DEPEN- penicillamine tablet

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Meda Pharmaceuticals Inc.

INN (इंटरनेशनल नाम):

PENICILLAMINE

रचना:

PENICILLAMINE 250 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

DEPEN is 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 DEPEN is 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 eye, where characteristic corneal

उत्पाद समीक्षा:

Depen® (penicillamine tablets, USP) Titratable Tablets: 250 mg functionally scored, oval, white tablets coded with 37-4401; available in bottles of 100 (NDC 0037-4401-01). Storage: Store at controlled room temperature 20°–25°C (68°–77°F). Protect from moisture. Dispense in a tight container. To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-526-3840 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured for: Meda Pharmaceuticals Inc. 1000 Mylan Blvd Canonsburg, PA 15317 ©2023 Viatris Inc. DEPEN is a registered trademark of Meda Pharmaceuticals Inc., a Viatris company. 500493-06               Rev. 7/2023 IN-4401-04

प्राधिकरण का दर्जा:

New Drug Application

उत्पाद विशेषताएं

DEPEN- PENICILLAMINE TABLET
MEDA PHARMACEUTICALS INC.
----------
DEPEN®
(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,
and insoluble in 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.
Depen (penicillamine tablets, USP) Titratable Tablets for oral
administration contain 250
mg of penicillamine.
Other ingredients (inactive): edetate disodium, hypromellose, lactose,
magnesium
stearate, magnesium trisilicate, polyethylene glycol, povidone,
starch, and stearic acid.
5
11
2
®
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 of
penicillamine-cysteine disulfide, a substance that is much more
soluble than cystine and
is excreted readily.
Penicillamin