PENICILLAMINE capsule

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Granules Pharmaceuticals Inc.

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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 — 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 o

Produkt oversigt:

Penicillamine capsules USP, 250 mg, are hard gelatin capsules, light cream opaque cap printed with a "GPI 250 mg" and light cream opaque body printed with a "907" contains white to off-white powder. They are supplied as follows: Bottles of 100 NDC 70010-907-01 Storage Store at 20 o to 25 o C (68 o to 77 o F). [see USP Controlled Room Temperature]. Dispense in tight, light-resistant container. Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 Rev: 12/2020

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

PENICILLAMINE- PENICILLAMINE CAPSULE
GRANULES PHARMACEUTICALS 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:
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: Anhydrous
lactose, FD & C Yellow #
6, gelatin, magnesium stearate, and titanium dioxide. In addition,
capsule printing ink
contains ammonium hydroxide, black iron oxide, propylene glycol, and
shellac glaze.
5
11
2
INDICATIONS
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_—
Wilson’s disease (hepatolenticular degeneration) occurs in
individuals who hav