Trientine Hydrocholoride Capsules USP FAQ's

Trientine hydrochloride Capsule is indicated in the treatment of patients with Wilson's disease who are intolerant of penicillamine. Trientine hydrochloride should be used when continued treatment with penicillamine is no longer possible because of intolerable or life endangering side effects. Trientine hydrochloride is not indicated for treatment of biliary cirrhosis.

Take Trientine hydrochloride Capsuleexactly as directed by your doctor. Do not take more or less than instructed by your doctor. Patients should be directed to take trientine hydrochloride Capsuleon an empty stomach, at least 1 hour before meals or 2 hours after meals and at least 1 hour apart from any other drug, food, or milk. The capsules should be swallowed whole with water and should not be opened or chewed.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Ask your doctor before using a vitamin or mineral supplement, and use only the type your doctor recommends. Some minerals can make it harder for your body to absorb trientine.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Call your doctor at once if you have:

• fever or skin rash;
• problems with speech, balance, walking, lifting, chewing, or swallowing;
• muscle pain or stiffness;
• muscle weakness, drooping eyelids, double vision; or
• symptoms of lupus (an autoimmune disorder)--joint
pain or swelling, headaches, confusion, chest pain, shortness of breath, skin sores, or numbness, cold feeling, or pale appearance of your fingers or toes.

Common side effects may include:

• heartburn, stomach pain, loss of appetite;
• black, tarry stools;
• general ill feeling;
• mouth sores; or
• Skin flaking, cracking, or thickening.

Trientine hydrochloride Capsule:  - Store between 36 to 46 degrees F




Important Safety Information

“Treatment of patients with Trientine Hydrochloride Capsules may be complicated by severe, sometimes lifethreatening, adverse effects. Trientine Hydrochloride Capsules should be administered under the supervision of a physician experienced in the use of this medication for the treatment of sickle cell anemia.”

“Hydroxyurea is mutagenic and clastogenic, and causes cellular transformation to a tumorigenic phenotype. Hydroxyurea is thus unequivocally genotoxic and a presumed transspecies carcinogen which implies a carcinogenic risk to humans. In patients receiving long-term hydroxyurea for myeloproliferative disorders, such as polycythemia vera and thrombocythemia, secondary leukaemia’s have been reported. It is unknown whether this leukemogenic effect is secondary to hydroxyurea or is associated with the patient's underlying disease. The physician and patient must very carefully consider the potential benefits of Trientine Hydrochloride Capsules relative to the undefined risk of developing secondary malignancies. Trientine Hydrochloride Capsules is used to treat chronic myeloid leukaemia or cervical cancer.”

“Your medical team will discuss with you the options for treating your cancer. They will take into account factors such as the type of cancer, where it is, which stage it is at and whether you have had treatment before. The results of blood tests and other investigations will also be considered. How well you feel and how you are likely to cope with treatment is also important.”

“Your cancer treatment will usually consist of a treatment session with Trientine Hydrochloride Capsules followed by a break of a number of days before the next treatment session with Trientine Hydrochloride Capsules. This cycle may be repeated many times as part of your cancer treatment. Trientine Hydrochloride Capsules works by damaging cancer cells in the body. Trientine Hydrochloride Capsules also affects healthy cells and treatment with Trientine Hydrochloride Capsules may damage your immune system. Your medical team may arrange for you to have some blood tests to check how well your immune system is working. Do not share your medicine with other people. It may not be suitable for them and may harm them. The pharmacy label on your medicine tells you how much medicine you should take. It also tells you how often you should take your medicine. This is the dose that you and your prescriber have agreed you should take. You should not change the dose of your medicine unless you are told to do so by your prescriber. If you feel that the medicine is making you unwell or you do not think it is working, then talk to your prescriber.