FAQs Archive - Sodium Oxybate Oral Solution

Q: Where do I report negative side effects?

If you need to report an Adverse Event that occurred with Hikma’s authorized generic Sodium Oxybate Oral Solution, please call 1-877-845-0689 or 1-800-962-8364 . You are also encouraged to report negative side effects of authorized generic Sodium Oxybate Oral Solution to the FDA. Visit https://www.fda.gov/medwatch or call 1-800-FDA-1088 .

What are the eligibility requirements for the Sodium Oxybate Oral Solution co-pay savings program?

The authorized generic Sodium Oxybate Oral Solution co-pay savings program [...]

By admin|2023-01-17T15:22:45+00:00January 17th, 2023|Sodium Oxybate Oral Solution|Comments Off

Where do I report negative side effects?

If you need to report an Adverse Event that occurred [...]

By admin|2023-01-17T15:21:57+00:00January 17th, 2023|Sodium Oxybate Oral Solution|Comments Off

What is the XYWAV and XYREM REMS?

Because of the serious risks associated with Sodium Oxybate Oral [...]

By admin|2023-01-17T15:21:27+00:00January 17th, 2023|Sodium Oxybate Oral Solution|Comments Off

What is an authorized generic drug?

The term “authorized generic drug” is most commonly used to [...]

By admin|2023-01-17T15:20:50+00:00January 17th, 2023|Sodium Oxybate Oral Solution|Comments Off

This website uses cookies and third party services. Please see our cookie policy and privacy policy for more information. Ok

Important Safety Information for Sodium Oxybate Oral Solution

WARNING: Taking Sodium Oxybate Oral Solution with other Central Nervous System (CNS) depressants such as medicines used to make you or your child fall asleep, including opioid analgesics, benzodiazepines, sedating antidepressants, antipsychotics, sedating anti-epileptic medicines, general anesthetics, muscle relaxants, alcohol, or street drugs, may cause serious medical problems, including trouble breathing (respiratory depression), low blood pressure (hypotension), changes in alertness (drowsiness), fainting (syncope), and death.

WARNING: CENTRAL NERVOUS SYSTEM DEPRESSION and ABUSE AND MISUSE

• Central Nervous System Depression
Sodium Oxybate Oral Solution is a Central Nervous System (CNS) depressant. In clinical trials at recommended doses, obtundation and clinically significant respiratory depression occurred in adult patients treated with Sodium Oxybate Oral Solution. Many patients who received Sodium Oxybate Oral Solution during clinical trials in narcolepsy were receiving CNS stimulants.