PENICILLAMINE capsule, gelatin coated

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

Penicillamine (UNII: GNN1DV99GX) (Penicillamine - UNII:GNN1DV99GX)

Beschikbaar vanaf:

Dr. Reddy's Laboratories Inc.

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Penicillamine capsules are indicated in the treatment of Wilson's disease, cystinuria, and in patients with severe, active rheumatoid arthritis who have failed to respond to an adequate trial of conventional therapy. Available evidence suggests that penicillamine capsules are not of value in ankylosing spondylitis. Wilson’s Disease — Wilson’s disease (hepatolenticular degeneration) occurs in individuals who have inherited an autosomal recessive defect that leads to an accumulation of copper far in excess of metabolic requirements. The excess copper is deposited in several organs and tissues, and eventually produces pathological effects primarily in the liver, where damage progresses to postnecrotic cirrhosis, and in the brain, where degeneration is widespread. Copper is also deposited as characteristic, asymptomatic, golden-brown Kayser-Fleischer rings in the corneas of all patients with cerebral symptomatology and some patients who are either asymptomatic or manifest only hepatic symptomatology. Two types of

Product samenvatting:

Penicillamine Capsules USP, 250 mg are white to off white colored granular powder filled in size-1 hard gelatin capsules with opaque white colored cap imprinted with 'RDY' with black ink and opaque white color body imprinted with '634' with black ink.   They are supplied as follows:   Bottles of 100 NDC 43598-634-01   Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].  Keep container tightly closed. ** For quantitative test for serum ceruloplasmin see: Morell, A.G.; Windsor, J.; Sternlieb, I.; Scheinberg, I.H.: Measurement of the concentration of ceruloplasmin in serum by determination of its oxidase activity, in “Laboratory Diagnosis of Liver Disease”, F.W. Sunderman; F.W. Sunderman, Jr. (eds.), St. Louis, Warren H. Green, Inc., 1968, pp. 193-195. *** Scheinberg, I.H.; Sternlieb, I.: N. Engl. J. Med. 293: 1300-1302, Dec. 18, 1975. † Lotz, M.; Potts, J.T. and Bartter, F.C.: Brit. Med. J. 2: 521, Aug. 28, 1965 (in Medical Memoranda). Rx only Distributor: Dr. Reddy’s Laboratories Inc., Princeton, NJ 08540   Made in India Issued: 0818

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

PENICILLAMINE - PENICILLAMINE CAPSULE, GELATIN COATED
DR. REDDY'S LABORATORIES INC.
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Physicians planning to use penicillamine should thoroughly familiarize
themselves with its
toxicity, special dosage considerations, and therapeutic benefits.
Penicillamine should never be
used casually. Each patient should remain constantly under the close
supervision of the physician.
Patients should be warned to report promptly any symptoms suggesting
toxicity.
DESCRIPTION
Penicillamine USP is a chelating agent used in the treatment of
Wilson's disease. It is also used to
reduce cystine excretion in cystinuria and to treat patients with
severe, active rheumatoid arthritis
unresponsive to conventional therapy (see INDICATIONS). It is
3-mercapto-D-valine. It is a white or
practically white, crystalline powder, freely soluble in water,
slightly soluble in alcohol, and insoluble
in chloroform and ether. Although its configuration is D, it is
levorotatory as usually measured:
[α] 25° = -62.5° ± 2° (c = 1, 1N NaOH),
D
calculated on a dried basis.
The molecular formula is C H NO S, giving it a molecular weight of
149.21. The structural formula
is:
It reacts readily with formaldehyde or acetone to form a
thiazolidine-carboxylic acid.
Penicillamine Capsules USP, for oral administration contains 250 mg of
penicillamine. Each capsule
contains the following inactive ingredients: Black iron oxide,
gelatin, microcrystalline cellulose,
magnesium stearate, potassium hydroxide, propylene glycol, shellac,
strong ammonia solution and
titanium dioxide.
CLINICAL PHARMACOLOGY
Penicillamine is a chelating agent recommended for the removal of
excess copper in patients with
Wilson's disease. From _in vitro_ studies which indicate that one atom
of copper combines with two
molecules of penicillamine, it would appear that one gram of
penicillamine should be followed by the
excretion of about 200 milligrams of copper; however, the actual
amount excreted is about one percent
of this.
Penicillamine also reduces excess cystine excretion in cyst