Broklin CR 82.5 mg Tablet: Each controlled release tablet contains Pregabalin USP 82.5 mg.
Broklin CR 165 mg Tablet: Each controlled release tablet contains Pregabalin USP 165 mg.
Broklin CR 330 mg Tablet: Each controlled release tablet contains Pregabalin USP 330 mg.
Pregabalin CR is a structural derivative of the inhibitory neurotransmitter gamma-amino butyric acid (GABA), it does not bind directly to GABA, GABAα or benzodiazepine receptors. It is inactive at serotonin and dopamine receptors and does not inhibit dopamine, serotonin or noradrenaline reuptake. Pregabalin CR binds with high affinity to the alpha,-delta site (an auxiliary subunit of voltage-gated calcium channels) in central nervous system tissues. It works by decreasing the number of signals that are sent out by damaged nerve in the body.
For the management of:
a) Route of Administration: Oral:
Dose:
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.
Conversion dose form pregabalin to pregabalin CR:
Pregabalin (dosed 2 or 3 times daily).
Pregabalin CR (dosed once a day).
75 mg/daily.
82.5 mg/day.
150 mg/daily.
165 mg/day.
225 mg/daily.
247.5 mg/3x82.5 mg/once a day.
300 mg/daily.
330 mg/day.
450 mg/daily.
495 mg/3x165 mg/once a day.
600 mg/daily.
660 mg/2x330 mg/once a day.
a) With Medicine: No pharmacokinetic interactions were observed between pregabalin and erythromycin, carbamazepine, gabapentin, lamotrigine, oral contraceptive, phenobarbital, phenytoin, topiramate and valproic acid.
Overdose:
The most commonly reported adverse events observed with Pregabalin when taken in overdose include reduced consciousness, depression/anxiety, confusional state and restlessness. Seizures and heart block have also been reported. There is no specific antidote for overdose with Pregabalin. If indicated, elimination of unabsorbed drug may be attempted by emesis or gastric lavage; Pregabalin can be removed by hemodialysis.
Pregnancy: Pregnancy Category C. Lactation: Small amount of Pregabalin is excreted in human milk. Decide to discontinue nursing or drug according to the importance of the drug.
Creatinine Clearance (CLcr) (mL/min).
Pregabalin CR Daily Dose (mg/day).
Dose Regimen.
Greater than or equal to 60.
165.
330.
495/3x165.
660/2x330.
Once a day.
30–60.
82.5.
165.
247.5/3x82.5.
330.
Once a day.
less than 30/hemodialysis.
Dose with Pregabalin.
Store below 30°C. Protect from light and moisture. Keep all medicines out of reach of children.