Syprine trientine hydrochloride is used to treat wilsons disease in patients who cannot take the medication known as penicillamine. There is no advantage in using trientine and penicillamine in combination. Rubidium acetylene carbides burns with slightly warm hydrochloric acid. Patients can only use one clovique connect copay card per fill. Trientine hydrochloride capsules usp 250 mg contains gelatin, iron oxide black, iron oxide red, iron oxide yellow, potassium hydroxide, propylene glycol. Other companies are charging thousands of dollars to set up accounts and give you access to their msds online database. Material may be irritating to the mucous membranes and upper respiratory tract. This msds has been prepared according to the hazard criteria of the controlled products regulations cpr and the msds contains all of the information required by the cpr. Despite decades of clinical use, knowledge of its pharmacology in human subjects remains incomplete. Repeat the acetone addition, trituration, and drying steps.
A normalphase highperformance liquid chromatographic assay. Wilsons disease is a condition where the body stores too much copper. Weigh the contents, and determine the average weight per capsule. The chemical structure of trientine hydrochloride is shown in fig1. Dec 22, 2016 trientine hydrochloride is n,nbis 2aminoethyl1,2ethanediamine dihydrochloride.
Articles of triethylenetetramine dihydrochloride are included as well. No predicted properties have been calculated for this compound. The bioavailability range of oral trientine in fasted rats. Trientine chelates heavy metals including copper, iron, and zinc and forms stable complexes that can be excreted by the kidneys.
Product identifier product name trientine product number ft37067 cas number 112243 ec number 2039506 1. Usp currently offers more than 3,500 reference standardshighly characterized specimens of drug substances, excipients, food ingredients, impurities, degradation products, dietary supplements, compendial reagents and performance calibrators. Hydrochloric acid, 37% ww safety data sheet according to federal register vol. Each capsule contains 250 mg trientine hydrochloride, usp and the inactive ingredient stearic acid. Uranium phosphide reacts with hydrochloric acid to release spontaneously flammable phosphines. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Used to promote excretion of copper in patients with wilson disease hepatolenticular degeneration who are intolerant of penicillamine 1 3 4 5 designated an orphan drug by fda for this use. Trientine hydrochloride api manufacturers suppliers drug. Commission regulation eu no 2015830 of 28 may 2015. Trientine hydrochloride is an oral chelator that is structurally unique from other known chelating agents.
Development and validation of a rapid hplc method for the. When released into the soil, this material may leach into groundwater. Linear formula nh 2 ch 2 ch 2 nhch 2 ch 2 2 nh 2 2hcl. Lithium silicide in contact with hydrogen chloride becomes incandescent.
Sloggemz 1 laboratory of the government chemist, cornwall house, waterloo. As cu is an essential cofactor for cuproenzymes, such as superoxide dismutase 1 sod1, depletion of copper may inhibit the activation of. As cu is an essential cofactor for cuproenzymes, such as superoxide dismutase 1 sod1, depletion of copper may inhibit the activation. Your new online msds binder is a place for you to store the material safety data sheets you need to deploy. Kadmon trientine hydrochloride ndc 6643570010 bottle contains 100 capsule does the patient need to activate the card before using it. Thermal stability of bottled vs blister pack containing. Trientine mobilizes copper ex vivo in human sera, increasing the supernatant percentage in an analytical ultracentrifugation experiment. May 31, 2017 trientine hydrochloride, usp is n,nbis 2aminoethyl1,2ethanediamine dihydrochloride.
Activation is not required for the copay card before use. Bis2aminoethyl1,2ethanediamine dihydrochloride, triethylenetetramine dihydrochloride cas number 38260014. The retrospective observational study by weiss et al. It is a white to pale yellow crystalline hygroscopic powder. Trientine hydrochloride was teratogenic in rats at doses similar to the human dose. View product specific information, msds, references and buying faq. Trientine hydrochloride drug entry triethylenetetramine. Trientine hydrochloride united states pharmacopeia usp reference standard synonym. Trientine chelates excess copper cu ions in the body. Buy high quality triethylenetetramine dihydrochloride 38260014 from toronto research chemicals inc. However, this product offers the advantage of room temperature storage, in comparison to the 300mg capsules which require fridge storage 1,3.
Safety data sheet according to 29cfr19101200 and ghs rev. Data sources include ibm watson micromedex updated 10 apr 2020, cerner multum updated 6 apr 2020, wolters kluwer updated. In patients who cannot tolerate as much as 1 gday initially, initiating dosage with 250 mgday, and increasing gradually to the requisite amount, gives closer control of the effects of the drug and may help to reduce the incidence of adverse reactions. Identification triturate an amount of the contents of capsules, equivalent to about 1. Trientine hydrochloride capsules, usp 250 mg chelating. Pdf triethylenetetramine pharmacology and its clinical applications. Trientine hydrochloride capsules, usp description n,n. Trientine hydrochloride, usp is n,nbis 2aminoethyl1,2ethanediamine dihydrochloride. Ensure personnel are trained on specific chemical hazards present in the lab. It is freely soluble in water, soluble in methanol, slightly soluble in ethanol, and insoluble in chloroform and ether. Development and validation of a rapid hplc method for the simultaneous determination of triethylenetetramine and its two main metabolites in human serum. Assay dissolve about 220 mg of trientine hydrochloride, accurately weighed, in 150 ml of water in a 250ml beaker.
