Syprine

Syprine is used to treat Wilson's disease, a disease in which there is too much copper in the body.

This medicine combines with excess copper in the body and may prevent your body from absorbing the copper in the foods you eat.

Removing copper from the body prevents damage to the liver, brain, and other organs.

The combination of copper and trientine is then easily removed by the kidneys and it passes from the body in urine.

Syprine is available only with your doctor's prescription. This product is available in the following dosage forms:

• Capsule

Before using Syprine, you must know all about the risks and complications associated with it. 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.

Pediatric Population: Anemia is especially likely to occur in children during treatment with trientine.

Geriatric Population: Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing the use of trientine in the elderly with use in other age groups.

Pregnancy: All Trimesters: Category C: Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding: 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.

Drug Interactions: 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.

Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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:

• Iron-deficiency—Trientine may make this condition worse

To use Syprine properly, you must follow all instructions given by your doctor. Take Syprine with water. The capsule should be swallowed whole. It must not be opened, crushed, or chewed.

Take this medicine on an empty stomach (at least 1 hour before or 2 hours after meals) and at least 1 hour before or after any other medicine, food, or milk. This will allow trientine to be better absorbed by your body.

Trientine will not cure Wilson's disease, but it will help remove the excess copper from your body. Therefore, you must continue to take this medicine regularly, as directed. You may have to take trientine for the rest of your life.

If Wilson's disease is not treated continually, it can cause severe liver damage and can cause death. Do not stop taking this medicine without first checking with your doctor.

It is very important for you to follow any special instructions from your doctor, such as following a low-copper diet.

You may need to avoid foods known to be high in copper, such as:

• chocolate
• mushrooms
• liver
• molasses
• broccoli
• cereals enriched with copper
• shellfish
• organ meats
• nuts

If you have any questions about this, check with your doctor. Take this medicine only as directed by your doctor. Do not take more or less of it and do not take it more often than your doctor ordered. If too much is used, it may increase the chance 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 form (capsules):

For Wilson's disease:

• Adults and teenagers—The usual dose is 750 milligrams (mg) to 1.25 grams a day. The dose may be divided into two to four smaller doses.
• Children—The usual dose is 500 to 750 mg a day. The dose may be divided into two to four smaller doses.

Missed Dose: Call your doctor or pharmacist for instructions. If you miss a dose of this medicine, double the next dose. Do not make up more than one missed dose at a time.

Storage: Store in the refrigerator. Do not freeze. Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed.

Before using Syprine, there are some precautions you must take. Your doctor should check your progress at regular visits to make sure trientine is working properly and to check for unwanted effects.

Laboratory tests may be needed. This will allow your doctor to change your dose, if necessary.

During the first month of treatment, you may need to take your temperature each night. Tell your doctor if you develop a fever or skin rash.

Do not take copper or iron preparations or any other mineral supplements within 2 hours of taking trientine. This includes any vitamin preparation that contains minerals.

If a capsule breaks open and the contents touch your skin, wash the area right away with water. Trientine may cause a rash.

As with many medications, there are several potential side effects associated with Syprine. 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:

Note: Signs of anemia are more likely to occur in children, menstruating women, and pregnant women, who usually need more iron than other patients. If these signs appear during trientine treatment, your doctor will need to do some tests.

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.