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: AlignScience Pharma Inc.

Presentation: TABLET, EXTENDED RELEASE, 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 US territories to trade professionals or patients with a valid prescription.
  2. All trademarks, brands and service marks that appear on this website are the property of their respective owners. GNH India does not claim ownership of or any affiliation with, any third party trademarks, brand or service marks appearing on this website.
  3. Third party trademarks are used only for bona fide purposes to identify the products as being that of their respective owners, which constitutes fair use of the trademark under the Trademarks Act, 1999. No sponsorship or endorsement on the part of GNH India should be inferred from the display or use of these trademarks.
  4. Read more

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 AlignScience Pharma 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.

  • No data
  • Postmarketing 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 [n- see ].
  • 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 ].
  • If metformin-associated lactic acidosis is suspected, immediately discontinue metformin hydrochloride and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended [see ].
  • WARNING: LACTIC ACIDOSIS
  • See full prescribing information for complete boxed warning.
  • Postmarketing cases of metformin-associated lactic acidosisu00a0n- haveu00a0n- 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. (5.1)
  • 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 metformin-associated lactic acidosis in these high risk groups are provided in the Full Prescribing Information. (5.1)
  • If lactic acidosis is suspected, discontinue metformin hydrochloride extended-release tablets and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended. (5.1)
  • Metformin hydrochloride extended-release tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
  • Metformin hydrochloride extended-release tablets is a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1)n
  • Adult Dosage for metformin hydrochloride extended-release tablets:
  • Renal Impairment:
  • Discontinuation for Iodinated Contrast Imaging Procedures:
  • Metformin hydrochloride extended-release tablets, USP 500 mg are white to off-white, capsule shaped, biconvex tablets, with u201cHXu201d debossed on one side and u201c500u201d debossed across the face of the other side.
  • u2022 Metformin hydrochloride extended-release tablets: 500 mg (3)n
  • Metformin hydrochloride extended-release tablets are contraindicated in patients with:
  • u2022 Severe renal impairment (eGFR below 30 mL/min/1.73 m) (4, 5.1)u2022 Hypersensitivity to metformin (4)u2022 Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. (4)n
  • No data
  • Lactic Acidosis:
  • VitaminMetformin may lower vitamin Bu00a0levels. Measure hematological parameters annually and vitamin Bu00a0at 2 to 3 year intervals and manage any abnormalities. (5.2)
  • Hypoglycemiau00a0n- with Concomitant Use with Insulin and Insulin Secretagogues:
  • The following adverse reactions are also discussed elsewhere in the labeling:
  • For metformin hydrochloride extended-release tablets, the most common adverse reactions (>5.0%) are diarrhea, nausea/vomiting, flatulence, asthenia, indigestion, abdominal discomfort, and headache. (6.1)n n
  • Table 2 presents clinically significant drug interactions with metformin hydrochloride extended-release tablets.
  • Carbonic anhydrase inhibitors may increase risk of lactic acidosis. Consider more frequent monitoring (7)
  • Drugs u00a0that u00a0reduce u00a0metformin u00a0clearance u00a0(such u00a0as u00a0ranolazine, u00a0vandetanib, dolutegravir, u00a0and u00a0cimetidine) u00a0may u00a0increase u00a0the u00a0accumulation u00a0of u00a0metformin. Consider the benefits and risks of concomitant use (7)
  • Alcohol can potentiate the effect of metformin on lactate metabolism. Warn patients against excessive alcohol intake (7)
  • No data
  • Females and Males of Reproductive Potential: Advise premenopausal females of the potential for an unintended pregnancy. (8.3)
  • Geriatric Use: Assess renal function more frequently. (8.5)
  • Hepatic Impairment: Avoid use in patients with hepatic impairment. (8.7)
  • No data
  • Metformin hydrochloride extended-release tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is -dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below:
  • Metformin hydrochloride, USP is a white to off-white crystalline compound with a molecular formula of CHN u2022 HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68.
