Metformin Hydrochloride (Metformin Hydrochloride)

Trade Name : metformin hydrochloride

Eon Labs, Inc.

TABLET, EXTENDED RELEASE

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 (Metformin Hydrochloride) which is also known as metformin hydrochloride and Manufactured by Eon Labs, Inc.. It is available in strength of 500 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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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 metformin hydrochloride or metformin hydrochloride extended release 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 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. (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/ metformin hydrochloride extended release and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended. (5.1)

No data

Adult Dosage for Metformin Hydrochloride:
Adult Dosage for Metformin Hydrochloride Extended Release:
Pediatric Dosage for Metformin Hydrochloride:
Renal Impairment:
Discontinuation for Iodinated Contrast Imaging Procedures:

Metformin hydrochloride is available as:
Metformin hydrochloride extended release is available as:

Metformin hydrochloride and metformin hydrochloride extended release are contraindicated in patients with:

4n- 5.1

No data

Lactic Acidosis:
Vitamin B Deficiency:
Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues:

The following adverse reactions are also discussed elsewhere in the labeling:
For metformin hydrochloride/metformin hydrochloride extended release, the most common adverse reactions (>5.0%) are diarrhea, nausea/vomiting, flatulence, asthenia, indigestion, abdominal discomfort, and headache. (6.1)

Table 3

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.

Metformin hydrochloride tablets, USP and Metformin hydrochloride extended-release tablets, USP are oral antihyperglycemic, which are biguanides, in the form of monohydrochlorides. 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 pK of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68.
Metformin hydrochloride tablets, USP contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride. In addition, each tablet contains the following inactive ingredients: hypromellose, magnesium stearate, polyethylene glycol, and povidone. In addition, 500 mg also contains colloidal silicon dioxide.
Metformin hydrochloride extended-release tablets, USP, 500 mg contain metformin hydrochloride as the active ingredient. In addition, each tablet contains the following inactive ingredients: carboxy methylcellulose sodium, colloidal silicon dioxide, hypromellose, magnesium stearate, and microcrystalline cellulose.

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).
Lactic Acidosis
Explain the risks of lactic acidosis, its symptoms, and conditions that predispose to its development. Advise patients to discontinue metformin hydrochloride/metformin hydrochloride extended release 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/metformin hydrochloride extended release. Instruct patients to inform their doctor that they are taking metformin hydrochloride/metformin hydrochloride extended release prior to any surgical or radiological procedure, as temporary discontinuation may be required n
Hypoglycemia
Inform patients that hypoglycemia may occur when metformin hydrochloride/metformin hydrochloride extended release 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 B12 Deficiency
Inform patients about importance of regular hematological parameters while receiving metformin hydrochloride/metformin hydrochloride extended release .
Females of Reproductive Age
Inform females that treatment with metformin hydrochloride/metformin hydrochloride extended release may result in ovulation in some premenopausal anovulatory women which may lead to unintended pregnancy n
Metformin Hydrochloride Extended Release Administration Information
Inform patients that metformin hydrochloride extended release 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.
Metformin hydrochloride tablets, USP, 500 mg, 850 mg, and 1000 mg are manufactured
by Epic Pharma, LLC
for Sandoz Inc.
Princeton, NJ 08540
Metformin hydrochloride extended-release tablets, USP, 500 mg are manufactured
by Cipla, Ltd.
Kurkumbh, India
for Sandoz Inc.
Princeton, NJ 08540

Metformin Hydrochloride Tablets, USP
and
Metformin Hydrochloride Extended Release Tablets, USP
(met FOR min)
Read the Patient Information that comes with metformin hydrochloride tablets and 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 tablets and metformin hydrochloride extended release tablets?
Serious side effects can happen in people taking metformin hydrochloride tablets or metformin hydrochloride extended release tablets, including:
Lactic Acidosis.
Stop taking metformin hydrochloride tablets or 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 tablets and metformin hydrochloride extended release tablets?
Who should not take metformin hydrochloride tablets or 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 tablets or metformin hydrochloride extended release tablets if you:
What should I tell my healthcare provider before taking metformin hydrochloride tablets or metformin hydrochloride extended release tablets?
Before taking metformin hydrochloride tablets or metformin hydrochloride extended release tablets, tell your healthcare provider if you:
Tell your healthcare provider about all the medicines you take,
Can metformin hydrochloride tablets or metformin hydrochloride extended release tablets be used in children?
Metformin hydrochloride tablets have been shown to effectively lower glucose levels in children (ages 10 to 16 years) with type 2 diabetes. Metformin hydrochloride tablets have not been studied in children younger than 10 years old. Metformin hydrochloride tablets have not been studied in combination with other oral glucose-control medicines or insulin in children. If you have any questions about the use of metformin hydrochloride tablets in children, talk with your doctor or other healthcare provider.
Metformin hydrochloride extended release tablets have not been studied in children.
How should I take metformin hydrochloride tablets or metformin hydrochloride extended release tablets?
What should I avoid while taking metformin hydrochloride tablets or metformin hydrochloride extended release tablets?
Do not drink a lot of alcoholic drinks while taking metformin hydrochloride tablets or 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 tablets and 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 tablets or metformin hydrochloride extended release tablets if you:
Common side effects of metformin hydrochloride tablets and 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 tablets or metformin hydrochloride extended release tablets have an unpleasant metallic taste when they start taking the medicine. It lasts for a short time.
Metformin hydrochloride tablets and 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 tablets and metformin hydrochloride extended release tablets?
Store metformin hydrochloride tablets and metformin hydrochloride extended release tablets at 68u00b0F to 77u00b0F (20u00b0C to 25u00b0C).
KEEP OUT OF THE REACH OF CHILDREN.
General information about the use of metformin hydrochloride tablets and 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 tablets and 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 tablets or metformin hydrochloride extended release tablets for a condition for which they were not prescribed. Do not share your medicine with other people.
What are the ingredients of metformin hydrochloride tablets and metformin hydrochloride extended release tablets?
Active ingredients: metformin hydrochloride.
Inactive ingredients in each tablet of metformin hydrochloride tablets: hypromellose, magnesium stearate, polyethylene glycol, and povidone. In addition, 500 mg also contains colloidal silicon dioxide.
Inactive ingredients in each tablet of metformin hydrochloride extended release tablets: carboxy methylcellulose sodium, colloidal silicon dioxide, hypromellose, magnesium stearate, and microcrystalline cellulose.
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.
Metformin hydrochloride tablets, USP, 500 mg, 850 mg, and 1000 mg are manufactured
by Epic Pharma, LLC
for Sandoz Inc.
Princeton, NJ 08540
Metformin hydrochloride extended-release tablets, USP, 500 mg are manufactured
by Cipla, Ltd.
Kurkumbh, India
for Sandoz Inc.
Princeton, NJ 08540

NDC 0185-4416-01
Metformin
Hydrochloride
Extended-Release
Tablets USP
500 mg
Rx only
100 Tablets
Sandoz

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Metformin Hydrochloride (Metformin Hydrochloride)

Trade Name : metformin hydrochloride

TABLET, EXTENDED RELEASE

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 (Metformin Hydrochloride)

Trade Name : metformin hydrochloride

TABLET, EXTENDED RELEASE

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)

Browse Our Services And Processes

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