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succimer

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Overview

What is Chemet?

CHEMET (succimer) is an orally active, heavy metal chelating agent. The chemical name for succimer is 2, 3-dimercaptosuccinic acid (DMSA). Its empirical formula is C H O S and molecular weight is 182.2. The -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.



What does Chemet look like?



What are the available doses of Chemet?

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What should I talk to my health care provider before I take Chemet?

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How should I use Chemet?

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.

Start dosage at 10 mg/kg or 350 mg/m every eight hours for five days. Initiation of therapy at higher doses is not recommended. (See for Dosing chart and number of capsules.) Reduce frequency of administration to 10 mg/kg or 350 mg/m 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.

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 CaNa EDTA with or without BAL may use CHEMET for subsequent treatment after an interval of four weeks. Data on the concomitant use of CHEMET with CaNa EDTA with or without BAL are not available, and such use is not recommended.


What interacts with Chemet?

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What are the warnings of Chemet?

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What are the precautions of Chemet?

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What are the side effects of Chemet?

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 ). 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. Several allergic reactions including urticaria and angioedema have been reported on repeated administration of the drug (see ). Mild to moderate neutropenia has been observed in some patients receiving succimer (see ). Table I presents adverse events reported with the administration of succimer for the treatment of lead and other heavy metal intoxication.

To report SUSPECTED ADVERSE REACTIONS, contact Recordati Rare Diseases Inc. at 1-888-575-8344 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

TABLE I INCIDENCE OF ADVERSE EVENTS IN DOMESTIC STUDIES REGARDLESS OF ATTRIBUTION OR SUCCIMER DOSAGE
Pediatric Patients (191)Adults (134)
% (n)%(n)
Digestive:12.02320.928
Body as a Whole:5.21015.721
Metabolic:4.2810.414
Nervous:1.0212.717
Skin and Appendages:2.6511.215
Special Senses:1.023.75
Respiratory3.770.71
Urogenital:0.0-3.75
Cardiovascular:0.0-1.82
Heme/Lymphatic:0.5 11.5 2
Musculoskeletal:0.0-3.04



What should I look out for while using Chemet?

CHEMET should not be administered to patients with a history of allergy to the drug.

Keep out of reach of pediatric patients. CHEMET is not a substitute for effective abatement of lead exposure.

Mild to moderate neutropenia has been observed in some patients receiving succimer. While a causal relationship to succimer has not been definitely established, neutropenia has been reported with other drugs in the same chemical class. A complete blood count with and should be obtained prior to and weekly during treatment with succimer. Therapy should either be withheld or discontinued if the absolute neutrophil count (ANC) is below 1200/mcL and the patient followed closely to document recovery of the ANC to above 1500/mcL or to the patient’s baseline neutrophil count. There is limited experience with reexposure in patients who have developed neutropenia. Therefore, such patients should be rechallenged only if the benefit of succimer therapy clearly outweighs the potential risk of another episode of neutropenia and then only with careful patient monitoring.

Patients treated with succimer should be instructed to promptly report any signs of infection. If infection is suspected, the above laboratory tests should be conducted immediately.


What might happen if I take too much Chemet?

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.


How should I store and handle Chemet?

