Pregacap
Generic Name
Pregabalin
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| pregacap 50 mg capsule | ৳ 13.00 | ৳ 130.00 |
Description
Overview of the medicine
Pregabalin 50 mg Capsule is an anticonvulsant and neuropathic pain medication. It is used to treat neuropathic pain, epilepsy (as adjunctive therapy for partial seizures), generalized anxiety disorder, and fibromyalgia.
Uses & Indications
Dosage
Adults
Dosage is individualized and titrated. Starting dose typically 75 mg twice daily or 50 mg three times daily. Maximum dose usually 600 mg/day, divided into 2-3 doses. Specific indications may have different maximums.
Elderly
No specific dose adjustment based solely on age, but renal function should be assessed and dose adjusted accordingly due to potential age-related decline in renal function.
Renal_impairment
Dose adjustment is required based on creatinine clearance. For CrCl 30-60 mL/min, reduce total daily dose by 50%. For CrCl 15-30 mL/min, reduce by 75%. For CrCl <15 mL/min, reduce by 75-90% and administer once daily.
How to Take
Take Pregabalin 50 mg Capsule orally, with or without food. Swallow the capsule whole with water. Do not chew or crush.
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, subsequently reducing the release of several excitatory neurotransmitters like glutamate, norepinephrine, and substance P. This action is believed to be responsible for its analgesic, anxiolytic, and anticonvulsant effects.
Pharmacokinetics
Onset
Clinical effects may be observed within 1 week for pain and anxiety indications, though full effect may take longer with dose titration.
Excretion
Primarily excreted unchanged in the urine. Renal clearance is directly proportional to creatinine clearance.
Half life
Approximately 6.3 hours.
Absorption
Rapidly absorbed after oral administration, peak plasma concentrations reached within 1.5 hours. Oral bioavailability is >90% and is independent of dose. Food slightly decreases the rate of absorption but not the extent.
Metabolism
Negligible systemic metabolism in humans; approximately 98% of the dose is excreted unchanged in the urine.
Side Effects
Contraindications
- Hypersensitivity to pregabalin or any component of the formulation.
Drug Interactions
Angiotensin Converting Enzyme (ACE) Inhibitors
Coadministration may potentiate the risk of angioedema. Use with caution.
Thiazolidinediones (e.g., pioglitazone, rosiglitazone)
May increase the risk of weight gain and peripheral edema when co-administered with pregabalin. Monitor for fluid retention and weight increase.
CNS Depressants (e.g., alcohol, benzodiazepines, opioids)
Concurrent use may enhance the CNS depressant effects of pregabalin, leading to increased somnolence and dizziness. Caution is advised.
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. In cases of overdose, supportive care and hemodialysis may be considered if necessary, as pregabalin is dialyzable.
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, caution should be exercised when administered to a nursing woman.
Side Effects
Contraindications
- Hypersensitivity to pregabalin or any component of the formulation.
Drug Interactions
Angiotensin Converting Enzyme (ACE) Inhibitors
Coadministration may potentiate the risk of angioedema. Use with caution.
Thiazolidinediones (e.g., pioglitazone, rosiglitazone)
May increase the risk of weight gain and peripheral edema when co-administered with pregabalin. Monitor for fluid retention and weight increase.
CNS Depressants (e.g., alcohol, benzodiazepines, opioids)
Concurrent use may enhance the CNS depressant effects of pregabalin, leading to increased somnolence and dizziness. Caution is advised.
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. In cases of overdose, supportive care and hemodialysis may be considered if necessary, as pregabalin is dialyzable.
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, caution should be exercised when administered to a nursing woman.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24-36 months from manufacturing date.
Availability
Pharmacies, Hospitals
Approval Status
Approved by regulatory authorities worldwide
Patent Status
Generic available
Clinical Trials
Extensive clinical trials have demonstrated pregabalin's efficacy and safety in various indications, including neuropathic pain, epilepsy, GAD, and fibromyalgia.
Lab Monitoring
- Renal function tests (creatinine clearance) in patients with kidney impairment.
- Monitor for worsening of depression, suicidal thoughts, or unusual changes in behavior.
Doctor Notes
- Advise patients on gradual dose tapering to avoid withdrawal symptoms.
- Counsel patients regarding potential CNS depressant effects and impairment of driving/operating machinery.
- Emphasize monitoring for suicidal ideation, especially at the start of therapy or with dose changes.
Patient Guidelines
- Do not stop taking this medicine suddenly without consulting your doctor, as it may lead to withdrawal symptoms.
- Avoid driving or operating machinery until you know how this medicine affects you, as it can cause dizziness and drowsiness.
- Report any unusual mood changes, thoughts of self-harm, or severe side effects to your doctor immediately.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is close to the 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
Pregabalin may cause dizziness, somnolence, and blurred vision, which can 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 engage in such activities.
Lifestyle Advice
- Avoid alcohol consumption while on pregabalin, as it can worsen dizziness and drowsiness.
- Maintain a healthy diet and regular exercise to manage weight gain, a common side effect.
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