CHEMET- succimer capsule

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

SUCCIMER (UNII: DX1U2629QE) (SUCCIMER - UNII:DX1U2629QE)

Commercializzato da:

Recordati Rare Diseases, Inc.

INN (Nome Internazionale):

SUCCIMER

Composizione:

SUCCIMER 100 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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.

Dettagli prodotto:

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

Stato dell'autorizzazione:

New Drug Application

Scheda tecnica

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