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Sabril Dosage

Generic name: VIGABATRIN 50mg in 1mL
Dosage form: powder, for oral solution

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

2.1       Important Dosing Instructions 

SABRIL is given orally with or without food. The SABRIL dosing regimen depends on the indication, age group, weight, and dosage form (tablets or powder for oral solution). Patients with impaired renal function require dose adjustment [see Dosage and Administration (2.4)]. 

SABRIL tablets and powder for oral solution are bioequivalent. Either tablet or powder can be used for CPS. Powder for oral solution should be used for IS; tablets should not be used for IS because of difficulty in the administration of tablets to infants and young children.

SABRIL powder for oral solution should be mixed with water prior to administration.

If using SABRIL powder for oral solution, physicians should review and discuss the Medication Guide and instructions for mixing and giving SABRIL with the patient or caregiver(s). Physicians should confirm that patients or caregiver(s) understand how to mix SABRIL powder with water and administer the correct daily dose. Empty the entire contents of each 500 mg packet into a clean cup, and dissolve in 10 mL of cold or room temperature water per packet (see Table 2). Administer the resulting solution using the 10 mL oral syringe supplied with the medication. The concentration of the final solution is 50 mg/mL. Discard the resulting solution if it is not clear (or free of particles) and colorless. Each individual dose should be prepared and used immediately. Discard any unused portion of the solution after administering the correct dose.

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 [see Warnings and Precautions (5.6)].

2.2       Refractory Complex Partial Seizures

Adults (Patients 17 Years of Age and Older)
Treatment should be initiated at 1000 mg/day (500 mg twice daily). Total daily dose may be increased in 500 mg increments at weekly intervals depending on response. The recommended dose of SABRIL in adults is 3000 mg/day (1500 mg twice daily).  A 6000 mg/day dose has not been shown to confer additional benefit compared to the 3000 mg/day dose and is associated with an increased incidence of adverse events.

In controlled clinical studies in adults with complex partial seizures, SABRIL was tapered by decreasing the daily dose 1000 mg/day on a weekly basis until discontinued [see Warnings and Precautions (5.6)].

Pediatric (Patients 10 to 16 Years of Age)
Treatment is based on body weight as shown in Table 1. Treatment should be initiated at a total daily dose of 500 mg/day (250 mg twice daily) and may be increased weekly in 500 mg/day increments to a total maintenance dose of 2000 mg/day (1000 mg twice daily). Patients weighing more than 60 kg should be dosed according to adult recommendations. 

 Table 1. Pediatric CPS Dosing Recommendations 
    Body Weight
[kg]
   Total Daily*
Starting Dose
[mg/day]
   Total Daily*
Maintenance Dose
[mg/day]
   25 to 60††    500    2000

*Administered in two divided doses.
†Maintenance dose is based on 3000 mg/day adult-equivalent dose
†† Patients weighing more than 60 kg should be dosed according to adult recommendations

In a controlled study in pediatric patients with complex partial seizures, SABRIL was tapered by decreasing the daily dose by one third every week for three weeks [see Warnings and Precautions (5.6)].

2.3       Infantile Spasms

The initial daily dosing is 50 mg/kg/day given in two divided doses (25 mg/kg twice daily); subsequent dosing can be titrated by 25 mg/kg/day to 50 mg/kg/day increments every 3 days, up to a maximum of 150 mg/kg/day given in 2 divided doses (75 mg/kg twice daily) [see Use in Specific Populations (8.4)].

Table 2 below describes how many packets and how many milliliters (mL) of water will be needed to prepare each individual dose. The concentration after reconstitution is 50 mg/mL.

 Table 2. Number of SABRIL Packets and mL of Water Needed for Each Individual Dose 
    Individual Dose [mg]
[Given Twice Daily]
    Total Number of
SABRIL Packets
    Total mL of Water
Required for Dissolving
    0 to 500     1 Packet     10 mL
    501 to 1000     2 Packets     20 mL
    1001 to 1500     3 Packets     30 mL

Table 3 provides the volume of the 50 mg/mL dosing solution that should be administered as individual doses in infants of various weights.

 Table 3. Infant Dosing Table 
  Weight
[kg]
  Starting Dose
50 mg/kg/day
  Maximum Dose
150 mg/kg/day
    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 

In a controlled clinical study in patients with infantile spasms, SABRIL was tapered by decreasing the daily dose at a rate of 25 mg/kg to 50 mg/kg every 3 to 4 days [see Warnings and Precautions (5.6)].

2.4       Patients with Renal Impairment

SABRIL is primarily eliminated through the kidney.

Infants
Information about how to adjust the dose in infants with renal impairment is unavailable.

Adult and pediatric patients 10 years and older

  • Mild renal impairment (CLcr >50 to 80 mL/min): dose should be decreased by 25%
  • Moderate renal impairment (CLcr >30 to 50 mL/min): dose should be decreased by 50%
  • Severe renal impairment (CLcr >10 to 30 mL/min): dose should be decreased by 75%.

CLcr in mL/min may be estimated from serum creatinine (mg/dL) using the following formulas:

  • Patients 10 to <12 years old:  CLcr (mL/min/1.73 m2) = (K × Ht) / Scr

                                            height (Ht) in cm; serum creatinine (Scr) in mg/dL
                                            K (proportionality constant): Female Child (<12 years):  K=0.55;
                                            Male Child (<12 years):  K=0.70

  • Adult and pediatric patients 12 years or older: CLcr (mL/min) = [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 [see Clinical Pharmacology (12.3) and Use in Specific Populations (8.6)].

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