PENICILLAMINE- penicillamine capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Actavis Pharma, 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 (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 of patients require t

Product summary:

Penicillamine capsules USP, 250 mg are white to off white, hard gelatin capsules and imprinted with “A98 ” on the cap with black ink. They are supplied as follows: Bottles of 100   (NDC 0591-4171-01) Storage 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]. Keep container tightly closed. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Manufactured In India By: Watson Pharma Private Ltd. Verna, Salcette Goa 403 722 INDIA Manufactured For: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 Rev. A 5/2018

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PENICILLAMINE- PENICILLAMINE CAPSULE
ACTAVIS PHARMA, INC.
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PENICILLAMINE CAPSULES USP
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, USP 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 structural formula is:
C H NO S M.W. 149.21
It reacts readily with formaldehyde or acetone to form a
thiazolidine-carboxylic acid.
Penicillamine capsules USP for oral administration contain 250 mg of
penicillamine, USP. Each capsule
contains the following inactive ingredients: magnesium stearate and
mannitol. Each capsule shell
contains: gelatin, sodium lauryl sulfate and titanium dioxide. The
imprinting ink contains: black iron
oxide, potassium hydroxide, propylene glycol and shellac.
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 e