Metformin Hydrochloride (Glucophage)

Trade Name : GLUCOPHAGE

Bristol-Myers Squibb Company

TABLET, FILM COATED

Strength 500 mg/1

METFORMIN HYDROCHLORIDE Biguanide [EPC],Biguanides [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Metformin Hydrochloride (Glucophage) which is also known as GLUCOPHAGE and Manufactured by Bristol-Myers Squibb Company. It is available in strength of 500 mg/1 per ml. Read more

Metformin Hydrochloride (Glucophage) 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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No data

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 ].
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 GLUCOPHAGE or GLUCOPHAGE XR and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended [see ].
WARNING: LACTIC ACIDOSISn n

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. ()
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. ()
If lactic acidosis is suspected, discontinue GLUCOPHAGE/ GLUCOPHAGE XR and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended. ()

GLUCOPHAGE is 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.GLUCOPHAGE XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
GLUCOPHAGE is a 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 GLUCOPHAGE XR is a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. n

Adult Dosage for GLUCOPHAGE
Adult Dosage for GLUCOPHAGE XR
Pediatric Dosage for GLUCOPHAGE
Renal Impairment
u00a0u00a0u00a0u00a0 ou00a0 Do not use in patients with eGFR below 30 mL/minute/1.73 mn n u00a0u00a0u00a0u00a0 ou00a0 Initiation is not recommended in patients with eGFR between 30-45 mL/minute/1.73 mn n u00a0u00a0u00a0u00a0 ou00a0 Assess risk/benefit of continuing if eGFR falls below 45 mL/minute/1.73 mn n u00a0u00a0u00a0u00a0 ou00a0 Discontinue if eGFR falls below 30 mL/minute/1.73 mn n
Discontinuation for Iodinated Contrast Imaging Procedures

GLUCOPHAGE is available as:
GLUCOPHAGE XR is available as:

GLUCOPHAGE and GLUCOPHAGE XR are contraindicated in patients with:

No data

For GLUCOPHAGE/GLUCOPHAGE XR, the most common adverse reactions (>5.0%) are diarrhea, nausea/vomiting, flatulence, asthenia, indigestion, abdominal discomfort, and headache. ()
To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.

The following adverse reactions are also discussed elsewhere in the labeling:

No data

Table 3 presents clinically significant drug interactions with GLUCOPHAGE/GLUCOPHAGE XR.

No data

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 ]. 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.

GLUCOPHAGE/GLUCOPHAGE XR 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:u00a0u00a0u00a0
Metformin hydrochloride 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 pK of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68.GLUCOPHAGE tablets contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients povidone and magnesium stearate. In addition, the coating for the 500 mg and 850 mg tablets contains hypromellose and the coating for the 1000 mg tablet contains hypromellose and polyethylene glycol.
GLUCOPHAGE XR contains 500 mg or 750 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 584.90 mg metformin base, respectively.GLUCOPHAGE XR 500 mg tablets contain the inactive ingredients hypromellose, microcrystalline cellulose, sodium carboxymethyl cellulose, and magnesium stearate.GLUCOPHAGE XR 750 mg tablets contain the inactive ingredients hypromellose, sodium carboxymethyl cellulose, magnesium stearate and iron oxide pigment red.

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 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 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 2550 mg based on body surface area comparisons.

No data

No data

Advise the patient to read the FDA-approved patient labeling (Patient Information).n n Explain the risks of lactic acidosis, its symptoms, and conditions that predispose to its development. Advise patients to discontinue GLUCOPHAGE/GLUCOPHAGE XR 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 GLUCOPHAGE/GLUCOPHAGE XR. Instruct patients to inform their doctor that they are taking GLUCOPHAGE/GLUCOPHAGE XR prior to any surgical or radiological procedure, as temporary discontinuation may be required [see ()].
Hypoglycemia:n- Array
Vitamin B Deficiency:n- Array
Females of Reproductive Age:n- Array
GLUCOPHAGE XR Administration Information:
Distributed by:Bristol-Myers Squibb CompanyPrinceton, NJ 08543 USAGLUCOPHAGEu00ae is a registered trademark of Merck Santu00e9 S.A.S., a subsidiary of Merck KGaA of Darmstadt, Germany, licensed to Bristol-Myers Squibb Company.

