Prebalin-CR
Generic Name
Pregabalin (Extended Release)
Manufacturer
XYZ Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| prebalin cr 825 mg tablet | ৳ 25.00 | ৳ 250.00 |
Description
Overview of the medicine
Pregabalin extended-release tablet is an anticonvulsant and neuropathic pain agent used to treat diabetic peripheral neuropathy, postherpetic neuralgia, and as an adjunctive therapy for partial-onset seizures in adults. The extended-release formulation allows for once-daily dosing.
Uses & Indications
Dosage
Adults
For neuropathic pain, initial dose typically 82.5 mg or 165 mg once daily, adjusted based on response and tolerability, up to a maximum of 330 mg once daily. For diabetic peripheral neuropathy, doses typically range from 165 mg to 330 mg once daily.
Elderly
Dosage adjustment may be necessary in elderly patients due to potential age-related decline in renal function. Start with lower doses and titrate slowly.
Renal_impairment
Dosage adjustment is required for patients with impaired renal function. Reduce dose proportionally to creatinine clearance. For example, for CrCl 30-50 mL/min, maximum dose should be 165 mg once daily.
How to Take
Take orally once daily, with or without food. Swallow the tablet whole; do not split, crush, or chew.
Mechanism of Action
Pregabalin binds with high affinity to the alpha-2-delta (α2δ) subunit of voltage-gated calcium channels in the central nervous system. This binding modulates the release of several excitatory neurotransmitters, including glutamate, norepinephrine, and substance P, which are involved in pain and seizure pathophysiology.
Pharmacokinetics
Onset
Pain relief usually within 1 week; seizure control within a few days to weeks.
Excretion
Primarily excreted unchanged in urine.
Half life
Approximately 6.3 hours.
Absorption
Well absorbed orally, bioavailability >90%. Peak plasma concentrations achieved in about 3 hours for CR formulation.
Metabolism
Negligible hepatic metabolism.
Side Effects
Contraindications
- Hypersensitivity to Pregabalin or any excipients
- Not recommended for children and adolescents under 18 years
Drug Interactions
CNS depressants (e.g., opioids, benzodiazepines, ethanol)
May potentiate central nervous system (CNS) depression, leading to increased sedation, dizziness, and respiratory depression. Use with caution.
Thiazolidinedione antidiabetic agents (e.g., pioglitazone, rosiglitazone)
May increase the risk of weight gain and peripheral edema.
Storage
Store below 30°C in a cool, dry place, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include somnolence, confusion, agitation, and disorientation. Treatment is supportive and symptomatic. Gastric lavage may be considered soon after ingestion. Hemodialysis is effective in removing Pregabalin from plasma.
Pregnancy & Lactation
Pregnancy Category C. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is excreted in human milk, so caution should be exercised when administered to a nursing woman. Consult a doctor.
Side Effects
Contraindications
- Hypersensitivity to Pregabalin or any excipients
- Not recommended for children and adolescents under 18 years
Drug Interactions
CNS depressants (e.g., opioids, benzodiazepines, ethanol)
May potentiate central nervous system (CNS) depression, leading to increased sedation, dizziness, and respiratory depression. Use with caution.
Thiazolidinedione antidiabetic agents (e.g., pioglitazone, rosiglitazone)
May increase the risk of weight gain and peripheral edema.
Storage
Store below 30°C in a cool, dry place, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include somnolence, confusion, agitation, and disorientation. Treatment is supportive and symptomatic. Gastric lavage may be considered soon after ingestion. Hemodialysis is effective in removing Pregabalin from plasma.
Pregnancy & Lactation
Pregnancy Category C. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is excreted in human milk, so caution should be exercised when administered to a nursing woman. Consult a doctor.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 to 36 months
Availability
Pharmacies, Hospitals
Approval Status
Approved
Patent Status
Generic available, patent expired for original formulation
Clinical Trials
Extensive clinical trials have demonstrated the efficacy and safety of Pregabalin in treating neuropathic pain and partial-onset seizures. Trials for extended-release formulations specifically confirmed once-daily dosing efficacy.
Lab Monitoring
- Renal function (creatinine clearance) for patients with renal impairment
- Monitor for changes in mood or behavior, especially suicidal thoughts
Doctor Notes
- Assess renal function before initiating treatment and adjust dose accordingly.
- Counsel patients on potential for dizziness and somnolence, advising caution with driving or operating machinery.
- Monitor for signs of abuse or dependence, especially in vulnerable populations.
- Gradually taper dose over at least 1 week to avoid withdrawal symptoms.
Patient Guidelines
- Take as directed by your doctor, do not stop taking it suddenly as it may cause withdrawal symptoms.
- Avoid alcohol consumption while on this medication.
- Report any unusual mood changes, suicidal thoughts, or signs of allergic reactions (e.g., swelling of face, lips, tongue).
- May cause dizziness or somnolence; avoid driving or operating heavy machinery until you know how it affects you.
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
Pregabalin may cause dizziness, somnolence, and blurred vision, which can impair your ability to drive or operate machinery. Do not drive or engage in hazardous activities until you know how this medication affects you.
Lifestyle Advice
- Maintain a healthy and balanced diet.
- Engage in regular, moderate exercise if possible.
- Manage stress effectively through relaxation techniques or counseling.
- Avoid activities that may increase risk of falls if experiencing dizziness.
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