Drug: Chemet

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 C4H6O4S2 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.

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Clinical experience with CHEMET has been limited. Consequently, the full spectrum and incidence of adverse reactions including the possibility of hypersensitivity or idiosyncratic reactions have not been determined. The most common events attributable to succimer, i.e., gastrointestinal symptoms or increases in serum transaminases, have been observed in about 10% of patients (see PRECAUTIONS). Rashes, some necessitating discontinuation of therapy, have been reported in about 4% of patients. If rash occurs, other causes (e.g. measles) should be considered before ascribing the reaction to succimer. Rechallenge with succimer may be considered if lead levels are high enough to warrant retreatment. One allergic mucocutaneous reaction has been reported on repeated administration of the drug (see PRECAUTIONS). Mild to moderate neutropenia has been observed in some patients receiving succimer (see WARNINGS). Table I presents adverse events reported with the administration of succimer for the treatment of lead and other heavy metal intoxication. TABLE I : INCIDENCE OF ADVERSE EVENTS IN DOMESTIC STUDIES REGARDLESS OF ATTRIBUTION OR SUCCIMER DOSAGE
  Pediatric Patients (191) Adults (134) % (n) % (n) Digestive: 12.0 23 20.9 28 Nausea, vomiting, diarrhea, appetite loss, hemorrhoidal symptoms, loose stools, metallic taste in mouth. Body as a Whole: 5.2 10 15.7 21 Back pain, abdominal cramps, stomach pains, head pain, rib pain, chills, flank pain, fever, flu-like symptoms, heavy head/tired, head cold, headache, moniliasis. Metabolic: 4.2 8 10.4 14 Elevated SGPT, SGOT, alkaline phosphatase, elevated serum cholesterol. Nervous: 1.0 2 12.7 17 Drowsiness, dizziness, sensorimotor neuropathy, sleepiness, paresthesia. Skin and Appendages: 2.6 5 11.2 15 Papular rash, herpetic rash, rash, mucocutaneous eruptions, pruritus. Special Senses: 1.0 2 3.7 5 Cloudy film in eye, ears plugged, otitis media, eyes watery. Respiratory 3.7 7 0.7 1 Throat sore, rhinorrhea, nasal congestion, cough. Urogenital: 0.0 - 3.7 5 Decreased urination, voiding difficulty, proteinuria increased. Cardiovascular: 0.0 1.8 2 Arrhythmia Heme/Lymphatic: 0.5* 1 1.5* 2 Mild to moderate neutropenia, increased platelet count, intermittent eosinophilia. Musculoskeletal: 0.0 3.0 4 Kneecap pain, leg pains. *Does not include neutropenia - see WARNINGS. To report SUSPECTED ADVERSE REACTIONS, contact Recordati Rare Diseases Inc. at 1-888-755-8344 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Read the Chemet (succimer) Side Effects Center for a complete guide to possible side effectsLearn More »

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Start dosage at 10 mg/kg or 350 mg/m² every eight hours for five days. Initiation of therapy at higher doses is not recommended. (See Table II for Dosing chart and number of capsules.) Reduce frequency of administration to 10 mg/kg or 350 mg/m² every 12 hours (two-thirds of initial daily dosage) for an additional two weeks of therapy. A course of treatment lasts 19 days. Repeated courses may be necessary if indicated by weekly monitoring of blood lead concentration. A minimum of two weeks between courses is recommended unless blood lead levels indicate the need for more prompt treatment. TABLE II : CHEMET (SUCCIMER) PEDIATRIC DOSING CHART
LBS KG DOSE (MG)* Number of CAPSULES* 18-35 8-15 100 1 36-55 16-23 200 2 56-75 24-34 300 3 76-100 35-44 400 4 >100 >45 500 5 *To be administered every 8 hours for 5 days, followed by dosing every 12 hours for 14 days. In young pediatric patients who cannot swallow capsules, CHEMET can be administered by separating the capsule and sprinkling the medicated beads on a small amount of soft food or putting them in a spoon and following with fruit drink. Identification of the source of lead in the pediatric patient's environment and its abatement are critical to a successful therapy outcome. Chelation therapy is not a substitute for preventing further exposure to lead and should not be used to permit continued exposure to lead. Patients who have received CaNa2EDTA with or without BAL may use CHEMET for subsequent treatment after an interval of four weeks. Data on the concomitant use of CHEMET with CaNa2EDTA with or without BAL are not available, and such use is not recommended.

