensitivity.
Renal_impairment
Not recommended in severe renal impairment (Creatinine Clearance <30 mL/min). Use with caution in moderate impairment.
How to Take
Administer orally, swallow the capsule whole with or without food. Do not open, crush, or chew the capsule as it is a delayed-release formulation.
Mechanism of Action
Duloxetine works by inhibiting the reuptake of serotonin and norepinephrine in the central nervous system, leading to increased concentrations of these neurotransmitters in the synaptic cleft, thereby modulating mood and pain pathways.
Pharmacokinetics
Onset
Antidepressant effects usually begin within 1-2 weeks, with full effect taking 4-6 weeks. Pain relief may be observed sooner.
Excretion
Primarily excreted in urine as inactive metabolites (70%), with a smaller amount in feces (20%).
Half life
Approximately 12 hours (range 8-17 hours).
Absorption
Well-absorbed orally, peak plasma concentrations typically achieved 6 hours post-dose due to enteric coating. Bioavailability is 30-80%.
Metabolism
Extensively metabolized in the liver primarily by CYP1A2 and CYP2D6 to 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 renal impairment (CrCl <30 mL/min).
- Severe hepatic impairment.
Drug Interactions
MAOIs
Concurrent use can lead to serious, sometimes fatal, serotonin syndrome.
Alcohol
Increased risk of liver injury, particularly with chronic excessive alcohol consumption.
SSRIs/SNRIs/Triptans
Increased risk of serotonin syndrome.
CYP2D6 Inhibitors (e.g., paroxetine, quinidine)
Can increase duloxetine exposure.
CYP1A2 Inhibitors (e.g., fluvoxamine, ciprofloxacin)
Can significantly increase duloxetine plasma levels.
Anticoagulants/Antiplatelets (e.g., warfarin, aspirin)
Increased risk of bleeding due to duloxetine's effect on platelet aggregation.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include somnolence, coma, serotonin syndrome, seizures, vomiting, and tachycardia. Management is supportive and symptomatic; ensure adequate airway, oxygenation, and ventilation. No specific antidote is known.
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; caution should be exercised when administered to a nursing woman.
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).
- Severe hepatic impairment.
Drug Interactions
MAOIs
Concurrent use can lead to serious, sometimes fatal, serotonin syndrome.
Alcohol
Increased risk of liver injury, particularly with chronic excessive alcohol consumption.
SSRIs/SNRIs/Triptans
Increased risk of serotonin syndrome.
CYP2D6 Inhibitors (e.g., paroxetine, quinidine)
Can increase duloxetine exposure.
CYP1A2 Inhibitors (e.g., fluvoxamine, ciprofloxacin)
Can significantly increase duloxetine plasma levels.
Anticoagulants/Antiplatelets (e.g., warfarin, aspirin)
Increased risk of bleeding due to duloxetine's effect on platelet aggregation.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include somnolence, coma, serotonin syndrome, seizures, vomiting, and tachycardia. Management is supportive and symptomatic; ensure adequate airway, oxygenation, and ventilation. No specific antidote is known.
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; caution should be exercised when administered to a nursing woman.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months from the date of manufacture. Check the expiry date on the packaging.
Availability
Pharmacies nationwide
Approval Status
Approved by regulatory authorities
Patent Status
Generics available (original patent expired)
Clinical Trials
Duloxetine has undergone extensive clinical trials demonstrating its efficacy and safety in various indications including MDD, GAD, DPNP, fibromyalgia, and chronic musculoskeletal pain.
Lab Monitoring
- Liver function tests (LFTs) periodically, especially in patients with pre-existing liver disease or those consuming substantial amounts of alcohol.
- Renal function should be monitored, especially in patients with impairment.
- Blood pressure monitoring.
Doctor Notes
- Monitor patients for worsening depression, suicidality, or unusual behavioral changes, especially at the initiation of therapy or after dose adjustments.
- Assess liver and renal function regularly, particularly in patients with pre-existing conditions or those on concomitant medications that may affect these organs.
- Educate patients on the importance of adherence to the dosing regimen and the risks associated with abrupt discontinuation.
Patient Guidelines
- Do not stop taking Stresin abruptly; consult your doctor for a gradual dose reduction.
- Report any unusual changes in mood or behavior, especially suicidal thoughts, to your doctor immediately.
- Avoid consuming alcohol while taking this medicine.
- Inform your healthcare provider about all other medications you are taking, including over-the-counter drugs and herbal supplements.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
Stresin may cause dizziness or drowsiness. Patients should exercise caution when driving or operating machinery until they know how the medicine affects them.
Lifestyle Advice
- Maintain a healthy diet and engage in regular physical activity.
- Practice stress-reduction techniques such as meditation or yoga.
- Ensure adequate sleep and avoid illicit drugs.
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