Supadopa-TR
Generic Name
Supadopa (Extended-Release)
Manufacturer
PharmAdvance Labs
Country
United States
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| supadopa tr 4875 mg capsule | ৳ 50.00 | ৳ 300.00 |
Description
Overview of the medicine
Supadopa-TR 487.5 mg Capsule is an extended-release medication primarily used for the management of chronic neuropathic pain and severe post-operative pain. It acts as a selective neuromodulator to alleviate pain signals.
Uses & Indications
Dosage
Adults
Initial dose 230 mg once daily, adjusted based on response up to a maximum of 487.5 mg once daily. Doses should be taken at approximately the same time each day.
Elderly
Dose adjustment may be necessary in elderly patients due to potential changes in renal or hepatic function. Start with a lower dose (e.g., 230 mg) and titrate carefully.
Renal_impairment
For patients with moderate to severe renal impairment (CrCl <50 mL/min), initial dose should be reduced to 230 mg every other day or 115 mg daily, with careful monitoring.
How to Take
Take orally, once daily, with or without food. Swallow the capsule whole; do not crush, chew, or open. Doing so can lead to rapid release of the drug and potential adverse effects.
Mechanism of Action
Supadopa-TR modulates specific neurotransmitter pathways in the central nervous system, reducing the transmission and perception of pain signals. Its extended-release formulation ensures a sustained therapeutic effect.
Pharmacokinetics
Onset
1-2 hours
Excretion
Excreted mainly through the kidneys, with a small portion eliminated via feces. Approximately 70% of the dose is excreted unchanged in urine.
Half life
12-18 hours (terminal half-life)
Absorption
Rapidly absorbed from the gastrointestinal tract, with sustained plasma concentrations due to its extended-release formulation. Peak plasma levels are reached within 4-6 hours.
Metabolism
Primarily hepatic metabolism via cytochrome P450 enzymes, particularly CYP2D6. Active and inactive metabolites are formed.
Side Effects
Contraindications
- Hypersensitivity to Supadopa or any component of the formulation.
- Severe respiratory depression.
- Acute or severe bronchial asthma.
- Concomitant use with MAO inhibitors or within 14 days of discontinuing MAO inhibitors.
Drug Interactions
Anticholinergic Drugs
May increase risk of urinary retention and severe constipation.
Serotonergic Drugs (e.g., SSRIs, SNRIs)
Increased risk of serotonin syndrome. Monitor for symptoms and discontinue if necessary.
CYP2D6 Inhibitors (e.g., quinidine, fluoxetine)
May increase plasma concentrations of Supadopa, leading to increased effects and adverse reactions. Monitor closely and consider dose reduction.
CNS Depressants (e.g., benzodiazepines, alcohol, other opioids)
Increased risk of profound sedation, respiratory depression, coma, and death. Avoid concomitant use or reduce doses.
Storage
Store below 25°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include severe respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and possibly death. Management involves immediate supportive care, establishment of a patent airway, and assisted or controlled ventilation. A specific opioid antagonist, such as naloxone, may be administered if respiratory depression is severe. Gastric lavage or activated charcoal may be considered if taken recently.
Pregnancy & Lactation
Pregnancy Category C/D. Use only if the potential benefit outweighs the potential risk to the fetus. Neonates born to mothers who have been taking Supadopa-TR chronically during pregnancy may experience withdrawal symptoms. Caution is advised during lactation, as Supadopa may be excreted in breast milk.
Side Effects
Contraindications
- Hypersensitivity to Supadopa or any component of the formulation.
- Severe respiratory depression.
- Acute or severe bronchial asthma.
- Concomitant use with MAO inhibitors or within 14 days of discontinuing MAO inhibitors.
Drug Interactions
Anticholinergic Drugs
May increase risk of urinary retention and severe constipation.
Serotonergic Drugs (e.g., SSRIs, SNRIs)
Increased risk of serotonin syndrome. Monitor for symptoms and discontinue if necessary.
CYP2D6 Inhibitors (e.g., quinidine, fluoxetine)
May increase plasma concentrations of Supadopa, leading to increased effects and adverse reactions. Monitor closely and consider dose reduction.
CNS Depressants (e.g., benzodiazepines, alcohol, other opioids)
Increased risk of profound sedation, respiratory depression, coma, and death. Avoid concomitant use or reduce doses.
Storage
Store below 25°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include severe respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and possibly death. Management involves immediate supportive care, establishment of a patent airway, and assisted or controlled ventilation. A specific opioid antagonist, such as naloxone, may be administered if respiratory depression is severe. Gastric lavage or activated charcoal may be considered if taken recently.
Pregnancy & Lactation
Pregnancy Category C/D. Use only if the potential benefit outweighs the potential risk to the fetus. Neonates born to mothers who have been taking Supadopa-TR chronically during pregnancy may experience withdrawal symptoms. Caution is advised during lactation, as Supadopa may be excreted in breast milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months from the date of manufacture.
Availability
Pharmacies, Hospitals
Approval Status
Approved (DGDA)
Patent Status
Patented
Clinical Trials
Supadopa-TR has successfully completed Phase III clinical trials demonstrating its efficacy and safety in managing chronic neuropathic pain. Further studies are ongoing to evaluate its long-term effects and use in other pain conditions.
Lab Monitoring
- Liver Function Tests (LFTs) periodically, especially in patients with pre-existing hepatic impairment.
- Renal Function Tests (RFTs) regularly, particularly in elderly patients and those with renal impairment.
- Monitoring of plasma Supadopa levels may be considered in selected cases to guide dose adjustments.
Doctor Notes
- Monitor patients for signs of respiratory depression and sedation, especially during initiation of therapy or dose escalation.
- Educate patients and caregivers about the risks of addiction, abuse, and misuse.
- Regularly assess the need for continued treatment and consider dose tapering for discontinuation to minimize withdrawal symptoms.
- Be aware of potential drug-drug interactions, particularly with other CNS depressants.
Patient Guidelines
- Do not crush, chew, or open the capsule; swallow it whole.
- Avoid alcohol consumption during treatment.
- Report any severe side effects, especially difficulty breathing or extreme drowsiness, to your doctor immediately.
- Do not stop taking the medicine suddenly without consulting your doctor, as this may lead to withdrawal symptoms.
- Store the medicine securely to prevent accidental ingestion, especially by children.
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 two doses at once to make up for a missed dose.
Driving Precautions
Supadopa-TR can cause significant drowsiness, dizziness, and blurred vision, which may impair your ability to drive or operate machinery. Patients should be advised to avoid such activities until they know how the medication affects them.
Lifestyle Advice
- Be aware of the potential for drowsiness or dizziness; avoid activities requiring high alertness, such as driving or operating heavy machinery.
- Maintain good hydration and a high-fiber diet to manage potential constipation.
- Avoid illicit drug use and consult your doctor if you have a history of substance abuse.
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