Indications

Pregabalin film-coated tablets are indicated for:

• Neuropathic pain associated with diabetic peripheral neuropathy.
• Postherpetic neuralgia.
• As an add-on therapy for partial-onset seizures in patients 1 month of age and older.
• Fibromyalgia.
• Neuropathic pain associated with spinal cord injury.

Pregabalin controlled-release tablets are indicated for:

• Neuropathic pain associated with diabetic peripheral neuropathy.
• Postherpetic neuralgia.

Pharmacology

Pregabalin, a structural derivative of GABA, binds with high affinity to the alpha2-delta site of voltage-gated calcium channels in the central nervous system. This binding is believed to be the mechanism behind its anti-pain and anti-seizure effects.

Dosage

The dosage depends on the condition and patient's kidney function.

• Diabetic Peripheral Neuropathic Pain:
  • Film-coated tablet: Start with 50 mg three times a day (150 mg/day). The dose can be increased to a maximum of 100 mg three times a day (300 mg/day) within one week.
  • Controlled-release tablet: Start with 165 mg once daily after an evening meal, and increase to a maximum of 330 mg once daily within one week.
• Postherpetic Neuralgia:
  • Film-coated tablet: Start with 75 mg twice a day or 50 mg three times a day (150 mg/day). The dose can be increased to 300 mg/day within one week. In some cases, the dose can be further increased to a maximum of 600 mg/day.
  • Controlled-release tablet: Start with 165 mg once daily, and increase to a maximum of 660 mg once daily. Doses above 330 mg/day should be reserved for patients who are tolerating the drug but not getting sufficient pain relief.
• Fibromyalgia: Start with 75 mg twice a day (150 mg/day). The dose can be increased to 150 mg twice a day (300 mg/day) within one week. If needed, the dose can be further increased to 225 mg twice a day (450 mg/day). The maximum recommended dose is 450 mg/day.
• Neuropathic pain with spinal cord injury: The starting dose is 75 mg twice a day (150 mg/day). The dose may be increased to 150 mg twice a day (300 mg/day) within one week. In some patients, the dose can be increased to a maximum of 300 mg twice a day (600 mg/day).

Administration

Pregabalin can be taken with or without food. The controlled-release tablet should be taken after an evening meal and swallowed whole. To discontinue treatment, the dose should be gradually reduced over a minimum of one week.

Interaction

Pregabalin is unlikely to be involved in significant drug interactions.

Contraindications

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

Side Effects

Common side effects in adults include dizziness, somnolence (sleepiness), dry mouth, edema, blurred vision, weight gain, and difficulty with concentration. In pediatric patients, common side effects are increased weight and increased appetite.

Pregnancy & Lactation

There are no adequate studies on the use of pregabalin in pregnant women. Women should be advised of the potential risks to the fetus. Small amounts of the drug have been found in the milk of nursing women, so breastfeeding is not recommended during treatment.

Precautions & Warnings

• Angioedema: Swelling of the throat, head, and neck can occur and may be life-threatening. The drug should be discontinued immediately if this or other hypersensitivity reactions (e.g., hives, wheezing) occur.
• Suicidal thoughts: Antiepileptic drugs, including pregabalin, increase the risk of suicidal thoughts or behavior.
• Respiratory depression: This may occur when used with other CNS depressants or in patients with underlying respiratory problems.
• Discontinuation: The drug should be tapered gradually over at least one week to avoid an increase in seizure frequency or other adverse reactions.
• Peripheral Edema: The drug may cause swelling in the extremities. Caution is needed when co-administering with thiazolidinedione antidiabetic agents.

Overdose Effects

Overdose can cause reduced consciousness, depression, confusion, agitation, and restlessness. Seizures and heart block have also been reported. There is no specific antidote. Treatment is supportive and may include gastric lavage.

Therapeutic Class

Pregabalin is classified as an adjunct and primary anti-epileptic drug.

Storage Conditions

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