Storage:Sandimmune is a registered trademark of Novartis Pharmaceuticals Corporation. ATGAM is a registered trademark of Pharmacia and Upjohn Company. Neoral is a registered trademark of Novartis Pharmaceuticals Corporation. Orthoclone OKT is a registered trademark of Ortho Biotech Inc. Maalox is a registered trademark of Novartis Consumer Health, Inc. NOVAPLUS is a registered trademark of Vizient, Inc. NMM00N          Rev. 01/18 Storage:Sandimmune is a registered trademark of Novartis Pharmaceuticals Corporation. ATGAM is a registered trademark of Pharmacia and Upjohn Company. Neoral is a registered trademark of Novartis Pharmaceuticals Corporation. Orthoclone OKT is a registered trademark of Ortho Biotech Inc. Maalox is a registered trademark of Novartis Consumer Health, Inc. NOVAPLUS is a registered trademark of Vizient, Inc. NMM00N          Rev. 01/18 Storage:Sandimmune is a registered trademark of Novartis Pharmaceuticals Corporation. ATGAM is a registered trademark of Pharmacia and Upjohn Company. Neoral is a registered trademark of Novartis Pharmaceuticals Corporation. Orthoclone OKT is a registered trademark of Ortho Biotech Inc. Maalox is a registered trademark of Novartis Consumer Health, Inc. NOVAPLUS is a registered trademark of Vizient, Inc. NMM00N          Rev. 01/18 Storage:Sandimmune is a registered trademark of Novartis Pharmaceuticals Corporation. ATGAM is a registered trademark of Pharmacia and Upjohn Company. Neoral is a registered trademark of Novartis Pharmaceuticals Corporation. Orthoclone OKT is a registered trademark of Ortho Biotech Inc. Maalox is a registered trademark of Novartis Consumer Health, Inc. NOVAPLUS is a registered trademark of Vizient, Inc. NMM00N          Rev. 01/18 Storage:Sandimmune is a registered trademark of Novartis Pharmaceuticals Corporation. ATGAM is a registered trademark of Pharmacia and Upjohn Company. Neoral is a registered trademark of Novartis Pharmaceuticals Corporation. Orthoclone OKT is a registered trademark of Ortho Biotech Inc. Maalox is a registered trademark of Novartis Consumer Health, Inc. NOVAPLUS is a registered trademark of Vizient, Inc. NMM00N          Rev. 01/18 Storage:Sandimmune is a registered trademark of Novartis Pharmaceuticals Corporation. ATGAM is a registered trademark of Pharmacia and Upjohn Company. Neoral is a registered trademark of Novartis Pharmaceuticals Corporation. Orthoclone OKT is a registered trademark of Ortho Biotech Inc. Maalox is a registered trademark of Novartis Consumer Health, Inc. NOVAPLUS is a registered trademark of Vizient, Inc. NMM00N          Rev. 01/18 Storage:Sandimmune is a registered trademark of Novartis Pharmaceuticals Corporation. ATGAM is a registered trademark of Pharmacia and Upjohn Company. Neoral is a registered trademark of Novartis Pharmaceuticals Corporation. Orthoclone OKT is a registered trademark of Ortho Biotech Inc. Maalox is a registered trademark of Novartis Consumer Health, Inc. NOVAPLUS is a registered trademark of Vizient, Inc. NMM00N          Rev. 01/18 Storage:Sandimmune is a registered trademark of Novartis Pharmaceuticals Corporation. ATGAM is a registered trademark of Pharmacia and Upjohn Company. Neoral is a registered trademark of Novartis Pharmaceuticals Corporation. Orthoclone OKT is a registered trademark of Ortho Biotech Inc. Maalox is a registered trademark of Novartis Consumer Health, Inc. NOVAPLUS is a registered trademark of Vizient, Inc. NMM00N          Rev. 01/18 Storage:Sandimmune is a registered trademark of Novartis Pharmaceuticals Corporation. ATGAM is a registered trademark of Pharmacia and Upjohn Company. Neoral is a registered trademark of Novartis Pharmaceuticals Corporation. Orthoclone OKT is a registered trademark of Ortho Biotech Inc. Maalox is a registered trademark of Novartis Consumer Health, Inc. NOVAPLUS is a registered trademark of Vizient, Inc. NMM00N          Rev. 01/18 Storage:Sandimmune is a registered trademark of Novartis Pharmaceuticals Corporation. ATGAM is a registered trademark of Pharmacia and Upjohn Company. Neoral is a registered trademark of Novartis Pharmaceuticals Corporation. Orthoclone OKT is a registered trademark of Ortho Biotech Inc. Maalox is a registered trademark of Novartis Consumer Health, Inc. NOVAPLUS is a registered trademark of Vizient, Inc. NMM00N          Rev. 01/18 100 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.,a subsidiary of Lannett Company, Inc.Seymour, IN 47274Made in the U.S.A.For: Recordati Rare Diseases Inc., Lebanon, NJ 08833, U.S.A.RECORDATI RARE DISEASES GROUPCHEMET 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: March 2018CIA72289F100 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.,a subsidiary of Lannett Company, Inc.Seymour, IN 47274Made in the U.S.A.For: Recordati Rare Diseases Inc., Lebanon, NJ 08833, U.S.A.RECORDATI RARE DISEASES GROUPCHEMET 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: March 2018CIA72289F100 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.,a subsidiary of Lannett Company, Inc.Seymour, IN 47274Made in the U.S.A.For: Recordati Rare Diseases Inc., Lebanon, NJ 08833, U.S.A.RECORDATI RARE DISEASES GROUPCHEMET 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: March 2018CIA72289F100 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.,a subsidiary of Lannett Company, Inc.Seymour, IN 47274Made in the U.S.A.For: Recordati Rare Diseases Inc., Lebanon, NJ 08833, U.S.A.RECORDATI RARE DISEASES GROUPCHEMET 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: March 2018CIA72289F100 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.,a subsidiary of Lannett Company, Inc.Seymour, IN 47274Made in the U.S.A.For: Recordati Rare Diseases Inc., Lebanon, NJ 08833, U.S.A.RECORDATI RARE DISEASES GROUPCHEMET 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: March 2018CIA72289F100 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.,a subsidiary of Lannett Company, Inc.Seymour, IN 47274Made in the U.S.A.For: Recordati Rare Diseases Inc., Lebanon, NJ 08833, U.S.A.RECORDATI RARE DISEASES GROUPCHEMET 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: March 2018CIA72289F100 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.,a subsidiary of Lannett Company, Inc.Seymour, IN 47274Made in the U.S.A.For: Recordati Rare Diseases Inc., Lebanon, NJ 08833, U.S.A.RECORDATI RARE DISEASES GROUPCHEMET 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: March 2018CIA72289F100 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.,a subsidiary of Lannett Company, Inc.Seymour, IN 47274Made in the U.S.A.For: Recordati Rare Diseases Inc., Lebanon, NJ 08833, U.S.A.RECORDATI RARE DISEASES GROUPCHEMET 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: March 2018CIA72289F100 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.,a subsidiary of Lannett Company, Inc.Seymour, IN 47274Made in the U.S.A.For: Recordati Rare Diseases Inc., Lebanon, NJ 08833, U.S.A.RECORDATI RARE DISEASES GROUPCHEMET 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: March 2018CIA72289F100 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.,a subsidiary of Lannett Company, Inc.Seymour, IN 47274Made in the U.S.A.For: Recordati Rare Diseases Inc., Lebanon, NJ 08833, U.S.A.RECORDATI RARE DISEASES GROUPCHEMET 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: March 2018CIA72289F100 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.,a subsidiary of Lannett Company, Inc.Seymour, IN 47274Made in the U.S.A.For: Recordati Rare Diseases Inc., Lebanon, NJ 08833, U.S.A.RECORDATI RARE DISEASES GROUPCHEMET 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: March 2018CIA72289F100 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.,a subsidiary of Lannett Company, Inc.Seymour, IN 47274Made in the U.S.A.For: Recordati Rare Diseases Inc., Lebanon, NJ 08833, U.S.A.RECORDATI RARE DISEASES GROUPCHEMET 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: March 2018CIA72289F100 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.,a subsidiary of Lannett Company, Inc.Seymour, IN 47274Made in the U.S.A.For: Recordati Rare Diseases Inc., Lebanon, NJ 08833, U.S.A.RECORDATI RARE DISEASES GROUPCHEMET 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: March 2018CIA72289F


