Neugalin
Generic Name
Pregabalin
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| neugalin 50 mg capsule | ৳ 14.60 | ৳ 146.00 |
Description
Overview of the medicine
Neugalin 50 mg Capsule contains Pregabalin, an anticonvulsant and neuropathic pain medication. It is primarily used to treat neuropathic pain associated with various conditions, fibromyalgia, and as an adjunctive therapy for partial onset seizures in adults. It can also be used for generalized anxiety disorder.
Uses & Indications
Dosage
Adults
Starting dose typically 75 mg twice daily or 50 mg three times daily (150 mg/day). May be increased gradually to a maximum of 300 mg twice daily (600 mg/day) based on individual response and tolerability.
Elderly
Due to potential for decreased renal function, lower starting doses and slower titration may be considered. Renal function should be monitored.
Renal_impairment
Dose adjustment is necessary. For creatinine clearance 30-60 mL/min: 75 mg/day in 2-3 divided doses. For 15-30 mL/min: 25-50 mg/day in 1-2 divided doses. For <15 mL/min or hemodialysis patients: 25 mg/day or 25 mg single dose after hemodialysis.
How to Take
Neugalin capsules should be swallowed whole with water, with or without food. It can be taken at any time of day, but should be taken at the same times each day.
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 the release of several excitatory neurotransmitters, including glutamate, noradrenaline, and substance P, thereby reducing neuronal excitability and pain signaling.
Pharmacokinetics
Onset
Analgesic effects may be observed within 1 week for neuropathic pain. Anxiolytic effects can be seen within 1 week for generalized anxiety disorder.
Excretion
Excreted largely unchanged in the urine (approximately 98% of the dose) by the kidneys. Renal clearance is directly proportional to creatinine clearance.
Half life
Approximately 6.3 hours.
Absorption
Rapidly absorbed following oral administration, with peak plasma concentrations occurring within 1 hour. Bioavailability is ≥90% and is not affected by food.
Metabolism
Pregabalin undergoes negligible metabolism in humans. Less than 0.1% of the dose is metabolized.
Side Effects
Contraindications
- Hypersensitivity to pregabalin or any of the excipients in the formulation.
Drug Interactions
ACE Inhibitors
Concomitant use with ACE inhibitors may lead to an increased risk of angioedema (e.g., facial swelling, perioral edema).
CNS Depressants (e.g., alcohol, opioids, benzodiazepines)
May potentiate the effects of alcohol and other CNS depressants, leading to increased drowsiness, dizziness, and decreased alertness. Concurrent use should be approached with caution.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include somnolence, confusion, agitation, and restlessness. Treatment is supportive and symptomatic; gastric lavage may be considered if ingestion is recent. Hemodialysis is an effective method for removing pregabalin from the plasma.
Pregnancy & Lactation
Pregnancy Category C. Studies in animals have shown reproductive toxicity. Not recommended for use during pregnancy unless the potential benefit justifies the potential risk to the fetus. Pregabalin is excreted into breast milk; therefore, breastfeeding is not recommended during treatment.
Side Effects
Contraindications
- Hypersensitivity to pregabalin or any of the excipients in the formulation.
Drug Interactions
ACE Inhibitors
Concomitant use with ACE inhibitors may lead to an increased risk of angioedema (e.g., facial swelling, perioral edema).
CNS Depressants (e.g., alcohol, opioids, benzodiazepines)
May potentiate the effects of alcohol and other CNS depressants, leading to increased drowsiness, dizziness, and decreased alertness. Concurrent use should be approached with caution.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include somnolence, confusion, agitation, and restlessness. Treatment is supportive and symptomatic; gastric lavage may be considered if ingestion is recent. Hemodialysis is an effective method for removing pregabalin from the plasma.
Pregnancy & Lactation
Pregnancy Category C. Studies in animals have shown reproductive toxicity. Not recommended for use during pregnancy unless the potential benefit justifies the potential risk to the fetus. Pregabalin is excreted into breast milk; therefore, breastfeeding is not recommended during treatment.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 to 36 months from manufacturing date, depending on specific manufacturer and storage conditions.
Availability
Pharmacies, Hospitals
Approval Status
Approved
Patent Status
Patent expired for original molecule; generic versions available
Clinical Trials
Extensive clinical trials have demonstrated the efficacy and safety of pregabalin for its approved indications, including neuropathic pain, fibromyalgia, and partial onset seizures. Post-marketing surveillance continues to monitor for new safety concerns.
Lab Monitoring
- Renal function should be regularly monitored, especially in elderly patients or those with pre-existing renal impairment, as dose adjustments may be necessary.
- Monitor for signs of peripheral edema and weight gain.
Doctor Notes
- Assess renal function before initiating and periodically during treatment, adjusting dose as needed.
- Counsel patients on the risk of CNS depression and advise against concomitant use with alcohol or other CNS depressants.
- Monitor for signs of suicidal ideation and changes in behavior, especially at the beginning of treatment or after dose changes.
- Advise patients not to discontinue abruptly to avoid withdrawal symptoms.
Patient Guidelines
- Do not stop taking Neugalin abruptly, as this may lead to withdrawal symptoms (e.g., insomnia, nausea, headache, anxiety). Gradually reduce the dose under medical supervision.
- Neugalin may cause dizziness and drowsiness; avoid driving or operating heavy machinery until you know how it affects you.
- Avoid alcohol consumption while taking this medicine, as it can increase side effects like dizziness and drowsiness.
- Report any unusual mood changes, suicidal thoughts, or signs of allergic reactions (swelling of face, lips, tongue) to your doctor immediately.
Missed Dose Advice
If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose. In that case, 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
Neugalin 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 Neugalin does not adversely affect their ability to perform such activities.
Lifestyle Advice
- Maintain a healthy lifestyle with regular exercise and a balanced diet to manage overall health and potential weight gain associated with pregabalin.
- Practice stress-reducing techniques like meditation or yoga, as pregabalin is sometimes used for anxiety disorders.
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