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Procysbi

"The U.S. Food and Drug Administration today approved Procysbi (cysteamine bitartrate) for the management of nephropathic cystinosis in children and adults. Procysbi was granted orphan product designation because it is intended to treat a rare dis"...

Procysbi

OVERDOSE

A single oral dose of cysteamine at 660 mg/kg was lethal to rats. Symptoms of acute toxicity were reduction of motor activity and generalized hemorrhage in gastrointestinal tract and kidneys.

Two cases of human over-dosing with immediate-release cysteamine bitartrate have been reported. In one case, the patient immediately vomited the drug and did not develop any symptoms. The second incident involved an accidental ingestion of a 200 to 250 mg/kg dose by a healthy 13 month old child. Vomiting and dehydration were experienced. The child was hospitalized and fluids were administered. A full recovery was made.

Should overdosing occur, the respiratory and cardiovascular systems should be supported appropriately. No specific antidote is known. Hemodialysis may be considered since cysteamine is poorly bound to plasma proteins.

CONTRAINDICATIONS

The use of PROCYSBI (cysteamine bitartrate) delayed-release capsules is contraindicated in patients who are hypersensitive to penicillamine.

Last reviewed on RxList: 5/13/2013
This monograph has been modified to include the generic and brand name in many instances.

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