Metformin 850mg Tablets

Manufacturer AUROBINDO PHARMA Active Ingredient Metformin Tablets(met FOR min) Pronunciation met FOR min
WARNING: Rarely, metformin may cause too much lactic acid in the blood (lactic acidosis). The risk is higher in people who have kidney problems, liver problems, heart failure, use alcohol, or take certain other drugs, including topiramate. The risk is also higher in people who are 65 or older and in people who are having surgery, an exam or test with contrast, or other procedures. If lactic acidosis happens, it can lead to other health problems and can be deadly. Kidney tests may be done while taking this drug.Do not take this drug if you have a very bad infection, low oxygen, or a lot of fluid loss (dehydration).Call your doctor right away if you have signs of too much lactic acid in the blood (lactic acidosis) like confusion; fast breathing; fast or slow heartbeat; a heartbeat that does not feel normal; very bad stomach pain, upset stomach, or throwing up; feeling very sleepy; shortness of breath; feeling very tired or weak; very bad dizziness; feeling cold; or muscle pain or cramps. @ COMMON USES: It is used to lower blood sugar in patients with high blood sugar (diabetes).
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Drug Class
Antidiabetic agent
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Pharmacologic Class
Biguanide
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Pregnancy Category
Not available
FDA Approved
Dec 1995
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Metformin is a medicine used to help control high blood sugar levels in people with type 2 diabetes. It works by helping your body use insulin more effectively, reducing the amount of sugar your liver makes, and decreasing the amount of sugar your body absorbs from food.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. It's recommended to take this medication with meals.

Continue taking your medication as instructed by your doctor or healthcare provider, even if you start to feel better. This will help ensure that you receive the full benefits of the treatment.

Storing and Disposing of Your Medication

To maintain the effectiveness and safety of your medication, store it at room temperature, protected from light. Keep it in a dry place, avoiding storage in a bathroom. It's essential to keep all medications in a secure location, out of the reach of children and pets.

What to Do If You Miss a Dose

If you miss a dose, skip it and resume your regular dosing schedule unless your doctor advises you to do otherwise. Do not take two doses at the same time or take extra doses, as this can increase the risk of side effects.
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Lifestyle & Tips

  • Maintain a balanced diet as recommended by your doctor or dietitian.
  • Engage in regular physical activity (e.g., 30 minutes of moderate exercise most days of the week).
  • Limit alcohol intake, as excessive alcohol can increase the risk of a serious side effect called lactic acidosis.
  • Monitor your blood sugar levels regularly as instructed by your healthcare provider.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial: 500 mg twice daily or 850 mg once daily with meals. Titrate gradually. Maintenance: 850 mg twice daily or 1000 mg twice daily with meals.
Dose Range: 500 - 2550 mg

Condition-Specific Dosing:

Type 2 Diabetes Mellitus: Initial: 500 mg twice daily or 850 mg once daily with meals. Increase by 500 mg weekly or 850 mg every 2 weeks as tolerated. Max: 2550 mg/day (IR) or 2000 mg/day (ER).
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: 10-16 years: Initial 500 mg twice daily with meals. Increase by 500 mg weekly as tolerated. Max: 2000 mg/day in divided doses.
Adolescent: 17 years and older: Same as adult dosing.
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Dose Adjustments

Renal Impairment:

Mild: eGFR 60-89 mL/min/1.73m²: No dose adjustment needed. Monitor eGFR annually.
Moderate: eGFR 45-59 mL/min/1.73m²: Initial dose should not exceed half of the maximum recommended dose (e.g., 1000 mg/day). Max dose 1700 mg/day. Monitor eGFR every 3-6 months. eGFR 30-44 mL/min/1.73m²: Not recommended to initiate. If already on metformin, reduce dose by 50% (e.g., max 1000 mg/day) and monitor eGFR every 3 months. Discontinue if eGFR falls below 30 mL/min/1.73m².
Severe: eGFR < 30 mL/min/1.73m²: Contraindicated.
Dialysis: Contraindicated in patients with end-stage renal disease (ESRD) or on dialysis due to accumulation and increased risk of lactic acidosis.

