Nitisinonedrug info
nitisinone 2 MG Oral Capsule
What it is used for
1 INDICATIONS & USAGE Nitisinone capsules are indicated for the treatment of adult and pediatric patients with hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. Nitisinone is a hydroxy-phenylpyruvate dioxygenase inhibitor indicated for the treatment of adult and pediatric patients with hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective August 6, 2026. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Description
Nitisinone capsules contains nitisinone, which is a hydroxyphenyl-pyruvate dioxygenase inhibitor indicated as an adjunct to dietary restriction of tyrosine and phenylalanine in the treatment of hereditary tyrosinemia type 1 (HT-1). Nitisinone occurs as white to yellow colored powder. It is practically insoluble in water and sparingly soluble in 2M Sodium Hydroxide, Ethanol and Methanol. Chemically, nitisinone is 2-[2-nitro-4-(trifluoromethyl)benzoyl] cyclohexane-1,3-dione, and the structural formula is: Figure 1. The molecular formula is C 14 H 10 F 3 NO 5 with a relative mass of 329.23 Inert ingredients in the formulation are: citric acid anhydrous, hypromellose, mannitol and stearic acid. The empty hard gelatin capsules contains gelatin, sodium lauryl sulfate and titanium dioxide. The capsules shells are imprinted in edible ink which contains black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. structure
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective August 6, 2026. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
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