Product Description

Indications: Pregabalin film-coated tablets are indicated for the treatment of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, fibromyalgia, neuropathic pain associated with spinal cord injury, and as adjunctive therapy for partial-onset seizures in patients aged 1 month and older. Pregabalin controlled-release tablets are 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 bind directly to GABAA, GABAB, or benzodiazepine receptors. Pregabalin binds with high affinity to the alpha2-delta subunit of voltage-gated calcium channels in the central nervous system. This action is believed to reduce calcium influx and decrease the release of excitatory neurotransmitters, contributing to its analgesic and anticonvulsant effects.Dosage & Administration:Diabetic Peripheral Neuropathy (DPN): Initial dose is 50 mg three times daily (150 mg/day). Dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability. Maximum recommended dose is 100 mg three times daily (300 mg/day). Pregabalin CR tablet therapy starts at 165 mg once daily and may be increased to 330 mg once daily within 1 week.Postherpetic Neuralgia (PHN): Recommended dose is 75-150 mg twice daily or 50-100 mg three times daily (150-300 mg/day). Patients not responding adequately after 2-4 weeks may receive up to 600 mg/day if tolerated. Pregabalin CR tablets may be increased up to 660 mg once daily in selected patients.Fibromyalgia: Initial dose is 75 mg twice daily (150 mg/day). Dose may be increased to 300 mg/day within 1 week, and up to 450 mg/day if needed.Neuropathic Pain Associated with Spinal Cord Injury: Starting dose is 75 mg twice daily (150 mg/day). Dose may be increased to 300 mg/day within 1 week and up to 600 mg/day depending on response and tolerability.Partial-Onset Seizures: Used as adjunctive therapy in patients aged 1 month and older according to physician recommendation.Administration: Pregabalin is taken orally with or without food. Pregabalin CR tablets should be taken once daily after an evening meal and swallowed whole without crushing, chewing, or splitting. When discontinuing therapy, the dose should be tapered gradually over at least 1 week.Interaction: Pregabalin has a low potential for clinically significant pharmacokinetic drug interactions. Concomitant use with CNS depressants may increase sedation and respiratory depression. Alcohol may enhance dizziness and drowsiness associated with Pregabalin.Contraindications: Pregabalin is contraindicated in patients with hypersensitivity to Pregabalin or any component of the formulation.Side Effects: Common side effects include dizziness, somnolence, dry mouth, peripheral edema, blurred vision, weight gain, difficulty concentrating, increased appetite, and fatigue. Pediatric patients may experience increased weight gain and appetite.Pregnancy & Lactation: There are no adequate and well-controlled studies in pregnant women. Pregnant women should be informed about potential fetal risks. Small amounts of Pregabalin are excreted in breast milk, and breastfeeding is generally not recommended during treatment.Precautions & Warnings: Serious hypersensitivity reactions including angioedema may occur and require immediate discontinuation. Pregabalin may increase the risk of suicidal thoughts or behavior. Respiratory depression can occur, especially when combined with CNS depressants or in patients with respiratory impairment. Abrupt discontinuation may increase seizure frequency or worsen symptoms; therefore, gradual tapering is recommended. Pregabalin may also cause peripheral edema, blurred vision, dizziness, and drowsiness, which may impair the ability to drive or operate machinery.Use in Special Populations: Safety and effectiveness for neuropathic pain, fibromyalgia, and spinal cord injury pain have not been established in pediatric patients. For adjunctive therapy in partial-onset seizures, safety in children below 1 month has not been established. Safety of extended-release tablets in pediatric patients has not been established.Overdose Effects: Symptoms of overdose may include reduced consciousness, agitation, confusion, depression, anxiety, restlessness, seizures, and heart block. There is no specific antidote. Treatment is supportive and symptomatic with monitoring of vital signs and maintenance of airway.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.