Pronunciation:

TRYE-en-teen hye-droe-KLOR-ide

Brand Names:

• Syprine

Dosage Forms:

• Capsule

Classifications:

Therapeutic—

Heavy Metal Chelator

Uses of This Medicine:

Trientine is used to treat Wilson's disease, a disease in which there is high levels of copper in the body in patients who are de-coppered and dependent to penicillamine.

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.

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—

Appropriate studies have not been performed on the relationship of age to the effects of trientine in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of trientine in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients taking this medicine.

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. 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:

• Copper deficiency or
• Iron deficiency—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

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.

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

Swallow the tablet whole. Do not crush, chew, or dissolve it.

Take this medicine at least 2 hours before or 2 hours after taking iron supplements.

Take this medicine at least 1 hour before or 2 hours after taking calcium, magnesium, or zinc.

If you are unable to swallow the tablet, you may divide the it into half.

The starting dose of Curvior™ tablets will depend on the amount of penicillamine you are currently taking. You should stop taking penicillamine before starting treatment with Curvior™ tablets.

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 Wilson's disease:
  • For oral dosage form (capsules):
    • Adults—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.
  • For oral dosage form (tablets):
    • Adults—At first, 300 to 3000 milligrams (mg), taken in divided doses (2 times a day). Your doctor may adjust your dose as needed and tolerated.
    • Children—Use and dose must be determined by your doctor.

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—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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

Remove the tablet from the blister pack only at the time of dosing. Do not store it for future use after opening the blister.

Precautions While Using This Medicine:

It is important that your doctor check your progress at regular visits to make sure that the medicine is working properly and o check for unwanted effects. Blood tests may be needed to check for unwanted effects.

This medicine may cause serious allergic reactions, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have difficulty in breathing or swallowing, fast heartbeat, skin itching, rash, or redness, or swelling of the face, throat, or tongue.

Check with your doctor right away if you have fever, chills, bone fractures, loss of appetite, pale skin, problems with memory or walking, sore throat or tongue, or unusual tiredness or weakness. These may be symptoms of copper or iron deficiency.

This medicine may worsen your symptoms (eg, nerve problems) at the start of treatment. Talk with your doctor if you have any concerns about this.

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 other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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 immediately if any of the following side effects occur:

Less common

Pale skin

trouble breathing

unusual bleeding or bruising

unusual tiredness or weakness

Incidence not known

Dark-colored urine

difficulty in breathing, chewing, talking, or swallowing

double vision

drooping eyelids

fever and chills

general feeling of discomfort or illness

headaches

inability to move the eyes

increased blinking or spasms of the eyelid

loss of appetite

muscle cramps, spasms, or stiffness

muscle or joint pain

sore tongue

sore throat

sticking out of the tongue

stomach cramps, pain, or tenderness

swollen glands

uncontrolled twisting movements of the neck, trunk, arms, or legs

unusual facial expressions

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Agitation

bone pain

coma

confusion

decreased urine output

dizziness

headache

hostility

irritability

lethargy

loss of appetite

muscle twitching

nausea

rapid weight gain

seizures

stupor

swelling of the face, ankles, or hands

trouble breathing

unusual tiredness or weakness

vomiting

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

Constipation

diarrhea

hair loss

mood changes

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.