Trientine (Capsules) Instructions for Use

ATC Code

A16AX12 (Trientine)

Active Substance

Trientine (Rec.INN registered by WHO)

Pharmacotherapeutic Group

Detoxifying agents, including antidotes. Drugs for the treatment of gastrointestinal diseases and metabolism

Pharmacological Action

Detoxifying agent for the treatment of metabolic disorders.

Wilson’s disease is a hereditary disease associated with impaired copper metabolism and its excessive accumulation, mainly in the liver and central nervous system. This means that the small amount of copper that enters the body from food and drinks accumulates to too high a level and can lead to liver damage and nervous system disorders.

Trientine removes copper from the body by binding it into a complex and subsequent excretion in the urine, helping to reduce the level of copper in the blood. Trientine can also bind to copper in the intestine and thus reduce the amount of copper entering the body.

Indications

Treatment of Wilson’s disease in adults, adolescents, and children over 5 years of age who are intolerant to penicillamine.

ICD codes

Dosage Regimen

Administer capsules orally.

Take the initial daily dose of 750 mg to 1250 mg in two to four divided doses.

Do not exceed the maximum adult daily dose of 2000 mg.

For children over 5 years of age, base the dose on age and body weight.

Initiate treatment with a daily dose of 500 mg to 750 mg in two or three divided doses.

Do not exceed the maximum pediatric daily dose of 1500 mg.

Take each dose on an empty stomach, at least one hour before or two hours after meals.

Swallow capsules whole with a full glass of water; do not chew or crush.

Space doses as evenly as possible throughout the waking hours.

Adjust the dosage regimen individually based on clinical response and regular monitoring of urinary copper excretion.

If a dose is missed, take it as soon as remembered unless it is almost time for the next dose; in that case, skip the missed dose and continue with the regular schedule.

Do not take a double dose to make up for a forgotten one.

Adverse Reactions

From the digestive system common – nausea; unknown – duodenitis, colitis.

From the skin uncommon – skin rash, skin itching, erythema; unknown – urticaria.

From the hematopoietic system unknown – iron deficiency anemia.

Contraindications

Hypersensitivity to trientine; children under 5 years of age (safety and efficacy have not been studied).

With caution

Impaired renal and/or liver function.

Use in Pregnancy and Lactation

If use during pregnancy is necessary, constant medical supervision is required for any effects on the child or changes in blood copper concentration.

In the postpartum period, constant supervision by the attending physician and monitoring of the child’s blood copper and ceruloplasmin levels are necessary.

It is not known whether Trientine is excreted in human breast milk. If use during breastfeeding is necessary, the expected benefit of therapy for the mother and the potential risk for the breastfed infant should be assessed. The dose of trientine is selected individually by the doctor.

Use in Hepatic Impairment

Use with caution in patients with impaired liver function.

Use in Renal Impairment

Use with caution in patients with impaired renal function.

Pediatric Use

Contraindicated in children under 5 years of age (safety and efficacy have not been established).

Geriatric Use

Approved for use in elderly patients.

Special Precautions

Iron preparations should be taken at least 2 hours after taking trientine.

After starting treatment, an exacerbation of the disease manifestations is possible.

The appearance of side effects may indicate the need for dosage regimen adjustment.

In case of impaired liver or kidney function, it is necessary to regularly monitor blood copper concentration and assess kidney or liver function.

Trientine may reduce blood iron concentration; if necessary, iron supplements may be required.

In children, an adequate blood copper concentration should be maintained for normal growth and mental development.

Drug Interactions

Not recommended for use with medicinal products containing zinc.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.