Trientine Hydrochloride (Trientine Hydrochloride)

Trade Name : Trientine Hydrochloride

Kadmon Pharmaceuticals, LLC

CAPSULE

Strength 250 mg/1

TRIENTINE HYDROCHLORIDE Metal Chelating Activity [MoA],Metal Chelator [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Trientine Hydrochloride (Trientine Hydrochloride) which is also known as Trientine Hydrochloride and Manufactured by Kadmon Pharmaceuticals, LLC. It is available in strength of 250 mg/1 per ml. Read more

Trientine Hydrochloride (Trientine Hydrochloride) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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About GNH

No data

Trientine hydrochloride is n n n -bis (2-aminoethyl)-1,2-ethanediamine dihydrochloride. It is a white to pale yellow crystalline hygroscopic powder. It is freely soluble in water, soluble in methanol, slightly soluble in ethanol, and insoluble in chloroform and ether.n nn
The empirical formula is Cn n n Hn n n Nn n n u00b72HCl with a molecular weight of 219.2. The structural formula is:n nn
NHn n n (CHn n n )n n n NH(CHn n n )n n n NH(CHn n n )n n n NHn n n u00b72HCl n nn
Trientine hydrochloride is a chelating compound for removal of excess copper from the body. Trientine Hydrochloride Capsules, USP are available as 250 mg capsules for oral administration. Each capsule contains 250 mg trientine hydrochloride, USP and the inactive ingredient stearic acid. The capsule shell consists of gelatin and titanium dioxide. The capsule shell ink contains shellac, titanium dioxide, FD&C yellow #5 aluminum lake, FD&C blue #1 aluminum lake, FD&C blue#2/indigo carmine aluminum lake, and FD&C blue #1/brilliant blue FCF aluminum lake.

Arrayn- Introduction
Wilsonu2019s disease (hepatolenticular degeneration) is an autosomal inherited metabolic defect resulting in an inability to maintain a near-zero balance of copper. Excess copper accumulates possibly because the liver lacks the mechanism to excrete free copper into the bile. Hepatocytes store excess copper but when their capacity is exceeded copper is released into the blood
and is taken up into extrahepatic sites. This condition is treated with a low copper diet and the use of chelating agents that bind copper to facilitate its excretion from the body.
Arrayn- Clinical Summary
Forty-one patients (18 male and 23 female) between the ages of 6 and 54 with a diagnosis of Wilsonu2019s disease and who were intolerant of d-penicillamine were treated in two separate studies with trientine hydrochloride. The dosage varied from 450 to 2400 mg per day. The average dosage required to achieve an optimal clinical response varied between 1000 mg and 2000 mg per day. The mean duration of trientine hydrochloride therapy was 48.7 months (range 2-164 months). Thirty-four of the 41 patients improved, 4 had no change in clinical global response, 2 were lost to follow-up and one showed deterioration in clinical condition. One of the patients who improved while on therapy with trientine hydrochloride experienced a recurrence of the symptoms of systemic lupus erythematosus which had appeared originally during therapy with penicillamine. Therapy with trientine hydrochloride was discontinued. No other adverse reactions, except iron deficiency, were noted among any of these 41 patients.
One investigator treated 13 patients with trientine hydrochloride following their development of intolerance to d-penicillamine. Retrospectively, he compared these patients to an additional group of 12 patients with Wilsonu2019s disease who were both tolerant of and controlled with d-penicillamine therapy, but who failed to continue any copper chelation therapy. The mean age at
onset of disease of the latter group was 12 years as compared to 21 years for the former group. The trientine hydrochloride group received d-penicillamine for an average of 4 years as compared to an average of 10 years for the non-treated group.
Various laboratory parameters showed changes in favor of the patients treated with trientine hydrochloride. Free and total serum copper, SGOT, and serum bilirubin all showed mean increases over baseline in the untreated group which were significantly larger than with the patients treated with trientine hydrochloride. In the 13 patients treated with trientine hydrochloride, previous symptoms and signs relating to d-penicillamine intolerance disappeared in 8 patients, improved in 4 patients, and remained unchanged in one patient. The neurological status in the trientine hydrochloride group was unchanged or improved over baseline, whereas in the untreated group, 6 patients remained unchanged and 6 worsened. Kayser-Fleischer rings improved significantly during trientine hydrochloride treatment.
The clinical outcome of the two groups also differed markedly. Of the 13 patients on therapy with trientine hydrochloride (mean duration of therapy 4.1 years; range 1 to 13 years), all were alive at the data cutoff date, and in the non-treated group (mean years with no therapy 2.7 years; range 3 months to 9 years), 9 of the 12 died of hepatic disease.
Arrayn- Chelating Properties
Preclinical Studies
Studies in animals have shown that trientine hydrochloride has cupriuretic activities in both normal and copper-loaded rats. In general, the effects of trientine hydrochloride on urinary copper excretion are similar to those of equimolar doses of penicillamine, although in one study they were significantly smaller.
Human Studies
Renal clearance studies were carried out with penicillamine and trientine hydrochloride on separate occasions in selected patients treated with penicillamine for at least one year. Six-hour excretion rates of copper were determined off treatment and after a single dose of 500 mg of penicillamine or 1.2 g of trientine hydrochloride. The mean urinary excretion rates of copper were as follows:
In patients n n n previously treated with chelating agents, a similar comparison was made:n nn
These results demonstrate that Trientine hydrochloride is effective as a cupriuretic agent in patients with Wilsonu2019s disease although on a molar basis it appears to be less potent or less effective than penicillamine. Evidence from a radio-labelled copper study indicates that the different cupriuretic effect between these two drugs could be due to a difference in selectivity of the drugs for different copper pools within the body.
Arrayn- Pharmacokinetics
Data on the pharmacokinetics of trientine hydrochloride are not available. Dosage adjustment recommendations are based upon clinical use of the drug (see n n n ).n nn

