PG CR® 82.5 Tablet: Each extended-release tablet contains Pregabalin USP 82.5 mg.
PG CR® 165 Tablet: Each extended-release tablet contains Pregabalin USP 165 mg.
PG CR® is the preparation of Pregabalin, used for the treatment of neuropathic pain and Postherpetic neuralgia (PHN). The active substance, Pregabalin, is a gamma-aminobutyric acid analogue (S)-3-(aminomethyl)- 5 methylhexanoic acid. Pregabalin binds to an auxiliary subunit (a2-δ protein) of voltage-gated calcium channels in the central nervous system, potentially displacing [H] -Gabapentin.
Pregabalin CR should be administered once daily after an evening meal. It should be swallowed whole and should not be split, crushed or chewed.
Conversion from Pregabalin Capsule to Pregabalin CR Tablet:
When switching from Pregabalin to Pregabalin CR on the day of the switch, instruct patients to take their morning dose of Pregabalin as prescribed and initiate Pregabalin CR therapy after an evening meal.
Administration in Renal Impairment:
Use of Pregabalin CR is not recommended for patients with creatinine clearance (CLcr) less than 30 mL/min or who are undergoing hemodialysis. Those patients should receive Pregabalin Capsule. Pregabalin clearance is directly proportional to creatinine clearance, so dosage reduction in patient with compromised renal function must be adjusted according to creatinine clearance. CLcr in mL/min may be estimated from serum creatinine (mg/dL) determination using the Cockcroft.
and Gault equation:
CLCr = (x 0.85 for female patients) 72 x serum creatinine (mg/dL).
[140-age (years)] x weight (kg).
Dosage Adjustment Based on Renal Function:
No pharmaceutical interactions were observed between Pregabalin CR and Erythromycin, Carbamazepine, Gabapentin, Lamotrigine, oral contraceptive, Phenobarbital, Phynytoin, Topiramate and Valproic acid.
Overdose:
The highest reported accidental overdose of Pregabalin CR during the clinical development program was 8000 mg and there was no notable clinical consequences.
Pregnancy Category C: Breastfeeding is not recommended during treatment with Pregabalin CR.
Use in Children and Adolescents:
The safety and efficacy of Pregabalin CR in Pediatric patients have not been established. In controlled studies, no overall differences in safety and efficacy were observed between geriatric patients and young patients.
It is advised not to drive a car or operating dangerous machineries. While taking Pregabalin, some patients with diabetes who gain weight may need to alter their diabetic medications. Alcohol should be avoided while taking this medicine.
Do not store above 25°C temperature. Keep away from light and wet place. Keep out of reach of children.