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CHEMET is not known to interact with other drugs including iron supplements; interactions have not been systematically studied. Concomitant administration of CHEMET with other chelation therapy, such as CaNa2EDTA is not recommended. Drug/Laboratory Tests Interaction Succimer may interfere with serum and urinary laboratory tests. In vitro studies have shown succimer to cause false positive results for ketones in urine using nitroprusside reagents such as Ketostix and falsely decreased measurements of serum uric acid and CPK. Last reviewed on RxList: 9/18/2013
This monograph has been modified to include the generic and brand name in many instances.

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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.

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CHEMET should not be administered to patients with a history of allergy to the drug.Last reviewed on RxList: 9/18/2013
This monograph has been modified to include the generic and brand name in many instances.

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Doses of 2300 mg/kg in the rat and 2400 mg/kg in the mouse produced ataxia, convulsions, labored respiration and frequently death. No case of overdosage has been reported in humans. Limited data indicate that succimer is dialyzable. In case of acute overdosage, induction of vomiting or gastric lavage followed by administration of an activated charcoal slurry and appropriate supportive therapy are recommended.

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100 mg capsules in bottle of 100 (NDC 55292-201-11). Store between 15°C and 25°C and avoid excessive heat. Manufactured by: Kremers Urban Pharmaceuticals Inc., Seymour, IN 47274, USA. For: Recordati Rare Diseases Inc., Lebanon, NJ 08833, U.S.A. Revised: February 2013 Last reviewed on RxList: 9/18/2013
This monograph has been modified to include the generic and brand name in many instances.

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The extent of clinical experience with CHEMET (succimer) is limited. Therefore, patients should be carefully observed during treatment. General: Elevated blood lead levels and associated symptoms may return rapidly after discontinuation of CHEMET (succimer) because of redistribution of lead from bone stores to soft tissues and blood. After therapy, patients should be monitored for rebound of blood lead levels, by measuring blood lead levels at least once weekly until stable. However, the severity of lead intoxication (as measured by the initial blood lead level and the rate and degree of rebound of blood lead) should be used as a guide for more frequent blood lead monitoring. All patients undergoing treatment should be adequately hydrated. Caution should be exercised in using CHEMET (succimer) therapy in patients with compromised renal function. Limited data suggests that CHEMET (succimer) is dialyzable, but that the lead chelates are not. Transient mild elevations of serum transaminases have been observed in 6-10% of patients during the course of succimer therapy. Serum transaminases should be monitored before the start of therapy and at least weekly during therapy. Patients with a history of liver disease should be monitored closely. No data are available regarding the metabolism of succimer in patients with liver disease. Clinical experience with repeated courses is limited. The safety of uninterrupted dosing longer than three weeks has not been established and it is not recommended. The possibility of allergic or other mucocutaneous reactions to the drug must be borne in mind on readministration (as well as during initial courses). Patients requiring repeated courses of CHEMET (succimer) should be monitored during each treatment course. One patient experienced recurrent mucocutaneous vesicular eruptions of increasing severity affecting the oral mucosa, the external urethral meatus and the perianal area on the third, fourth and fifth courses of the drug. The reaction resolved between courses and upon discontinuation of therapy. Carcinogenesis, Mutagenesis and Impairment of Fertility: CHEMET (succimer) has not been tested for carcinogenic potential in long-term animal studies. CHEMET (succimer) up to a dose of 510 mg/kg/day in males and 100 mg/kg/day in females did not show any adverse effect on fertility and reproductive performance. It was not mutagenic in the Ames bacterial assay and in the mammalian cell forward gene mutation assay. Pregnancy: Teratogenic Effects - Pregnancy Category C. CHEMET (succimer) has been shown to be teratogenic and fetotoxic in pregnant mice when given subcutaneously in a dose range of 410 to 1640 mg/kg/day during the period of organogenesis. In a developmental study in rats, Chemet (succimer) produced maternal toxicity and deaths at the dose of 720 mg/kg/day or more during organogenesis. The dose of 510 mg/kg/day was the highest tolerable dose in pregnant rats. Impaired development of reflexes was noted in pups of 720 mg/kg/day group dam. There are no adequate and well controlled studies in pregnant women. CHEMET (succimer) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs and heavy metals are excreted in human milk, nursing mothers requiring CHEMET (succimer) therapy should be discouraged from nursing their infants. Pediatric Use: Refer to the INDICATIONS and DOSAGE AND ADMINISTRATION sections. Safety and efficacy in pediatric patients less than 12 months of age have not been established.Last reviewed on RxList: 9/18/2013
This monograph has been modified to include the generic and brand name in many instances.

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