Trade Name: Metformin Hydrochloride

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Granules Pharmaceuticals Inc.

Presentation: TABLET, HUMAN PRESCRIPTION DRUG

Strength: 500 mg/1

Storage and handling

METFORMIN HYDROCHLORIDE Biguanide [EPC],Biguanides [CS]

Disclaimer:
  1. These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
  2. Trademark shown are property of their respective owners and GNH India does not lay any claim on them.
  3. Read more
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  • WARNING: LACTIC ACIDOSISn n nPostmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metforminu00ad associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metforminu00ad 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 n ].n n n n nRisk 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 n n n n , n ].n n n n nIf metformin-associated lactic acidosis is suspected, immediately discontinue metformin hydrochloride tablets and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended [ n n n ].n
  • WARNING: LACTIC ACIDOSIS
  • Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. Symptoms included malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Laboratory abnormalities included elevated blood lactate levels, anion gap acidosis, increased lactate/pyruvate ratio; and metformin plasma levels generally >5 mcg/mL. ( n ) n
  • Risk factors include renal impairment, concomitant use of certain drugs, age >65 years old, radiological studies with contrast, surgery and other procedures, hypoxic states, excessive alcohol intake, and hepatic impairment. Steps to reduce the risk of and manage metforminu00ad associated lactic acidosis in these high risk groups are provided in the Full Prescribing Information. ( n ) n
  • If lactic acidosis is suspected, discontinue metformin hydrochloride tablets and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended. ( n ) n
  • Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.
  • Metformin hydrochloride tablets are biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. (n n n )n nn
  • Adult Dosage for metformin hydrochloride tablets:
  • Pediatric Dosage for metformin hydrochloride tablets:
  • Renal Impairment:
  • u00a0 Metformin Hydrochloride Tablets, USP are available as:n n n u2022 Tablets: 500 mg - White to off-white, round, biconvex, film coated tablets debossed withn n n Gn n n 10 on one side and plain on the other side.n n n u2022 Tablets: 850 mg - White to off-white, round, biconvex, film coated tablets debossed withn n n G;11 onu00a0one side and plain on the other side.n n n u2022 Tablets: 1000 mg - White to off-white, oval, biconvex, scored, film coated tablets debossed with n n n G and12 on either side of the scoreline on one side and plain on the other side.n nn
  • Metformin Hydrochloride Tablets: 500 mg, 850 mg, and 1000 mg (n n n )n n n
  • Metformin hydrochloride tablets are contraindicated in patients with:
  • Severe renal impairment (eGFR below 30 mL/min/1.73 m2) (n n n , n n n )n n n
  • Hypersensitivity to metformin (n n n )n n n
  • Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. (n n n )n n n
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  • Lactic Acidosis:
  • Vitamin Bn- Arrayn- u00a0n- Deficiency:
  • Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues:
  • The following adverse reactions are also discussed elsewhere in the labeling:
  • For metformin hydrochloride tablets, the most common adverse reactions (>5.0%) are diarrhea, nausea/vomiting, flatulence, asthenia, indigestion, abdominal discomfort, and headache. (n n n )n nn
  • To report SUSPECTED ADVERSE REACTIONS, contact Granules Pharmaceuticals Inc at 1-877-770-3183 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
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  • Table 3 presents clinically significant drug interactions with metformin hydrochloride tablets.n n n n n
  • Carbonic anhydrase inhibitors may increase risk of lactic acidosis. Consider more frequent monitoring (n n n )n n n
  • Drugs that reduce metformin clearance (such as ranolazine, vandetanib, dolutegravir, and cimetidine) may increase the accumulation of metformin. Consider the benefits and risks of concomitant use (n n n )n n n
  • Alcohol can potentiate the effect of metformin on lactate metabolism. Warn patients against excessive alcohol intake (n n n )n n n
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  • Females and Males of Reproductive Potential: Advise premenopausal females of the potential for an unintended pregnancy. (n n n )n n n
  • Geriatric Use: Assess renal function more frequently. (n n n )n n n
  • Hepatic Impairment: Avoid use in patients with hepatic impairment. (n n n )n n n
  • 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 has been established. Lactic acidosis has been reported in approximately 32% of metformin overdose cases [see n n n ]n n n 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.n nn
  • Metformin hydrochloride tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is n n n dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below:n n n n n u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 n nn
  • Metformin hydrochloride, USP is a white to off-white crystalline compound with a molecular formula of Cn n n Hn n n Nn n n u2022 HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone and in methylene chloride. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68.n nn
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  • Long-term carcinogenicity studies have been performed in rats (dosing duration of 104 weeks) and mice (dosing duration of 91 weeks) at doses up to and including 900 mg/kg/day and 1500 mg/kg/day, respectively. These doses are both approximately 3 times the maximum recommended human daily dose of 2550 mg based on body surface area comparisons. No evidence of carcinogenicity with metformin was found in either male or female mice. Similarly, there was no tumorigenic potential observed with metformin in male rats. There was, however, an increased incidence of benign stromal uterine polyps in female rats treated with 900 mg/kg/day.
  • There was no evidence of a mutagenic potential of metformin in the following n n n tests: Ames test (n n n . n n n gene mutation test (mouse lymphoma cells), or chromosomal aberrations test (human lymphocytes). Results in the n n n mouse micronucleus test were also negative.n n n n
