Diliner-DR
Generic Name
Duloxetine
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| diliner dr 60 mg dr capsule | ৳ 16.11 | ৳ 96.66 |
Description
Overview of the medicine
Duloxetine is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) used to treat major depressive disorder, generalized anxiety disorder, and certain types of chronic pain, including diabetic peripheral neuropathic pain, fibromyalgia, and chronic musculoskeletal pain. Its delayed-release formulation ensures prolonged action and once-daily dosing.
Uses & Indications
Dosage
Adults
MDD/GAD: Initially 20-30 mg once daily; may increase to 60 mg once daily. Max 120 mg/day. DPNP/Fibromyalgia/Chronic Pain: 60 mg once daily.
Elderly
Similar to adult dosing, but caution and slower titration may be advised due to potential for renal/hepatic impairment and increased sensitivity.
Renal_impairment
Contraindicated in severe renal impairment (CrCl <30 mL/min). For moderate impairment, caution is advised, and lower doses may be considered.
How to Take
Administer orally once daily, with or without food. Swallow the capsule whole; do not chew, crush, or open the capsule.
Mechanism of Action
Duloxetine works by increasing the levels of serotonin and norepinephrine, two natural substances in the brain that help maintain mental balance and stop pain signals from being sent through the body. This action occurs by inhibiting their reuptake in the central nervous system.
Pharmacokinetics
Onset
Antidepressant and anxiolytic effects typically begin within 2-4 weeks. Pain relief may be observed sooner.
Excretion
Primarily excreted in urine (approximately 70%) and about 20% in feces as inactive metabolites.
Half life
Approximately 12 hours (range 8-17 hours).
Absorption
Well absorbed orally. Bioavailability is approximately 50%. Peak plasma concentrations are reached 6-10 hours post-administration due to delayed-release formulation. Food delays time to peak concentration but does not affect total absorption.
Metabolism
Extensively metabolized in the liver by CYP1A2 and CYP2D6 to inactive metabolites.
Side Effects
Contraindications
- Hypersensitivity to duloxetine or any component of the formulation.
- 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
Alcohol
Increased risk of liver injury, especially in chronic heavy users.
Monoamine Oxidase Inhibitors (MAOIs)
Risk of serotonin syndrome (contraindicated).
CYP1A2 Inhibitors (e.g., Fluvoxamine, Ciprofloxacin)
Can significantly increase duloxetine plasma concentrations.
CYP2D6 Inhibitors (e.g., Paroxetine, Fluoxetine, Quinidine)
Can affect duloxetine metabolism.
Drugs that increase bleeding risk (e.g., Warfarin, NSAIDs, Antiplatelets)
Increased risk of bleeding due to duloxetine's effect on platelet aggregation.
Other Serotonergic Drugs (SSRIs, SNRIs, Triptans, Opioids, TCAs, St. John's Wort)
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. Management involves symptomatic and supportive care. There is no specific antidote for duloxetine overdose.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Duloxetine is excreted in breast milk; use with caution in nursing mothers.
Side Effects
Contraindications
- Hypersensitivity to duloxetine or any component of the formulation.
- 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
Alcohol
Increased risk of liver injury, especially in chronic heavy users.
Monoamine Oxidase Inhibitors (MAOIs)
Risk of serotonin syndrome (contraindicated).
CYP1A2 Inhibitors (e.g., Fluvoxamine, Ciprofloxacin)
Can significantly increase duloxetine plasma concentrations.
CYP2D6 Inhibitors (e.g., Paroxetine, Fluoxetine, Quinidine)
Can affect duloxetine metabolism.
Drugs that increase bleeding risk (e.g., Warfarin, NSAIDs, Antiplatelets)
Increased risk of bleeding due to duloxetine's effect on platelet aggregation.
Other Serotonergic Drugs (SSRIs, SNRIs, Triptans, Opioids, TCAs, St. John's Wort)
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. Management involves symptomatic and supportive care. There is no specific antidote for duloxetine overdose.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Duloxetine is excreted in breast milk; use with caution in nursing mothers.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24-36 months from the manufacturing date
Availability
Pharmacies, hospitals
Approval Status
Approved by FDA/DGDA
Patent Status
Generic available
Clinical Trials
Extensive clinical trials have demonstrated the efficacy and safety of duloxetine in its approved indications, including major depressive disorder, generalized anxiety disorder, and various chronic pain syndromes. These studies have supported its use as a first-line or second-line agent in these conditions.
Lab Monitoring
- Liver function tests (ALT, AST, bilirubin) periodically, especially in patients with pre-existing liver disease or those consuming substantial amounts of alcohol.
- Blood pressure monitoring, particularly at treatment initiation and dose adjustments.
- Renal function (creatinine clearance) if impairment is suspected or in elderly patients.
Doctor Notes
- Counsel patients on the importance of adherence to the prescribed regimen and the need for gradual discontinuation under medical supervision to avoid withdrawal symptoms.
- Monitor patients for the emergence or worsening of suicidal thoughts and behaviors, especially at the beginning of treatment or following dose changes.
- Assess for liver function periodically, particularly in patients with a history of liver disease or significant alcohol consumption.
- Advise patients about potential drug interactions, especially with MAOIs and other serotonergic agents.
Patient Guidelines
- Take Diliner-DR exactly as prescribed by your doctor and do not stop abruptly without consulting them.
- Swallow the capsule whole; do not chew, crush, or open it, as this can affect the delayed-release mechanism.
- Report any unusual mood changes, worsening depression, or suicidal thoughts to your doctor immediately.
- Avoid alcohol consumption while taking this medicine due to an increased risk of liver damage.
- Inform your doctor or pharmacist about all other medications, herbal products, and supplements you are taking to avoid potential drug interactions.
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.
Driving Precautions
Diliner-DR may cause dizziness or drowsiness. Patients should be advised to exercise caution when operating machinery or driving until they are reasonably certain that the medicine does not adversely affect their ability to perform such activities.
Lifestyle Advice
- Engage in regular physical activity, which can help improve mood and manage pain.
- Maintain a balanced diet and ensure adequate hydration.
- Practice stress management techniques such as mindfulness, meditation, or yoga.
- Prioritize getting sufficient and consistent sleep.
- Regularly communicate with your healthcare provider about your symptoms and progress.
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