Nervalin 50

Indications

Nervalin is prescribed for:

• Neuropathic pain due to diabetic peripheral neuropathy (DPN)
• Postherpetic neuralgia (PHN)
• As an additional therapy for partial-onset seizures in patients aged 1 month and older
• Fibromyalgia
• Neuropathic pain from spinal cord injury

Nervalin CR tablet is prescribed for:

• Neuropathic pain due to diabetic peripheral neuropathy (DPN)
• Postherpetic neuralgia (PHN)

Pharmacology

Pregabalin, a structural derivative of gamma-aminobutyric acid (GABA), does not bind directly to GABAA, GABAB, or benzodiazepine receptors. It binds with high affinity to the alpha2-delta site (an auxiliary subunit of voltage-gated calcium channels) in central nervous system tissues. Although the precise mechanism of Pregabalin is unclear, animal studies suggest its binding to the alpha2-delta subunit may contribute to its pain-relieving and anti-seizure properties.

Dosage

Neuropathic Pain due to Diabetic Peripheral Neuropathy in Adults (DPN):

• Maximum dose: 100 mg three times daily (300 mg/day) for patients with creatinine clearance of at least 60 ml/min.
• Initial dose: 50 mg three times daily (150 mg/day).
• Dose adjustment: Increase to 300 mg/day within 1 week based on effectiveness and tolerability.
• Pregabalin CR capsule: Start at 165 mg once daily, increasing to 330 mg once daily within 1 week based on patient response and tolerability. Maximum recommended dose is 330 mg once daily.

Postherpetic Neuralgia in Adults (PHN):

• Recommended dose: 75 to 150 mg twice daily or 50 to 100 mg three times daily (150 to 300 mg/day) for patients with creatinine clearance of at least 60 ml/min.
• Initial dose: 75 mg twice daily or 50 mg three times daily (150 mg/day).
• Dose adjustment: Increase to 300 mg/day within 1 week based on effectiveness and tolerability. If pain relief is insufficient after 2-4 weeks, the dose may be increased to a maximum of 600 mg/day, depending on tolerability.
• Pregabalin CR capsule: Start at 165 mg once daily, increasing to 330 mg once daily within 1 week. If pain relief is insufficient after 2-4 weeks, the dose may be increased to 660 mg once daily, depending on tolerability. Maximum recommended dose is 660 mg once daily.

Management of Fibromyalgia in Adults:

• Recommended dose: 300 to 450 mg/day.
• Initial dose: 75 mg twice daily (150 mg/day).
• Dose adjustment: Increase to 150 mg twice daily (300 mg/day) within 1 week. If needed, increase to 225 mg twice daily (450 mg/day).

Neuropathic Pain due to Spinal Cord Injury in Adults:

• Recommended dose range: 150 to 600 mg/day.
• Initial dose: 75 mg twice daily (150 mg/day).
• Dose adjustment: Increase to 150 mg twice daily (300 mg/day) within 1 week. If pain relief is insufficient after 2-3 weeks, the dose may be increased to a maximum of 300 mg twice daily.

Conversion from Pregabalin Capsules to Pregabalin CR Capsule Tablet:

• On the day of the switch, take the morning dose of Pregabalin capsule as prescribed and initiate Pregabalin CR capsule therapy after an evening meal.

Administration

Route: Pregabalin is taken orally and can be consumed with or without food. Pregabalin CR tablets should be taken after an evening meal and swallowed whole without splitting, crushing, or chewing. If a dose is missed, follow these guidelines:

• After an evening meal: Take the usual dose prior to bedtime with a snack.
• Before bedtime: Take the usual dose after a morning meal.
• After a morning meal: Take the usual dose at the next evening meal.

When discontinuing Pregabalin and Pregabalin CR, taper off gradually over at least one week.

Interactions

• Drug Interactions: Unlikely to cause significant pharmacokinetic interactions.
• Food Interactions: Not applicable.

Contraindications

• Known hypersensitivity to Pregabalin or any of its components.

Side Effects

Common side effects in adults: dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, and cognitive impairment. In pediatric patients for partial onset seizures: increased weight and appetite.

Pregnancy & Lactation

No adequate studies in pregnant women. Pregnant women should be informed of potential risks. Pregabalin is found in small amounts in breast milk; breastfeeding is not recommended during treatment due to potential tumorigenic risks.

Precautions & Warnings

• Angioedema requiring emergency treatment may occur; discontinue Nervalin immediately if symptoms develop.
• Discontinue if hypersensitivity reactions occur.
• Increased risk of suicidal thoughts or behavior with antiepileptic drugs.
• Monitor for respiratory depression when used with CNS depressants or in patients with respiratory impairment.
• May cause dizziness and somnolence; caution while driving or operating machinery.
• Gradual discontinuation recommended to avoid increased seizure frequency or other adverse reactions.
• Peripheral edema may occur; use caution when coadministering with thiazolidinedione antidiabetic agents.

Use in Special Populations

• Safety and effectiveness in pediatric patients for neuropathic pain and fibromyalgia not established.
• For adjunctive therapy of partial onset seizures, safety in patients below 1 month not established.
• Safety of Nervalin extended-release tablets in pediatric patients not established.

Overdose Effects

Symptoms: reduced consciousness, depression/anxiety, confusion, agitation, restlessness, seizures, and heart block. No specific antidote. Treatment includes emesis or gastric lavage if indicated, supportive care, and monitoring vital signs.

Therapeutic Class

Adjunct anti-epileptic drugs, Primary anti-epileptic drugs

Storage Conditions

Store in a cool, dry place (below 30°C), protected from light and moisture. Keep out of reach of children.

Common Questions about Nervalin 50 mg Capsule

• What is Nervalin 50 mg Capsule?
  • An anticonvulsant used to treat neurotic pain, shingles, seizures, and fibromyalgia.
• How long to use before seeing improvement?
  • Use until improvement in health conditions is observed.
• Frequency of use?
  • As prescribed by the doctor.
• Before or after food?
  • After food, as prescribed.
• Storage and disposal?
  • Keep in a cool, dry place, out of reach of children and pets.
• Does it work the same for each disease?
  • No, its mechanism varies by condition.
• Duration of use?
  • Depends on the condition being treated; consult a doctor.
• Continue use if feeling fine?
  • Yes, consult a doctor before stopping.
• Can it be taken with Diazepam?
  • Yes, they can be used together.
• Can it cause weight gain?
  • Yes, due to increased hunger; consult a dietician if concerned.

Quick Tips

• Take as prescribed.
• May cause sleepiness; avoid driving or tasks requiring concentration.
• Report any vision changes or mood changes to your doctor.
• Do not stop abruptly; consult your doctor for gradual discontinuation.