Metformin hydrochloride safety data sheet supersedes revision. Metformin hydrochloride european pharmacopoeia ep reference standard synonym. Metformin hcl msds pdf email protected by start bootstrap. Metformin hydrochloride extendedrelease tablets are contraindicated in patients with. Identification of the substancemixture and of the companyundertaking. Your new online msds binder is a place for you to store the material safety data sheets you need to deploy. It selectively lowers the hepatic gluconeogenesis without rising insulin production, causing weight gain or hypoglycemia. Lists used were valid at the time of sds preparation. Composition and information on ingredients composition. Identification product name 1,1dimethylbiguanide hydrochloride cat no. Metformin is an oral diabetes medicine that helps control blood sugar levels. Metformin hydrochloride is referred to as metformin. Metformin hcl is one of the most effective and widely used therapeutics for treatment of type 2 diabetes.
Metformin hydrochloride extendedrelease tablets usp 500 mg and mg manufacturer lupin limited goa 403 722 india distributor lupin pharmaceuticals, inc. Metformin hydrochloride european pharmacopoeia ep reference. Triturate a quantity of the powdered tablets, equivalent to about 50 mg of metformin hydrochloride, with 10 ml of water, and filter. Each janumet 50850 mg tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg of. N,ndimethylbiguanide hydrochloride lasa supergenerics limited c105,mahad ind area, khaire, birwadi, tal mahad, dist. Metformin hydrochloride metformini hydrochloridum c4h12cln5 mr 165. Packaging and storage preserve in wellclosed containers. People usually get sick 12 hours to three days after they eat something contaminated. Fire and explosion assume that this product is capable of sustaining combustion. May cause eye, skin, or respiratory system irritation. Synjardy empagliflozin and metformin hydrochloride tablets fda. Severe renal impairment egfr metformin hydrochloride, renal impairment.
Qualitative and quantitative composition each janumet 50500 mg tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin and 500 mg of metformin hydrochloride. Metformin hydrochloride c4h12cln5 cid 14219 structure, chemical names, physical and. Ac429720050 casno 1115704 synonyms metformin hydrochloride recommended use laboratory chemicals. Metformin, marketed under the trade name glucophage among others, is the firstline medication for the treatment of type 2 diabetes, particularly in people who are overweight. Metformin is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. Hazard identification percent by weight 100% potential acute health effects. Uses advised against food, drug, pesticide or biocidal product use. There was no evidence of a mutagenic potential of metformin hcl alone in the following in vitro tests. The action of metformin is progressive and no final assessment of the patients real response should be made before the 21st day of treatment. For patients switching from combined therapy with separate metformin and rosiglitazone preparations, the usual initial dosage of the fixed combination is the same as the patients existing dosage of the individual drugs. Imidodicarbinimidic, n,ndimethyl, monohydrochloride two strengths are available.
Data sources include ibm watson micromedex updated 4 may 2020, cerner multum updated 4 may 2020, wolters kluwer updated. Patients currently receiving metformin hydrochloride. Metformin hydrochloride pharmaceutical secondary standard. Metformin is dialyzable with a clearance of up to 170 mlmin under good hemodynamic conditions. Metformin hydrochloride is the hydrochloride salt of the biguanide metformin with antihyperglycemic and potential antineoplastic activities. Metformin oral tablet is a prescription drug thats used along with diet and exercise to treat high blood sugar levels caused by type 2 diabetes. Fortamet, glucophage, glucophage xr, glumetza, riomet. The main active ingredient is a biguanide that reduces glycemia and improves insulin action. Metformin hydrochloride extendedrelease tablets definition metformin hydrochloride extendedrelease tablets contain nlt 90. Metformin hydrochloride may be used as a pharmaceutical reference standard for. The retention time of the major peak from the sample solution corresponds to that from the standard solution, as. Metformin hydrochloride is a hydrochloride resulting from the reaction of metformin with one molar equivalent of hydrogen chloride. New zealand data sheet metformin 1 metformin 500mg, 850mg. Metformin hcl in a 104week carcinogenicity study in rats at doses up to 900 mgkgday, the incidences of benign stromal uterine polyps were increased in female rats at 900 mgkgday which is approximately four times the maximal recommended human daily dose of 2000 mg of metformin hcl component of repaglinide and metformin hydrochloride.