Hepatic Impairment:

Mild: Use with caution. Monitor liver function.
Moderate: Generally not recommended due to increased risk of lactic acidosis.
Severe: Contraindicated due to increased risk of lactic acidosis.

Pharmacology

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Mechanism of Action

Metformin is a biguanide that decreases hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis. It also decreases intestinal absorption of glucose and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. It does not stimulate insulin secretion and therefore does not cause hypoglycemia.
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Pharmacokinetics

Absorption:

Bioavailability: 50-60%
Tmax: 2-3 hours (immediate-release)
FoodEffect: Food decreases the extent and slightly delays the absorption of metformin.

Distribution:

Vd: 654 ± 358 L
ProteinBinding: <5%
CnssPenetration: Limited

Elimination:

HalfLife: Plasma elimination half-life is approximately 6.2 hours; blood half-life is approximately 17.6 hours.
Clearance: Renal clearance is approximately 3.5 times greater than creatinine clearance, indicating tubular secretion.
ExcretionRoute: Renal (primarily unchanged)
Unchanged: >90%
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Pharmacodynamics

OnsetOfAction: Days to weeks for full glucose-lowering effect
PeakEffect: Typically within 2-3 weeks of stable dosing
DurationOfAction: Approximately 12 hours (immediate-release)

Safety & Warnings

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BLACK BOX WARNING

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 distress. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (>5 mmol/L), anion gap acidosis (without evidence of ketonuria or ketonemia), and an increased lactate/pyruvate ratio; metformin plasma levels generally >5 mcg/mL. If metformin-associated lactic acidosis is suspected, discontinue GLUCOPHAGE and institute general supportive measures promptly in a hospital setting. Prompt hemodialysis is recommended. Risk factors include renal impairment, concomitant use of certain drugs (e.g., carbonic anhydrase inhibitors), age 65 years or greater, radiological studies with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, and hepatic impairment.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Stomach problems that occur later during treatment, which may be a sign of lactic acidosis (an acid health problem in the blood)
Low blood sugar, which can be characterized by:
+ Dizziness
+ Headache
+ Feeling sleepy or weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating

If you experience low blood sugar, follow your doctor's instructions for managing the condition, which may include taking glucose tablets, liquid glucose, or some fruit juices.

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they bother you or do not go away:

Stomach pain or heartburn
Gas
Diarrhea, upset stomach, or vomiting
Feeling tired or weak
Headache

This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Signs of lactic acidosis: unusual muscle pain, trouble breathing, unusual sleepiness, stomach pain, nausea, vomiting, feeling cold, dizziness, lightheadedness, or a slow/irregular heartbeat. Seek immediate medical attention.
  • Signs of vitamin B12 deficiency: unusual tiredness, weakness, numbness or tingling in hands or feet, sore tongue, or memory problems.
  • Severe or persistent diarrhea, nausea, or vomiting (especially if new or worsening).
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, other medications, foods, or substances. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, such as:
+ Acidic blood problems
+ Kidney disease
+ Liver disease
Recent medical events, including:
+ A heart attack
+ A stroke
Any difficulties with eating or drinking, including situations where you may be required to fast before a procedure or surgery.
* Upcoming or recent medical exams or tests that involve contrast agents, particularly if you have had one within the past 48 hours.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before consuming alcohol, discuss the potential risks with your doctor.

If you experience low blood sugar, do not operate a vehicle, as this can increase your risk of being involved in an accident. Monitor your blood sugar levels as instructed by your doctor. Additionally, have your blood work checked as directed by your doctor and discuss the results with them.

