Pregaba 150mg Capsule 10pcs

Pregaba is indicated for:

• Neuropathic pain associated with diabetic peripheral neuropathy (DPN)
• Postherpetic neuralgia (PHN)
• Adjunctive therapy for partial-onset seizures in patients 1 month of age and older
• Fibromyalgia
• Neuropathic pain associated with spinal cord injury

Pregaba CR tablet is indicated for:

• Neuropathic pain associated with diabetic peripheral neuropathy (DPN)
• Postherpetic neuralgia (PHN)

Pharmacology

Pregabalin, a structural derivative of gamma-aminobutyric acid (GABA), binds with high affinity to the alpha2-delta site of voltage-gated calcium channels in the central nervous system. Although its exact mechanism of action is not fully understood, animal studies suggest this binding may contribute to its pain-relieving and seizure-controlling effects.

Dosage

Neuropathic pain associated with diabetic peripheral neuropathy in adults (DPN):

• Maximum dose: 100 mg three times a day (300 mg/day) for patients with creatinine clearance of at least 60 ml/min.
• Initial dose: 50 mg three times a day (150 mg/day), which can be increased to 300 mg/day within a week based on response and tolerability.
• Pregabalin CR: Start with 165 mg once daily, increasing to 330 mg once daily within a week based on response and tolerability. Maximum dose: 330 mg once daily.

Postherpetic neuralgia in adults (PHN):

• Recommended dose: 75 to 150 mg twice daily or 50 to 100 mg three times a day (150 to 300 mg/day) for patients with creatinine clearance of at least 60 ml/min.
• Initial dose: 75 mg twice daily or 50 mg three times a day (150 mg/day), increasing to 300 mg/day within a week based on response and tolerability.
• If insufficient pain relief is experienced with 300 mg/day after 2-4 weeks, and the patient tolerates the drug, the dose may be increased up to 600 mg/day.
• Pregabalin CR: Start with 165 mg once daily, increasing to 330 mg once daily within a week. If insufficient pain relief is experienced with 330 mg once daily after 2-4 weeks, and the patient tolerates the drug, the dose may be increased up to 660 mg once daily.

Fibromyalgia in adults:

• Recommended dose: 300 to 450 mg/day.
• Initial dose: 75 mg twice daily (150 mg/day), increasing to 300 mg/day within a week based on response and tolerability.
• If insufficient benefit is experienced with 300 mg/day, the dose may be increased to 450 mg/day.

Neuropathic pain associated with spinal cord injury in adults:

• Recommended dose range: 150 to 600 mg/day.
• Initial dose: 75 mg twice daily (150 mg/day), increasing to 300 mg/day within a week based on response and tolerability.
• If insufficient pain relief is experienced after 2-3 weeks at 150 mg twice daily, and the patient tolerates the drug, the dose may be increased to 300 mg twice daily.

Conversion from Pregabalin capsules to Pregabalin CR tablets:

• On the day of the switch, take the morning dose of Pregabalin capsule as prescribed and start Pregabalin CR after an evening meal.

Pregabalin tablet to Pregabalin CR capsule dose conversion:

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

Administration

Pregabalin is taken orally, with or without food. Pregabalin CR tablets should be taken after an evening meal, swallowed whole, and not split, crushed, or chewed. If a dose is missed, it should be taken as soon as remembered with food, either before bedtime or with the next meal.

Interactions

Drug Interactions: Pregaba is unlikely to be involved in significant pharmacokinetic drug interactions.

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

Side Effects

Common side effects in adults:

• Dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, difficulty with concentration.

Common side effects in pediatric patients:

• Increased weight and appetite.

Pregnancy & Lactation

• There are no adequate studies in pregnant women. Pregnant women should be advised of potential fetal risk.
• Small amounts of pregabalin are detected in the milk of lactating women. Due to potential tumorigenicity risk, breastfeeding is not recommended during treatment with pregabalin.

Precautions & Warnings

• Angioedema (swelling of the throat, head, neck) can occur and may require emergency treatment. Discontinue immediately if this occurs.
• Hypersensitivity reactions (hives, dyspnea, wheezing) require immediate discontinuation.
• Antiepileptic drugs, including Pregaba, may increase the risk of suicidal thoughts or behavior.
• Respiratory depression may occur when used with CNS depressants or in patients with underlying respiratory impairment.
• Pregaba may cause dizziness, somnolence, and impair the ability to drive or operate machinery.
• Rapid discontinuation may increase seizure frequency or cause adverse reactions; taper off gradually over at least one week.
• Pregaba may cause peripheral edema. Caution when coadministering with thiazolidinedione antidiabetic agents.

Use in Special Populations

• Safety and effectiveness in pediatric patients have not been established for neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, neuropathic pain associated with spinal cord injury, and fibromyalgia.
• For partial onset seizures, safety and effectiveness in pediatric patients below the age of 1 month have not been established.
• The safety and effectiveness of Pregaba extended-release tablets in pediatric patients have not been established.

Overdose Effects

Symptoms of overdose include reduced consciousness, depression/anxiety, confusion, agitation, restlessness, seizures, and heart block. There is no specific antidote; supportive care, including monitoring of vital signs and clinical status, is recommended.

Therapeutic Class

• Adjunct anti-epileptic drugs
• Primary anti-epileptic drugs

Storage Conditions

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