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Metformin Hydrochloride (Metformin Hydrochloride)

Trade Name : Metformin Hydrochloride

Teva Pharmaceuticals USA, Inc.

TABLET, EXTENDED RELEASE

Strength 750 mg/1

METFORMIN HYDROCHLORIDE Biguanide [EPC],Biguanides [CS]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Metformin Hydrochloride (Metformin Hydrochloride) which is also known as Metformin Hydrochloride and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 750 mg/1 per ml. Read more

Metformin Hydrochloride (Metformin 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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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Metformin hydrochloride extended-release tablets USP are oral antihyperglycemic drugs used in the management of type 2 diabetes. Metformin hydrochloride, USP (-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown:
  • CHNu2022HCl M.W. 165.63
  • Metformin hydrochloride, USP is a white to off-white crystalline compound. Metformin hydrochloride, USP is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pK of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride, USP is 6.68.
  • Metformin hydrochloride extended-release tablets USP contain 500 mg or 750 mg of metformin hydrochloride, USP as the active ingredient. In addition, each tablet contains the following inactive ingredients: ethylcellulose, hypromellose, magnesium stearate and microcrystalline cellulose. The 750 mg tablet also contains ferric oxide red and ferric oxide yellow.
  • Metformin hydrochloride extended-release tablets USP meet USP .
  • No data
  • No data
  • Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
  • Metformin hydrochloride extended-release tablets are contraindicated in patients with:
  • Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (> 5 mmol/Liter), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio; and metformin plasma levels generally > 5 mcg/mL (see PRECAUTIONS).
  • Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g., carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, and hepatic impairment.
  • Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided (see , , and ).
  • If metformin-associated lactic acidosis is suspected, immediately discontinue metformin hydrochloride tablets or metformin hydrochloride extended-release tablets and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended (see ).
  • No data
  • In a U.S. double-blind clinical study of metformin hydrochloride tablets in patients with type 2 diabetes, a total of 141 patients received metformin hydrochloride tablet therapy (up to 2550 mg per day) and 145 patients received placebo. Adverse reactions reported in greater than 5% of the metformin hydrochloride tablet patients, and that were more common in metformin hydrochloride tablet- than placebo-treated patients, are listed in .
  • Diarrhea led to discontinuation of study medication in 6% of patients treated with metformin hydrochloride tablets. Additionally, the following adverse reactions were reported in u2265 1.0% to u2264 5.0% of metformin hydrochloride tablet patients and were more commonly reported with metformin hydrochloride tablets than placebo: abnormal stools, hypoglycemia, myalgia, lightheaded, dyspnea, nail disorder, rash, sweating increased, taste disorder, chest discomfort, chills, flu syndrome, flushing, palpitation.
  • In worldwide clinical trials over 900 patients with type 2 diabetes have been treated with metformin hydrochloride extended-release tablets in placebo- and active-controlled studies. In placebo-controlled trials, 781 patients were administered metformin hydrochloride extended-release tablets and 195 patients received placebo. Adverse reactions reported in greater than 5% of the metformin hydrochloride extended-release tablet patients, and that were more common in metformin hydrochloride extended-release tablet- than placebo-treated patients, are listed in .
  • Diarrhea led to discontinuation of study medication in 0.6% of patients treated with metformin hydrochloride extended-release tablets. Additionally, the following adverse reactions were reported in 1.0% to 5.0% of metformin hydrochloride extended-release tablet patients and were more commonly reported with metformin hydrochloride extended-release tablets than placebo: abdominal pain, constipation, distention abdomen, dyspepsia/heartburn, flatulence, dizziness, headache, upper respiratory infection, taste disturbance.
  • Cholestatic, hepatocellular, and mixed hepatocellular liver injury have been reported with postmarketing use of metformin.
  • In clinical trials with metformin hydrochloride tablets in pediatric patients with type 2 diabetes, the profile of adverse reactions was similar to that observed in adults.
