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Succimer Dosage

Applies to the following strength(s): 100 mg

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Usual Pediatric Dose for:

Additional dosage information:

Usual Pediatric Dose for Lead Poisoning - Severe

1 year or older:
Initial dose: 10 mg/kg or 350 mg/m2 orally every 8 hours for five days
Maintenance dose: 10 mg/kg or 350 mg/m2 orally every 12 hours for 14 days

8 kg to 15 kg:
Initial dose: 100 mg orally every 8 hours for five days
Maintenance dose: 100 mg orally every 12 hours for 14 days

16 kg to 23 kg:
Initial dose: 200 mg orally every 8 hours for five days
Maintenance dose: 200 mg orally every 12 hours for 14 days

24 kg to 34 kg:
Initial dose: 300 mg orally every 8 hours for five days
Maintenance dose: 300 mg orally every 12 hours for 14 days

35 kg to 44 kg:
Initial dose: 400 mg orally every 8 hours for five days
Maintenance dose: 400 mg orally every 12 hours for 14 days

45 kg or greater:
Initial dose: 500 mg orally every 8 hours for five days
Maintenance dose: 500 mg orally every 12 hours for 14 days

Repeated courses may be administered if indicated by weekly blood lead concentration levels, with a minimum of two weeks between courses unless blood lead levels indicate the need for more rapid treatment.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

Mild to moderate neutropenia has been reported in some patients receiving succimer. While a causal relationship to succimer has not been absolutely established, neutropenia has been reported with other drugs in the same chemical class. A complete blood count with white blood cell differential and direct platelet counts should be obtained prior to and weekly during succimer therapy. Succimer 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. In patients who develop neutropenia, there is limited experience with reexposure. 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 should be instructed to promptly report any signs of infection. If infection is suspected, the above laboratory tests should be conducted promptly.

Since the extent of clinical experience with succimer is limited, patients should be carefully observed during treatment.

Elevated blood lead levels and associated symptoms may rapidly return following discontinuation of 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 with at least once- weekly laboratory measurements until stable. Nonetheless, 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.

Patients should be adequately hydrated during treatment with succimer.

Caution should be exercised in patients with compromised renal function.

Mild, transient elevations of serum transaminases have been observed in some patients during treatment with succimer therapy. Serum transaminases should be monitored prior to and at least weekly during therapy. Patients with a history of liver disease should be monitored closely.

Clinical experience with repeated courses of succimer therapy is limited. The safety of uninterrupted dosing lasting longer than three weeks has not been established and is not recommended.

The possibility of allergic or other mucocutaneous reactions to succimer should be considered, particularly upon readministration (as well as during initial courses). Patients requiring repeated courses of succimer should be monitored during each course.

Dialysis

Data not available

Other Comments

Patients should maintain adequate hydration during succimer therapy.

The capsule content can be given in a small amount of food if young children are unable to swallow the capsules.

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