Be aware that stress, such as fever, infection, injury, or surgery, can make it more challenging to control your blood sugar levels. Changes in physical activity, exercise, or diet can also impact your blood sugar. Adhere to the diet and exercise plan recommended by your doctor to maintain optimal blood sugar control.

If you experience diarrhea or vomiting, contact your doctor promptly, as you may need to increase your fluid intake to prevent excessive fluid loss. In hot weather or during physical activity, be cautious and drink plenty of fluids to avoid dehydration.

Long-term treatment with metformin may lead to a decrease in vitamin B-12 levels. If you have a history of low vitamin B-12 levels, consult with your doctor.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

For individuals of childbearing age who have not been ovulating, there is a potential risk of pregnancy. To avoid pregnancy, use birth control while taking this medication. If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the benefits and risks to you and your baby.
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Overdose Information

Overdose Symptoms:

  • Lactic acidosis (most serious and common symptom)
  • Hypoglycemia (rare with metformin monotherapy, but possible with co-ingestion of other antidiabetic agents or alcohol)
  • Severe gastrointestinal upset

What to Do:

Call 911 or your local emergency number immediately. For poison control, call 1-800-222-1222. Treatment for lactic acidosis involves immediate hospitalization, general supportive measures, and prompt hemodialysis to remove metformin and correct acidosis.

Drug Interactions

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Contraindicated Interactions

  • Iodinated contrast agents (temporarily discontinue metformin at the time of or prior to the procedure and for 48 hours after, and restart only after renal function has been re-evaluated and found to be normal).
  • Alcohol (acute or chronic excessive intake due to increased risk of lactic acidosis).
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Major Interactions

  • Carbonic anhydrase inhibitors (e.g., topiramate, zonisamide, acetazolamide, dichlorphenamide) - may increase risk of lactic acidosis.
  • Drugs that reduce metformin clearance (e.g., cimetidine, ranolazine, dolutegravir, isavuconazole, trimethoprim, vandetanib) - may increase metformin levels and risk of lactic acidosis.
  • Drugs that affect renal function (e.g., NSAIDs, ACE inhibitors, ARBs, diuretics) - may increase risk of lactic acidosis by impairing renal function.
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Moderate Interactions

  • Cationic drugs (e.g., amiloride, digoxin, morphine, procainamide, quinidine, quinine, triamterene, trimethoprim, vancomycin) - may compete for renal tubular transport, potentially increasing metformin levels.
  • Nifedipine - may increase metformin absorption and Cmax.
  • Furosemide - may increase metformin plasma and blood Cmax without altering renal clearance.
  • Glucocorticoids, sympathomimetics, diuretics, thyroid products, phenothiazines, oral contraceptives, phenytoin, nicotinic acid, calcium channel blockers, isoniazid - may cause hyperglycemia, requiring dose adjustment of metformin.
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Renal function (eGFR)

Rationale: To assess baseline kidney function and determine appropriate dosing, as metformin is renally excreted and accumulation can lead to lactic acidosis.

Timing: Prior to initiation of therapy

HbA1c

Rationale: To establish baseline glycemic control.

Timing: Prior to initiation of therapy

Vitamin B12 levels

Rationale: Long-term metformin use can be associated with decreased vitamin B12 levels.

Timing: Consider baseline, especially in patients at risk for deficiency

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Routine Monitoring

Renal function (eGFR)

Frequency: At least annually; more frequently (every 3-6 months) in elderly, renally impaired, or those at risk for renal impairment.

Target: >60 mL/min/1.73m² (ideally)

Action Threshold: Discontinue if eGFR falls below 30 mL/min/1.73m²; re-evaluate dose if eGFR 30-59 mL/min/1.73m².

HbA1c

Frequency: Every 3-6 months

Target: Individualized, typically <7%

Action Threshold: If target not met, consider dose adjustment or addition of other antidiabetic agents.

