A medical food for the dietary management of Phenylketonuria (PKU).
Description
Each round, coated white tablet contains:
Active Ingredients:
L-Tyrosine
L-Tryptophan
L-Methionine
L-Isoleucine
L-Valine
L-Threonine
L-Leucine
L-Arginine
L-Histidine
L-Lysine
Vitamin B6
Vitamin B12
Inactive Ingredients:
Tricalcium phosphate, potato starch, dicalcium phosphate, colloidal hydrated silica, rice starch, magnesium stearate, titanium dioxide, shellac, talcum, olive oil.
Indication and Usage
PreKUnil® tablets are indicated for the distinct nutritional requirements of individuals under a physician’s treatment for Phenylketonuria; with particular emphasis on blocking the offending amino acid phenylalanine from crossing the blood brain barrier.
Precautions
For individuals with Phenylketonuria only. Do not use PreKUnil® tablets during pregnancy or if planning a pregnancy. If one becomes pregnant, stop taking PreKUnil® immediately and contact a doctor specialized in inborn errors of metabolism.
Adverse Reactions
None known
Contraindications
Known hypersensitivity to any of the components in the product is a contraindication.
Drug Interactions
None known
Patient Information
PreKUnil® tablets are a medical food for people with Phenylketonuria only. For use only under the direction and supervision of a licensed metabolic physician.
Dosage and Administration
Usual dose is 0.5 tablet per kg body weight per day or as directed by a physician.
Dosage is dependant on the age, body weight, medical condition and individual phenylalanine tolerance.
How Supplied
Available as a non-scored, round, coated, white colored tablet. Supplied in bottles of 550 tablets.
Storage
Store in a cool, dry place away from direct sunlight. When not in use, reseal and keep container closed. Dispense from the original container.
USE ONLY UNDER THE DIRECTION OF A DOCTOR SPECIALIZED IN INBORN ERRORS OF METABOLISM.
