sodium oxybate .5 g/mL
sodium oxybate · SOLUTION · Hikma Pharmaceuticals USA Inc.
sodium oxybate is a solution containing sodium oxybate at .5 g/mL, taken oral. Manufactured by Hikma Pharmaceuticals USA Inc..
Key Facts
- Brand Name
- sodium oxybate
- Generic Name
- sodium oxybate
- NDC Code (Product)
0054-9628- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Strength
- .5 g/mL
- Dosage Form
- SOLUTION
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule III (Controlled)
- Application #
- NDA021196
- Marketing Start
- 01/03/2023
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Sodium oxybate oral solution is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients with narcolepsy. Pediatric use information is approved for Jazz Pharmaceuticals Inc.’s XYREM (sodium oxybate) Oral Solution. However, due to Jazz Pharmaceuticals Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Sodium oxybate oral solution is a central nervous system depressant indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients with narcolepsy (1) .
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Dosage for Adult Patients Initiate dosage at 4.5 g per night orally, divided into two doses (2.1) . Titrate to effect in increments of 1.5 g per night at weekly intervals (0.75 g at bedtime and 0.75 g taken 2.5 to 4 hours later) (2.1) . Recommended dosage range: 6 g to 9 g per night orally (2.1) . Total Nightly Dose Take at Bedtime Take 2.5 to 4 Hours Later 4.5 g per night 2.25 g 2.25 g 6 g per night 3 g 3 g 7.5 g per night 3.75 g 3.75 g 9 g per night 4.5 g 4.5 g Important Administration Information Prepare both doses prior to bedtime; dilute each dose with approximately 1/4 cup of water in pharmacy-provided containers (2.3) . Allow 2 hours after eating before dosing (2.3) . Take each dose while in bed and lie down after dosing (2.3) . Patients with Hepatic Impairment Recommended starting dosage is one-half of the original dosage per night administered orally, divided into two doses (2.4) . 2.1 Adult Dosing Information The recommended starting dosage is 4.5 grams (g) per night administered orally, divided into two doses: 2.25 g at bedtime and 2.25 g taken 2.5 to 4 hours later (see Table 1). Increase the dosage by 1.5 g per night at weekly intervals (addi…
Contraindications
4 CONTRAINDICATIONS Sodium oxybate oral solution is contraindicated for use in: combination with sedative hypnotics [see Warnings and Precautions (5.1) ] . combination with alcohol [see Warnings and Precautions (5.1) ] . patients with succinic semialdehyde dehydrogenase deficiency [see Clinical Pharmacology (12.3) ] . In combination with sedative hypnotics or alcohol (4) Succinic semialdehyde dehydrogenase deficiency (4)
Drug Interactions
7 DRUG INTERACTIONS Concomitant use with divalproex sodium: An initial reduction in sodium oxybate oral solution dose of at least 20% is recommended (2.5 , 7.2) . 7.1 Alcohol, Sedative Hypnotics, and CNS Depressants Sodium oxybate is contraindicated for use in combination with alcohol or sedative hypnotics. Use of other CNS depressants may potentiate the CNS-depressant effects of sodium oxybate [see Warnings and Precautions (5.1) ] . 7.2 Divalproex Sodium Concomitant use of sodium oxybate with divalproex sodium results in an increase in systemic exposure to GHB, which was shown to cause a greater impairment on some tests of attention and working memory in a clinical study [see Clinical Pharmacology (12.3) ] . An initial dose reduction of sodium oxybate oral solution is recommended when used concomitantly with divalproex sodium [see Dosage and Administration (2.5) ] . Prescribers are advised to monitor patient response closely and adjust dose accordingly if concomitant use of sodium oxybate oral solution and divalproex sodium is warranted.
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions appear in other sections of the labeling: CNS depression [see Warnings and Precautions (5.1) ] Abuse and Misuse [see Warnings and Precautions (5.2) ] Respiratory Depression and Sleep-Disordered Breathing [see Warnings and Precautions (5.4) ] Depression and Suicidality [see Warnings and Precautions (5.5) ] Other Behavioral or Psychiatric Adverse Reactions [see Warnings and Precautions (5.6) ] Parasomnias [see Warnings and Precautions (5.7) ] Use in Patients Sensitive to High Sodium Intake [see Warnings and Precautions (5.8) ] Most common adverse reactions in adults (≥5% and at least twice the incidence with placebo) were nausea, dizziness, vomiting, somnolence, enuresis, and tremor (6.1) . To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472, or FDA at 1-800-FDA-1088 or www.fda.gov/Medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in cli…
Frequently Asked Questions
What is sodium oxybate used for?
sodium oxybate contains sodium oxybate. It is a solution taken oral. Consult your doctor for specific uses.
Is sodium oxybate a controlled substance?
Yes, sodium oxybate is classified as CIII under the DEA Controlled Substances Act.
What is the generic name for sodium oxybate?
The generic name for sodium oxybate is sodium oxybate. There are 7 other brand versions of sodium oxybate.
What is the NDC code for sodium oxybate .5 g/mL?
The NDC (National Drug Code) for sodium oxybate .5 g/mL is 0054-9628, listed by Hikma Pharmaceuticals USA Inc..