Product Description

Indications: Film-coated Pregabalin tablet is indicated for neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, fibromyalgia, neuropathic pain related to spinal cord injury, and as adjunctive therapy for partial-onset seizures in patients aged 1 month and older. Controlled-release Pregabalin tablet is indicated for neuropathic pain associated with diabetic peripheral neuropathy and postherpetic neuralgia.

Pharmacology: Pregabalin is a structural analogue of gamma-aminobutyric acid (GABA). It does not directly bind to GABAA, GABAB, or benzodiazepine receptors. Pregabalin selectively binds with high affinity to the alpha2-delta subunit of voltage-gated calcium channels in the central nervous system. This interaction is believed to reduce neurotransmitter release and neuronal excitability, contributing to its anticonvulsant and analgesic effects.

Dosage:

Diabetic Peripheral Neuropathy (DPN) in adults: The recommended starting dose is 50 mg three times daily (150 mg/day) in patients with creatinine clearance ≥60 mL/min. The dose may be increased within one week to 100 mg three times daily (300 mg/day), which is the maximum recommended dose. For controlled-release tablets, therapy should begin with 165 mg once daily and may be increased to 330 mg once daily within one week. The maximum recommended dose for the controlled-release formulation is 330 mg daily.

Postherpetic Neuralgia (PHN) in adults: Initial dosing is 75 mg twice daily or 50 mg three times daily (150 mg/day). Depending on response and tolerability, the dose may be increased to 300 mg/day within one week. Patients with inadequate pain relief after 2-4 weeks may receive up to 600 mg/day in divided doses. Controlled-release tablets should begin at 165 mg once daily and may be increased to 330 mg daily within one week. In selected patients tolerating therapy, the dose may be increased up to 660 mg once daily.

Fibromyalgia in adults: Recommended dosing ranges from 300-450 mg/day. Treatment should begin with 75 mg twice daily (150 mg/day) and may be increased to 150 mg twice daily (300 mg/day) within one week. If necessary, the dose may be further increased to 225 mg twice daily (450 mg/day).

Neuropathic pain associated with spinal cord injury: The starting dose is 75 mg twice daily (150 mg/day). Depending on efficacy and tolerability, the dose may be increased to 150 mg twice daily (300 mg/day) within one week. Patients with insufficient relief after 2-3 weeks may receive up to 300 mg twice daily (600 mg/day).

Conversion from Pregabalin capsules to controlled-release tablets: On the day of conversion, patients should take the morning dose of regular Pregabalin as usual and begin the controlled-release tablet after the evening meal.

Equivalent daily dose conversion:

75 mg/day capsule = 82.5 mg/day CR

150 mg/day capsule = 165 mg/day CR

225 mg/day capsule = 247.5 mg/day CR

300 mg/day capsule = 330 mg/day CR

450 mg/day capsule = 495 mg/day CR

600 mg/day capsule = 660 mg/day CR

Administration: Pregabalin is administered orally and may be taken with or without food. Controlled-release tablets should be taken after an evening meal and swallowed whole without crushing, chewing, or splitting. If a dose is missed, specific instructions based on timing of meals and bedtime should be followed. Discontinuation should be gradual over at least one week to minimize withdrawal symptoms or seizure risk.

Interaction: Pregabalin is unlikely to cause significant pharmacokinetic drug interactions. No clinically significant food interactions have been reported.

Contraindications: Contraindicated in patients with known hypersensitivity to Pregabalin or any component of the formulation.

Side Effects: Common side effects in adults include dizziness, somnolence, dry mouth, peripheral edema, blurred vision, weight gain, and impaired concentration or attention. Pediatric patients may experience increased appetite and weight gain.

Pregnancy & Lactation: Adequate studies in pregnant women are lacking. Pregnant women should be informed about potential fetal risks. Small amounts of Pregabalin are excreted into breast milk; therefore, breastfeeding is generally not recommended during therapy.

Precautions & Warnings: Pregabalin may cause angioedema, including swelling of the face, throat, and neck, which can lead to life-threatening respiratory compromise. Immediate discontinuation is required if hypersensitivity reactions occur. Antiepileptic drugs, including Pregabalin, may increase the risk of suicidal thoughts or behavior. Respiratory depression may occur, especially when used with CNS depressants or in patients with respiratory impairment. The drug may impair the ability to drive or operate machinery due to dizziness and drowsiness. Abrupt discontinuation should be avoided as it may increase seizure frequency or worsen symptoms. Peripheral edema may occur, particularly when combined with thiazolidinedione antidiabetic agents.

Use in Special Populations: Safety and effectiveness for diabetic peripheral neuropathy, postherpetic neuralgia, spinal cord injury pain, and fibromyalgia have not been established in pediatric patients. For adjunctive treatment of partial-onset seizures, safety below 1 month of age has not been established. Controlled-release tablets are not approved for pediatric use.

Overdose Effects: Symptoms of overdose may include reduced consciousness, agitation, confusion, anxiety, restlessness, seizures, and heart block. There is no specific antidote. Supportive treatment, airway protection, monitoring of vital signs, and elimination of unabsorbed drug through gastric lavage or emesis may be considered when appropriate.

Therapeutic Class: Adjunct anti-epileptic drugs, primary anti-epileptic drugs.

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