June 25, 2016
Recommended Topic Related To:

Orfadin

"Below is a list of the most popular prescription drugs dispensed in 2011 with links to drug monographs. The list may include the medication brand name and generic name.

Note: This information pertains to U.S. prescriptions only./"...

A A A

Orfadin




Overdosage
Contraindications

OVERDOSE

Accidental ingestion of ORFADIN by individuals eating normal diets not restricted in tyrosine and phenylalanine will result in elevated tyrosine levels. In healthy subjects given a single 1 mg/kg dose of nitisinone, the plasma tyrosine level reached a maximum of 1200 micromol/L at 48 to 120 hours after dosing. After a washout period of 14 days, the mean value of plasma tyrosine was still 808 micromol/L. Fasted follow-up samples obtained from volunteers several weeks later showed tyrosine values back to normal. There were no reports of changes in vital signs or laboratory data of any clinical significance. One patient reported sensitivity to sunlight. Hypertyrosinemia has been reported with ORFADIN treatment [see WARNINGS AND PRECAUTIONS].

CONTRAINDICATIONS

None.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 6/21/2016

Overdosage
Contraindications

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.