Tiopronin

Tiopronin delayed-release tablets are indicated, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults and pediatric patients 9 years of age and older with severe homozygous cystinuria, who are not responsive to these measures alone.

Tiopronin Delayed-Release Tablets, for oral use:

• 300 mg tablets: Round, white to off-white tablet imprinted with “L6” on one side with red ink and blank on the other side.

The following adverse reactions are discussed in greater detail in other sections of the labeling:

• Proteinuria
  [see Warnings and Precautions (5.1)]
• Hypersensitivity
  [see Warnings and Precautions (5.2)]

Tiopronin delayed-release tablets are a reducing and cystine-binding thiol drug (CBTD) for oral use. Tiopronin is N-(2-Mercaptopropionyl) glycine and has the following structure:

Tiopronin has the molecular formula C₅H₉NO₃S and a molecular weight of 163.19 g/mol. In this drug product tiopronin exists as a dl racemic mixture.

Tiopronin is a white to off-white color crystalline powder, which is freely soluble in water.

Each tiopronin delayed-release tablet contains 300 mg of tiopronin. The inactive ingredients in tiopronin delayed-release tablets include lactose monohydrate, hydroxypropyl cellulose, hydroxypropyl cellulose (low substitute), magnesium stearate, hydroxypropyl methylcellulose E5, methacrylic acid and ethyl acrylate copolymer (Eudragit L 100-55), talc, triethyl citrate.

Each tablet is imprinted with red pharmaceutical ink which contains: alcohol, butyl alcohol, FD & C Red # 40, propylene glycol, shellac and titanium dioxide.

Tiopronin Delayed-Release Tablets,

They are available as follows:

Bottles of 90 with child-resistant closure:                              NDC 60219-2009-9

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Keep this and all medications out of the reach of children.