PENICILLAMINE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Oceanside Pharmaceuticals

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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).

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

PENICILLAMINE- PENICILLAMINE CAPSULE
OCEANSIDE PHARMACEUTICALS
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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