Trientine hydrochloride is indicated in the treatment of patients with Wilsonu2019s disease who are intolerant of penicillamine. Clinical experience with Trientine hydrochloride is limited and alternate dosing regimens have not been well-characterized; all endpoints in determining an individual patientu2019s dose have not been well defined. Trientine hydrochloride and penicillamine cannot be considered interchangeable. Trientine hydrochloride should be used when continued treatment with penicillamine is no longer possible because of intolerable or life endangering side effects.
Unlike penicillamine, trientine hydrochloride is not recommended in cystinuria or rheumatoid arthritis. The absence of a sulfhydryl moiety renders it incapable of binding cystine and, therefore, it is of no use in cystinuria. In 15 patients with rheumatoid arthritis, trientine hydrochloride was reported not to be effective in improving any clinical or biochemical parameter after 12 weeks of treatment.
Trientine hydrochloride is not indicated for treatment of biliary cirrhosis.

Hypersensitivity to this product.

Patient experience with trientine hydrochloride is limited (see n n n ). Patients receiving trientine hydrochloride should remain under regular medical supervision throughout the period of drug administration. Patients (especially women) should be closely monitored for evidence of iron deficiency anemia.n nn

No data

Clinical experience with trientine hydrochloride has been limited. The following adverse reactions have been reported in a clinical study in patients with Wilsonu2019s disease who were on therapy with trientine hydrochloride: iron deficiency, systemic lupus erythematosus (see n n n ). In addition, the following adverse reactions have been reported in marketed use: dystonia, muscular spasm, myasthenia gravis.n nn
Trientine hydrochloride is not indicated for treatment of biliary cirrhosis, but in one study of 4 patients treated with trientine hydrochloride for primary biliary cirrhosis, the following adverse reactions were reported: heartburn; epigastric pain and tenderness; thickening, fissuring and flaking of the skin; hypochromic microcytic anemia; acute gastritis; aphthoid ulcers; abdominal pain; melena; anorexia; malaise; cramps; muscle pain; weakness; rhabdomyolysis. A causal relationship of these reactions to drug therapy could not be rejected or established.
To report SUSPECTED ADVERSE REACTIONS, contact Kadmon Pharmaceuticals, LLC at 1-877-377-7862 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

There is a report of an adult woman who ingested 30 grams of trientine hydrochloride without apparent ill effects. No other data on overdosage are available.

