Cystagon (cysteamine bitartrate)

 CYSTAGON® (cystamine bitartrate) Capsules for oral administration contain cysteine ​​bitartrate, a cysteine ​​reduction agent that reduces the cysteine ​​content of cells in patients with cystinosis, an inherited defect of lysosomal transport. CYSTAGON® (cysteamine bitartrate) is the bitartrate salt of cysteamine, an aminothiol, beta-mercaptoethylamine. Cysteamine bitartrate is a highly water-soluble white powder with a molecular weight of 227 and the molecular formula C2H7NS • C4H6O6. It has the following chemical structure




Each CYSTAGON® (cysteamine bitartrate) Capsule contains 50 mg or 150 mg of cysteamine free base as cysteamine bitartrate. CYSTAGON® (cysteamine bitartrate) Capsules contain the accompanying dormant fixings: colloidal silicon dioxide, croscarmellose sodium, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, gelatin, magnesium stearate, microcrystalline cellulose, drug coat, pregelatinized starch, silicon dioxide, sodium lauryl sulfate, engineered dark iron oxide and titanium dioxide.


DOSAGE AND ADMINISTRATION


For the administration of nephropathic cystinosis, cysteamine treatment ought to be started immediately once the finding is affirmed (i.e., expanded white cell cystine).


New patients ought to be begun on ¼ to 1/6 of the upkeep portion of CYSTAGON® (cysteamine bitartrate) . The portion ought to then be raised steadily more than four to about a month and a half to stay away from narrow mindedness.


The suggested CYSTAGON® (cysteamine bitartrate) support portion for kids up to mature 12 years is 1.30 grams/m2/day of the free base, given in four separated dosages. Unblemished CYSTAGON® (cysteamine bitartrate) cases ought not be managed to youngsters under the time of around six years because of the gamble of yearning. CYSTAGON® (cysteamine bitartrate) containers might be controlled to kids under the time of roughly six years by sprinkling the case contents over food. Patients over the age of 12 110 pounds weight ought to get 2.0 grams/day, separated multiple times everyday.


On the off chance that a portion is missed, it ought to be taken quickly. Assuming that it is in the span of two hours of the following portion, avoid the missed portion and return to the ordinary dosing plan. Try not to twofold portion.


At the point when CYSTAGON® (cysteamine bitartrate) is very much endured, the objective of treatment is to keep leukocyte cystine levels under 1 nmol/½ cystine/mg protein five to six hours following organization of CYSTAGON® (cysteamine bitartrate) . Patients with less fortunate decency actually get critical advantage assuming white cell cystine levels are under 2 nmol/½ cystine/mg protein. The CYSTAGON® (cysteamine bitartrate) portion can be expanded to a limit of 1.95 grams/m2/day to accomplish this level. The portion of 1.95 grams/m2/day has been related with an expanded pace of withdrawal from treatment because of prejudice and an expanded occurrence of unfriendly occasions.


Cystinotic patients taking cysteamine hydrochloride or phosphocysteamine arrangements might be moved to equimolar dosages of CYSTAGON® (cysteamine bitartrate) containers.


The suggested upkeep portion of 1.30 grams/m2/day can be approximated by regulating CYSTAGON® (cysteamine bitartrate) as indicated by the accompanying table, which thinks about surface region as well as weight.

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