Dissolve20mgofmetformin hydrochloride crs in water r and dilute to 5 ml with thesamesolvent. Metformin may also cause headaches, make your skin flush, cause changes to your fingernails, and cause muscle pain. Safety data sheet creation date 30apr2010 revision date 23jan2018 revision number 3 1. Glipizide and metformin hydrochloride tablet, film coated. Metformin hydrochloride, pharmaceutical secondary standard. Metformin hcl, usp is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The ph of a 1% aqueous solution of metformin hydrochloride is 6. Hazardous identification material safety data sheet material metformin hydrochloride extendedrelease tablets 500 mg and mg manufacturer lupin limited goa 403 722 india. Metformin also induces a profound shift in the faecal microbial community profile in diabetic mice and this may contribute to its mode of action possibly through an effect on glucagonlike peptide1 secretion. Sds repaglinide and metformin hcl tablets usp july 2015. Known hypersensitivity to sitagliptin phosphate, metformin hydrochloride or any other. Microsoft word msds metformin hcl er tabs rev 1 july 2011 author. Metformin hcl, usp is a white to offwhite crystalline compound with a molecular formula of c 4 h 11 n 5 hcl and a molecular weight of 165.
You have selected the maximum number of product attributes 3 to compare. Very toxic to aquatic life with long lasting effects. List of drug master files dmf of metformin hydrochloride active pharmaceutical ingredient api submitted to the u. Janumet sitagliptin phosphate metformin hcl is contraindicated in patients with. Health metformin is contraindicated in patients with renal disease or renal dysfunction e. In addition, modified release 500 mg metformin tablets and several fixed combination tablets containing a combination of metformin and either glibenclamide, rosiglitazone or sitagliptin are registered. The maximum daily dose of metformin should preferably be divided into 23 daily doses. Factors that may increase the risk of lactic acidosis see section warnings. Dec 20, 2018 metformin oral tablet is a prescription drug thats used along with diet and exercise to treat high blood sugar levels caused by type 2 diabetes. It is also used in the treatment of polycystic ovary syndrome.
Material may be irritating to the mucous membranes and upper respiratory tract. Symptoms include diarrhea, fever and stomach cramps treatment is most effective when it is done early, so we strongly recommend that all women be screened as early in their pregnancy as possible. Metformin hydrochloride monograph for professionals. Metformin will not produce a hypoglycaemic state when used alone, however, it increases insulin effectiveness. May 22, 2015 metformin hydrochloride is a white to offwhite crystalline compound with a molecular formula of c4h11n5hcl and a molecular weight of 165. This sds was prepared in accordance with 29 cfr 1910. Initially, a total daily metformin hydrochloride dosage similar to the patients existing dosage and 100 mg of canagliflozin, administered in 2 divided doses. Calculate the quantity, in mg, of metformin hydrochloride c 4 h 11 n 5 hcl in the portion of tablets taken by the formula. Metformin may give you an unpleasant taste in your mouth. Metformin is used with a proper diet and exercise program and possibly with other medications to control high blood sugar. Metformin hydrochloride united states pharmacopeia usp reference standard synonym. Metformin hydrochloride is a white to offwhite crystalline compound with a molecular formula of c4h11n5 hcl and a molecular weight of 165.
