CUPRIMINE Capsule (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Bausch Health US, LLC

Λέξεις κλειδιά

25010-705

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BOXED WARNING SECTION

Physicians planning to use penicillamine should thoroughly familiarize themselves with its toxicity, special dosage considerations, and therapeutic benefits. Penicillamine should never be used casually. ...

1. Description

Penicillamine, USP is a chelating agent used in the treatment of Wilsons disease. It is also used to reduce cystine excretion in cystinuria and to treat patients with severe, active rheumatoid arthritis ...

2. Clinical Pharmacology

Penicillamine is a chelating agent recommended for the removal of excess copper in patients with Wilsons disease. From in vitro studies which indicate that one atom of copper combines with two molecules ...

3. Indications and Usage

CUPRIMINE is indicated in the treatment of Wilsons disease, cystinuria, and in patients with severe, active rheumatoid arthritis who have failed to respond to an adequate trial of conventional therapy. ...

4. Contraindications

Except for the treatment of Wilsons disease or certain patients with cystinuria, use of penicillamine during pregnancy is contraindicated (see WARNINGS). Although breast milk studies have not been reported ...

5. Warnings

The use of penicillamine has been associated with fatalities due to certain diseases such as aplastic anemia, agranulocytosis, thrombocytopenia, Goodpastures syndrome, and myasthenia gravis. Because of ...

6. Precautions

Some patients may experience drug fever, a marked febrile response to penicillamine, usually in the second to third week following initiation of therapy. Drug fever may sometimes be accompanied by a macular ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal carcinogenicity studies have not been done with penicillamine. There is a report that five of ten autoimmune disease-prone New Zealand black (NZB) hybrid mice developed lymphocytic leukemia ...

6.7. Pregnancy

See WARNINGS, Pregnancy.

6.9. Nursing Mothers

See CONTRAINDICATIONS.

6.10. Pediatric Use

The efficacy of CUPRIMINE in juvenile rheumatoid arthritis has not been established.

6.11. Geriatric Use

Clinical studies of CUPRIMINE are limited in subjects aged 65 and over; they did not include sufficient numbers of elderly subjects aged 65 and over to adequately determine whether they respond differently ...

7. Adverse Reactions

Penicillamine is a drug with a high incidence of untoward reactions, some of which are potentially fatal. Therefore, it is mandatory that patients receiving penicillamine therapy remain under close medical ...

10. Dosage and Administration

In all patients receiving penicillamine, it is important that CUPRIMINE be given on an empty stomach, at least one hour before meals or two hours after meals, and at least one hour apart from any other ...

11. How Supplied

CUPRIMINE Capsules, USP 250 mg, are pale yellow to ivory opaque hard gelatin capsules imprinted with ATON 705 on the cap and CUPRIMINE on the body. They are supplied as follows: NDC 25010-705-15 in bottles ...

12. Storage and Handling

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tightly closed container. Keep container tightly closed.

14. References

** For quantitative test for serum ceruloplasmin see: Morell, A.G.; Windsor, J.; Sternlieb, I.;Scheinberg, I.H.: Measurement of the concentration of ceruloplasmin in serum by determination of its oxidase ...