Tiopronin
Generic Name: tiopronin
Brand Names:
Venxxiva
11 DESCRIPTION VENXXIVA (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 empirical formula C 5 H 9 NO 3 S and a molecular weight of 163.19. 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.
Overview
11 DESCRIPTION VENXXIVA (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 empirical formula C 5 H 9 NO 3 S and a molecular weight of 163.19. 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.
Uses
1 INDICATIONS AND USAGE VENXXIVA is 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. Additional pediatric use information is approved for Mission Pharmacal Company’s Thiola EC (tiopronin delayed-release) tablets. However, due to Mission Pharmacal Company’s marketing exclusivity rights, this drug product is not labeled with that information.
Dosage
2 DOSAGE AND ADMINISTRATION The recommended initial dosage in adult patients is 800 mg/day. In clinical studies, the average dosage was about 1,000 mg/day. ( 2.1 ) The recommended initial dosage in pediatric patients 9 years of age and older is 15 mg/kg/day. Avoid dosages greater than 50 mg/kg per day in pediatric patients. ( 5.1 , 8.4 ) Measure urinary cystine 1 month after initiation of VENXXIVA and every 3 months thereafter. ( 2.3 ) Administer VENXXIVA in 3 divided doses at the same times each day, without food. ( 2.1 ) 2.1 Recommended Dosage Adults : The recommended initial dosage in adult patients is 800 mg/day. In clinical studies, the average dosage was about 1,000 mg/day. Pediatrics : The recommended initial dosage in pediatric patients 9 years of age and older is 15 mg/kg/day.
Side Effects
6 ADVERSE REACTIONS 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 )] Most common adverse reactions (≥10%) are nausea, diarrhea or soft stools, oral ulcers, rash, fatigue, fever, arthralgia, proteinuria, and emesis. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Cycle Pharmaceuticals Ltd at 1-857-437-3969 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Interactions
7 DRUG INTERACTIONS 7.1 Alcohol Tiopronin is released faster from VENXXIVA in the presence of alcohol and the risk for adverse events associated with VENXXIVA when taken with alcohol is unknown. Avoid alcohol consumption 2 hours before and 3 hours after taking VENXXIVA [see Clinical Pharmacology ( 12.3 )] .
Warnings
5 WARNINGS AND PRECAUTIONS Proteinuria, including nephrotic syndrome, and membranous nephropathy, has been reported with tiopronin use. Pediatric patients receiving greater than 50 mg/kg of tiopronin per day may be at increased risk for proteinuria. ( 2.1 , 5.1 , 8.4 ) Hypersensitivity reactions have been reported during tiopronin treatment. ( 4 , 5.2 ) 5.1 Proteinuria Proteinuria, including nephrotic syndrome, and membranous nephropathy, have been reported with tiopronin use. Pediatric patients receiving greater than 50 mg/kg of tiopronin per day may be at increased risk for proteinuria. [see Dosage and Administration ( 2.3 ), Adverse Reactions ( 6.1 , 6.2 ), Use in Specific Populations ( 8.4 )] . 4 CONTRAINDICATIONS VENXXIVA is contraindicated in patients with hypersensitivity to tiopronin or any other components of VENXXIVA [see Warnings and Precautions ( 5.2 )] . Hypersensitivity to tiopronin or any component of VENXXIVA ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary Available published case report data with tiopronin have not identified a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. Renal stones in pregnancy may result in adverse pregnancy outcomes (see Clinical Considerations ) . In animal reproduction studies, there were no adverse developmental outcomes with oral administration of tiopronin to pregnant mice and rats during organogenesis at doses up to 2 times a 2 grams/day human dose (based on mg/m 2 ).
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING 100 mg delayed-release, white to off-white, round shaped, enteric-coated tablets imprinted with "1A" with black ink on one side and plain on other side, free from physical defects. Bottles of 300 with child-resistant closure, NDC 70709-121-30.
Frequently Asked Questions
What is Tiopronin used for?▼
1 INDICATIONS AND USAGE VENXXIVA is 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. Additional pediatric use information is approved for Mission Pharmacal Company’s Thiola EC (tiopronin delayed-release) tablets. However, due to Mission Pharmacal Company’s marketing exclusivity rights, this drug product is not labeled with that information.