Blood glucose (fasting and postprandial)

Frequency: Daily to weekly, depending on patient and treatment goals

Target: Individualized (e.g., FBG 80-130 mg/dL, PPG <180 mg/dL)

Action Threshold: Persistent hyperglycemia or hypoglycemia (rare with metformin monotherapy).

Vitamin B12 levels

Frequency: Periodically (e.g., every 1-2 years) in patients on long-term therapy or with symptoms of deficiency.

Target: Normal range

Action Threshold: Supplement if levels are low or symptoms of deficiency (e.g., anemia, neuropathy) develop.

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Symptom Monitoring

  • Symptoms of lactic acidosis (malaise, myalgia, respiratory distress, somnolence, abdominal distress, hypothermia, hypotension, resistant bradyarrhythmias)
  • Symptoms of vitamin B12 deficiency (fatigue, weakness, numbness/tingling, memory problems, anemia)
  • Gastrointestinal side effects (nausea, vomiting, diarrhea, abdominal discomfort, metallic taste)

Special Patient Groups

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Pregnancy

Metformin crosses the placenta. While some studies suggest it may be used in gestational diabetes or type 2 diabetes during pregnancy, insulin is generally the preferred agent for glycemic control in pregnancy. Use should be based on a careful risk-benefit assessment by the healthcare provider.

Trimester-Specific Risks:

First Trimester: Limited data, but no clear evidence of increased risk of major birth defects.
Second Trimester: May be considered for glycemic control, but insulin is often preferred.
Third Trimester: May be considered, but close monitoring of maternal and fetal well-being is essential.
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Lactation

Metformin is excreted into breast milk in small amounts. The amount ingested by the infant is generally considered low and unlikely to cause adverse effects in healthy, full-term infants. Monitor breastfed infants for signs of hypoglycemia or gastrointestinal upset. Considered L3 (moderately safe) by some sources.

Infant Risk: Low risk for healthy, full-term infants. Monitor for hypoglycemia or GI upset.
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Pediatric Use

Approved for use in children 10 years of age and older with type 2 diabetes. Dosing should be carefully titrated, and renal function monitored, similar to adults.

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Geriatric Use

Use with caution in elderly patients due to increased likelihood of decreased renal function. Renal function should be assessed more frequently in this population. The risk of lactic acidosis increases with age and impaired renal function.

Clinical Information

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Clinical Pearls

  • Metformin is typically the first-line pharmacologic agent for type 2 diabetes, especially in overweight or obese patients, due to its efficacy, low risk of hypoglycemia, and potential for weight neutrality or modest weight loss.
  • Gastrointestinal side effects (nausea, diarrhea, abdominal discomfort) are common, especially at initiation. These can often be minimized by starting with a low dose, titrating slowly, and taking the medication with meals.
  • Extended-release (ER) formulations may improve GI tolerability.
  • Patients should be educated on the symptoms of lactic acidosis and instructed to seek immediate medical attention if they occur.
  • Temporarily discontinue metformin before or at the time of iodinated contrast imaging procedures and for 48 hours after, restarting only after renal function has been re-evaluated and found to be normal.
  • Long-term metformin use can lead to vitamin B12 deficiency; consider periodic monitoring and supplementation if needed, especially in patients with neuropathy or anemia.
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Alternative Therapies

  • Sulfonylureas (e.g., glipizide, glyburide, glimepiride)
  • DPP-4 inhibitors (e.g., sitagliptin, saxagliptin)
  • SGLT2 inhibitors (e.g., empagliflozin, canagliflozin, dapagliflozin)
  • GLP-1 receptor agonists (e.g., liraglutide, semaglutide)
  • Thiazolidinediones (e.g., pioglitazone, rosiglitazone)
  • Insulin
  • Alpha-glucosidase inhibitors (e.g., acarbose, miglitol)
  • Meglitinides (e.g., repaglinide, nateglinide)
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 30 tablets (850mg IR)
Generic Available: Yes
Insurance Coverage: Tier 1 (Preferred Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.