CYSTAGON Capsule (2019)
Βιβλιογραφική αναφορά
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Mylan Pharmaceuticals Inc.
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1. Description
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 ...
2. Clinical Pharmacology
Mechanism of Action Cystinosis is an autosomal recessive inborn error of metabolism in which the transport of cystine out of lysosomes is abnormal; in the nephropathic form, accumulation of cystine and ...
3. Indications and Usage
CYSTAGON is indicated for the management of nephropathic cystinosis in children and adults.
4. Contraindications
CYSTAGON is contraindicated in patients who have developed hypersensitivity to it or to cysteamine or penicillamine.
5. Warnings
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 ...
6.1. General
Gastrointestinal tract symptoms including nausea, vomiting, anorexia and abdominal pain have been associated with cysteamine, sometimes severe. In addition, gastrointestinal ulceration and bleeding have ...
6.2. Information for Patients
See attached information for patients and parents and/or guardians.
6.3. Laboratory Tests
Leukocyte cystine measurements are useful to determine adequate dosage and compliance. When measured 5 to 6 hours after CYSTAGON administration, the goal should be a level <1 nmol/½ cystine/mg protein. ...
6.4. Drug Interactions
None have been described. CYSTAGON can be administered with electrolyte and mineral replacements necessary for management of the Fanconi Syndrome as well as vitamin D and thyroid hormone.
6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility
Cysteamine has not been tested for its carcinogenic potential in long-term animal studies. Cysteamine was not mutagenic in the Ames test. It produced a negative response in an <em>in-vitro</em> sister ...
6.7. Pregnancy
Teratology studies have been performed in rats at oral doses in a range of 37.5 to 150 mg/kg/day (about 0.2 to 0.7 times the recommended human maintenance dose on a body surface basis) and have revealed ...
6.9. Nursing Mothers
It is not known whether cysteamine is excreted in human milk. Because many drugs are excreted in human milk and because of the manifested potential of cysteamine for developmental toxicity in suckling ...
6.10. Pediatric Use
The safety and effectiveness of CYSTAGON for cystinotic children have been established. Cysteamine therapy should be initiated as soon as the diagnosis of nephropathic cystinosis has been confirmed.
7. Adverse Reactions
In three clinical trials, cysteamine or phosphocysteamine have been administered to 246 children with cystinosis. Causality of side effects is sometimes difficult to determine because adverse effects may ...
8. Drug Abuse and Dependence
CYSTAGON has not been associated with abuse potential, psychological or physical dependence in humans.
9. Overdosage
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 ...
10. Dosage and Administration
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 ...
11. How Supplied
CYSTAGON (cysteamine bitartrate) Capsules are hard gelatin capsules which provide 50 mg or 150 mg of cysteamine free base as cysteamine bitartrate: CYSTAGON Capsules, 50 mg are white, opaque capsules printed ...
12. Storage and Handling
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant ...
13. Clinical Studies
There are approximately 200 pre-transplant cystinosis patients in the United States with nephropathic cystinosis and clinical studies have included almost all of them, in addition to about 40 studied in ...