Download msds pdf search msds currently available for download bioworld offers trishcl buffer 1m, ph 8. Triethylenetetramine teta and trien, also called trientine, is an organic compound with the formula ch 2 nhch 2 ch 2 nh 2 2. Capsules syprine contain gelatin, iron oxides, stearic acid, and titanium dioxide as inactive ingredients. Short communication a normalphase highperformance liquid chromatographic assay for aziridine residue in trientine dihydrochloride e.
Trientine hydrochloride is the hydrochloride salt form of a metal chelating agent with potential antiangiogenic activity. Trientine hydrochloride cas 38260014 cayman chemical. Trientine hydrochloride capsules, usp are available as 250 mg capsules for oral administration. The frequencies of both resorptions and fetal abnormalities, including hemorrhage and edema, increased while fetal copper concentrations decreased when trientine hydrochloride was given in the maternal diets of rats. Draft guidance on trientine hydrochloride this draft guidance, once finalized, will represent the food and drug administration s fdas current thinking on this topic. You can use an alternative approach if the approach satisfies. Triethylenetatramine teta is a highly selective divalent cuii chelator and orphan drug that revereses copper overload in tissues. Trientine dihydrochloride is a chelating agent which is used to bind and remove copper in the body in the treatment of wilsons disease. This draft guidance, once finalized, will represent the food and drug administrations fdas current thinking on this. This oily liquid is colorless but, like many amines, assumes a yellowish color due to impurities resulting from airoxidation. Carbon oxides, nitrogen oxides, hydrogen chloride 5. Trientine hydrochloride is a chelating compound for removal of excess copper from the body.
Syprine trientine hydrochloride capsules, 250 mg, targretin bexarotene capsules, 75 mg, targretin bexarotene gel, 1%. Firstline use of trientine dihydrochloride is offlabel. Its salt form, trientine triethylenetetramine dihydrochloride or 2,2,2tetramine was introduced in. Sep 09, 2019 provides accurate and independent information on more than 24,000 prescription drugs, overthecounter medicines and natural products. Trientine hydrochloride monograph for professionals. However, we make no warranty of merchantability or any other warranty, express or implied, with. It is the metal chelating agent used to bind and remove excess copper in. Identification of the substancemixture and of the companyundertaking 1. Syprine trientine hydrochloride dose, indications, adverse.
Trientine dihydrochloride api manufacturers suppliers. It consists of a polyaminelike structure different from dpenicillamine, as it lack sulfhydryl groups. Trientine hydrochloride united states pharmacopeia usp. Trientine hydrochloride c6h20cl2n4 cid 71433 structure, chemical names, physical and chemical properties, classification, patents, literature, biological. Syprine trientine hydrochloride is available as 250 mg capsules for oral administration. Pdf triethylenetetramine teta, a cuiiselective chelator, is commonly used for the treatment of. Ensure that medical personnel are aware of the materials involved and take precautions to protect themselves. Trientine hydrochloride tnt is chemically known as n22aminoethylaminoethylethane1,2diaminehydrochloride1. Trientine is a wellestablished active substance and trientine dihydrochloride 300mg capsules were first licensed in the united kingdom uk in 1985 2. Clinical experience with syprine is limited and alternate dosing regimens have not been wellcharacterized. Calcium carbide reacts with hydrogen chloride gas with incandescence. Triethylenetetramine teta, a selective cuiichelator used in the treatment of wilsons disease, is now undergoing clinical trials for the treatment of heart failure in diabetes. The adult dosage of trientine dihydrochloride is 12002400 mg 48 capsules daily in 2 to 4 divided doses, preferably 3060 minutes before meals.
Trientine medicines sps specialist pharmacy service. Trientine hydrochloride is n,nbis 2aminoethyl1,2ethanediamine dihydrochloride. Searches without any special characters listed below will return items that contain the exact values entered in the search field. Safety data sheet trientine according to regulation ec no 19072006, annex ii, as amended. Here, we first used liquid chromatographymass spectrometry lcms to detect and identify major metabolites of.
It does not create or confer any rights for or on any person and does not operate to bind fda or the public. When released into the soil, this material may evaporate to a moderate extent. Capsules syprine contain gelatin, iron oxides, stearic acid, and titanium dioxide as. Trientine dihydrochloride manufactured by univar is available as 300 mg capsules. Its salt form, trientine triethylenetetramine dihydrochloride or 2,2,2tetramine was introduced in 1969 as an alternative to dpenicillamine. The capsule shell consists of gelatin and titanium dioxide. Mar 27, 2017 trientine, chemically known as triethylenetetramine or n,nbis2aminoethyll,2ethanediamine belongs to the class of polyethylene polyamines. Assay preparation remove, as completely as possible, the contents of not less than 20 capsules. Trientine hydrochloride safety data sheet section 2. Maintain material safety data sheets msds for all chemicals. Handling and storage precautions for safe handling avoid contact with skin and eyes. Niosh manual of analytical methods nmam, fourth edition triethylenetetramine see ethylenedeamine, method 2540, for procedure nh 2 ch 2 ch 2 nhch 2 2 mw.
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