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Cystagon Generic Name & Formulations
Legal Class
Rx
General Description
Cysteamine bitartrate 50mg, 150mg; caps.
Pharmacological Class
Cystine-depleting agent.
How Supplied
Caps—500
Manufacturer
Cystagon Indications
Indications
Management of nephropathic cystinosis.
Cystagon Dosage and Administration
Adult
New patients: start on ¼ to ⅙ of the maintenance dose; increase gradually over 4–6 weeks. Maintenance: >12yrs and >110lbs: 2g/day divided 4 times daily. Max 1.95g/m2/day. Goal of therapy to keep leukocyte cystine levels below 1nmol/½ cystine/mg protein 5–6 hours after administration. Patients taking cysteamine HCl or phosphocysteamine solutions may be transferred to equimolar doses of cysteamine bitartrate.
Children
1.3g/m2/day in 4 divided doses. Max 1.95g/m2/day. If <6yrs old: do not give intact caps; may open and sprinkle capsule contents over food.
Cystagon Contraindications
Contraindications
Penicillamine hypersensitivity.
Cystagon Boxed Warnings
Not Applicable
Cystagon Warnings/Precautions
Warnings/Precautions
Withhold dose if skin rash develops, may be restarted at a lower dose then titrated slowly; if severe, do not readminister. Monitor blood counts, LFTs, vision, skin, bones. Measure leukocyte cystine levels every 3 months, more frequently when transferring from cysteamine HCl or phosphocysteamine solutions. Pregnancy (Cat.C). Nursing mothers: not recommended.
Cystagon Pharmacokinetics
See Literature
Cystagon Interactions
Not Applicable
Cystagon Adverse Reactions
Adverse Reactions
Vomiting, anorexia, fever, diarrhea, lethargy, rash; skin or bone lesions (reduce dose if appears), leukopenia, abnormal LFTs, CNS effects, GI ulceration/bleeding, pseudotumor cerebri, papilledema; rare: interstitial nephritis with early renal failure.
Cystagon Clinical Trials
See Literature
Cystagon Note
Not Applicable
Cystagon Patient Counseling
See Literature