  • Metformin hydrochloride extended-release tablets, USP 500 mg contains 500 mg of metformin hydrochloride, USP which is equivalent to 389.93 mg metformin base.
  • Metformin hydrochloride extended-release tablets, USP 500 mg contain the inactive ingredients microcrystalline cellulose, povidone, hypromellose, colloidal silicon dioxide and magnesium stearate.
  • No data
  • 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 1,500 mg/kg/day, respectively. These doses are both approximately 3 times the maximum recommended human daily dose of 2,550 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.u00a0 u00a0 u00a0
  • There was no evidence of a mutagenic potential of metformin in the following tests: Ames test (), gene mutation test (mouse lymphoma cells), or chromosomal aberrations test (human lymphocytes). Results in the mouse micronucleus test were also negative.
  • 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 2,550 mg based on body surface area comparisons.
  • A 24-week, double-blind, placebo-controlled study of metformin hydrochloride extended-release tablets, taken once daily with the evening meal, was conducted in patients with type 2 diabetes mellitus who had failed to achieve glycemic control with diet and exercise. Patients entering the study had a mean baseline HbA1c of 8.0% and a mean baseline FPG of 176 mg/dL. The treatment dose was increased to 1,500 mg once daily if at Week 12 HbA1c was u22657.0% but <8.0% (patients with HbA1c u22658.0% were discontinued from the study). At the final visit (24-week), mean HbA1c had increased 0.2% from baseline in placebo patients and decreased 0.6% with metformin hydrochloride extended-release tablets.
  • A 16-week, double-blind, placebo-controlled, dose-response study of metformin hydrochloride extended-release tablets, taken once daily with the evening meal or twice daily with meals, was conducted in patients with type 2 diabetes mellitus who had failed to achieve glycemic control with diet and exercise. The results are shown in Table 6.
  • Mean baseline body weight was 193 lbs, 192 lbs, 188 lbs, 196 lbs, 193 lbs and 194 lbs in the metformin hydrochloride extended-release tablets 500 mg, 1,000 mg, 1,500 mg, and 2,000 mg once daily, 1,000 mg twice daily and placebo arms, respectively. u00a0Mean change in body weight from baseline to week 16 was -1.3 lbs, -1.3 lbs, -0.7 lbs, -1.5 lbs, -2.2 lbs and -1.8 lbs, respectively.
  • A 24-week, double-blind, randomized study of metformin hydrochloride extended-release tablets, taken once daily with the evening meal, and metformin hydrochloride tablets, taken twice daily (with breakfast and evening meal), was conducted in patients with type 2 diabetes mellitus who had been treated with metformin hydrochloride tablets 500 mg twice daily for at least 8 weeks prior to study entry. The results are shown in Table 7.
  • Mean baseline body weight was 210 lbs, 203 lbs and 193 lbs in the metformin hydrochloride tablets 500 mg twice daily, and metformin hydrochloride extended-release tablets 1,000 mg and 1,500 mg once daily arms, respectively. Mean change in body weight from baseline to week 24 was 0.9 lbs, 1.1 lbs and 0.9 lbs, respectively.
  • No data
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • Lactic Acidosis:
  • Explain the risks of lactic acidosis, its symptoms, and conditions that predispose to its development. Advise patients to discontinue metformin hydrochloride extended-release 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 extended-release tablets. Instruct patients to inform their doctor that they are taking metformin hydrochloride extended-release tablets prior to any surgical or radiological procedure, as temporary discontinuation may be required n
  • Hypoglycemia
  • Inform patients that hypoglycemia may occur when metformin hydrochloride extended-release 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
  • Vitamin B Deficiency:
  • Inform patients about importance of regular hematological parameters while receiving metformin hydrochloride extended-release tablets .
  • Females of Reproductive Age:
  • Inform females that treatment with metformin hydrochloride extended-release tablets may result in ovulation in some premenopausal anovulatory women which may lead to unintended pregnancy n
  • Metformin hydrochloride extended-release tablets Administration Information:
  • Inform patients that metformin hydrochloride extended-release tablets must be swallowed whole and not crushed, cut, or chewed, and that the inactive ingredients may occasionally be eliminated in the feces as a soft mass that may resemble the original tablet.
  • Manufacturn- ed for:
  • AlignScience Pharma Inc.
  • Block No.23, No.1 Haizheng Road,
  • Xukou Town, Fuyang,
  • Hangzhou 311404, Zhejiang,
  • China
  • Manufactured by:
