Gabarol 25 mg capsule: Each capsule contains Pregabalin BP 25 mg.
Gabarol 50 mg capsule: Each capsule contains Pregabalin BP 50 mg.
Gabarol 75 mg capsule: Each capsule contains Pregabalin BP 75 mg.
Gabarol 100 mg capsule: Each capsule contains Pregabalin BP 100 mg.
Gabarol 150 mg capsule: Each capsule contains Pregabalin BP 150 mg.
Gabarol CR 82.5 mg tablet: Each extended release tablet contains Pregabalin BP 82.5 mg.
Gabarol CR 165 mg tablet: Each extended release tablet contains Pregabalin BP 165 mg.
Gabarol CR 330 mg tablet: Each extended release tablet contains Pregabalin BP 330 mg.
Gabarol is the preparation of Pregabalin, which is a structural derivative of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA). It does not bind directly to GABA A , GABA B or benzodiazepine receptors. Pregabalin binds with high affinity to the alpha 2 -delta site (an auxiliary subunit of voltage-gated calcium channels) in central nervous system tissues. Although the mechanism of action of Pregabalin has not been fully elucidated, results in animal studies suggest that binding to the alpha 2 -delta subunit may be involved in Pregabalin's anti-nociceptive and antiseizure effects.
Route of administration : Gabarol is taken in oral route. It can be taken with or without food. Gabarol CR tablet should be administered after an evening meal. It should be swallowed whole and should not be split, crushed or chewed. When discontinuing both Gabarol and Gabarol CR, it should be gradually tapered over a minimum of 1 week.
Neuropathic pain associated with diabetic peripheral neuropathy in adults (DPN): Gabarol max recommended dose is 100 mg three times a day (300 mg/day). Dosing should begin at 50 mg three times a day (150 mg/day). Gabarol CR: Begin dosing at 165 mg once daily, increase to 330 mg once daily within 1 week. Max dose is 330 mg once daily.
Postherpetic neuralgia in adults (PHN): Gabarol 75 to 150 mg two times a day or 50 to 100 mg three times a day (150 to 300 mg/day). May increase up to 600 mg/day. Gabarol CR: Begin at 165 mg once daily, increase to 330 mg once daily within 1 week; max 660 mg once daily.
Adjunctive therapy for partial onset seizures in patients 1 month of age and older: Adults (17 years and older): 150 mg/day initial, max 600 mg/day in 2 or 3 divided doses. Pediatric >=30 kg: 2.5 mg/kg/day initial, max 10 mg/kg/day. Pediatric <30 kg: 3.5 mg/kg/day initial, max 14 mg/kg/day.
Fibromyalgia in adults: 300 to 450 mg/day (begin at 75 mg twice daily, increase to 150 mg twice daily).
Neuropathic pain with spinal cord injury: 150 to 600 mg/day (begin at 75 mg twice daily).
Renal impairment: Adjust dosage according to creatinine clearance. Gabarol CR is not recommended for CLcr < 30 ml/min or hemodialysis.
Alcohol, lorazepam, and oxycodone potentiate somnolence and cognitive impairment; ACE inhibitors may increase peripheral edema and angioedema risk.
Pregabalin is contraindicated in patients with known hypersensitivity to pregabalin or any other components of this product.
Common: Dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, abnormal thinking (difficulty concentrating), increased appetite (pediatric).
Overdose
In case of overdose with pregabalin, sign and symptoms are reduced consciousness, depression/anxiety, confusional state, agitation and restlessness. Seizures and heart block have also been reported. There is no specific antidote. If indicated, elimination of unabsorbed drug may be attempted by emesis or gastric lavage; usual precautions should be observed to maintain the airway. General supportive care of the patient is indicated including monitoring of vital signs and observation of the clinical status of the patient.
Category C. Animal studies show reproductive toxicity; advise pregnant women of potential fetal risk. Lactation: Small amounts detected in breast milk; breastfeeding is not recommended during treatment.
Store below 25°C in a cool, dry place. Protect from light and moisture. Keep out of reach of children.