What are the side effects of Tiopronin?▼
6 ADVERSE REACTIONS 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 )] Most common adverse reactions (≥10%) are nausea, diarrhea or soft stools, oral ulcers, rash, fatigue, fever, arthralgia, proteinuria, and emesis. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Cycle Pharmaceuticals Ltd at 1-857-437-3969 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Can I take Tiopronin during pregnancy?▼
8.1 Pregnancy Risk Summary Available published case report data with tiopronin have not identified a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. Renal stones in pregnancy may result in adverse pregnancy outcomes (see Clinical Considerations ) . In animal reproduction studies, there were no adverse developmental outcomes with oral administration of tiopronin to pregnant mice and rats during organogenesis at doses up to 2 times a 2 grams/day human dose (based on mg/m 2 ).
What are the important warnings for Tiopronin?▼
5 WARNINGS AND PRECAUTIONS Proteinuria, including nephrotic syndrome, and membranous nephropathy, has been reported with tiopronin use. Pediatric patients receiving greater than 50 mg/kg of tiopronin per day may be at increased risk for proteinuria. ( 2.1 , 5.1 , 8.4 ) Hypersensitivity reactions have been reported during tiopronin treatment. ( 4 , 5.2 ) 5.1 Proteinuria Proteinuria, including nephrotic syndrome, and membranous nephropathy, have been reported with tiopronin use. Pediatric patients receiving greater than 50 mg/kg of tiopronin per day may be at increased risk for proteinuria. [see Dosage and Administration ( 2.3 ), Adverse Reactions ( 6.1 , 6.2 ), Use in Specific Populations ( 8.4 )] . 4 CONTRAINDICATIONS VENXXIVA is contraindicated in patients with hypersensitivity to tiopronin or any other components of VENXXIVA [see Warnings and Precautions ( 5.2 )] . Hypersensitivity to tiopronin or any component of VENXXIVA ( 4 )
Related Medications
Dorzolamide Hydrochloride Timolol Maleate
dorzolamide hydrochloride timolol maleate
11 DESCRIPTION Dorzolamide hydrochloride and timolol maleate ophthalmic solution, USP is the combination of a topical carbonic anhydrase inhibitor and a topical beta-adrenergic receptor blocking agent. Dorzolamide hydrochloride is described chemically as: (4 S-trans )-4-(ethylamino)-5,6-dihydro-6-methyl-4 H -thieno[2,3- b ]thiopyran-2-sulfonamide 7,7-dioxide monohydrochloride. Dorzolamide hydrochloride is optically active. The specific rotation is: [a] 25°C (C=1, water) = ~ -17°.
Caltha Palustris, Clematis Erecta, Galium Aparine, Hedera Helix, Juniperus Communis, Sedum Acre, Sempervivum Tectorum, Thuja Occidentalis, Urtica Urens, Echinacea (angustifolia), Argentum Metallicum, Calcarea Fluorica, Nitricum Acidum, Phosphorus, Cortisone Aceticum, Aurum Metallicum, Apis Mellifica, Ononis Spinosa, Gaertner Bacillus (bach)
caltha palustris, clematis erecta, galium aparine, hedera helix, juniperus communis, sedum acre, sempervivum tectorum, thuja occidentalis, urtica urens, echinacea (angustifolia), argentum metallicum, calcarea fluorica, nitricum acidum, phosphorus, cortisone aceticum, aurum metallicum, apis mellifica, ononis spinosa, gaertner bacillus (bach)
Standardized Insect Venom Allergenic Extract [EPC]
HOMEOPATHIC INDICATIONS: For the temporary relief of symptoms related to illness and infections such as cold and flu.** **These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.
Acid Benz, Cimicifuga, Colchicum, Ledum, Pulsatilla, Ruta Gr, Calc Phos
acid benz, cimicifuga, colchicum, ledum, pulsatilla, ruta gr, calc phos
Nitrogen Binding Agent [EPC]
Uses Temporarily relieves occasional heel discomfort often caused by daily activities and exercises. It also temporarily relieves occasional sharp localized aches, strong heel discomfort in the morning and after rest, and aggravated aches by prolonged weight-bearing activity.* *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED. This product is not intended to diagnose, treat, cure, or prevent any disease.
Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.