Tioxil
Generic Name
Duloxetine
Manufacturer
MediCo Pharmaceuticals
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| tioxil 60 mg capsule | ৳ 10.00 | ৳ 80.00 |
Description
Overview of the medicine
Duloxetine is a serotonin and noradrenaline reuptake inhibitor (SNRI) used primarily 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 Musculoskeletal Pain: Initiate with 30 mg once daily for 1 week, then increase to 60 mg once daily.
Elderly
No specific dose adjustment for elderly patients based on age; however, caution is advised due to potential for decreased renal/hepatic function. Start with a lower dose if necessary.
Renal_impairment
Avoid use in patients with severe renal impairment (CrCl < 30 mL/min). For moderate impairment (CrCl 30-60 mL/min), consider a lower starting dose or reduced frequency.
How to Take
Take orally with or without food. Swallow the capsule whole; do not chew, crush, or open the capsule.
Mechanism of Action
It works by increasing the levels of serotonin and norepinephrine in the brain, which helps to improve mood, reduce pain, and lessen anxiety.
Pharmacokinetics
Onset
Therapeutic effects for depression and anxiety may take 2-4 weeks to become apparent. Pain relief may also require several weeks.
Excretion
Approximately 70% of the dose is excreted in the urine as metabolites, and about 20% is excreted in the feces.
Half life
The mean elimination half-life is approximately 12 hours.
Absorption
Well absorbed after oral administration, peak plasma concentrations typically occur 6 to 10 hours post-dose. Food intake can delay the time to peak concentration but does not affect the extent of absorption.
Metabolism
Extensively metabolized in the liver, primarily by cytochrome P450 enzymes CYP1A2 and CYP2D6, to inactive metabolites.
Side Effects
Contraindications
- Hypersensitivity to duloxetine or any component of the formulation.
- Uncontrolled narrow-angle glaucoma.
- Concomitant use with Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of discontinuing MAOI treatment.
- Severe renal impairment (CrCl < 30 mL/min).
- Severe hepatic impairment or end-stage renal disease.
Drug Interactions
MAOIs
Risk of serious, sometimes fatal, reactions including serotonin syndrome.
CYP2D6 inhibitors (e.g., paroxetine, quinidine)
May increase duloxetine plasma concentrations.
CNS depressants (e.g., alcohol, benzodiazepines, opioids)
Enhanced CNS depressant effects.
Anticoagulants/Antiplatelet agents (e.g., warfarin, aspirin)
Increased risk of bleeding due to duloxetine's effect on platelet aggregation.
CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin, enoxacin)
May increase duloxetine plasma concentrations.
Other serotonergic drugs (SSRIs, SNRIs, triptans, tramadol, tryptophan)
Increased risk of serotonin syndrome.
Storage
Store below 30°C. Protect from moisture and light. Keep out of reach of children.
Overdose
Symptoms of overdose include somnolence, coma, seizures, vomiting, and tachycardia. Management is symptomatic and supportive; ensure adequate airway, ventilation, and oxygenation. Monitor cardiac rhythm and vital signs. There is no specific antidote.
Pregnancy & Lactation
Pregnancy Category C. Not recommended during pregnancy unless the potential benefit justifies the potential risk to the fetus. It is excreted in breast milk; therefore, caution is advised during breastfeeding.
Side Effects
Contraindications
- Hypersensitivity to duloxetine or any component of the formulation.
- Uncontrolled narrow-angle glaucoma.
- Concomitant use with Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of discontinuing MAOI treatment.
- Severe renal impairment (CrCl < 30 mL/min).
- Severe hepatic impairment or end-stage renal disease.
Drug Interactions
MAOIs
Risk of serious, sometimes fatal, reactions including serotonin syndrome.
CYP2D6 inhibitors (e.g., paroxetine, quinidine)
May increase duloxetine plasma concentrations.
CNS depressants (e.g., alcohol, benzodiazepines, opioids)
Enhanced CNS depressant effects.
Anticoagulants/Antiplatelet agents (e.g., warfarin, aspirin)
Increased risk of bleeding due to duloxetine's effect on platelet aggregation.
CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin, enoxacin)
May increase duloxetine plasma concentrations.
Other serotonergic drugs (SSRIs, SNRIs, triptans, tramadol, tryptophan)
Increased risk of serotonin syndrome.
Storage
Store below 30°C. Protect from moisture and light. Keep out of reach of children.
Overdose
Symptoms of overdose include somnolence, coma, seizures, vomiting, and tachycardia. Management is symptomatic and supportive; ensure adequate airway, ventilation, and oxygenation. Monitor cardiac rhythm and vital signs. There is no specific antidote.
Pregnancy & Lactation
Pregnancy Category C. Not recommended during pregnancy unless the potential benefit justifies the potential risk to the fetus. It is excreted in breast milk; therefore, caution is advised during breastfeeding.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24-36 months from manufacturing date.
Availability
Available in pharmacies
Approval Status
Approved
Patent Status
Off-patent (Generic versions available)
Clinical Trials
Extensive clinical trials have been conducted for its approved indications, demonstrating efficacy and safety across various patient populations.
Lab Monitoring
- Liver function tests (LFTs) periodically, especially in patients with pre-existing liver disease or those with substantial alcohol intake.
- Blood pressure and heart rate monitoring.
Doctor Notes
- Emphasize the importance of gradual discontinuation to minimize withdrawal symptoms.
- Monitor patients for clinical worsening, suicidality, or unusual changes in behavior, especially at the initiation of therapy or after dose changes.
- Advise patients to avoid alcohol due to increased risk of hepatotoxicity.
- Regularly assess blood pressure, especially in patients with pre-existing hypertension.
Patient Guidelines
- Take the medicine regularly as prescribed and do not stop abruptly without consulting your doctor.
- Report any worsening of depression, unusual changes in behavior, or suicidal thoughts to your doctor immediately.
- Avoid alcohol consumption while taking this medicine.
- This medicine may cause dizziness or drowsiness; exercise caution when driving or operating machinery.
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 double the dose to catch up.
Driving Precautions
Tioxil (Duloxetine) may cause dizziness, drowsiness, or blurred vision. Patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that duloxetine therapy does not adversely affect their ability to engage in such activities.
Lifestyle Advice
- Engage in regular physical activity.
- Maintain a balanced diet.
- Practice stress management techniques.
- Ensure adequate sleep.
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