Pronunciation:

pen-i-SIL-a-meen

Brand Names:

• Cuprimine
• Depen

Dosage Forms:

• Tablet
• Capsule

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 .

Classifications:

Therapeutic—

Antirheumatic

Uses of This Medicine:

Penicillamine 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.

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

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.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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 this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Aurothioglucose

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Auranofin
• Gold Sodium Thiomalate
• Magnesium Sulfate

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Iron

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. 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 this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• 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, take it 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.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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:

More common

Fever

joint pain

lesions on the face, neck, scalp, and/or trunk

skin rash, hives, or itching

swollen and/or painful glands

ulcers, sores, or white spots on lips or in mouth

Less common

Bloody or cloudy urine

shortness of breath, troubled breathing, tightness in chest, or wheezing

sore throat and fever with or without chills

swelling of face, feet, or lower legs

unusual bleeding or bruising

unusual tiredness or weakness

weight gain

Rare

Abdominal or stomach pain (severe)

blisters on skin

bloody or black, tarry stools

chest pain

coughing or hoarseness

dark urine

difficulty in breathing, chewing, talking, or swallowing

eye pain, blurred or double vision, or any change in vision

general feeling of discomfort or illness or weakness

lower back or side pain

muscle weakness

painful or difficult urination

pale stools

pinpoint red spots on skin

redness, tenderness, itching, burning, or peeling of skin

red or irritated eyes

red, thick, or scaly skin

ringing or buzzing in the ears

spitting blood

yellow eyes or skin

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Diarrhea

lessening or loss of sense of taste

loss of appetite

nausea or vomiting

stomach pain (mild)

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.