Pegalin 25 Capsule: Each capsule contains 25 mg Pregabalin BP.
Pegalin 50 Capsule: Each capsule contains 50 mg Pregabalin BP.
Pegalin 75 Capsule: Each capsule contains 75 mg Pregabalin BP.
Pegalin 100 Capsule: Each capsule contains 100 mg Pregabalin BP.
Pegalin 150 Capsule: Each capsule contains 150 mg Pregabalin BP.
Pegalin ER 82.5 Tablet: Each extended release tablet contains 82.5 mg Pregabalin BP.
Pegalin ER 165 Tablet: Each extended release tablet contains 165 mg Pregabalin BP.
Pegalin ER 330 Tablet: Each extended release tablet contains 330 mg Pregabalin BP.
Pregabalin is an analogue of the neurotransmitter gamma aminobutyric acid (GABA). It has analgesic and anticonvulsant activity.
Pregabalin is an antiepileptic used as an adjunct in the treatment of partial seizures with or without secondary generalisation. It is also used in the treatment of generalised anxiety disorder and neuropathic pain.
Pregabalin is given by mouth in 2 or 3 divided doses daily.
Fibromyalgia: The initial dose is 75 mg two times a day (150 mg/day) and 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).
Postherpetic Neuralgia: Dosing should begin at 75 mg two times a day (150 mg/day) and 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 following 2 to 4 weeks of treatment with 300 mg/day and who are able to tolerate Pregabalin, may be further increased to 300 mg two times a day (600 mg/day).
Epilepsy: The initial adult dose is 150 mg daily increased after 1 week according to response to 300 mg daily and then to 600 mg daily after another week.
Generalised Anxiety Disorder: The initial adult dose is 150 mg daily; this may be increased at weekly intervals in steps of 150 mg, to a maximum of 600 mg daily.
Neuropathic Pain: The initial adult dose is 150 mg daily increased after 3 to 7 days according to response to 300 mg daily and then to 600 mg daily after another 7 days.
Use in Children and Adolescents (<18 years of age): The safety and effectiveness of Pregabalin has not been established in patients below the age of 18 years, with either epilepsy or neuropathic pain.
Administration in Renal Impairment:
Creatinine Clearance (mL/min).
Total Pregabalin Daily dose *.
Dose Regimen.
Starting dose (mg/day).
Max. dose (mg/day).
≥ 60.
150.
600.
BID or TID.
30-60.
75.
300.
BID or TID.
15-30.
25-50.
150.
QD or BID.
< 15.
25.
75.
QD.
Supplementary dosage following haemodialysis (mg).
25.
100.
Single dose<sup>+</sup>.
TID= Three divided doses; BID = Two divided doses; QD = Single daily dose.
+ Supplementary dose is a single additional dose.
Pegalin ER tablet should be administered once daily after an evening meal. It should be swallowed whole and should not be split, crushed or chewed.
Dosing recommendations for Pegalin ER tablets:
*Prescription only*
Indication:
Dosing Regimen.
Initial Dose.
Maximum Dose.
DPN Pain.
Single dose per day.
165 mg/day.
330 mg/day within 1 week.
PHN.
Single dose per day.
165 mg/day.
330 mg/day within 1 week. Maximum dose of 660 mg/day.
In *in vivo* studies no clinically relevant pharmacokinetic interactions were observed between Pregabalin and Phenytoin, Carbamazepine, Valproic Acid, Lamotrigine, Gabapentin, Lorazepam, Oxycodone or Ethanol. In addition, population pharmacokinetic analysis indicated that the three commonly used drug classes, oral antidiabetics, diuretics and insulin, and the commonly used antiepileptic drugs Phenytoin, Carbamazepine, Valproic.
Pregabalin has not been studied in pregnant women and Pregabalin should not be used during pregnancy unless the benefit to the mother clearly outweighs the potential risk to the fetus. Use in lactation: It is not known if Pregabalin is excreted in the breast milk of humans; however, it is present in the milk of rats. Therefore, breastfeeding is not recommended in women taking Pregabalin.
Overdosage In overdoses up to 15 g, no unexpected adverse reactions were reported. In the post-marketing experience, the most commonly reported adverse events observed when Pregabalin was taken in overdose included affective disorder, somnolence, confusional state, depression, agitation and restlessness. There is no specific antidote for Pregabalin. Treatment of Pregabalin overdose should be symptomatic and supportive.
Dizziness, somnolence, and blurred vision may impair a patient's ability to perform skilled tasks such as driving. Licensed drug information states that care is required when withdrawing Pregabalin therapy, regardless of the indication. Use in.
Store at below 30°C in a dry place protected from light. Keep out of reach of children.