PENICILLAMINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lupin Pharmaceuticals, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 (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 eye, where characte

Product summary:

Penicillamine tablets, USP (Titratable Tablets) are white colored, oval shaped, film coated tablets with single score line on both sides. On one side, tablets are debossed with "LU" on left and "L17" on right side of the score line and plain on other side. Bottles of 100 Tablets NDC 70748-153-01 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container. To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States Manufactured by: Lupin Limited Nagpur 441 108 INDIA January 2020                                                                                                                           ID#: 263695

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PENICILLAMINE - PENICILLAMINE TABLET
LUPIN PHARMACEUTICALS, INC.
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PENICILLAMINE TABLETS, USP (TITRATABLE TABLETS
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,
insoluble in chloroform, ether, acetone, benzene and carbon
tetrachloride. Although its
configuration is D, it is levorotatory as usually measured:
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, corn starch, edetate
disodium,
hypromellose, magnesium stearate, polyethylene glycol and povidone.
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
5
11
2
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 of
penicillamine-cysteine disulfide, a substance that is much more
soluble than cystine and
is excreted readily.
Penicillamine interferes with the for