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Preclinical Toxicology:

Non-Clinical Toxicology
CHEMET should not be administered to patients with a history of allergy to the drug.

Keep out of reach of pediatric patients. CHEMET is not a substitute for effective abatement of lead exposure.

Mild to moderate neutropenia has been observed in some patients receiving succimer. While a causal relationship to succimer has not been definitely established, neutropenia has been reported with other drugs in the same chemical class. A complete blood count with and should be obtained prior to and weekly during treatment with succimer. Therapy should either be withheld or discontinued if the absolute neutrophil count (ANC) is below 1200/mcL and the patient followed closely to document recovery of the ANC to above 1500/mcL or to the patient’s baseline neutrophil count. There is limited experience with reexposure in patients who have developed neutropenia. Therefore, such patients should be rechallenged only if the benefit of succimer therapy clearly outweighs the potential risk of another episode of neutropenia and then only with careful patient monitoring.

Patients treated with succimer should be instructed to promptly report any signs of infection. If infection is suspected, the above laboratory tests should be conducted immediately.

Drug Interaction:

The extent of clinical experience with CHEMET is limited. Therefore, patients should be carefully observed during treatment.

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 ). 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. Several allergic reactions including urticaria and angioedema have been reported on repeated administration of the drug (see ). Mild to moderate neutropenia has been observed in some patients receiving succimer (see ). Table I presents adverse events reported with the administration of succimer for the treatment of lead and other heavy metal intoxication.

To report SUSPECTED ADVERSE REACTIONS, contact Recordati Rare Diseases Inc. at 1-888-575-8344 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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