کپسول ترینتین نانو دارو پژوهان پردیس 250 میلی گرم-سایپر

Trientine

Category:

Antidotes and chelators › copper chelators

Description:

Trientine hydrochloride is N.N'-bis(2-aminoethyl)-1,2-ethanediamine dihydrochloride. C6H18N4.2HCI

Trientine hydrochloride is a chelating agent. It controls the amount of copper in the body by binding to it. The copper can then be passed from the body.

Indications and usage:

Trientine is used for the treatment of Wilson's disease which is genetic metabolic defect that causes excess copper to build up in the body. It is used in patients who cannot tolerate Penicillamine treatment.

Contraindications:

Hypersensitivity to this product

Drug Interactions:

Iron preparations and acid indigestion remedies may be taken but at a different time of day than trientine.

Pregnancy:

FDA category: C

There are no adequate and well-controlled studies in pregnant women.

If you become pregnant or are planning to become pregnant, you must tell your doctor. You and your doctor can fully discuss the potential benefits of treatment whilst considering any possible risks that there may be with continuing treatment.

Pregnant women should be monitored throughout pregnancy for any effects on the baby or changes in copper levels in the blood.

Breast feeding:

It is not known whether this drug is excreted in human milk.

Babies born to mothers being treated with trientine should be monitored for blood levels of copper and ceruloplasmin.

Pediatric Use:

Controlled studies of the safety and effectiveness of trientine in pediatric patients have not been conducted. It has been used clinically in pediatric patients as young as 6 years with no reported adverse experiences.

Dosage and administration:

Systemic evaluation of dose and/or interval between dose has not been done. However, on limited clinical experience, the recommended initial dose of Trientine is 500-750 mg/day for pediatric patients and 750-1250 mg/day for adults given in divided doses two, three or four times daily. This may be increased to a maximum of 2000 mg/day for adults or 1500 mg/day for pediatric patients age 12 or under.

The daily dose of Trientine should be increased only when the clinical response is not adequate or the concentration of free serum copper is persistently above 20 mcg/dL. Optimal long-term maintenance dosage should be determined at 6-12 month intervals.

Warnings and Precautions:

- Trientine is not an alternative to penicillamine for rheumatoid arthritis or cystinuria. Penicillamine induced systemic lupus erythematosus may not resolve on transfer to trientine.

- Patients (especially women) should be closely monitored for evidence of iron deficiency anemia.

- This medicine should be taken when stomach is empty. This means an hour before meals or 2 hours after meals and at least one hour apart from any other drug, food, or milk.

- Do not take indigestion remedies or medicines containing iron or zinc, 2 hours before or after you take this medicine.

- The capsules should be swallowed whole with water and should not be opened or chewed. Because of the potential for contact dermatitis, any site of exposure to the capsule contents should be washed with water promptly.

- For the first month of treatment, the patient should have his temperature taken nightly, and he should be asked to report any symptom such as fever or skin eruption.

- If patient forgets to take one or more doses, another dose should be taken as soon as possible, then continue as the doctor's prescription. Do not take a double dose to make up for a forgotten dose.

- Patients should be instructed to inform their physician if they are taking any medications including prescription drugs or any nonprescription drugs.

Adverse Effects:

Iron deficiency, systemic lupus erythematosus, dystonia, muscular spasm, myasthenia gravis

How supplied:

Trientine hydrochloride 250 is supplied as one bottle including 100 capsules with a leaflet in each box.

Storage:

- Store refrigerated at 2-8°C (36-46°F).

- Keep container tightly closed and to protect from moisture keep the silica gel sachet in the bottle.

- Protect from light.

- Keep out of the reach of children.

Nano Daru Pajuhan Pardis Co., Tehran, Iran

E-mail: patient@nanodaru.com

URL: www.nanodaru.com