Pegaron 25 mg (Capsule)

Indications

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

Pharmacology

• Structural derivative of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA)
• Binds with high affinity to the alpha2-delta site in central nervous system tissues
• Anti-nociceptive and antiseizure effects

Dosage

• Maximum recommended dose for neuropathic pain associated with diabetic peripheral neuropathy is 100 mg three times a day (300 mg/day)
• Recommended dose for postherpetic neuralgia is 75 to 150 mg two times a day or 50 to 100 mg three times a day (150 to 300 mg/day)
• Maximum recommended dose for the treatment of fibromyalgia is 300 to 450 mg/day
• Recommended dose range for neuropathic pain associated with spinal cord injury is 150 to 600 mg/day
• Dosing guidelines for switching from Pregabalin capsules to Pregabalin CR capsule tablet

Administration

• Route of administration - oral route
• Can be taken with or without food

Interaction

• Unlikely to be involved in significant pharmacokinetic drug interactions
• No significant drug interaction with food and others

Contraindications

• Contraindicated in patients with known hypersensitivity to Pregabalin or any of its components

Side Effects

• Common side effects in adults include dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, and thinking abnormal
• Common side effects in pediatric patients for the treatment of partial onset seizures are increased weight and increased appetite

Pregnancy & Lactation

• No adequate and well-controlled studies in pregnant women
• Small amounts detected in the milk of lactating women
• Breastfeeding not recommended due to potential risk of tumorigenicity

Precautions & Warnings

• Angioedema can occur and may be associated with life threatening respiratory compromise requiring emergency treatment
• Prompt discontinuation in case of hypersensitivity reactions
• Increased risk of suicidal thoughts or behavior
• Respiratory depression may occur when used with concomitant CNS depressants or in the setting of underlying respiratory impairment
• May cause dizziness, somnolence, and impairment of patient's ability
• Increased seizure frequency or other adverse reactions with rapid discontinuation
• May cause peripheral edema
• Caution should be exercised when coadministering with thiazolidinedione antidiabetic agents

Use in Special Populations

• Safety and effectiveness not established in pediatric patients for various indications
• Safety and effectiveness of Pegaron extended-release tablet in pediatric patients not established

Overdose Effects

• Signs and symptoms include reduced consciousness, depression/anxiety, confusional state, agitation, restlessness, seizures, and heart block
• No specific antidote
• General supportive care indicated

Therapeutic Class

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

Storage Conditions

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

Chemical Structure

• Molecular Formula: C8H17NO2

Related Brands

• GABA-P 50 mg (Capsule) - renata-limited
• GABA-P 75 mg (Capsule) - renata-limited
• Gabarol 25 mg (Capsule) - aci-limited
• Gabarol 50 mg (Capsule) - aci-limited
• Gabarol 75 mg (Capsule) - aci-limited