Estados Unidos - inglês - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - penicillamine (unii: gnn1dv99gx) (penicillamine - unii:gnn1dv99gx) - penicillamine tablets are indicated in the treatment of wilson's disease, cystinuria, and in patients with severe, active rheumatoid arthritis who have failed to respond to an adequate trial of conventional therapy. available evidence suggests that penicillamine tablets are not of value in ankylosing spondylitis. wilson's disease (hepatolenticular degeneration) results from the interaction of an inherited defect and an abnormality in copper metabolism. the metabolic defect, which is the consequence of the autosomal inheritance of one abnormal gene from each parent, manifests itself in a greater positive copper balance than normal. as a result, copper is deposited in several organs and appears eventually to produce pathologic effects most prominently seen in the brain, where degeneration is widespread; in the liver, where fatty infiltration, inflammation, and hepatocellular damage progress to postnecrotic cirrhosis; in the kidney, where tubular and glomerular dysfunction results; and in the eye, where characte

Estados Unidos - inglês - NLM (National Library of Medicine)

granules pharmaceuticals inc. - penicillamine (unii: gnn1dv99gx) (penicillamine - unii:gnn1dv99gx) - penicillamine capsules are indicated in the treatment of wilson's disease, cystinuria, and in patients with severe, active rheumatoid arthritis who have failed to respond to an adequate trial of conventional therapy. available evidence suggests that penicillamine capsules are not of value in ankylosing spondylitis. wilson’s disease — wilson’s disease (hepatolenticular degeneration) occurs in individuals who have inherited an autosomal recessive defect that leads to an accumulation of copper far in excess of metabolic requirements. the excess copper is deposited in several organs and tissues, and eventually produces pathological effects primarily in the liver, where damage progresses to postnecrotic cirrhosis, and in the brain, where degeneration is widespread. copper is also deposited as characteristic, asymptomatic, golden-brown kayser-fleischer rings in the corneas of all patients with cerebral symptomatology and some patients who are either asymptomatic or manifest only hepatic symptomatology. two types o

Estados Unidos - inglês - NLM (National Library of Medicine)

proficient rx lp - penicillamine (unii: gnn1dv99gx) (penicillamine - unii:gnn1dv99gx) - penicillamine capsules are indicated in the treatment of wilson's disease, cystinuria, and in patients with severe, active rheumatoid arthritis who have failed to respond to an adequate trial of conventional therapy. available evidence suggests that penicillamine capsules are not of value in ankylosing spondylitis. wilson’s disease — wilson’s disease (hepatolenticular degeneration) occurs in individuals who have inherited an autosomal recessive defect that leads to an accumulation of copper far in excess of metabolic requirements. the excess copper is deposited in several organs and tissues, and eventually produces pathological effects primarily in the liver, where damage progresses to postnecrotic cirrhosis, and in the brain, where degeneration is widespread. copper is also deposited as characteristic, asymptomatic, golden-brown kayser-fleischer rings in the corneas of all patients with cerebral symptomatology and some patients who are either asymptomatic or manifest only hepatic symptomatology. two types o

Reino Unido - inglês - MHRA (Medicines & Healthcare Products Regulatory Agency)

alliance pharmaceuticals ltd - penicillamine - oral tablet - 125mg

Reino Unido - inglês - MHRA (Medicines & Healthcare Products Regulatory Agency)

alliance pharmaceuticals ltd - penicillamine - oral tablet - 250mg

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - penicillamine, quantity: 250 mg - tablet, film coated - excipient ingredients: povidone; stearic acid; microcrystalline cellulose; titanium dioxide; glycerol; hypromellose; sodium starch glycollate - severe, active rheumatoid arthritis. as a chelating agent in the treatment of wilson's disease and lead poisoning. d-penamine will enhance urinary excretion of gold and mercury and other heavy metals. in the treatment of cysturia in cases where high-fluid regimens are not adequate, or in conjunction with them.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - penicillamine, quantity: 125 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; povidone; glycerol; titanium dioxide; hypromellose; stearic acid; sodium starch glycollate - severe, active rheumatoid arthritis. as a chelating agent in the treatment of wilson's disease and lead poisoning. d-penamine will enhance urinary excretion of gold and mercury and other heavy metals. in the treatment of cysturia in cases where high-fluid regimens are not adequate, or in conjunction with them.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - penicillamine -

Estados Unidos - inglês - NLM (National Library of Medicine)

mission pharmacal company - tiopronin (unii: c5w04go61s) (tiopronin - unii:c5w04go61s) - thiola ec is indicated, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults and pediatric patients 20 kg and greater with severe homozygous cystinuria, who are not responsive to these measures alone. thiola ec is contraindicated in patients with hypersensitivity to tiopronin or any other components of thiola ec [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/m 2 ). 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/m 2 ). 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 thiola ec. thiola ec is indicated in pediatric patients weighing 20 kg or more 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)] . thiola ec tablets are not approved for use in pediatric patients weighing less than 20 kg [see dosage and administration ( 2.1)] . 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.

Estados Unidos - inglês - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - tiopronin (unii: c5w04go61s) (tiopronin - unii:c5w04go61s) - tiopronin 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 (tiopronin) tablets. however, due to mission pharmacal company’s marketing exclusivity rights, this drug product is not labeled with that information. tiopronin is contraindicated in patients with hypersensitivity to tiopronin or any other components of tiopronin 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 adver