  • Fertility of male or female rats was unaffected by metformin when administered at doses as high as 600 mg/kg/day, which is approximately 2 times the maximum recommended human daily dose of 2550 mg based on body surface area comparisons.
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  • Advise the patient to read the FDA-approved patient labeling (Patient Information).n n n n n Explain the risks of lactic acidosis, its symptoms, and conditions that predispose to its development. Advise patients to discontinue metformin hydrochloride tablets immediately and to promptly notify their healthcare provider if unexplained hyperventilation, myalgias, malaise, unusual somnolence or other nonspecific symptoms occur. Counsel patients against excessive alcohol intake and inform patients about importance of regular testing of renal function while receiving metformin hydrochloride tablets. Instruct patients to inform their doctor that they are taking metformin hydrochloride tablets prior to any surgical or radiological procedure, as temporary discontinuation may be required [n n n ].n n n n n Inform patients that hypoglycemia may occur when metformin hydrochloride tablets is coadministered with oral sulfonylureas and insulin. Explain to patients receiving concomitant therapy the risks of hypoglycemia, its symptoms and treatment, and conditions that predispose to its development [n n n ].n nn
  • Vitamin B12 Deficiency
  • Inform patients about importance of regular hematological parameters while receiving metformin hydrochloride tablets [n n n ]. n nn
  • Females of Reproductive Age
  • Inform females that treatment with metformin hydrochloride tablets may result in ovulation in some premenopausal anovulatory women which may lead to unintended pregnancy [n n n ].n n n n Manufactured by: n nn
  • Granules India Limited,
  • Hyderabad-500081, INDIA
  • MADE IN INDIA n n n n n n- Arrayn- Granules Pharmaceuticals Inc.n n n n
  • PATIENT INFORMATION
  • Metformin Hydrochloride Tablets
  • (
  • Read the Patient Information that comes with metformin hydrochloride tablets before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your medical condition or treatment.
  • Arrayn- Array
  • Arrayn- Lactic Acidosis. n- Array
  • Arrayn- Array
  • What are metformin hydrochloride tablets?
  • Metformin hydrochloride 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 tablets do not cause your body to make more insulin.n n n n
  • Some conditions increase your chance of getting lactic acidosis, or cause other problems if you take either of these medicines. Most of the conditions listed below can increase your chance of getting lactic acidosis.n n n n n
  • What should I tell my healthcare provider before taking n- metformin hydrochloride tablets?
  • Before taking metformin hydrochloride Tablets, tell your healthcare provider if you:
  • Tell your healthcare provider about all the medicines you take,
  • Can n- metformin hydrochloride tablets be used in children?n- How should I take n- metformin hydrochloride tablets?
  • What should I avoid while taking n- metformin hydrochloride tablets?
  • Do not drink a lot of alcoholic drinks while taking metformin hydrochloride 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 n- metformin hydrochloride 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 tablets if you:
  • Common side effects of metformin hydrochloride tablets include diarrhea, nausea, and upset stomach. These side effects generally go away after you take the medicine for a while. Taking your medicine with meals can help reduce these side effects. Tell your doctor if the side effects bother you a lot, last for more than a few weeks, come back after they've gone away, or start later in therapy. You may need a lower dose or need to stop taking the medicine for a short period or for good.
  • About 3 out of every 100 people who take metformin hydrochloride tablets have an unpleasant metallic taste when they start taking the medicine. It lasts for a short time.
  • Metformin hydrochloride 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.
  • To report SUSPECTED ADVERSE REACTIONS, contact Granules Pharmaceuticals Inc at 1-877-770-3183 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • How should I store n- metformin hydrochloride tablets?
  • Store metformin hydrochloride tablets at 68u00baF to 77u00baF (20u00baC to 25u00baC).
  • Arrayn- metformin hydrochloride tablets and all medicines out of the reach of children.
  • General information about the use of n- metformin hydrochloride tablets.
  • 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 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 tablets for a condition for which it was not prescribed. Do not share your medicine with other people. n n n n n n n
  • Active ingredients of Metformin hydrochloride tablets: metformin hydrochloride. n n n n Inactive ingredients in each tablet of metformin hydrochloride tablets: Povidone (k-30), Povidone (k-90), pregelatinized starch, and magnesium stearate. In addition, the coating for the tablet contains artificial blackberry flavor, hypromellose, macrogol and titanium dioxide.n nn
  • What is type 2 diabetes?
  • Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body produces does not work as well as it should. Your body can also make too much sugar. When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems. n n n n The main goal of treating diabetes is to lower your blood sugar to a normal level.n nn
  • High blood sugar can be lowered by diet and exercise, and by certain medicines when necessary.
  • Talk to your healthcare provider about how to prevent, recognize, and take care of low blood sugar (hypoglycemia), high blood sugar (hyperglycemia), and problems you have because of your diabetes.
  • Manufactured by:
  • Granules India Limited,
  • Hyderabad-500081, INDIA
  • MADE IN INDIA
  • Manufactured for:n n n n n Chantilly, VA 20151n nn
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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Metformin Hydrochloride (Metformin Hydrochloride) which is also known as Metformin Hydrochloride and Manufactured by Granules Pharmaceuticals Inc.. It is available in strength of 500 mg/1.

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.

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