Film-coated tablet is indicated for:

• Neuropathic pain associated with diabetic peripheral neuropathy
• Postherpetic neuralgia
• Adjunctive therapy in the treatment of partial-onset seizures in patients aged 1 month and older
• Fibromyalgia
• Neuropathic pain associated with spinal cord injury

Controlled release tablet is indicated for:

• Neuropathic pain associated with diabetic peripheral neuropathy
• Postherpetic neuralgia

Pregabalin is a structural analogue of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA). However, it does not bind directly to GABA_A, GABA_B, or benzodiazepine receptors. Pregabalin binds with high affinity to the alpha2-delta subunit of voltage-gated calcium channels in central nervous system tissues. Although its exact mechanism of action is not fully understood, experimental studies suggest that binding to this subunit is responsible for its anticonvulsant and analgesic (anti-nociceptive) effects.

Neuropathic pain associated with diabetic peripheral neuropathy in adults (DPN): The maximum recommended dose of Pregabalin is 100 mg three times a day (300 mg/day) in patients with creatinine clearance of at least 60 ml/min. Dosing should begin at 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability. Begin dosing of Pregabalin CR capsule at 165 mg once daily and increase to 330 mg once daily within 1 week based on individual patient response and tolerability. The maximum recommended dose of Pregabalin CR capsule is 330 mg once daily.

Postherpetic neuralgia in adults (PHN): The recommended dose of Pregabalin is 75 to 150 mg two times a day or 50 to 100 mg three times a day (150 to 300 mg/day) in patients with creatinine clearance of at least 60 ml/min. Dosing should begin at 75 mg two times a day or 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability. Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 300 mg/day and who are able to tolerate Pregabalin, may be treated with up to 300 mg two times a day or 200 mg three times a day (600 mg/day).

Begin dosing of Pregabalin CR capsule at 165 mg once daily and increase to 330 mg once daily within 1 week based on individual patient response and tolerability. Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 330 mg once daily and who are able to tolerate Pregabalin CR capsule, may be treated with up to 660 mg once daily. In view of the dose-dependent adverse reactions and the higher rate of treatment discontinuation due to adverse reactions, dosing above 330 mg/day should be reserved only for those patients who have on-going pain and are tolerating 330 mg daily. The maximum recommended dose of Pregabalin CR capsule is 660 mg once daily.

Management of fibromyalgia in adults: The recommended dose of Pregabalin is 300 to 450 mg/day. Dosing should begin at 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient benefit with 300 mg/day may be further increased to 225 mg two times a day (450 mg/day).

Neuropathic pain associated with spinal cord injury in adults: The recommended dose range of Pregabalin is 150 to 600 mg/day. The recommended starting dose is 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient pain relief after 2 to 3 weeks of treatment with 150 mg two times a day and who tolerate Pregabalin may be treated with up to 300 mg two times a day.

Conversion from Pregabalin capsules to Pregabalin CR capsule tablet: When switching from Pregabalin capsules to Pregabalin CR capsule tablet on the day of the switch, instruct patients to take their morning dose of Pregabalin capsule as prescribed and initiate Pregabalin CR capsule therapy after an evening meal.

Pregabalin tablet total daily dose (dosed 2 or 3 times daily): Pregabalin CR capsule capsule dose (dosed once a day)

• 75 mg/daily: 82.5 mg/day
• 150 mg/daily: 165 mg/day
• 225 mg/daily: 247.5 mg/day
• 300 mg/daily: 330 mg/day
• 450 mg/daily: 495 mg/day
• 600 mg/daily: 660 mg/day

Route of administration: Pregabalin is taken in oral route. It can be taken with or without food. Pregabalin CR tablet should be administered after an evening meal. It should be swallowed whole and should not be split, crushed or chewed. If patients miss taking their dose of Pregabalin CR after an evening meal, then they should take their usual dose of Pregabalin CR prior to bedtime following a snack. If they miss taking the dose of Pregabalin CR prior to bedtime, then they should take their usual dose of Pregabalin CR following a morning meal. If they miss taking the dose of Pregabalin CR following the morning meal, then they should take their usual dose of Pregabalin CR at the usual time that evening following an evening meal. When discontinuing both Pregabalin and Pregabalin CR, it should be gradually tapered over a minimum of 1 week.

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

The most common side effects in adults include dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, and abnormal thinking (mainly difficulty in concentration or attention). In pediatric patients treated for partial-onset seizures, the most common side effects are increased weight and increased appetite.

There are no adequate and well-controlled studies of pregabalin in pregnant women. Pregnant women should be informed about the potential risk to the fetus. Small amounts of pregabalin have been detected in breast milk. Due to potential risk, breastfeeding is not recommended during treatment with pregabalin.

Angioedema (e.g., swelling of the face, throat, head, and neck) may occur and can be life-threatening due to respiratory compromise; emergency treatment may be required. Pregabalin should be discontinued immediately in such cases. It should also be stopped immediately if hypersensitivity reactions occur (e.g., hives, dyspnea, wheezing). Antiepileptic drugs, including pregabalin, may increase the risk of suicidal thoughts or behavior. Respiratory depression may occur when used with CNS depressants or in patients with underlying respiratory disease; careful monitoring and dose adjustment are required. Pregabalin may cause dizziness and somnolence, impairing the ability to drive or operate machinery. Abrupt discontinuation may lead to increased seizure frequency or withdrawal symptoms; it should be tapered gradually over at least 1 week. Peripheral edema may occur. Caution is advised when used with thiazolidinedione antidiabetic agents.

Children and adolescents: Safety and efficacy have not been established for neuropathic pain, postherpetic neuralgia, spinal cord injury-related neuropathic pain, and fibromyalgia. For adjunctive treatment of partial-onset seizures, safety and efficacy have not been established in infants below 1 month of age. The safety of extended-release formulations in pediatric patients has also not been established.

Symptoms of overdose include decreased consciousness, depression/anxiety, confusion, agitation, and restlessness. Seizures and heart block have also been reported. There is no specific antidote. Management includes removal of unabsorbed drug by emesis or gastric lavage if appropriate, airway protection, and supportive care with monitoring of vital signs and clinical status.

Adjunct anti-epileptic drugs, Primary anti-epileptic drugs

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