Deloxi
Generic Name
Duloxetine 60 mg DR Capsule
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| deloxi 60 mg dr capsule | ৳ 18.00 | ৳ 72.00 |
Description
Overview of the medicine
Deloxi 60 mg DR Capsule is a medication primarily used to treat major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain, fibromyalgia, and chronic musculoskeletal pain. It is a serotonin-norepinephrine reuptake inhibitor (SNRI).
Uses & Indications
Dosage
Adults
MDD/GAD: 60 mg once daily. DPNP/Fibromyalgia/Chronic MSK pain: Start with 30 mg once daily for a week, then increase to 60 mg once daily. Max 120 mg/day for some conditions.
Elderly
Similar to adults, but cautious titration recommended.
Renal_impairment
Not recommended for severe renal impairment (CrCl <30 mL/min). For moderate impairment, careful monitoring.
How to Take
Take orally, with or without food. Swallow the capsule whole; do not chew, crush, or open it, as it is a delayed-release formulation.
Mechanism of Action
Duloxetine is a potent inhibitor of neuronal reuptake of both serotonin and norepinephrine and a weak inhibitor of dopamine reuptake. It enhances the activity of these neurotransmitters in the central nervous system, which contributes to its antidepressant, anxiolytic, and pain-relieving effects.
Pharmacokinetics
Onset
Depression/Anxiety: 2-4 weeks; Pain: 1-2 weeks.
Excretion
Primarily via urine (70%) and feces (20%) as metabolites.
Half life
Approximately 12 hours.
Absorption
Well absorbed orally, peak plasma concentration at 6 hours (DR formulation). Food delays Tmax.
Metabolism
Extensively metabolized in the liver by CYP1A2 and CYP2D6.
Side Effects
Contraindications
- Hypersensitivity to duloxetine or any component
- Concomitant use with MAOIs (Monoamine Oxidase Inhibitors) 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
Risk of serotonin syndrome. Contraindicated.
Warfarin
Increased risk of bleeding.
CYP2D6 Inhibitors (e.g., paroxetine, quinidine)
Increased duloxetine plasma levels, though less significant clinically than CYP1A2 inhibition.
CYP1A2 Inhibitors (e.g., fluvoxamine, ciprofloxacin)
Increased duloxetine plasma levels.
Other Serotonergic Drugs (e.g., SSRIs, triptans, fentanyl, tramadol, St. John's Wort)
Increased risk of serotonin syndrome.
Storage
Store below 30°C in a dry place, away from light. Keep out of reach of children.
Overdose
Symptoms of overdose include somnolence, coma, serotonin syndrome, seizures, vomiting, and tachycardia. Management is symptomatic and supportive, including maintaining an open airway, cardiac and vital sign monitoring. Activated charcoal may be considered. There is no specific antidote.
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.
Side Effects
Contraindications
- Hypersensitivity to duloxetine or any component
- Concomitant use with MAOIs (Monoamine Oxidase Inhibitors) 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
Risk of serotonin syndrome. Contraindicated.
Warfarin
Increased risk of bleeding.
CYP2D6 Inhibitors (e.g., paroxetine, quinidine)
Increased duloxetine plasma levels, though less significant clinically than CYP1A2 inhibition.
CYP1A2 Inhibitors (e.g., fluvoxamine, ciprofloxacin)
Increased duloxetine plasma levels.
Other Serotonergic Drugs (e.g., SSRIs, triptans, fentanyl, tramadol, St. John's Wort)
Increased risk of serotonin syndrome.
Storage
Store below 30°C in a dry place, away from light. Keep out of reach of children.
Overdose
Symptoms of overdose include somnolence, coma, serotonin syndrome, seizures, vomiting, and tachycardia. Management is symptomatic and supportive, including maintaining an open airway, cardiac and vital sign monitoring. Activated charcoal may be considered. There is no specific antidote.
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.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months
Availability
Pharmacies, hospitals
Approval Status
Approved by FDA and DGDA
Patent Status
Patent expired, generic versions available
Clinical Trials
Extensive clinical trials have demonstrated the efficacy and safety of duloxetine for its approved indications. Post-marketing surveillance continues to monitor for adverse events.
Lab Monitoring
- Liver function tests (ALT, AST) especially in patients with pre-existing liver disease or those on concomitant hepatotoxic drugs
- Blood pressure monitoring, especially at initiation and dose escalation
- Renal function (CrCl) for severe impairment
Doctor Notes
- Counsel patients on the black box warning regarding suicidality, especially for younger patients.
- Emphasize the importance of gradual discontinuation to avoid withdrawal symptoms.
- Monitor blood pressure regularly, particularly in patients with pre-existing hypertension.
- Assess liver function periodically, especially in patients with risk factors for liver disease or concomitant medications affecting liver.
- Caution with concomitant use of drugs affecting hemostasis due to increased bleeding risk.
Patient Guidelines
- Take exactly as prescribed by your doctor.
- Do not stop taking this medicine suddenly, as it can cause withdrawal symptoms. Consult your doctor for gradual dose reduction.
- Report any unusual changes in mood or behavior, especially suicidal thoughts, to your doctor immediately.
- Avoid alcohol while taking this medicine.
- Be aware of potential dizziness or drowsiness, especially when starting treatment. Avoid driving or operating heavy machinery until you know how this medicine affects you.
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 continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
This medicine may cause dizziness, drowsiness, or blurred vision. Patients should be cautious when driving or operating machinery until they are certain the medicine does not adversely affect their ability to perform such activities.
Lifestyle Advice
- Maintain a healthy and balanced diet.
- Engage in regular physical activity as advised by your doctor.
- Practice stress-reduction techniques.
- Avoid excessive alcohol consumption.
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