  • Overdose of metformin hydrochloride has occurred, including ingestion of amounts greater than 50 grams. Hypoglycemia was reported in approximately 10% of cases, but no causal association with metformin hydrochloride has been established. Lactic acidosis has been reported in approximately 32% of metformin overdose cases (see ). Metformin is dialyzable with a clearance of up to 170 mL/min under good hemodynamic conditions. Therefore, hemodialysis may be useful for removal of accumulated drug from patients in whom metformin overdosage is suspected.
  • There is no fixed dosage regimen for the management of hyperglycemia in patients with type 2 diabetes with metformin hydrochloride extended-release tablets or any other pharmacologic agent. Dosage of metformin hydrochloride extended-release tablets must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily doses. The maximum recommended daily dose of metformin hydrochloride extended-release tablets in adults is 2000 mg.
  • Metformin hydrochloride extended-release tablets should generally be given once daily with the evening meal. Metformin hydrochloride extended-release tablets should be started at a low dose, with gradual dose escalation, both to reduce gastrointestinal side effects and to permit identification of the minimum dose required for adequate glycemic control of the patient.
  • During treatment initiation and dose titration (see ), fasting plasma glucose should be used to determine the therapeutic response to metformin hydrochloride extended-release tablets and identify the minimum effective dose for the patient. Thereafter, glycosylated hemoglobin should be measured at intervals of approximately 3 months. n
  • Monitoring of blood glucose and glycosylated hemoglobin will also permit detection of primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication, and secondary failure, i.e., loss of an adequate blood glucose lowering response after an initial period of effectiveness.
  • Short-term administration of metformin hydrochloride extended-release tablets may be sufficient during periods of transient loss of control in patients usually well-controlled on diet alone.
  • Metformin hydrochloride extended-release tablets must be swallowed whole and never crushed or chewedn- PATIENT INFORMATION
  • Metformin hydrochloride extended-release tablets USP, 500 mg are available as white to off-white oval caplets, debossed with u201c93u201d on one side and u201c7267u201d on the other side. They are available in bottles of 100 (NDC 0093-7267-01) and 1000 (NDC 0093-7267-10).
  • Metformin hydrochloride extended-release tablets USP, 750 mg are available as brick red (mottled), oval caplets, debossed with u201c93u201d on one side and u201c7212u201d on the other side. They are available in bottles of 100 (NDC 0093-7212-01).
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
  • Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
  • KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
  • Manufactured In Israel By:
  • Teva Pharmaceutical Ind. Ltd.
  • Jerusalem, 9777402, Israel
  • Manufactured For:
  • Teva Pharmaceuticals USA, Inc.
  • North Wales, PA 19454
  • Rev. AR 4/2017
  • Metformin (met for' min) Hydrochloride Extended-Release Tablets USP
  • Read this information carefully before you start taking this medicine and each time you refill your prescription. There may be new information. This information does not take the place of your doctoru2019s advice. Ask your doctor or pharmacist if you do not understand some of this information or if you want to know more about this medicine.
  • What are metformin hydrochloride extended-release tablets?
  • Metformin hydrochloride extended-release tablets are used to treat type 2 diabetes. This is also known as non-insulin-dependent diabetes mellitus. People with type 2 diabetes are not able to make enough insulin or respond normally to the insulin their bodies make. When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems including kidney damage, amputations, and blindness. Diabetes is also closely linked to heart disease. The main goal of treating diabetes is to lower your blood sugar to a normal level.
  • High blood sugar can be lowered by diet and exercise, by a number of medicines taken by mouth, and by insulin shots. Before you take metformin hydrochloride extended-release tablets, try to control your diabetes by exercise and weight loss. While you take your diabetes medicine, continue to exercise and follow the diet advised for your diabetes. No matter what your recommended diabetes management plan is, studies have shown that maintaining good blood sugar control can prevent or delay complications of diabetes, such as blindness.
