Bivara
Generic Name
Pregabalin
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| bivara 50 mg tablet | ৳ 75.00 | ৳ 750.00 |
Description
Overview of the medicine
Bivara 50 mg Tablet contains Pregabalin, an anticonvulsant and neuropathic pain agent, used to treat neuropathic pain, epilepsy, and generalized anxiety disorder.
Uses & Indications
Dosage
Adults
For neuropathic pain: Initial dose 75 mg twice daily or 50 mg three times daily, adjusted up to 300 mg twice daily or 200 mg three times daily. Maximum 600 mg/day. For GAD: Initial 150 mg/day, gradually increased to 300-600 mg/day.
Elderly
Dose adjustment required based on renal function. Lower starting doses are often recommended.
Renal_impairment
Reduced dose required; e.g., CrCl 30-60 mL/min, 25-50 mg twice daily or 75 mg once daily. Dosage must be individualized based on creatinine clearance.
How to Take
Take orally with or without food. Swallow the tablet whole with water. Do not crush, chew, or break the tablet.
Mechanism of Action
Binds to the alpha-2-delta subunit of voltage-gated calcium channels in the central nervous system, reducing the release of several neurotransmitters like glutamate, norepinephrine, and substance P. This leads to reduced neuronal excitability.
Pharmacokinetics
Onset
Analgesic effects may be seen within 1 week for neuropathic pain. Anxiolytic effects may also begin within 1 week.
Excretion
Primarily excreted unchanged by the kidneys. Renal excretion is the major route of elimination.
Half life
Approximately 6.3 hours, consistent across healthy subjects and patients with epilepsy or neuropathic pain.
Absorption
Rapidly absorbed after oral administration, peak plasma concentrations typically within 1 hour.
Metabolism
Minimally metabolized in humans. Less than 0.1% of the dose is excreted as N-methylated derivative in urine.
Side Effects
Contraindications
- Known hypersensitivity to Pregabalin or any excipients of the formulation.
Drug Interactions
Ethanol (Alcohol)
Increased impairment of motor function and sedation.
Benzodiazepines (e.g., Lorazepam)
Increased risk of sedation, dizziness, and respiratory depression.
Opioid analgesics (e.g., Oxycodone)
May enhance CNS depressant effects, leading to increased sedation and respiratory depression.
Thiazolidinedione antidiabetic agents
May increase risk of weight gain and peripheral edema when co-administered.
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 coma. Treatment is supportive and symptomatic, with gastric lavage or activated charcoal if appropriate. Hemodialysis can remove Pregabalin from the plasma.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Not recommended during breastfeeding as it is excreted in human milk.
Side Effects
Contraindications
- Known hypersensitivity to Pregabalin or any excipients of the formulation.
Drug Interactions
Ethanol (Alcohol)
Increased impairment of motor function and sedation.
Benzodiazepines (e.g., Lorazepam)
Increased risk of sedation, dizziness, and respiratory depression.
Opioid analgesics (e.g., Oxycodone)
May enhance CNS depressant effects, leading to increased sedation and respiratory depression.
Thiazolidinedione antidiabetic agents
May increase risk of weight gain and peripheral edema when co-administered.
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 coma. Treatment is supportive and symptomatic, with gastric lavage or activated charcoal if appropriate. Hemodialysis can remove Pregabalin from the plasma.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Not recommended during breastfeeding as it is excreted in human milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months from the date of manufacture, specific to batch.
Availability
Pharmacies, hospitals
Approval Status
Approved by regulatory bodies worldwide, including DGDA
Patent Status
Patent expired, generic versions widely available
Clinical Trials
Pregabalin has undergone extensive clinical trials demonstrating its efficacy and safety for neuropathic pain, epilepsy, and generalized anxiety disorder.
Lab Monitoring
- Renal function (creatinine clearance) before and during treatment, especially in elderly and renally impaired patients.
- Baseline liver function tests (LFTs) and periodic monitoring if clinically indicated.
Doctor Notes
- Counsel patients on the risk of central nervous system (CNS) depression, including somnolence and dizziness, and advise against driving or operating machinery.
- Emphasize the importance of gradual dose reduction to minimize withdrawal symptoms upon discontinuation.
- Monitor for signs of abuse or misuse, particularly in patients with a history of substance abuse.
Patient Guidelines
- Do not stop taking this medicine suddenly without consulting your doctor, as it can lead to withdrawal symptoms.
- Avoid alcohol consumption during treatment, as it may increase side effects like dizziness and somnolence.
- Report any unusual mood changes, thoughts of self-harm, or allergic reactions (e.g., swelling of face, lips) to your doctor immediately.
Missed Dose Advice
If a dose is missed, 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 double the dose to make up for a missed one.
Driving Precautions
May cause dizziness, somnolence, and blurred vision. Patients should be advised not to drive or operate heavy machinery until they know how Bivara 50 mg Tablet affects their ability to perform such activities.
Lifestyle Advice
- Maintain a healthy diet and regular exercise to manage weight gain, a common side effect.
- Practice stress-reducing techniques such as yoga or meditation, especially if taking it for anxiety.
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