Systemic evaluation of dose and/or interval between dose has not been done. However, on limited clinical experience, the recommended initial dose of trientine hydrochloride 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 hydrochloride 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 (see n n n ).n nn
It is important that trientine hydrochloride be given on an empty stomach, at least one hour before meals or two hours after meals and at least one hour apart from any other drug, food, or milk. The capsules should be swallowed whole with water and should not be opened or chewed.

Trientine Hydrochloride Capsules, USP, 250 mg are opaque white capsules coded KD034 250 mg on the body of the capsule printed in green ink and Kadmon n on the cap of the capsule printed in blue ink. They are supplied as follows:n
NDC 66435-700-10 in bottles of 100.
NDC 66435-700-12 blister pack (contains 12 Clovique (trientine hydrochloride), capsules 250mg).
NDC 66435-700-20 carton (contains 10 Clovique blister packs)
Bottle:
Keep container tightly closed.
Store at 2-8u00b0C (36u00b0F and 46u00b0F).
Carton/Blister Pack:
Clovique carton should be kept refrigerated at 2-8u00b0C (36u00b0F and 46u00b0F).
For patient convenience, individual blister pack (or tray) may be stored for a maximum single period of 30 days at or below room temperature (25u00b0C (77u00b0F)) with protection from sources of heat and humidity. Capsules stored at room temperature should be discarded after 30 days.
Manufactured by:
Manufactured For:
C151.00042
Rev. 12/2018

NDC 66435-700-10 Rx only
Trientine Hydrochloriden n nCapsules, USPn n n250 mg n
Each capsule containsn n ntrientine hydrochloride 250 mgn
Kadmon n n n nPharmaceuticals, LLC 100 capsulesn
Store at 2-8u00b0C (36-46u00b0F).
Usual Dosage: See accompanyingn n nprescribing information.n
Keep container tightly closed.
Dispense in tight container.
Contains FD&C Yellow No. 5n n n(tartrazine) as a color additive.n
Distributed by:n n nKadmon Pharmaceuticals, LLCn n nWarrendale, PA 15086, USAn
Manufactured by:n n nXceliencen n nTampa, FL 33607, USAn
Product of the USA
C151.00038n n n70014020n
PRINCIPAL DISPLAY PANEL - Blister Carton
NDC 66435-700-20 Rx Only
CLOVIQUEu2122n nTrientine Hydrochloride Capsules, USPn
250 mg
120 Capsules
Carton contains 10 Unit Dose Packsn nA Unit Dose Pack contains 12 Trientine Hydrochloriden nCapsules, USP, 250 mg eachn
Kadmonu00aen nPharmaceuticals, LLCn
Pharmacist: Cloviqueu2122 carton and blistern npacks should be kept refrigerated at 2-8u00b0Cn n(36-46u00b0F) until dispensed to the patient.n
Patient: Cloviqueu2122 carton should be keptn nrefrigerated at 2-8u00b0C (36-46u00b0F).n nFor patient convenience, individual blistern npacks may be stored for a maximum singlen nperiod of 30 days at or below roomn ntemperature (25u00b0C (77u00b0F)) with protectionn nfrom sources of heat and humidity.n
Capsules should not be removed fromn nblisters until immediately beforen nadministration. Any remaining capsulesn nstored at room temperature should ben ndiscarded after 30 days.n
Usual Dosage: See accompanyingn nprescribing information.n
Contains FD&C Yellow No. 5 (tartrazine) asn na color additive.n
Distributed by:n nKadmon Pharmaceuticals, LLCn nWarrendale, PA 15086, USAn
Manufactured by:n nXceliencen nTampa, FL 33607, USAn
Product of the USA
C151.00039n n70014022n

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Trientine Hydrochloride (Trientine Hydrochloride)

Trade Name : Trientine Hydrochloride

CAPSULE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Trientine Hydrochloride (Trientine Hydrochloride)

Trade Name : Trientine Hydrochloride

CAPSULE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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Swiss Drugs

NZ Drugs

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