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Tiopronin (Thiola)

Trade Name : Thiola

Mission Pharmacal Company

TABLET, SUGAR COATED

Strength 100 mg/1

TIOPRONIN Cystine Disulfide Reduction [MoA],N-substituted Glycines [CS],Reducing and Complexing Thiol [EPC]

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Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Tiopronin (Thiola) which is also known as Thiola and Manufactured by Mission Pharmacal Company. It is available in strength of 100 mg/1 per ml. Read more

Tiopronin (Thiola) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • THIOLA is indicated, in combinationnwith high fluid intake, alkali, and diet modification, for the preventionnof cystine stone formation in adults and pediatric patients 20 kgnand greater with severe homozygous cystinuria, who are not responsivento these measures alone.
  • THIOLA is a reducing and complexingnthiol indicated, in combination with high fluid intake, alkali, andndiet modification, for the prevention of cystine stone formation innadults and pediatric patients 20 kg and greater with severe homozygousncystinuria, who are not responsive to these measures alone. ()
  • No data
  • The recommended initial dosage in adult patients is 800nmg/day. In clinical studies, the average dosage was about 1,000 mg/day.n()
  • The recommended initial dosage in pediatric patients 20nkg and greater is 15 mg/kg/day. Avoid dosages greater than 50 mg/kgnper day in pediatric patients. (, , )
  • Administer THIOLA in 3 divided doses at the same times eachnday at least one hour before or 2 hours after meals. ()
  • Measure urinary cystine 1 month after initiation of THIOLAnand every 3 months thereafter. ()
  • Tablets for oral use:100 mg tablets: round, white and imprinted in red with u201cMu201d on onenside
  • Tablets: 100 mg ()
  • THIOLA is contraindicated innpatients with hypersensitivity to tiopronin or any other componentsnof THIOLA .
  • Hypersensitivity to tiopronin or any component of THIOLAn()
  • No data
  • Proteinuria, including nephrotic syndrome, and membranousnnephropathy, has been reported with tiopronin use. Pediatric patientsnreceiving greater than 50 mg/kg of tiopronin per day may be at increasednrisk for proteinuria. (, , )
  • Hypersensitivity reactions have been reported during tioproninntreatment. (, )
  • The following adverse reactionsnare discussed in greater detail in other sections of the labeling:
  • Most common adverse reactionsn(u226510%) are nausea, diarrhea or soft stools, oral ulcers, rash, fatigue,nfever, arthralgia, proteinuria, and emesis. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Mission Pharmacal Company at toll-free phone # 1-800-298-1087 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No data
  • Lactation: Breastfeeding is not recommended. ()
  • Geriatric: Choose dose carefully and monitor renal functionnin the elderly. ()
  • There is no information onnoverdosage with tiopronin.
  • THIOLA (tiopronin) immediate-release tablets are a reducing and cystine-bindingnthiol drug (CBTD) for oral use. Tiopronin is N-(2-Mercaptopropionyl)nglycine and has the following structure:
  • Tiopronin has the empiricalnformula CHNOS and a molecular weight of 163.20. In this drug productntiopronin exists as a dl racemic mixture.
  • Tiopronin is a white crystalline powder,nwhich is freely soluble in water.
  • Each Thiola tablet contains 100 mg of tiopronin.n The inactive ingredients in THIOLA tablets include calcium carbonate,ncarnauba wax, ethyl cellulose, dimethylaminoethyl methacrylate: butylnmethacrylate: methyl methacrylate copolymer (Eudragit E 100), hydroxy-propylncellulose, lactose monohydrate, magnesium stearate, povidone, sugar,ntalc, titanium dioxide.
  • No data
  • Carcinogenesis
  • Mutagenesis
  • in vivo
  • Impairment of Fertility
  • 100 mg round, white, immediate-release tablet imprinted in red withnu201cMu201d on one side and blank on the other side: Bottles of 100 0178-0900-01.
  • Store at 25u00b0C (77u00b0F); excursions permittednto 15-30u00b0C (59-86u00b0F) .
  • Lactationn- [see Use in Specific Populations ()]
  • Manufactured and packaged by Mission PharmacalnCompany, San Antonio, TX 78230 1355Distributed by Retrophin,nInc., San Diego, CA 92130
  • THIOLA n Label NDC:n0178-0900-01

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