PENICILLAMINE capsule

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

PENICILLAMINE (UNII: GNN1DV99GX) (PENICILLAMINE - UNII:GNN1DV99GX)

Доступно од:

Navinta LLC

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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

Резиме производа:

Penicillamine Capsules USP, 250 mg are opaque ivory colored hard gelatin capsules containing white to off white powder and are imprinted with "114" and "NAV" in black ink. They are supplied as follows: NDC 68475-201-01 in bottles of 100. Storage 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. Manufactured for: Navinta LLC 1499 lower Ferry Road, Ewing, NJ 08618 Made in India Rev. 10/2021 31141021 R0 ** 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).

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

PENICILLAMINE - PENICILLAMINE CAPSULE
NAVINTA LLC
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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 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 alcohol, insoluble in chloroform and in 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 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, USP for oral administration contain 250 mg of
penicillamine. Each
capsule contains the following inactive ingredients: lactose
monohydrate, magnesium
stearate, D&C yellow no. 10, gelatin and titanium dioxide. The
imprinting ink contains
shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol,
propylene glycol, strong
ammonia solution, black iron oxide, potassium hydroxide and purified
water.
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