Data from FDA - Curated by EPG Health - Last updated 22 December 2016
CONTRAINDICATIONS Except for the treatment of Wilson 's disease or certain patients with cystinuria, use of penicillamine during pregnancy is contraindicated (see WARNINGS).
Although breast milk studies have not been reported in animals or humans,
Patients with a history of penicillamine-related aplastic anemia or agranulocytosis should not be restarted on penicillamine (see WARNINGS and
Because of its
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 cutaneous eruption.
In the case of drug fever in patients with Wilson 's disease or cystinuria,
Then penicillamine should be reinstituted with
Systemic steroid therapy may be necessary, and is usually
In the case of drug fever in rheumatoid arthritis patients, because
The skin and mucous membranes should be observed for
Early and late rashes have occurred.
Early rash occurs during the first few months of treatment and is more common.
It is usually a generalized pruritic, erythematous, maculopapular or morbilliform rash and resembles the
Early rash usually disappears within days after stopping penicillamine and seldom recurs when the drug is restarted at a lower dosage.
Pruritus and early rash may often be controlled by the concomitant administration of antihistamines.
Less commonly, a late rash may be seen, usually after six months or more of treatment, and
It is usually on the trunk, is accompanied by
Late rash may take weeks to
The appearance of a drug eruption accompanied by fever, arthralgia,
The lupus erythematosus-like syndrome is not associated with hypocomplementemia and may be present
The development of a
The stomatitis usually recurs on rechallenge but often
These oral lesions are frequently dose-related and may preclude further
Hypogeusia (a blunting or
This may last two to three months or more and may
Penicillamine should not be used in patients who are receiving concurrently gold therapy, antimalarial or cytotoxic drugs, oxyphenbutazone or phenylbutazone because these drugs are also associated with similar serious hematologic and renal
Patients who have had
The possibility of reactions from
Patients with Wilson 's disease or cystinuria should be given 25 mg/day of pyridoxine during therapy, since
Patients also may receive
In Wilson 's disease, multivitamin preparations must be copper-free.
Rheumatoid arthritis patients whose
Mineral supplements should not be given, since they
In Wilson 's disease, this may be a result of adding the effects of the
In cystinuria, a
If necessary, iron may be given in
Penicillamine causes an
In the rat this results in
In man this may be the cause of
Therapy with penicillamine may be continued in the presence of these lesions.
They may not recur if
Other reported effects probably due to
The effects of penicillamine on collagen and elastin make it advisable to consider a reduction in dosage to 250 mg/day, when surgery is contemplated.
There is a report that five of ten
Penicillamine is directly mutagenic to S. typhimurium strain TA92 in the Ames test;
Penicillamine does not induce gene mutations in Chinese hamster V79 cells.
Penicillamine induces sister-chromatid exchanges and chromosome
Pregnancy Pregnancy Category D (see WARNINGS, Pregnancy) Nursing Mothers See CONTRAINDICATIONS. Pediatric Use The efficacy of CUPRIMINE in juvenile rheumatoid arthritis has not been
Review of reported clinical trials with penicillamine in the elderly suggest
Because elderly patients are more likely to have
Therefore, it is mandatory that patients receiving penicillamine therapy remain under
Reported incidences (%) for the most commonly occurring
Some patients may show a lupus erythematosus-like syndrome similar to drug-induced lupus produced by other pharmacological agents (see PRECAUTIONS).
Urticaria and exfoliative dermatitis have occurred.
Thyroiditis has been reported; hypoglycemia in association with anti-insulin antibodies has been reported.
Gastrointestinal Anorexia, epigastric
Isolated cases of reactivated peptic ulcer have occurred, as have hepatic
Intrahepatic cholestasis and
There have been a few reports of
Some patients may report a blunting,
Gastrointestinal side effects are usually reversible following cessation of therapy.
Hematological Penicillamine can cause bone marrow
Leukopenia (2 %) and thrombocytopenia (4 %) have occurred.
Thrombotic thrombocytopenic purpura, hemolytic anemia, red cell aplasia, monocytosis, leukocytosis, eosinophilia, and thrombocytosis have also been reported.
syndrome) have been reported.
Visual and psychic
Neuromuscular Myasthenia gravis (see WARNINGS); dystonia.
Bronchial asthma also has been reported.
The chelating action of the drug may cause
There have been reports associating penicillamine with leukemia.
However, circumstances involved in these reports are such that a cause and effect relationship to the drug has not been
To report SUSPECTED
DOSAGE AND ADMINISTRATION In all patients receiving penicillamine,
Wilson 's Disease
This equals the difference between quantitatively determined total copper and ceruloplasmin-copper.
It is seldom necessary to
If the patient is intolerant to therapy with CUPRIMINE, alternative treatment is trientine hydrochloride.
In patients who can not tolerate as much as 1 g/day initially, initiating dosage with 250 mg/day, and
By reducing urinary cystine,
In some instances,
The usual dosage of CUPRIMINE in the treatment of cystinuria is 2 g/day for adults, with a range of 1 to 4 g/day.
For pediatric patients, dosage can be based on 30 mg/kg/day.
The total daily amount should be divided into four doses.
Initiating dosage with 250 mg/day, and
In addition to taking CUPRIMINE, patients should drink copiously.
Thus, in determining dosage, the inherent tubular
Med. J. 2: 521, Aug. 28, 1965 (in Medical Memoranda).
Add 2 mL of
Add 5 drops of
Cystine will turn the mixture magenta.
Although penicillamine is rarely excreted unchanged, it also will turn the mixture magenta.
If there is any question as to which substance is causing the reaction, a ferric chloride test can be done to eliminate
Penicillamine will turn the
Cystine will not produce any change in appearance.
When treatment with CUPRIMINE has been interrupted because of
Initial Therapy The currently
If there is
If there is
Maintenance Therapy The maintenance dosage of CUPRIMINE must be individualized, and
Some need less.
Changes in maintenance dosage levels may not be reflected clinically or in the erythrocyte sedimentation rate for two to three months after each dosage adjustment.
In those patients who do respond, but who evidence
These may be self-limited and can subside within twelve weeks.
They are usually controlled by the addition of non-steroidal anti-inflammatory drugs, and only if
In the rheumatoid patient, migratory polyarthralgia due to
Discontinuance or a
Duration of Therapy The
If the patient has been in
Concomitant Drug Therapy CUPRIMINE should not be used in patients who are receiving gold therapy, antimalarial or cytotoxic drugs, oxyphenbutazone, or phenylbutazone (see PRECAUTIONS).
Other measures, such as salicylates, other non-steroidal anti-inflammatory drugs, or systemic corticosteroids, may be continued when penicillamine is initiated.
Steroid withdrawal must be done gradually, and
Dosage Frequency Based on clinical experience, dosages up to 500 mg/day can be given as a single daily dose.
Dosages in excess of 500 mg/day should be administered in divided doses.
|Agency product number||GNN1DV99GX|
|Date Last Revised||17-12-2015|
|Type||HUMAN PRESCRIPTION DRUG|
|Storage and handling||Storage Keep container tightly closed.|
|Marketing authorisation holder||Aton Pharma, Inc.|
|Warnings||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.|