PATIENT INFORMATION GLUCOPHAGE [gloo-ku014d-fahzh] (metformin hydrochloride) Tablets and GLUCOPHAGE XR [gloo-ku014d-fahzh X-R](metformin hydrochloride) Extended-Release Tablets
Read the Patient Information that comes with GLUCOPHAGE and GLUCOPHAGE XR 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.n n n n
Lactic Acidosis. n- Array
u00a0You have a higher chance of getting lactic acidosis if you:
What are GLUCOPHAGE and GLUCOPHAGE XR?
Who should not take GLUCOPHAGE or GLUCOPHAGE XR?
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.u200bu200b
Do not take GLUCOPHAGE or GLUCOPHAGE XR if you:
What should I tell my healthcare provider before taking GLUCOPHAGE or GLUCOPHAGE XR?
Before taking GLUCOPHAGE or GLUCOPHAGE XR, tell your healthcare provider if you:
Tell your healthcare provider about all the medicines you take,
Can GLUCOPHAGE or GLUCOPHAGE XR be used in children?
GLUCOPHAGE has been shown to effectively lower glucose levels in children (ages 10-16 years) with type 2 diabetes. GLUCOPHAGE has not been studied in children younger than 10 years old. GLUCOPHAGE has not been studied in combination with other oral glucose-control medicines or insulin in children. If you have any questions about the use of GLUCOPHAGE in children, talk with your doctor or other healthcare provider.GLUCOPHAGE XR has not been studied in children.
How should I take GLUCOPHAGE or GLUCOPHAGE XR?
What should I avoid while taking GLUCOPHAGE or GLUCOPHAGE XR?
Do not drink a lot of alcoholic drinks while taking GLUCOPHAGE or GLUCOPHAGE XR. 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 GLUCOPHAGE and GLUCOPHAGE XR?
u00a0Call 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 GLUCOPHAGE or GLUCOPHAGE XR if you:
Common side effects of GLUCOPHAGE and GLUCOPHAGE XR 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 GLUCOPHAGE or GLUCOPHAGE XR have an unpleasant metallic taste when they start taking the medicine. It lasts for a short time.
GLUCOPHAGE and GLUCOPHAGE XR 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 GLUCOPHAGE and GLUCOPHAGE XR?n- Keep GLUCOPHAGE and GLUCOPHAGE XR and all medicines out of the reach of children.
General information about the use of GLUCOPHAGE and GLUCOPHAGE XR
What are the ingredients of GLUCOPHAGE and GLUCOPHAGE XR?
Active ingredients of GLUCOPHAGE: metformin hydrochloride.
Inactive ingredients in each tablet of GLUCOPHAGE: povidone and magnesium stearate. In addition, the coating for the 500 mg and 850 mg tablets contain hypromellose and the coating for the 1000 mg tablet contains hypromellose and polyethylene glycol.
Active ingredients of GLUCOPHAGE XR: metformin hydrochloride.
Inactive ingredients in each tablet of GLUCOPHAGE XR 500 mg: sodium carboxymethyl cellulose, hypromellose, microcrystalline cellulose, and magnesium stearate.
Inactive ingredients in each tablet of GLUCOPHAGE XR 750 mg: sodium carboxymethyl cellulose, hypromellose, and magnesium stearate.
What is type 2 diabetes?
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.
GLUCOPHAGE is a registered trademark of Merck Santu00e9 S.A.S., a subsidiary of Merck KGaA of Darmstadt, Germany, licensed to Bristol-Myers Squibb Company.
Other brands listed are the trademarks of their respective owners.

-----------------------------------------n- REPRESENTATIVE PACKAGING
See section for a complete list of available packages of GLUCOPHAGE and GLUCOPHAGE XR.
100 TabletsNDC 0087-6060-05
GLUCOPHAGEu00ae(metformin hydrochloride) TabletsRx only500 mgBristol-Myers Squibb

100 TabletsNDC 0087-6070-05GLUCOPHAGEn (metformin hydrochloride) TabletsRx only850 mgBristol-Myers Squibb

100 TabletsNDC 0087-6071-11GLUCOPHAGEn (metformin hydrochloride) TabletsRx only1000 mgBristol-Myers Squibb

100 TabletsNDC 0087-6063-13GLUCOPHAGEXR(metformin HCl) Extended-Release Tablets500 mgRx onlyBristol-Myers Squibb

100 TabletsNDC 0087-6064-13GLUCOPHAGEu00aeXR(metformin HCl) Extended-Release Tablets750 mgRx onlyBristol-Myers Squibb

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Metformin Hydrochloride (Glucophage)

Trade Name : GLUCOPHAGE

TABLET, FILM COATED

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Metformin Hydrochloride (Glucophage)

Trade Name : GLUCOPHAGE

TABLET, FILM COATED

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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Disclaimer

Browse from other international pharmaceuticals

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US NDC

Canadian DIN

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