PENICILLAMINE tablet, film coated

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 tablets 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 tablets are not of value in ankylosing spondylitis. Wilson’s Disease  - Wilson’s disease (hepatolenticular degeneration) results from the interaction of an inherited defect and an abnormality in copper metabolism. The metabolic defect, which is the consequence of the autosomal inheritance of one abnormal gene from each parent, manifests itself in a greater positive copper balance than normal. As a result, copper is deposited in several organs and appears eventually to produce pathologic effects most prominently seen in the brain, where degeneration is widespread; in the liver, where fatty infiltration, inflammation, and hepatocellular damage progress to postnecrotic cirrhosis; in the kidney, where tubular and glomerular dysfunction results; and in the

Резиме производа:

Penicillamine Tablets USP, 250 mg (Titratable Tablets) - White to off-white, oval, biconvex coated tablets coded with “2000” on one side and scored (functional scoring) on both sides; available in bottles of 100 (NDC 0254-2000-01). Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container. To report SUSPECTED ADVERSE REACTIONS, contact Par Pharmaceutical at 1-800-828-9393 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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 OS2000-01-74-01 Issued: 07/2018

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

PENICILLAMINE- PENICILLAMINE TABLET, FILM COATED
PAR PHARMACEUTICAL, INC.
----------
PENICILLAMINE TABLETS, USP
(TITRATABLE TABLETS) RX ONLY
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 3-mercapto-D-valine, a disease modifying
antirheumatic drug. 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° ± 2.0° (C = 1, 1 _N_NaOH)
D
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 tablets, USP (Titratable Tablets) for oral
administration contain 250 mg of penicillamine.
Other ingredients (inactive): anhydrous lactose, copovidone, corn
starch (maize), edetate disodium
5
11
2
dihydrate, hypromellose, lactose monohydrate, magnesium stearate,
magnesium trisilicate, polyethylene
glycol, povidone and stearic acid.
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 cystinuria.
This is done, at least in part, by
disulfide interchange between penicillamine and cystine, resulting in
formation