SPL Set ID: 645c8387-30d5-4a86-a5d8-2f6b5df6d5f0

Nitisinone capsules contain 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 yellowish-white, crystalline powder. It is practically insoluble in water, soluble in 2M sodium hydroxide and in methanol, and sparingly soluble in alcohol. Chemically, nitisinone is 2-(2-nitro-4-trifluoromethylbenzoyl) 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 Hard, white-opaque capsule, marked as “2”, “5”, “10” or “20” on the capsule body indicating the strengths of nitisinone, intended for oral administration, and the following logo on the capsule cap: . Each capsule contains 2 mg, 5 mg, 10 mg or 20 mg nitisinone, plus pre-gelatinized starch and stearic acid. The capsule shell is gelatin and titanium dioxide and the blue imprint is composed of FD & C Blue #2-Aluminum Lake, shellac, propylene glycol and strong ammonia solution. nitisinone structure ID Logo