Nirova
Generic Name
Pregabalin
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| nirova 100 mg capsule | ৳ 1,095.00 | ৳ 6,570.00 |
Description
Overview of the medicine
Nirova 100 mg Capsule contains Pregabalin, an anticonvulsant and analgesic medication. It is primarily used to treat neuropathic pain, epilepsy (partial seizures), generalized anxiety disorder, and fibromyalgia.
Uses & Indications
Dosage
Adults
Neuropathic Pain: Initial dose 75 mg twice daily, may be increased to 300 mg/day (150 mg twice daily) within 1 week, and up to a maximum of 600 mg/day (300 mg twice daily). Epilepsy: Initial dose 75 mg twice daily, may be increased up to 600 mg/day in divided doses. Fibromyalgia: Initial 75 mg twice daily, increased to 150 mg twice daily. Maximum 450 mg/day. GAD: Initial 150 mg/day, increased to 300-600 mg/day.
Elderly
Dose reduction may be necessary due to age-related decrease in renal function. Start with a lower dose.
Renal_impairment
Dose adjustment is required based on creatinine clearance. For severe impairment (CrCl <15 mL/min), a significantly reduced dose or longer dosing interval is needed. Hemodialysis patients require a supplementary dose after dialysis.
How to Take
Nirova capsules should be taken orally, with or without food. Swallow the capsule whole with water.
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, which is thought to reduce the release of several neurotransmitters including glutamate, noradrenaline, and substance P. This action provides anticonvulsant, anxiolytic, and analgesic effects.
Pharmacokinetics
Onset
Pain relief can be experienced within 1 week for neuropathic pain. Full therapeutic effects for epilepsy or anxiety may take longer.
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, with peak plasma concentrations occurring within 1.5 hours. Oral bioavailability is >90% and is independent of dose.
Metabolism
Negligible hepatic metabolism in humans; approximately 98% of the dose is recovered unchanged in the urine.
Side Effects
Contraindications
- Hypersensitivity to pregabalin or to any of the excipients.
Drug Interactions
CNS Depressants (e.g., opioids, benzodiazepines, alcohol)
Increased risk of additive CNS depression, respiratory depression, and sedation. Concomitant use should be approached with caution.
Thiazolidinedione Antidiabetics (e.g., rosiglitazone, pioglitazone)
May increase the risk of weight gain and peripheral edema when used with pregabalin.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include somnolence, confusion, agitation, and, rarely, coma. Treatment is supportive and symptomatic; hemodialysis may be beneficial in severe cases.
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 into human milk; therefore, breastfeeding is not recommended.
Side Effects
Contraindications
- Hypersensitivity to pregabalin or to any of the excipients.
Drug Interactions
CNS Depressants (e.g., opioids, benzodiazepines, alcohol)
Increased risk of additive CNS depression, respiratory depression, and sedation. Concomitant use should be approached with caution.
Thiazolidinedione Antidiabetics (e.g., rosiglitazone, pioglitazone)
May increase the risk of weight gain and peripheral edema when used with pregabalin.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include somnolence, confusion, agitation, and, rarely, coma. Treatment is supportive and symptomatic; hemodialysis may be beneficial in severe cases.
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 into human milk; therefore, breastfeeding is not recommended.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the date of manufacture. Check the expiration date on the packaging.
Availability
Pharmacies, hospitals
Approval Status
Approved
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Pregabalin has undergone extensive clinical trials demonstrating its efficacy and safety for approved indications, including studies on neuropathic pain, epilepsy, GAD, and fibromyalgia.
Lab Monitoring
- Renal function monitoring, especially in elderly patients or those with pre-existing renal impairment.
- Monitor for signs of peripheral edema and weight gain.
Doctor Notes
- Counsel patients on the importance of gradual withdrawal to avoid severe withdrawal symptoms.
- Monitor for signs of misuse or dependence, especially in patients with a history of substance abuse.
- Be aware of increased risk of respiratory depression when co-administered with CNS depressants or in patients with respiratory compromise.
Patient Guidelines
- Do not stop taking this medicine abruptly without consulting your doctor, as it can lead to withdrawal symptoms.
- Report any unusual changes in mood, behavior, or suicidal thoughts to your doctor immediately.
- Avoid alcohol consumption while taking Nirova.
- Be aware of potential for dizziness and drowsiness; avoid driving or operating machinery until you know how it affects you.
Missed Dose Advice
If a dose is missed, take it as soon as you remember, unless it is almost time for your next dose. In that case, 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
Nirova may cause dizziness, somnolence, and blurred vision. Patients should be advised not to drive, operate complex machinery, or engage in other potentially hazardous activities until they are reasonably certain that Nirova does not adversely affect their ability to perform such tasks.
Lifestyle Advice
- Engage in regular, moderate exercise to help manage pain and improve mood.
- Maintain a balanced diet and healthy weight.
- Practice stress-reduction techniques like meditation or yoga.
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