Indication

 

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.

 

Dosage & Administration

 

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+

 

TID= Three divided doses; BID = Two divided doses; QD = Single daily dose

* Total daily dose (mg/day) should be divided as indicated by dose regimen to

provide mg/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:

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.

 

 

Precautions

 

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
Pregnancy: 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.