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PROCYSBI
Overview
What is PROCYSBI?
PROCYSBI, for oral administration, is a cystine-depleting agent that lowers the cystine content of cells in patients with nephropathic cystinosis, an inherited defect of lysosomal transport.
PROCYSBI contains the bitartrate salt of cysteamine. The chemical name for cysteamine bitartrate is ethanethiol, 2-amino, (2,3)-2,3-dihydroxybutanedioate (1:1) (salt). Cysteamine bitartrate is a highly water soluble white powder with a molecular weight of 227.24 and the molecular formula CHNS ∙ CHO. It has the following chemical structure:
Each PROCYSBI delayed-release capsule contains either 25 mg cysteamine (equivalent to 74 mg cysteamine bitartrate) or 75 mg cysteamine (equivalent to 221 mg cysteamine bitartrate). PROCYSBI delayed release granules contain the following inactive ingredients: Eudragit L 30 D-55, hypromellose, microcrystalline cellulose, purified water, sodium lauryl sulfate, talc, and triethyl citrate. Capsule shell ingredients are gelatin, ink (blue and white), and titanium dioxide.
What does PROCYSBI look like?
What are the available doses of PROCYSBI?
Delayed-release capsules: 25 mg and 75 mg cysteamine ()
What should I talk to my health care provider before I take PROCYSBI?
Lactation:
8.2
How should I use PROCYSBI?
PROCYSBI is indicated for the treatment of nephropathic cystinosis in adults and pediatric patients 1 year of age and older.
See full prescribing information for weight-based dosing tables for the starting and maintenance dosage. ()
For initial intolerance, temporarily discontinue and then re-start PROCYSBI at a lower dosage and gradually increase to the maintenance dosage. ()
What interacts with PROCYSBI?
Sorry No Records found
What are the warnings of PROCYSBI?
Sorry No Records found
What are the precautions of PROCYSBI?
Sorry No Records found
What are the side effects of PROCYSBI?
Sorry No records found
What should I look out for while using PROCYSBI?
The use of PROCYSBI is contraindicated in patients with a serious hypersensitivity reaction, including anaphylaxis, to penicillamine or cysteamine.
What might happen if I take too much PROCYSBI?
One case of overdosing with PROCYSBI has been reported. A 16-year old male patient suffered nausea and vomiting after he mistakenly took a second dose of PROCYSBI 30 minutes after his usual dose.
Two cases of overdosing with immediate-release cysteamine bitartrate have been reported in two patients. In the first case, the patient immediately vomited after ingesting an unknown dose and did not develop any symptoms. The second case 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. The patient fully recovered from the overdosing.
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.
How should I store and handle PROCYSBI?
Clindamycin Phosphate Topical Solution USP, 1% containing clindamycin phosphate equivalent to 10 mg clindamycin per milliliter is available in the following sizes:
