Xyrem Indications, Dosage, Storage, Stability - Sodium oxybate

Xyrem Indications, Dosage, Storage, Stability - Sodium oxybate

INDICATIONS AND USAGE

Xyrem^® (sodium oxybate) oral solution is indicated for the treatment of cataplexy in patients with narcolepsy.

In Xyrem^® clinical trials, approximately 80% of patients maintained concomitant stimulant use (see BLACK BOX WARNINGS).

Xyrem^® is required to be taken at bedtime while in bed and again 2.5 to 4 hours later. The recommended starting dose is 4.5 g/day divided into two equal doses of 2.25 g. The starting dosage can then be increased to a maximum of 9 g/day in increments of 1.5 g/day (0.75 g per dose). Two weeks are recommended between dosage increases to evaluate clinical response and minimize adverse effects. Xyrem^® is effective at doses of 6 to 9 g/day. The efficacy and safety of Xyrem^® at doses higher than 9 g/day have not been investigated, and doses greater than 9 g/day ordinarily should not be administered.

Prepare both doses of Xyrem^® prior to bedtime. Each dose of Xyrem^® must be diluted with two ounces (60 mL, 1/4 cup, or 4 tablespoons) of water in the child resistant dosing cups provided prior to ingestion. The first dose is to be taken at bedtime while in bed and the second taken 2.5 to 4 hours later while sitting in bed. Patients will probably need to set an alarm to awaken for the second dose. The second dose must be prepared prior to ingesting the first dose, and should be placed in close proximity to the patient's bed. After ingesting each dose patients should then lie down and remain in bed.

Patients with compromised liver function will have increased elimination half-life and systemic exposure along with reduced clearance (see Pharmacokinetics). As a result, the starting dose should be decreased by one-half and dose increments should be titrated to effect while closely monitoring potential adverse events.

Each bottle of Xyrem^® is provided with a child resistant cap and two dosing cups with child resistant caps.

See the Medication Guide for a complete description.

Xyrem^® (sodium oxybate) is a clear to slightly opalescent oral solution. It is supplied in kits containing one bottle of Xyrem^®, a press-in-bottle-adaptor, a 10 mL oral measuring device (plastic syringe), a Medication Guide, a professional insert, and two 90 mL dosing cups with child resistant caps. Each amber oval PET bottle contains 180 mL of Xyrem^® oral solution at a concentration of 500 mg/mL and is sealed with a child resistant cap.

NDC 62161-008-20: Each tamper evident single unit carton contains one 180 mL bottle (500 mg/mL) of Xyrem^®, one press-in-bottle-adaptor, one oral dispensing syringe, and two dosing cups with child resistant caps.

Store at 25°C (77°F);excursions permitted up to 15°- 30°C (59°- 86°F). See USP Controlled Room Temperature.

Xyrem^® is a Schedule III drug under the Controlled Substances Act. Xyrem^® should be handled according to state and federal regulations. It is safe to dispose of Xyrem^® oral solution down the sanitary sewer.