Weve included the most sought after safety data sheets, and the. Metformin hcl is an abbreviation for metformin hydrochloride. If the suffix psy, narc or drug precursor, or motbiotox appears, export authorizations are mandatory in france or. Australian public assessment report for vildagliptinmetformin. Galvus met vildagliptin metformin hydrochloride 50 mg850. It is effective in glycemic control and decreases the intestinal absorption of glucose, without the problem of serious lactic acidosis. Metaglip glipizide and metformin hcl tablets contain 2 oral antihyperglycemic drugs used in the management of type 2 diabetes, glipizide and metformin hydrochloride. Metformin hydrochloride is an antidiabetic preparation. Identification of the substancemixture and of the companyundertaking 1. Metformin hydrochloride 500mg metformin hydrochloride 850mg metformin hydrochloride mg excipient of known effect propylene glycol this excipient may cause skin irritation.
Metformin hydrochloride extendedrelease tablets type of posting revision bulletin posting date 22feb2019 official date 01mar2019 expert committee chemical medicines monographs 3 reason for revision compliance in accordance with the rules and procedures of the 20152020 council of experts, the chemical. Our msds database is an easy to use, do it yourself tool, and best of all. Page 27 safety data sheet according to 19072006ec, article 31 printing date 27. Other companies are charging thousands of dollars to set up accounts and give you access to their msds online database. Glipizide is an oral antihyperglycemic drug of the sulfonylurea class. Actos is indicated for use in combination with a sulfonylurea or metformin when diet and. Therefore, hemodialysis may be useful for removal of accumulated drug from patients in whom metformin overdosage is suspected.
Metformin hydrochloride api dmfs us drug master file. In a controlled initial therapy trial of glipizide and metformin hydrochloride tablets, 2. Its metabolic effects, including the inhibition of hepatic gluconeogenesis, are mediated at least in part by activation of the lkb1ampk ampactivated protein kinase pathway. Metformin is sometimes used together with insulin or other medications, but it is not for treating type 1 diabetes. See actual entry in rtecs for complete information.
Metformin hydrochloride united states pharmacopeia usp. Dailymed metformin hcl er metformin hydrochloride extended. Jan 17, 2020 a second doubleblind, placebocontrolled study n51, with 16 weeks of randomized treatment, demonstrated that in patients with type 2 diabetes controlled on insulin for 8 weeks with an average hba 1c of 7. It has a role as an environmental contaminant, a hypoglycemic agent and a xenobiotic. Metformin hydrochloride investigated as a drug and primart irritant. Slightly hazardous in case of skin contact irritant, of eye contact irritant, of ingestion, of inhalation. Glucophage metformin hcl is indicated to improve glycemic control in adult patients with responsive, stable, mild, nonketosis prone, type 2 diabetes mellitus as an adjunct to proper dietary management, exercise, and weight reduction, or when insulin therapy is not appropriate. Metformin hydrochloride api dmfs us drug master file dmf. Isolate hydrogen chloride from heat, direct sunlight, alkalies reacts vigorously, organic materials, and oxidizers especially nitric acid and chlorates, amines, metals, copper and alloys e. Dissolve 20 mg of the substance to be examined in water rand dilute to 5 ml with the same solvent. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform.
Precautionary statements p280 wear protective glovesprotective clothingeye protectionface. Metformin is an antidiabetic agent that reduces blood glucose levels and improves insulin sensitivity. Only select registry of toxic effects of chemical substances rtecs data is presented here. Metformin is a biguanide hypoglycaemic agent and an oral antidiabetic medication widely used in the treatment of type 2 diabetes. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Patients receiving immediaterelease may switch to extendedrelease once a day at same total daily dose up to 2000 mgday metformin, if not contraindicated, should be. It reduces the amount of sugar made by the liver, limits the amount of sugar absorbed into the body from the diet, and makes insulin receptors more sensitive helping the body respond better to its own insulin. Galvus met vildagliptin metformin hydrochloride 50 mg. Metformin and other biguanides may antagonize the action of glucagon, thus reducing fasting glucose levels.622 712 1346 1283 350 502 1088 493 410 613 990 176 686 644 646 1093 1386 376 482 1150 1046 170 1416 1189 1327 1092 697 791 955 713 798 170 1378 834 1256 723 495 1126 65 807 811 1351 613 1360