Tiopronin (Thiola Ec)

Trade Name : Thiola EC

Mission Pharmacal Company

TABLET, DELAYED RELEASE

Strength 300 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 Ec) which is also known as Thiola EC and Manufactured by Mission Pharmacal Company. It is available in strength of 300 mg/1 per ml. Read more

Tiopronin (Thiola Ec) 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

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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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About GNH

No data

THIOLA EC is indicated,nin combination with high fluid intake, alkali, and diet modification,nfor the prevention of cystine stone formation in adults and pediatricnpatients 20 kg and greater with severe homozygous cystinuria, whonare not responsive to these measures alone.
THIOLA EC 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 EC in 3 divided doses at the same timesneach day, with or without food. Maintain a routine pattern with regardnto meals. ()
Swallow THIOLA EC tablets whole. ()
Measure urinary cystine 1 month after initiation of THIOLAnEC and every 3 months thereafter. ()

Tablets for oral use:100 mgntablets: round, white to off-white and imprinted in red with u201cT1u201dnon one side300 mg tablets: round, white to off-white andnimprinted in red with u201cT3u201d on one side
Tablets: 100 mg and 300 mg ()

THIOLA EC is contraindicated in patients with hypersensitivitynto tiopronin or any other components of THIOLA EC .

Hypersensitivity to tiopronin or any component of THIOLAnEC ()

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 reactions are discussed in greaterndetail in other sections of the labeling:
Most common adverse reactions (u226510%) are nausea,ndiarrhea or soft stools, oral ulcers, rash, fatigue, fever, arthralgia,nproteinuria, and emesis. ()
To report SUSPECTED ADVERSE REACTIONS,ncontact Mission Pharmacal Company at toll-free phone # 1-800-298-1087nor FDA at 1-800-FDA-1088 or .

Tiopronin is released faster from THIOLA EC in the presence of alcoholnand the risk for adverse events associated with THIOLA EC when takennwith alcohol is unknown. Avoid alcohol consumption 2 hours beforenand 3 hours after taking THIOLA EC .

No data

Lactation: Breastfeeding is not recommended. ()
Geriatric: Choose dose carefully and monitor renal functionnin the elderly. ()

There is no information on overdosage with tiopronin.

THIOLA EC (tiopronin) delayed-release tabletsnare a reducing and cystine-binding thiol drug (CBTD) for oral use.nTiopronin is Nu2011(2u2011Mercaptopropionyl) glycine and has the followingnstructure:
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 EC tablet contains 100 or 300nmg of tiopronin. The inactive ingredients in THIOLA EC tablets includenlactose monohydrate, hydroxypropyl cellulose, hydroxypropyl cellulosen(low substitute), magnesium stearate, hydroxypropyl methylcellulosenE5, methacrylic acid: ethyl acrylate copolymer (Eudragit L 100-55),ntalc, triethyl citrate.

No data

Carcinogenesis
Mutagenesis
in vivo
Impairment of Fertility

100 mg delayed-release, round, white to off-white tablet imprintednwith u201cT1u201d on one side with red ink and blank on the other side: Bottlesnof 300 0178-0902-01.
300 mg delayed-release, round, white tonoff-white tablet imprinted with u201cT3u201d on one side with red ink andnblank on the other side: Bottles of 90 0178-0901-90.
Store at 25u00b0C (77u00b0F); excursionsnpermitted to 15-30u00b0C (59-86u00b0F) .

Administration Instructions
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 ECNDC: 0178-0902-01
Thiola ECNDC: 0178-0901-90

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Today, the exact cause for many rare diseases remains unknown

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GNH Provides Contract Manufacturing services for: Generic Medicines with following

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Tiopronin (Thiola Ec)

Trade Name : Thiola EC

TABLET, DELAYED RELEASE

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

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Tiopronin (Thiola Ec)

Trade Name : Thiola EC

TABLET, DELAYED RELEASE

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

COMPANY

SERVICES

QUICK LINKS

CONTACT US

Can’t find what
you’re looking for?