País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
SUCCIMER (UNII: DX1U2629QE) (SUCCIMER - UNII:DX1U2629QE)
Recordati Rare Diseases, Inc.
SUCCIMER
SUCCIMER 100 mg
ORAL
PRESCRIPTION DRUG
CHEMET is indicated for the treatment of lead poisoning in pediatric patients with blood lead levels above 45 mcg/dL. CHEMET is not indicated for prophylaxis of lead poisoning in a lead-containing environment; the use of CHEMET should always be accompanied by identification and removal of the source of the lead exposure. CHEMET should not be administered to patients with a history of allergy to the drug.
100 mg capsules in bottle of 100 (NDC 55292-201-11). Store between 15°C and 25°C and avoid excessive heat. Manufactured by: Lannett Company, Inc. Seymour, IN 47274 For: Recordati Rare Diseases Inc., Lebanon, NJ 08833, U.S.A. RECORDATI RARE DISEASES GROUP CHEMET is a registered trademark of Recordati Rare Diseases Inc. This product label may have been updated. For the most recent prescribing information, please visit www.recordatirarediseases.com. Revised: October 2018 CIA72289G
New Drug Application
CHEMET- SUCCIMER CAPSULE RECORDATI RARE DISEASES, INC. ---------- CHEMET® (SUCCIMER) CAPSULE 100 MG R ONLY DESCRIPTION CHEMET (succimer) is an orally active, heavy metal chelating agent. The chemical name for succimer is _meso_ 2, 3-dimercaptosuccinic acid (DMSA). Its empirical formula is C H O S and molecular weight is 182.2. The _meso_-structural formula is: Succimer is a white crystalline powder with an unpleasant, characteristic mercaptan odor and taste. Each CHEMET opaque white capsule for oral administration contains beads coated with 100 mg of succimer and is imprinted black with CHEMET 100. Inactive ingredients in medicated beads are: povidone, sodium starch glycolate, starch and sucrose. Inactive ingredients in capsule are: gelatin, iron oxide, titanium dioxide and other ingredients. CLINICAL PHARMACOLOGY Succimer is a lead chelator; it forms water soluble chelates and, consequently, increases the urinary excretion of lead. PRECLINICAL TOXICOLOGY: Succimer has low acute oral toxicity, with oral median lethal doses in rodents in excess of 3.6 g/kg. In a 28-day toxicity study, dogs receiving 30 and 100 mg/kg/day had lower urinary specific gravity and an increase in renal tubular regenerative hyperplasia. No renal toxicity was noted in dogs given 50 mg/kg/day orally for 14 consecutive days. In a chronic 6-month oral toxicity study, one male dog died (out of 7) at a dose of 200 mg/kg/day attributed to associated renal toxicity. Treatment related renal tubule epithelial changes in this study were observed in dogs after chronic X 4 6 4 2 (6-month) exposure to 110 and 200 mg/kg/day for 17 days then to 80 and 140 mg/kg/day for the remainder of the study. These changes were dose-dependent and correlated with increased kidney weights in male and female dogs at the 10 mg/kg/day dose. Nephropathy was not observed in dogs treated at 10 mg/kg/day. Reduced platelet counts were noted in 5 of 7 dogs receiving either 80 or 140 mg/kg/day for 3 or 6 months, although group means were not statistically different from concurr Leia o documento completo