Држава: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
PENICILLAMINE (UNII: GNN1DV99GX) (PENICILLAMINE - UNII:GNN1DV99GX)
Proficient Rx LP
ORAL
PRESCRIPTION DRUG
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
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 71205-916-00 Storage Store at 20o to 25o C (68o to 77o F). [see USP Controlled Room Temperature]. Dispense in tight, light-resistant container. Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151 Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320 Rev: 12/2020
Abbreviated New Drug Application
PENICILLAMINE- PENICILLAMINE CAPSULE PROFICIENT RX LP ---------- 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 have inherited a Прочитајте комплетан документ