  • Metformin hydrochloride extended-release tablets help control your blood sugar in a number of ways. These include helping your body respond better to the insulin it makes naturally, decreasing the amount of sugar your liver makes, and decreasing the amount of sugar your intestines absorb. Metformin hydrochloride extended-release tablets do not cause your body to make more insulin. Because of this, when taken alone, they rarely cause hypoglycemia (low blood sugar), and usually do not cause weight gain. However, when they are taken with a sulfonylurea or with insulin, hypoglycemia is more likely to occur, as is weight gain.
  • Tell your doctor if you are pregnant or plan to become pregnant. Metformin hydrochloride extended-release tablets may not be right for you. Talk with your doctor about your choices. You should also discuss your choices with your doctor if you are nursing a child.
  • Can metformin hydrochloride extended-release tablets be used in children?
  • Metformin hydrochloride extended-release tablets have not been studied in children.
  • How should I take metformin hydrochloride extended-release tablets?
  • Your doctor will tell you how much medicine to take and when to take it. You will probably start out with a low dose of the medicine. Your doctor may slowly increase your dose until your blood sugar is better controlled. You should take metformin hydrochloride extended-release tablets with meals.
  • Your doctor may have you take other medicines along with metformin hydrochloride extended-release tablets to control your blood sugar. These medicines may include insulin shots. Taking metformin hydrochloride extended-release tablets with insulin may help you better control your blood sugar while reducing the insulin dose.
  • Continue your exercise and diet program and test your blood sugar regularly while taking metformin hydrochloride extended-release tablets. Your doctor will monitor your diabetes and may perform blood tests on you from time to time to make sure your kidneys and your liver are functioning normally. There is no evidence that metformin hydrochloride extended-release tablets cause harm to the liver or kidneys.
  • Tell your doctor if you:
  • Metformin hydrochloride extended-release tablets must be swallowed whole and never crushed or chewed.
  • What should I avoid while taking metformin hydrochloride extended-release tablets?
  • Do not drink a lot of alcoholic drinks while taking metformin hydrochloride extended-release tablets. This means you should not binge drink for short periods, and you should not drink a lot of alcohol on a regular basis. Alcohol can increase the chance of getting lactic acidosis.
  • What are the side effects of metformin hydrochloride extended-release tablets?
  • Call your doctor right away if you have any of the following symptoms, which could be signs of lactic acidosis:
  • Most people who have had lactic acidosis with metformin have other things that, combined with the metformin, led to the lactic acidosis. Tell your doctor if you have any of the following, because you have a higher chance for getting lactic acidosis with metformin hydrochloride extended-release tablets if you:
  • The best way to keep from having a problem with lactic acidosis from metformin is to tell your doctor if you have any of the problems in the list above. Your doctor may decide to stop your metformin hydrochloride extended-release tablets for a while if you have any of these things.
  • Other Side Effects.
  • About 3 out of every 100 people who take metformin hydrochloride extended-release tablets have an unpleasant metallic taste when they start taking the medicine. It lasts for a short time.
  • Metformin hydrochloride extended-release tablets rarely cause hypoglycemia (low blood sugar) by themselves. However, hypoglycemia can happen if you do not eat enough, if you drink alcohol, or if you take other medicines to lower blood sugar.
  • General advice about prescription medicines
  • If you have questions or problems, talk with your doctor or other healthcare provider. You can ask your doctor or pharmacist for the information about metformin hydrochloride extended-release tablets that is written for healthcare professionals. Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use metformin hydrochloride extended-release tablets for a condition for which they were not prescribed. Do not share your medicine with other people.
  • Manufactured In Israel By:
  • Teva Pharmaceutical Ind. Ltd.
  • Jerusalem, 9777402, Israel
  • Manufactured For:
  • Teva Pharmaceuticals USA, Inc.
  • North Wales, PA 19454
  • Rev. K 4/2017
  • No data
  • No data

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