Indications

Nepco (Pregabalin) is indicated for:

• Neuropathic pain associated with diabetic peripheral neuropathy and spinal cord injury.
• Postherpetic neuralgia.
• Adjunctive therapy for partial-onset seizures in patients 1 month of age and older.
• Fibromyalgia. The controlled-release (CR) tablet is indicated for neuropathic pain associated with diabetic peripheral neuropathy and postherpetic neuralgia.

Pharmacology

Pregabalin is a structural derivative of GABA. It does not bind directly to GABA receptors but binds with high affinity to the alpha2-delta (α2​−δ) site, an auxiliary subunit of voltage-gated calcium channels in the central nervous system. This binding is believed to be involved in its anti-nociceptive (pain-reducing) and antiseizure effects.

Dosage

The dosage for Nepco varies by condition and formulation.

• Neuropathic Pain (DPN):
  • Film-coated: Starting dose is 50 mg three times a day (150 mg/day). Can be increased to a maximum of 100 mg three times a day (300 mg/day).
  • CR: Starting dose is 165 mg once daily. Can be increased to a maximum of 330 mg once daily.
• Postherpetic Neuralgia (PHN):
  • Film-coated: Starting dose is 75-150 mg twice daily or 50-100 mg three times daily (150-300 mg/day). Can be increased to a maximum of 600 mg/day.
  • CR: Starting dose is 165 mg once daily. Can be increased to a maximum of 660 mg once daily.
• Fibromyalgia: The recommended dose is 300 to 450 mg/day. The starting dose is 75 mg twice a day (150 mg/day).
• Spinal Cord Injury Pain: The recommended dose range is 150 to 600 mg/day. The starting dose is 75 mg twice a day (150 mg/day).

Administration

Nepco is taken orally, with or without food. The CR tablet should be taken after an evening meal and swallowed whole. When discontinuing the medication, it should be tapered gradually over a minimum of 1 week to avoid increased seizure frequency.

Interaction

Nepco is not expected to be involved in significant pharmacokinetic drug interactions.

Contraindications

Pregabalin is contraindicated in patients with a known hypersensitivity to the drug or any of its components.

Side Effects

The most common side effects in adults are dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, and difficulty with concentration. In pediatric patients for partial-onset seizures, the most common side effects are increased weight and increased appetite.

Pregnancy & Lactation

There are no adequate studies of pregabalin in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Small amounts of the drug are found in human milk, so breastfeeding is not recommended due to the potential risk of tumorigenicity.

Precautions & Warnings

• Hypersensitivity: Angioedema (swelling of the throat, head, and neck) and other hypersensitivity reactions can occur. The drug should be discontinued immediately if these symptoms appear.
• Suicidal Thoughts: Antiepileptic drugs, including Nepco, increase the risk of suicidal thoughts or behavior.
• CNS Depression: The drug can cause dizziness and somnolence, which may impair the ability to drive or operate machinery.
• Withdrawal: Rapid discontinuation can increase seizure frequency.
• Peripheral Edema: The drug may cause peripheral edema, and caution should be exercised when co-administered with thiazolidinedione antidiabetic agents.

Use in Special Populations

The safety and effectiveness of Nepco have not been established in pediatric patients for neuropathic pain, fibromyalgia, or postherpetic neuralgia. For partial-onset seizures, safety and effectiveness have not been established for patients under 1 month of age.

Overdose Effects

Overdose symptoms may include reduced consciousness, confusion, agitation, restlessness, and seizures. There is no specific antidote. Management should be supportive, including monitoring vital signs.

Therapeutic Class

Nepco is an adjunct and primary anti-epileptic drug.

Storage Conditions

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