CYSTAGON- cysteamine bitartrate capsule

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

CYSTEAMINE BITARTRATE (UNII: QO84GZ3TST) (CYSTEAMINE - UNII:5UX2SD1KE2)

Disponibil de la:

Mylan Pharmaceuticals Inc.

INN (nume internaţional):

CYSTEAMINE BITARTRATE

Compoziție:

CYSTEAMINE 50 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

CYSTAGON® is indicated for the management of nephropathic cystinosis in children and adults. CYSTAGON® is contraindicated in patients who have developed hypersensitivity to it or to cysteamine or penicillamine. CYSTAGON® has not been associated with abuse potential, psychological or physical dependence in humans.

Rezumat produs:

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 with CYSTA 50 on the body and MYLAN on the cap. They are available as follows: NDC 0378-9040-05 bottles of 500 capsules CYSTAGON® Capsules, 150 mg are white, opaque capsules printed with CYSTAGON 150 on the body and MYLAN on the cap. They are available as follows: NDC 0378-9045-05 bottles of 500 capsules 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 closure. PHARMACIST: Detach Patient Information Leaflet at each perforation and give leaflet to patient. The following information is available for patients and/or guardians in the patient leaflet.

Statutul autorizaţiei:

New Drug Application

Caracteristicilor produsului

CYSTAGON- CYSTEAMINE BITARTRATE CAPSULE
MYLAN PHARMACEUTICALS INC.
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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 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 C H NS • C H O . 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, sodium lauryl sulfate and
titanium dioxide.
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 formation of crystals damage various organs, especially
the kidney, leading
to renal tubular Fanconi Syndrome and progressive glomerular failure,
with end stage
renal failure by the end of the first decade of life. In four studies
of cystinosis patients
before cysteamine was available, renal death (need for transplant or
dialysis) occurred at
median age of less than 10 years. Patients with cystinosis also
experience growth
failure, rickets, and photophobia due to cystine deposits in the
cornea. With time most
organs are damaged, including the retina, muscles and central nervous
system.
Cysteamine is an aminothiol that participates within lysosomes in a
thiol-disulfide
interchange reaction converting cystine into cysteine and
cysteine-cysteamine mixed
disulfide, both of which can exit the lysosome in patients