Cystagon
Loading...Cystagon Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
If a skin rash develops, CYSTAGON® should be withheld until the rash clears. CYSTAGON® may be restarted at a lower dose under close supervision, then slowly titrated to the therapeutic dose. If a severe skin rash develops such as erythema multiforme bullosa or toxic epidermal necrolysis, CYSTAGON® should not be readministered.
CNS symptoms such as seizures, lethargy, somnolence, depression, and encephalopathy have been associated with cysteamine. If CNS symptoms develop, the patient should be carefully evaluated and the dose adjusted as necessary. Neurological complications have been described in some cystinotic patients not on cysteamine treatment. This may be a manifestation of the primary disorder. Patients should not engage in hazardous activities until the effects of CYSTAGON® on mental performance are known.
Gastrointestinal ulceration and bleeding have been reported in patients receiving cysteamine bitartrate. Physicians should remain alert for signs of ulceration and bleeding and should inform patients and/or guardians about the signs and symptoms of serious G.I. toxicity and what steps to take if they occur.
Post marketing reports include one report of interstitial nephritis with early renal failure. A causal relationship between this event and cysteamine bitartrate therapy has not been established.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
CYSTAGON® is indicated for the management of nephropathic cystinosis in children and adults.
History
There is currently no drug history available for this drug.
Other Information
CYSTAGON® (cysteamine bitartrate) Capsules for oral administration, contain cysteamine bitartrate, a cystine depleting agent which lowers the cystine content of cells in patients with cystinosis, an inherited defect of lysosomal transport. CYSTAGON® 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® Capsule contains 50 mg or 150 mg of cysteamine free base as cysteamine bitartrate. CYSTAGON® Capsules contain the following inactive ingredients: ammonium hydroxide, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, gelatin, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, pregelatinized starch, propylene glycol, silicon dioxide, sodium lauryl sulfate and titanium dioxide.
Sources
Cystagon Manufacturers
-
Mylan Pharmaceuticals Inc.
![Cystagon (Cysteamine Bitartrate) Capsule [Mylan Pharmaceuticals Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Cystagon | Mylan Pharmaceuticals Inc.
For the management of nephropathic cystinosis, cysteamine therapy should be initiated promptly once the diagnosis is confirmed (i.e., increased white cell cystine).
New patients should be started on ¼ to 1/6 of the maintenance dose of CYSTAGON®. The dose should then be raised gradually over four to six weeks to avoid intolerance.
The recommended CYSTAGON® maintenance dose for children up to age 12 years is 1.30 grams/m2/day of the free base, given in four divided doses. Intact CYSTAGON® capsules should not be administered to children under the age of approximately six years due to the risk of aspiration. CYSTAGON® capsules may be administered to children under the age of approximately six years by sprinkling the capsule contents over food. Patients over age 12 and over 110 pounds weight should receive 2.0 grams/day, divided four times daily.
If a dose is missed, it should be taken as soon as possible. If it is within two hours of the next dose, skip the missed dose and go back to the regular dosing schedule. Do not double dose.
When CYSTAGON® is well tolerated, the goal of therapy is to keep leukocyte cystine levels below 1 nmol/½ cystine/mg protein five to six hours following administration of CYSTAGON®. Patients with poorer tolerability still receive significant benefit if white cell cystine levels are below 2 nmol/½ cystine/mg protein. The CYSTAGON® dose can be increased to a maximum of 1.95 grams/m2/day to achieve this level. The dose of 1.95 grams/m2/day has been associated with an increased rate of withdrawal from treatment due to intolerance and an increased incidence of adverse events.
Cystinotic patients taking cysteamine hydrochloride or phosphocysteamine solutions may be transferred to equimolar doses of CYSTAGON® capsules.
The recommended maintenance dose of 1.30 grams/m2/day can be approximated by administering CYSTAGON® according to the following table, which takes surface area as well as weight into consideration.
Weight in
Pounds mg of Cysteamine Free Base
Every 6 Hours 0–10 100 11–20 150 21–30 200 31–40 250 41–50 300 51–70 350 71–90 400 91–110 450 > 110 500Patients over age 12 and over 110 pounds should receive 2.0 grams/day given in four divided doses as a starting maintenance dose. This dose should be reached after 4 to 6 weeks of incremental dosage increases as stated above. The dose should be raised if the leukocyte cystine level remains > 2 nmol/½ cystine/mg/protein.
Leukocyte cystine measurements, taken 5 to 6 hours after dose administration, are recommended for new patients after the maintenance dose is achieved. Patients being transferred from cysteamine hydrochloride or phosphocysteamine solutions to capsules should have their white cell cystine levels measured in 2 weeks, and thereafter every 3 months to assess optimal dosage as described above.
If CYSTAGON® is poorly tolerated initially due to gastrointestinal tract symptoms or transient skin rashes, therapy should be temporarily stopped, then re-instituted at a lower dose and gradually increased to the proper dose.
Login To Your Free Account