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|Depen

PENICILLAMINE (Systemic)

Some commonly used brand names are:

In the U.S.—

• Cuprimine
• Depen

In Canada—

• Cuprimine
• Depen

Category

• Antidote, to heavy metals
• antirheumatic, disease-modifying
• antiurolithic, cystine calculi
• chelating agent

Description

Penicillamine (pen-i-SIL-a-meen) is used in the treatment of medical problems such as Wilson"s disease (too much copper in the body) and rheumatoid arthritis. Also, it is used to prevent kidney stones. Penicillamine may also be used for other conditions as determined by your doctor.

In addition to the helpful effects of this medicine, it has side effects that can be very serious. Before you take penicillamine, be sure that you have discussed the use of it with your doctor.

This medicine is available only with your doctor"s prescription, in the following dosage forms:

• Oral
• Capsules (U.S. and Canada)
• Tablets (U.S. and Canada)

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For penicillamine, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to penicillin or to penicillamine. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Penicillamine may cause birth defects if taken during pregnancy.

Breast-feeding—It is not known whether penicillamine passes into breast milk. Do not breast feed an infant while taking this medication.

Children—Although there is no specific information about the use of penicillamine in children, it is not expected to cause different side effects or problems in children than it does in adults.

Older adults—This medicine has been tested in a limited number of patients 65 years of age or older. In clinical trials, elderly people may have an increased chance for getting a skin rash.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking penicillamine, it is important that your health care professional know if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine, especially:

• Gold compounds (e.g., Ridaura) or
• Phenylbutazone—The chance of serious side effects may be increased

Other medical problems—The presence of other medical problems may affect the use of penicillamine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood disease caused by penicillamine treatment, history of or
• Kidney disease or history of (only for patients with rheumatoid arthritis)—The chance of side effects may be increased

Proper Use of This Medicine

Since penicillamine is taken in different ways for different medical problems, it is very important that you understand exactly why you are taking this medicine and how to take it. See below for information on specific medical problems. If you have any questions about this, check with your doctor.

For patients taking this medicine to prevent kidney stones :

• Take this medicine on an empty stomach (at least 1 hour before meals or 2 hours after meals) and at least 1 hour before or after any other food, milk, or medicine.
• You should drink 2 full glasses (8 ounces each) of water at bedtime and another 2 full glasses (8 ounces each) during the night.
• It is very important that you follow any special instructions from your doctor, such as following a low-methionine diet. If you have any questions about this, check with your doctor.

For patients taking this medicine for rheumatoid arthritis :

• Take this medicine on an empty stomach (at least 1 hour before meals or 2 hours after meals) and at least 1 hour before or after any other food, milk, or medicine.
• After you begin taking this medicine, 2 to 3 months may pass before you feel its effects. It is very important that you keep taking the medicine, even if you do not feel better, in order to give it time to work.

For patients taking this medicine for Wilson"s disease :

• Take this medicine on an empty stomach (at least 1 hour before meals or 2 hours after meals).
• It is very important that you follow any special instructions from your doctor, such as following a low-copper diet. If you have any questions about this, check with your doctor.
• After you begin taking this medicine, 1 to 3 months may pass before you notice any improvement in your condition.

For patients taking this medicine for lead poisoning :

• Take this medicine on an empty stomach (2 hours before meals or at least 3 hours after meals).

For all patients :

• Take this medicine regularly as directed. Do not stop taking it without first checking with your doctor , since stopping the medicine and then restarting it may increase the possibility of side effects.

Dosing—The dose of penicillamine will be different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of penicillamine. If your dose is different, do not change it unless your doctor tells you to do so.

• For oral dosage forms (capsules or tablets):
  • For Wilson"s disease (too much copper in the body):
    • Adults and teenagers—At first, 250 milligrams (mg) four times a day. After a while your doctor may need to increase the dose, depending on the amount of copper in your urine. Most people do not need more than 2000 mg a day (two 250-mg capsules or tablets four times a day).
    • Children (older than 6 months of age)—At first, 250 mg a day. After a while your doctor may need to increase the dose, depending on the amount of copper in your urine. Older children may need the same dose as adults.
  • For rheumatoid arthritis:
    • Adults—At first, 125 or 250 mg once a day. Your doctor may increase the dose after a few months, depending on how well the medicine is working and whether it causes any side effects. The largest dose is not more than 1500 mg a day (two 250-mg capsules or tablets three times a day).
    • Children—Use and dose must be determined by your doctor.
  • For preventing kidney stones:
    • Adults—At first, 500 mg (two 250-mg capsules or tablets) four times a day. After a while your doctor may need to change the dose, depending on the results of your urine tests. Some people may need as much as 4000 mg a day (four 250-mg capsules or tablets four times a day).
    • Children—The dose is based on body weight and must be determined by your doctor. At first, 7.5 mg per kilogram (kg) (about 3.5 mg per pound) of body weight four times a day. After a while your doctor may need to change the dose, depending on the results of your urine tests.

Missed dose—If you miss a dose of this medicine and your dosing schedule is:

• One dose a day—Take the missed dose as soon as possible. But if you do not remember the missed dose until the next day, skip the missed dose and go back to your regular dosing schedule. Do not double the next day"s dose.
• Two doses a day—Take the missed dose as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
• More than two doses a day—If you remember within an hour or so of the missed dose, take it right away. But if you do not remember until later, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you have any questions about this, check with your doctor.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store this medicine in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Your doctor should check your progress at regular visits to make sure that this medicine does not cause unwanted effects.

Before having any kind of surgery (including dental surgery), tell the medical doctor or dentist in charge that you are taking this medicine.

Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.

Do not take iron preparations or vitamin preparations containing iron without checking with your healthcare provider. If your doctor tells you to take iron preparations, or vitamin preparations containing iron, do not take them within 2 hours of the time you take this medicine. Taking the two medicines too close together may keep the penicillamine from working properly.

Tell your doctor right away if you get a fever, sore throat, chills, bruising, or bleeding. These may be symptoms of a serious blood problem.

Tell your doctor right away if you have trouble breathing, noisy breathing, or an unexplained cough. These may be symptoms of a serious lung problem.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Additional Information

Once a product has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, penicillamine is used in certain patients with the following conditions:

• Felty"s syndrome
• Heavy metal toxicity
• Rheumatoid vasculitis

Other than the above information, there is no additional information relating to proper use, precautions or side effects for these uses.

Revised: 01/20/2005

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