Country: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
Penicillamine (UNII: GNN1DV99GX) (Penicillamine - UNII:GNN1DV99GX)
Oceanside Pharmaceuticals
ORAL
PRESCRIPTION DRUG
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 (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 patients require t
Penicillamine Capsules, USP 250 mg, are pale yellow to ivory opaque hard gelatin capsules imprinted with “ATON 705” on the cap and “CUPRIMINE” on the body. They are supplied as follows: NDC 68682-020-10 in bottles of 100 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tightly closed container. 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).
New Drug Application Authorized Generic
PENICILLAMINE- PENICILLAMINE CAPSULE OCEANSIDE PHARMACEUTICALS ---------- PENICILLAMINE CAPSULES, USP 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 ether, acetone, benzene, and carbon tetrachloride. Although its configuration is D, it is levorotatory as usually measured: calculated on a dried basis. The empirical 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 for oral administration contain 250 mg of penicillamine. Each capsule contains the following inactive ingredients: D&C Yellow No. 10, gelatin, lactose monohydrate, magnesium stearate, and 5 11 2 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 1 g of penicillamine should be followed by the excretion of about 200 mg of copper; however, the actual amount excreted is about 1% of this. Penicillamine also reduces excess cystine excretion in cystinuria. This is done, at least in part, by disulfide interchange between penicillamine and cystine, result Aqra d-dokument sħiħ