Gabarol® is the preparation of Pregabalin, which is an analogue of neurotransmitter
gamma-amino-butyric acid (GABA). It does not bind directly to GABAA or GABAB or
benzodiazepine receptors. It binds with high affinity to the alpha2-delta site (an auxiliary
subunit of voltage-gated calcium channels) in central nervous system.
Indication and usage
Gabarol® is indicated for –
Management of neuropathic pain associated with diabetic peripheral neuropathy
Management of postherpetic neuralgia
Adjunctive therapy for adult patients with partial seizures
Management of fibromyalgia
Dose & administration
Adults over 18 years of age:
Gabarol® is given orally with or without food. Dosing amounts and frequency of dosing will
be decided by the physician.
Neuropathic pain associated with diabetic peripheral neuropathy: Dosing should begin at 50
mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1
week based on efficacy and tolerability. The maximum recommended dose of Gabarol® is
100 mg three times a day (300 mg/day) in patients with creatinine clearance of at least 60
Postherpetic neuralgia: The recommended dose is 150 mg to 300 mg daily in 2-3 divided
doses in patients with creatinine clearance of at least 60mL/min. Dosing should begin at
150 mg daily in 2-3 divided doses and may be increased to 300 mg/day within 1 week
based on efficacy and tolerability.
Epilepsy: The initial dose is 150 mg daily in 2-3 divided doses as adjunctive therapy in the
treatment of partial onset seizures in adults. In general, it is recommended that patients be
started on a total daily dose not greater than 150 mg daily (75 mg two times a day, or 50
mg three times a day). Based on individual patient response and tolerability, the dosage
may be increased to 300 mg daily in 2 divided doses after 1 week. The maximum dose of
600 mg daily given in 2 divided doses may be achieved after an additional week.
Fibromyalgia: The recommended dose is 300 to 450 mg daily. Dosing should being at 150
mg daily in two divided doses and may be increased to 300 mg daily in 2 divided doses
within 1 week based on efficacy and tolerability. Patients who do not experience sufficient
benefit with 300 mg daily may be further increased to 450 mg daily in 2 divided doses.
Children and adolescents (<18 years of age)
The safety and efficacy of Pregabalin has not been established in patients below the age of
18 years, with either epilepsy or neuropathic pain.
Use in elderly (Over 65 years of age)
Elderly patients may require a dose reduction of Pregabalin due to decreased renal function.
Patients with hepatic impairment
No dosage adjustment is required for patients with hepatic impairment.
Patients with renal impairment
Pregabalin is eliminated from the systemic circulation primarily by renal excretion as
Use in pregnancy and lactation
Pregnancy: Pregabalin is a pregnancy Category C drug. It should be used during pregnancy
only if the potential benefit justifies the potential risk to the fetus.
Lactation: It is not know if Pregabalin is excreted in the breast milk of humans but because
of the potential for tumorigenicity shown for Pregabalin in animal studies, a decision should
be made whether to discontinue nursing or to discontinue the drug, taking into account the
importance of the drug to the mother.
≥60 150 600 2-3 divided dose
≥30 – <60 75 300 2-3 divided dose
≥15 – <30 25 – 50 150 1-2 divided dose
< 15 25 75 Once daily
Supplementary dosage following haemodialysis (mg)
25 100 Single dose
Angioedema can occur, and may be associated with life-threatening respiratory compromise
requiring emergency treatment. Pregabalin should be discontinued immediately in these
cases. Hypersensitivity reactions (e.g. hives, dyspnea, and wheezing) can occur. Pregabalin
should be discontinued immediately in these cases. Increased seizure frequency may occur
in patients with seizure disorders if Pregabalin is rapidly discontinued. Withdraw Pregabalin
gradually over a minimum of 1 week. Pregabalin may cause peripheral edema. Exercise
caution when co-administering Pregabalin and Thiazolidinedione antidiabetic agents.
Pregabalin may cause dizziness and somnolence and impair patients’ ability to drive or
Most common side effects are dizziness, somnolence, dry mouth, edema, blurred vision,
weight gain and thinking abnormal (primarily difficulty with concentration/attention).
There are no significant interactions between Pregabalin and other antiepileptic drugs like
carbamazepine, valproic acid, lamotrigine, phenytoin, phenobarbital, and topiramate. Co
administration of Pregabalin with the oral contraceptives like norethisterone and ethinyl
oestradiol does not influence the steady state pharmacokinetics of either agent. Pregabalin
may potentiate the effects of ethanol and lorazepam.
Pregabalin is contraindicated in patients with known hypersensitivity to Pregabalin or any of
its other components.
In overdose up to 15 mg, no unexpected adverse reactions were reported. The most
common adverse events are affective disorder, somnolence, confusional state, depression,
agitation and restlessness. Elimination of unabsorbed drug may be attempted by emesis or
gastric lavage or hemodialysis if necessary.
Store in a cool and dry place. Protect from light.