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trientine hydrochloride Capsules 250 mg

Dossier type
CTD
Dossier status
Outdated
Country of origin
India
GMP approvals
WHO
Manufacturer #31073

This pharmaceutical company specializes in oncology and has nearly two decades of experience developing generic and specialty drugs. They focus on delivering affordable, world-class chemotherapy medications across a wide range of therapeutic areas. Their robust research and development team possesses expertise in complex drug molecule development, serving diverse markets globally. With over 35 developed generics and specialty drugs, they have filed over 40 dossiers across 25 countries in emerging markets. The company is committed to expanding its presence in the oncology therapeutic area within emerging markets.

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Trientine hydrochloride

Trientine hydrochloride is used to treat Wilson's disease in patients who cannot take the medication known as Penicillamine. In patients with this condition, the body stores too much copper. Wilson’s disease is treated with a low copper diet and chelating agents that bind copper to facilitate its excretion from the body. But unlike penicillamine, this drug is not recommended in the treatment of cystinuria or rheumatoid arthritis. The absence of a sulfhydryl moiety renders Trientine hydrochloride incapable of binding cystine and is of no use in cystinuria. Trientine hydrochloride is marketed under the brand Syprine among others. Trientine hydrochloride was first launched by Merck, Sharp & Dohme in the U.S. in 1986 under the brand name Syprine for the oral treatment of Wilson's disease. Trientine was introduced in 1969 as an alternative to D-penicillamine. It has a polyamine-like structure different from D-penicillamine because it lacks sulfhydryl groups.

Forms and Dosage

Trientine hydrochloride is sold in a capsule and a gelatin-coated capsule. The dosage recommended in the treatment of Wilson’s disease varies by age. For age above 13 and older is 750 to 1250 mg, orally. It is divided into doses given 2, 3, or 4 times daily with a Maximum daily dose capped at 2000 mg. for treatment amongst children younger than 12, the standard dose is 500 to 750 mg taken orally with a maximum daily dose capped at 1500 mg daily.

The cost of Trientine hydrochloride

In the USA, the cost for Trientine oral capsule 250 mg is $24,105 for a supply of 90 capsules, depending on the pharmacy and insurance, and other payment plans. The price of the branded treatment has jumped from $652 in 2010 to $21,267 for 100 pills. The same medication costs higher still in India, at USD26,000 approximately for a supply of 100 tablets of 250 mg strength.

How does Trientine hydrochloride work?

Trientine chelates excess copper and facilitates its excretion from the body. More recently, it has been found that trientine may also decrease intestinal copper absorption. However, the exact mechanism of action of Trientine hydrochloride is unknown. It also inhibits the absorption and metabolic action of iron and other heavy metals. Trientine produces a deficiency of copper in some storage pools, even though Wilson’s disease already creates that in excess.

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