Generic name: vigabatrin
Dosage form: powder, for oral solution
This dosage information does not include all the information needed to use Sabril safely and effectively. See full prescribing information for Sabril.
The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.
Infantile Spasms (1 Month to 2 Years of Age)
Physicians should review and discuss the Medication Guide with the caregiver(s) prior to preparation and administration of SABRIL. Physicians should confirm that caregiver(s) understand how to reconstitute SABRIL and to administer the correct dose to their infants.
SABRIL should be given as twice daily oral administration with or without food. The initial dosing is 50 mg/kg/day given in two divided doses and can be titrated by 25-50 mg/kg/day increments every 3 days up to a maximum of 150 mg/kg/day [see USE IN SPECIFIC POPULATIONS, Pediatric Use (8.4)].
The entire contents of the appropriate number of packets (500 mg/packet) of powder should be emptied into an empty cup, and should be dissolved in 10 mL of cold or room temperature water per packet using the 10 mL oral syringe supplied with the medication. Discard the resulting solution if it is not clear (or free of particles) and colorless. The concentration of the final solution is 50 mg/mL. Table 1 below describes how many packets and how many mL of water will be needed to prepare each individual dose. Each individual dose should be prepared immediately before use and administered cold or at room temperature. Discard any unused portion of the solution after administering the correct dose.
|Each Individual Dose (Prepared and Given Twice Daily)||Number of Packets||Number of mL of Water for Dissolving|
|0 to 500 mg||1 packet||10 mL|
|501 to 1000 mg||2 packets||20 mL|
|1001 to 1500 mg||3 packets||30 mL|
Table 2 provides the volume that should be administered as individual doses in infants of various weights is presented below:
|3||1.5 mL twice daily||4.5 mL twice daily|
|4||2 mL twice daily||6 mL twice daily|
|5||2.5 mL twice daily||7.5 mL twice daily|
|6||3 mL twice daily||9 mL twice daily|
|7||3.5 mL twice daily||10.5 mL twice daily|
|8||4 mL twice daily||12 mL twice daily|
|9||4.5 mL twice daily||13.5 mL twice daily|
|10||5 mL twice daily||15 mL twice daily|
|11||5.5 mL twice daily||16.5 mL twice daily|
|12||6 mL twice daily||18 mL twice daily|
|13||6.5 mL twice daily||19.5 mL twice daily|
|14||7 mL twice daily||21 mL twice daily|
|15||7.5 mL twice daily||22.5 mL twice daily|
|16||8 mL twice daily||24 mL twice daily|
Patients with Renal Impairment
SABRIL is primarily eliminated through the kidney. Information about how to adjust the dose in pediatric patients with renal impairment is unavailable.
The following dose adjustments are pertinent to the possible use of this dosage form in adults with renal impairment:
In patients with mild renal impairment (CLcr >50 to 80 mL/min), the dose should be decreased by 25%; in patients with moderate renal impairment (CLcr >30 to 50 mL/min), the dose should be decreased by 50%; and in patients with severe renal impairment (CLcr >10 to <30 mL/min), the dose should be decreased by 75%.
CLcr in mL/min may be estimated from a serum creatinine (mg/dL) determination using the following formula:
CLcr *= [140-age (years)]×weight (kg)/72×serum creatinine (mg/dL)]
*[×0.85 for female patients]
The effect of dialysis on SABRIL clearance has not been adequately studied.
General Dosing Considerations
Monitoring of SABRIL plasma concentrations to optimize therapy is not helpful. If a decision is made to discontinue SABRIL, the dose should be gradually reduced. In a controlled clinical study in patients with IS, vigabatrin was tapered by decreasing the dose at a rate of 25-50 mg/kg every 3-4 days [see WARNINGS AND PRECAUTIONS, Withdrawal of Antiepileptic Drugs (AEDs) (5.6)].