PENICILLAMINE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

ANI Pharmaceuticals, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic 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 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

Product summary:

Penicillamine capsules, 250 mg, USP, are ivory-colored capsules containing a white to off-white powder, and are imprinted with AMG on the cap and 309 on the body in black ink. They are supplied as follows: NDC 43975-309-10 in bottles of 100. Storage Keep container tightly closed. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container, as defined in the USP. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Rx Only Manufactured For: Amerigen Pharmaceuticals, Inc. Lyndhurst, NJ 07071 USA OS1033/00 Rev. 02/2019

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PENICILLAMINE- PENICILLAMINE CAPSULE
ANI PHARMACEUTICALS, INC.
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PENICILLAMINE CAPSULES, USP
Physicians planning to use penicillamine should thoroughly
familiarized 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: magnesium
stearate and povidone.
The capsule shells contain D&C Yellow No. 10, titanium dioxide,
gelatin, shellac,
propylene glycol, potassium hydroxide and black iron oxide.
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;
5
11
2
however, the actual amount excreted is about one percent of this.
Penicillami