apronin 10000 kiu ml injection - search results

United States - English - NLM (National Library of Medicine)

thiola- tiopronin tablet, sugar coated

mission pharmacal company - tiopronin (unii: c5w04go61s) (tiopronin - unii:c5w04go61s) - tiopronin 100 mg - thiola ® is indicated for the prevention of cystine (kidney) stone formation in patients with severe homozygous cystinuria with urinary cystine greater than 500 mg/day, who are resistant to treatment with conservative measures of high fluid intake, alkali and diet modification, or who have adverse reactions to d-penicillamine. cystine stones typically occur in approximately 10,000 persons in the united states who are homozygous for cystinuria. these persons excrete abnormal amounts of cystine in urine of over 250 mg/g creatinine, as well as excessive amounts of other dibasic amino acids (lysine, arginine and ornithine). in addition, they show varying intestinal transport defects for these same amino acids. the stone formation is the result of poor aqueous solubility of cystine. since there are no known inhibitors of the crystallization of cystine, the stone formation is determined primarily by the urinary supersaturation of cystine. thus, cystine stones could theoretically form whenever urinary cystine concentration exceeds the solubility limit. cystine solubility in urine is ph-dependent, and ranges from 170-300 mg/liter at ph 5, 190-400 mg/liter at ph 7 and 220-500 mg/liter at ph 7.5. the goal of therapy is to reduce urinary cystine concentration below its solubility limit. it may be accomplished by dietary means aimed at reducing cystine synthesis and by a high fluid intake in order to increase urine volume and thereby lower cystine concentration. unfortunately, the above conservative measures alone may be ineffective in controlling cystine stone formation in some homozygous patients with severe cystinuria (urinary cystine exceeding 500 mg/day). in such patients, d-penicillamine has been used as an additional therapy. like thiola ™ , dpenicillamine undergoes thiol-disulfide exchange with cystine, thereby lowering the amount of sparingly soluble cystine in urine. however, d-penicillamine treatment is frequently accompanied by adverse reactions, such as dermatologic complications, hypersensitivity reactions, hematologic abnormalities and renal disturbances. thiola ® may have a particular therapeutic role in such patients. the use of thiola ® during pregnancy is contraindicated, except in those with severe cystinuria where the anticipated benefit of inhibited stone formation clearly outweighs possible hazards of treatment (see precautions). thiola ® should not be begun again in patients with a prior history of developing agranulocytosis, aplastic anemia or thrombocytopenia on this medication. mothers maintained on thiola ® treatment should not nurse their infants.

United States - English - NLM (National Library of Medicine)

ax pharmaceutical corp- tiopronin powder

ax pharmaceutical corp - tiopronin (unii: c5w04go61s) (tiopronin - unii:c5w04go61s) - tiopronin 495 g in 500 g

United States - English - NLM (National Library of Medicine)

tiopronin- tiopronin powder

ax pharmaceutical corp - tiopronin (unii: c5w04go61s) (tiopronin - unii:c5w04go61s) -

United States - English - NLM (National Library of Medicine)

tiopronin base powder

bluebay shandong co.,ltd - tiopronin (unii: c5w04go61s) (tiopronin - unii:c5w04go61s) -

United States - English - NLM (National Library of Medicine)

tiopronin tablet, delayed release

torrent pharmaceuticals limited - tiopronin (unii: c5w04go61s) (tiopronin - unii:c5w04go61s) - 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. 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. tiopronin delayed-release tablets are contraindicated in patients with hypersensitivity to tiopronin or any other components of tiopronin delayed-release tablets [see warnings and precautions (5.2)] . 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/m2 ). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk renal stones in pregnancy may increase the risk of adverse pregnancy outcomes, such as preterm birth and low birth weight. data animal data no findings of fetal malformations could be attributed to the drug in reproduction studies in mice and rats at doses up to 2 times the highest recommended human dose of 2 grams/day (based on mg/m2 ). risk summary there are no data on the presence of tiopronin in either human or animal milk or on the effects of the breastfed child. a published study suggests that tiopronin may suppress milk production. because of the potential for serious adverse reactions, including nephrotic syndrome, advise patients that breastfeeding is not recommended during treatment with tiopronin delayed-release tablets. tiopronin delayed-release tablets are indicated in pediatric patients 9 years of age and older with severe homozygous cystinuria, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation who are not responsive to these measures alone. this indication is based on safety and efficacy data from a trial in patients 9 years to 68 years of age and clinical experience. proteinuria, including nephrotic syndrome, has been reported in pediatric patients. pediatric patients receiving greater than 50 mg/kg tiopronin per day may be at greater risk [see dosage and administration (2.1, 2.3), warnings and precautions (5.1) and adverse reactions (6.1)] . tiopronin delayed-release tablets are not approved for use in pediatric patients weighing less than 20 kg or in pediatric patients unable to swallow tablets [see dosage and administration (2.1)] . 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. this drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.