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Sabril

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Sabril

Sabril

INDICATIONS

Refractory Complex Partial Seizures (CPS)

SABRIL is indicated as adjunctive therapy for adults and pediatric patients 10 years of age and older with refractory complex partial seizures who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss [see WARNINGS AND PRECAUTIONS]. SABRIL is not indicated as a first line agent for complex partial seizures.

Infantile Spasms (IS)

SABRIL is indicated as monotherapy for pediatric patients with infantile spasms 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss [see WARNINGS AND PRECAUTIONS].

DOSAGE AND ADMINISTRATION

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 Patients with Renal Impairment].

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].

Refractory Complex Partial Seizures

Adults (Patients > 16 Years of Age)

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].

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 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 Doset [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].

Infantile Spasms

The initial daily dosing is 50 mg/kg/day given in two divided doses; 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 [see Use In Specific Populations].

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].

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.

Pediatric patients 10 years and older, and adult patients
  • Mild renal impairment (CLcr > 50 - 80 mL/min): dose should be decreased by 25%
  • Moderate renal impairment (CLcr > 30 - 50 mL/min): dose should be decreased by 50%
  • Severe renal impairment (CLcr > 10 - 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
  • Pediatric patients 12 years or older and adult patients: 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 and Use in Specific Populations].

HOW SUPPLIED

Dosage Forms And Strengths

Tablet: 500 mg: white, oval, film-coated, biconvex, scored on one side, and debossed with OV 111 on the other.

Powder for Oral Solution: 500 mg packets of a white to off-white granular powder.

SABRIL 500 mg tablets are white, film-coated, oval, biconvex, scored on one side, and debossed with OV 111 on the other. They are supplied as bottles of 100 (NDC 67386-111-01).

SABRIL 500 mg packets contain a white to off-white granular powder. They are supplied in packages of 50 (NDC 67386211-65).

Storage and Handling

Store at 20 to 25°C (68 to 77°F). See USP controlled room temperature.

Marketed by: Lundbeck, Deerfield, IL 60015, U.S.A. Revised: 10/2013

Last reviewed on RxList: 11/18/2013
This monograph has been modified to include the generic and brand name in many instances.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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