PENICILLAMINE capsule

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Par Pharmaceutical, Inc.

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. W il son’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.

Резиме производа:

Penicillamine Capsules USP, 250 mg are pale yellow colored capsules containing a white or nearly white powder and are coded “PAR” on cap and “146” on body. They are supplied as follows: NDC 49884-146-01      in bottle of 100. Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Dist. by: Par Pharmaceutical Chestnut Ridge, NY 10977 U.S.A. Mfg. by: Par Formulations Private Limited, 9/215, Pudupakkam, Kelambakkam-603 103. Made in India Mfg. Lic. No.: TN00002121 OS146-01-74-02 Revised: 11/2018

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

PENICILLAMINE- PENICILLAMINE CAPSULE
PAR PHARMACEUTICAL, INC.
----------
PENICILLAMINE CAPSULES, USP
RX ONLY
BOXED WARNING
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
in alcohol, and insoluble in ether,
acetone, benzene, and carbon tetrachloride. 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 and
magnesium stearate. In addition, the
empty hard gelatin capsule shells also contain D & C yellow 10,
gelatin and titanium dioxide. The
capsules are printed with tek ink containing black iron oxide,
potassium hydroxide, titanium dioxide and
shellac.
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11
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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
excreti