dextac
Generic Name
Duloxetine
Manufacturer
Acme Laboratories Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| dextac 30 mg capsule | ৳ 10.00 | ৳ 100.00 |
Description
Overview of the medicine
Dextac 30 mg Capsule contains Duloxetine, which is a Selective Serotonin and Norepinephrine Reuptake Inhibitor (SNRI). It is 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: Initiate with 30 mg once daily for 1 week, then increase to 60 mg once daily. Max 120 mg/day. For DPNP/Fibromyalgia/Chronic Pain: Initiate with 30 mg once daily for 1 week, then increase to 60 mg once daily. Max 60 mg/day for DPNP/Fibromyalgia, Max 120 mg/day for chronic pain.
Elderly
Initiate with 30 mg once daily. Gradually increase dosage under careful monitoring.
Renal_impairment
Not recommended for patients with severe renal impairment (CrCl < 30 mL/min) or end-stage renal disease.
How to Take
Take orally with or without food. Swallow the capsule whole; do not chew, crush, or open it, as this may affect the extended-release properties.
Mechanism of Action
Duloxetine is a potent inhibitor of neuronal reuptake of both serotonin and norepinephrine. It weakly inhibits dopamine reuptake, leading to increased levels of these neurotransmitters in the synaptic cleft, thereby enhancing mood and reducing pain perception.
Pharmacokinetics
Onset
Antidepressant and anxiolytic effects typically manifest within 1-4 weeks of continuous treatment. Pain relief may be observed sooner.
Excretion
Primarily excreted in the urine (approximately 70%) as inactive metabolites, and to a lesser extent in feces (approximately 20%).
Half life
The mean elimination half-life is approximately 12 hours (range 8-17 hours).
Absorption
Well absorbed orally with peak plasma concentrations typically reached in about 6 hours. Bioavailability ranges from 32% to 80%, increasing with higher doses.
Metabolism
Extensively metabolized in the liver, primarily by CYP1A2 and CYP2D6 isoenzymes, 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 MAOI treatment.
- 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
Alcohol
Increased risk of liver injury, especially with chronic heavy alcohol use.
Anticoagulants (e.g., Warfarin)
Increased risk of bleeding due to duloxetine's potential effect on platelet aggregation. Monitor INR.
Monoamine Oxidase Inhibitors (MAOIs)
Concomitant use is contraindicated due to the risk of serotonin syndrome, which can be fatal. A washout period of at least 14 days is required.
SSRIs/SNRIs/Triptans/Tricyclic Antidepressants
Increased risk of serotonin syndrome when co-administered with other serotonergic drugs.
CYP2D6 Inhibitors (e.g., paroxetine, fluoxetine, quinidine)
May increase duloxetine plasma levels, though less pronounced than CYP1A2 inhibitors.
CYP1A2 Inhibitors (e.g., fluvoxamine, cimetidine, quinolone antibiotics)
May significantly increase duloxetine plasma levels, requiring dose adjustment.
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 somnolence, coma, serotonin syndrome, seizures, vomiting, and tachycardia. There is no specific antidote for duloxetine overdose. Management should involve supportive and symptomatic treatment. Activated charcoal may be administered soon after ingestion.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonates exposed to SNRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. It is excreted in human milk; caution should be exercised when Dextac is administered to a nursing woman.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24-36 months from the date of manufacture. Refer to the specific product packaging for exact shelf life.
Availability
Pharmacies nationwide
Approval Status
Approved by FDA/DGDA
Patent Status
Generic available
Clinical Trials
Duloxetine has undergone extensive placebo-controlled and active-comparator clinical trials demonstrating its efficacy and safety for approved indications in adults. These studies have shown significant improvements in symptoms of depression, anxiety, and various chronic pain conditions.
Lab Monitoring
- Monitor liver function tests (ALT, AST, bilirubin) periodically, especially in patients with pre-existing liver disease or who consume substantial amounts of alcohol.
- Monitor renal function in patients with renal impairment.
Doctor Notes
- Monitor patients closely for clinical worsening and suicidality, especially during the initial phase of therapy or when the dose is changed.
- Caution is advised in patients with a history of seizures, bipolar disorder, or conditions that could predispose to hyponatremia.
- Liver function tests should be performed before initiating treatment and periodically thereafter, particularly in patients with liver disease or heavy alcohol use.
- Assess blood pressure regularly, as duloxetine can cause an increase in blood pressure.
Patient Guidelines
- Do not stop taking Dextac suddenly without consulting your doctor, as abrupt discontinuation can cause withdrawal symptoms.
- Report any worsening of depression, suicidal thoughts, or unusual changes in mood or behavior to your doctor immediately.
- Avoid or limit alcohol consumption during treatment with Dextac due to increased risk of liver injury.
- Be cautious when driving or operating hazardous machinery until you know how Dextac affects you, as it may cause dizziness or drowsiness.
- Inform your doctor about all other medications, supplements, and herbal products you are taking to avoid potential drug interactions.
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 resume your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Dextac (Duloxetine) may cause dizziness, drowsiness, or blurred vision. Patients should be advised to exercise caution when operating machinery or driving until they are reasonably certain that Dextac therapy does not adversely affect their ability to engage in such activities.
Lifestyle Advice
- Engage in regular physical activity as tolerated to improve mood and overall well-being.
- Maintain a balanced diet and regular sleep schedule.
- Practice stress-reduction techniques such as mindfulness or meditation.
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