Sapropterin (Oral Route)

Name: Sapropterin (Oral Route)

Geriatric

Appropriate studies on the relationship of age to the effects of sapropterin have not been performed in the geriatric population. Safety and efficacy have not been established.

Pregnancy

Information about this sapropterin-oral-route
Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

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.

Other Interactions

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.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage forms (solution or tablets):
    • Adults and children 7 years of age and older—Dose is based on body weight and must be determined by your doctor. The starting dose is usually 10 to 20 milligrams (mg) per kilogram (kg) of body weight per day. Your doctor may adjust your dose if needed.
    • Children 1 month to 6 years of age—Dose is based on body weight and must be determined by your doctor. The starting dose is usually 10 mg per kg of body weight per day. Your doctor may adjust your dose if needed.
    • Children younger than 1 month of age—Use and dose must be determined by your doctor. .

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

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