  • Haimen Pharma Inc.,
  • No.163, Zhuhai Rd,
  • Binjiang Street, Haimen,
  • Jiangsu 226100, China (CHN)
  • Rev. April 2019
  • Metformin Hydrochloride (met-FOR-min HYE-droe-KLOR-ide) Extended-Release Tablets, USP
  • Read the Patient Information that comes with metformin hydrochloride extended-release 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.
  • What is the most important information I should know about metformin hydrochloride extended-release tablets?
  • Serious side effects can happen in people taking metformin hydrochloride extended-release tablets, including:
  • Lactic Acidosis.
  • Stop taking metformin hydrochloride extended-release tablets and call your healthcare provider right away if you get any of the following symptoms of lactic acidosis:
  • You have a higher chance of getting lactic acidosis if you:
  • What are metformin hydrochloride extended-release tablets?
  • Metformin hydrochloride extended-release tablets works longer in your body. 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.
  • Who should not take metformin hydrochloride extended-release tablets?
  • 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.
  • Do not take metformin hydrochloride extended-release tablets if you:
  • What should I tell my healthcare provider before taking metformin hydrochloride extended-release tablets?
  • Before taking metformin hydrochloride extended-release tablets, tell your healthcare provider if you:
  • Tell your healthcare provider about all the medicines you take,
  • Can metformin hydrochloride extended-release tablets be used in children?
  • Metformin hydrochloride extended-release tablets has not been studied in children.
  • How should I take metformin hydrochloride extended-release tablets?
  • 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:
  • Common side effects of metformin hydrochloride extended-release 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 theyu2019ve 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 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.
  • How should I store metformin hydrochloride extended-release tablets?
  • Store metformin hydrochloride extended-release tablets at 68u00b0F to 77u00b0F (20u00b0C to 25u00b0C).
  • Keep metformin hydrochloride extended-release tablets and all medicines out of the reach of children.
  • General information about the use of metformin hydrochloride extended-release 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 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 it was not prescribed. Do not share your medicine with other people.
  • What are the ingredients of metformin hydrochloride extended-release tablets?
  • Active ingredient of metformin hydrochloride extended-release tablets: metformin hydrochloride.
  • Inactive ingredients in each tablet of metformin hydrochloride extended-release tablets: microcrystalline cellulose, povidone, hypromellose, colloidal silicon dioxide and magnesium stearate.
  • 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.
  • 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, 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.
  • Manufacturn- ed for:
  • AlignScience Pharma Inc.
  • Block No.23, No.1 Haizheng Road,
  • Xukou Town, Fuyang,
  • Hangzhou 311404, Zhejiang,
  • China
  • Manufactured by:
  • Haimen Pharma Inc.,
  • No.163, Zhuhai Rd,
  • Binjiang Street, Haimen,
  • Jiangsu 226100, China (CHN)
  • Rev. April 2019
  • 100 Tablets - NDC 69948-001-05 - METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS - 500 mg - Rx only - AlignScience Pharma Inc.
  • 600 Tablets - NDC 69948-001-12 - METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS - 500 mg - Rx only - AlignScience Pharma Inc.

Ask for Quote

Browse Our Services And Processes

Name Patient Supply

Name Patient Supply

Validated Cold Chain Shipment

Validated Cold Chain Shipment

Comparator Sourcing for Clinical Trials

Comparator Sourcing for Clinical Trials

Our Process - The Gnh Way

Our Process - The Gnh Way

Other Pharmaceutical Products

Apidra  100Iu/ml x 3ml - Insulin Glulisine (Monocomponent Insulin Glulisine )

Apidra 100Iu/ml x 3ml - Insulin Glulisine (Monocomponent Insulin Glulisine )

Paclitaxel - Abraxane

Paclitaxel - Abraxane

Liposomal Amphotericin - B for Injection IP (AmBisome)

Liposomal Amphotericin - B for Injection IP (AmBisome)

Beclomethasone Dipropionate and Levosalbutamol Inhaler (Aerocort)

Beclomethasone Dipropionate and Levosalbutamol Inhaler (Aerocort)

Monobenzone Cream USP 20% (Albaquin)

Monobenzone Cream USP 20% (Albaquin)

Melphalan Injection IP 50mg (Alkacel)

Melphalan Injection IP 50mg (Alkacel)

Are you an existing customer or a vendor of GNH India? Log in here to