Pregaba
Generic Name
Pregabalin
Manufacturer
Beximco Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| pregaba 25 mg capsule | ৳ 10.50 | ৳ 105.00 |
Description
Overview of the medicine
Pregabalin is an anticonvulsant and neuropathic pain agent used to treat various conditions, including neuropathic pain (diabetic neuropathy, postherpetic neuralgia), fibromyalgia, and as an adjunctive therapy for partial-onset seizures. It is also used for generalized anxiety disorder.
Uses & Indications
Dosage
Adults
Initial dose typically 25-75 mg twice or thrice daily, adjusted based on response and tolerability, usually up to 150-300 mg twice daily. The 25 mg dose is primarily for initiation or very low dose titration.
Elderly
Dose adjustment may be necessary due to potential age-related decline in renal function. Start with a lower dose.
Renal_impairment
Dose reduction is required based on creatinine clearance. For example, CrCl 30-60 mL/min, maximum dose may be reduced to 75 mg twice daily. For CrCl <15 mL/min, dose may be 25 mg once daily or every other day.
How to Take
Take orally with or without food. Swallow the capsule whole with water. Do not crush, chew, or open the capsule.
Mechanism of Action
Pregabalin binds with high affinity to the alpha2-delta (α2-δ) subunit of voltage-gated calcium channels in the central nervous system. This binding modulates calcium influx at nerve terminals, thereby reducing the release of several excitatory neurotransmitters, including glutamate, norepinephrine, and substance P. This action contributes to its analgesic, anxiolytic, and anticonvulsant effects.
Pharmacokinetics
Onset
Onset of analgesic effect can be observed within 1 week for neuropathic pain. Anxiolytic effects may appear within days.
Excretion
Primarily excreted unchanged in the urine, with renal excretion being the main elimination route.
Half life
Approximately 6.3 hours. It is renally excreted, and half-life may be prolonged in patients with renal impairment.
Absorption
Rapidly and well absorbed after oral administration, with peak plasma concentrations occurring within 1.5 hours. Oral bioavailability is ≥90% and is independent of dose.
Metabolism
Undergoes negligible hepatic metabolism in humans; approximately 98% is excreted unchanged in the urine.
Side Effects
Contraindications
- Hypersensitivity to pregabalin or any component of the formulation.
- History of angioedema (swelling of face, lips, tongue, or throat) with previous pregabalin use.
Drug Interactions
CNS Depressants (e.g., alcohol, benzodiazepines, opioids)
Concomitant use may potentiate CNS depressant effects, leading to increased somnolence, dizziness, and respiratory depression. Use with caution.
Thiazolidinedione Antidiabetic Agents (e.g., rosiglitazone)
Concomitant use may increase the risk of weight gain and peripheral edema.
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, confusion, agitation, and restlessness. Management is supportive and symptomatic. Hemodialysis may be beneficial in severely overdosed patients with significant renal impairment.
Pregnancy & Lactation
Pregnancy Category C. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Pregabalin is excreted in human milk; therefore, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Side Effects
Contraindications
- Hypersensitivity to pregabalin or any component of the formulation.
- History of angioedema (swelling of face, lips, tongue, or throat) with previous pregabalin use.
Drug Interactions
CNS Depressants (e.g., alcohol, benzodiazepines, opioids)
Concomitant use may potentiate CNS depressant effects, leading to increased somnolence, dizziness, and respiratory depression. Use with caution.
Thiazolidinedione Antidiabetic Agents (e.g., rosiglitazone)
Concomitant use may increase the risk of weight gain and peripheral edema.
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, confusion, agitation, and restlessness. Management is supportive and symptomatic. Hemodialysis may be beneficial in severely overdosed patients with significant renal impairment.
Pregnancy & Lactation
Pregnancy Category C. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Pregabalin is excreted in human milk; therefore, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
2 to 3 years from manufacturing date, check specific packaging for details.
Availability
Available in pharmacies, hospitals, and clinics
Approval Status
FDA approved (initial approval for Pregabalin)
Patent Status
Generic versions available, original patent expired
Clinical Trials
Extensive clinical trials have established pregabalin's efficacy and safety for its approved indications. Ongoing research continues to explore potential new applications.
Lab Monitoring
- No specific routine laboratory monitoring is required for pregabalin. Renal function should be monitored in patients with pre-existing renal impairment.
Doctor Notes
- Counsel patients on the risk of suicidal ideation and depression; monitor for changes.
- Warn patients about the potential for dizziness and somnolence, especially when initiating therapy or increasing dose.
- Advise gradual tapering of the dose to prevent withdrawal symptoms upon discontinuation.
- Exercise caution in patients with a history of substance abuse or cardiovascular disease.
Patient Guidelines
- Do not discontinue pregabalin abruptly; gradual tapering is required to avoid withdrawal symptoms.
- Avoid alcohol and other CNS depressants while taking this medication.
- Inform your doctor if you experience any unusual changes in mood, behavior, or suicidal thoughts.
- This medicine may cause dizziness or blurred vision, so be careful 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 take a double dose to make up for a missed one.
Driving Precautions
Pregabalin can cause dizziness, somnolence, and blurred vision, which may impair your ability to drive or operate machinery. Patients should be advised not to drive or operate complex machinery until they are reasonably certain that pregabalin does not adversely affect their ability to perform such activities.
Lifestyle Advice
- Maintain a balanced diet and engage in regular, moderate exercise to manage potential weight gain.
- Ensure adequate sleep and manage stress to support overall well-being.
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