In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of sodium oxybate in children below 16 years of age. Safety and efficacy have not been established.
Appropriate studies on the relationship of age to the effects of sodium oxybate have not been performed in the geriatric population. However, elderly patients are more likely to have unwanted effects (e.g., clumsiness or memory loss) or age-related liver disease, which may require caution in patients receiving sodium oxybate.
|All Trimesters||B||Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Morphine Sulfate Liposome
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Breathing problems (e.g., hypopnea or sleep apnea) or
- Depression, history of—Use with caution. May make these conditions worse.
- Drug abuse or dependence, history of—Dependence on sodium oxybate may be more likely to develop.
- Heart failure, history of or
- Hypertension (high blood pressure) or
- Kidney problems—The amount of sodium in this medicine may make these conditions worse.
- Liver problems—May increase the amount of sodium oxybate in the body and a smaller dose may be needed.
- Succinic semialdehyde dehydrogenase deficiency (rare inborn metabolism disorder)—Sodium oxybate should not be used in patients with this condition.