Metformin 1000mg 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 people with type 2 diabetes control their blood sugar. It works by reducing the amount of sugar your liver makes, decreasing how much sugar your body absorbs from food, and making your body more sensitive to insulin. It's often the first medicine prescribed for type 2 diabetes.
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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. It's essential to complete the full course of treatment as prescribed.

Storing and Disposing of Your Medication

To maintain the effectiveness and safety of your medication, store it at room temperature, away from direct light. Keep it in a dry place, avoiding storage in a bathroom. Ensure that all medications are kept 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 to make up for the missed one.
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Lifestyle & Tips

  • Take metformin with food to reduce stomach upset.
  • Follow a healthy diet plan as recommended by your doctor or dietitian.
  • Engage in regular physical activity as advised by your healthcare provider.
  • Limit alcohol intake, as it can increase the risk of a serious side effect called lactic acidosis.
  • Stay well-hydrated, especially during illness or strenuous exercise.

Dosing & Administration

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Adult Dosing

Standard Dose: 1000 mg twice daily with meals (extended-release up to 2000 mg once daily)
Dose Range: 500 - 2550 mg

Condition-Specific Dosing:

Type 2 Diabetes Mellitus (Immediate-Release): Initial: 500 mg twice daily or 850 mg once daily with meals. Titrate by 500 mg weekly or 850 mg every 2 weeks to a maximum of 2550 mg/day in divided doses.
Type 2 Diabetes Mellitus (Extended-Release): Initial: 500 mg or 1000 mg once daily with the evening meal. Titrate by 500 mg weekly to a maximum of 2000-2500 mg/day once daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (approved for ≥10 years)
Adolescent: ≥10 years: Initial 500 mg twice daily with meals. Titrate by 500 mg weekly to a maximum of 2000 mg/day in divided doses.
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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 1000 mg/day. Max dose 2000 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% (max 1000 mg/day). Monitor eGFR every 3 months.
Severe: eGFR <30 mL/min/1.73m²: Contraindicated.
Dialysis: Contraindicated in patients on dialysis due to increased risk of lactic acidosis.

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Metformin is a biguanide that improves glycemic control by decreasing hepatic glucose production, decreasing intestinal absorption of glucose, and improving insulin sensitivity by increasing peripheral glucose uptake and utilization. It does not stimulate insulin secretion and therefore does not cause hypoglycemia when used alone.
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Pharmacokinetics

Absorption:

Bioavailability: 50-60% (oral, immediate-release)
Tmax: 2-3 hours (immediate-release); 7 hours (extended-release)
FoodEffect: Food decreases the extent and slightly delays the absorption of metformin.

Distribution:

Vd: 654 L (average in healthy subjects)
ProteinBinding: <5%
CnssPenetration: Limited

Elimination:

HalfLife: 6.2 hours (plasma); 17.6 hours (blood)
Clearance: Renal clearance is approximately 3.5 times higher than creatinine clearance, indicating tubular secretion.
ExcretionRoute: Renal
Unchanged: >90%
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Pharmacodynamics

OnsetOfAction: Days to weeks for full glucose-lowering effect
PeakEffect: Variable, typically within 2-3 weeks of stable dosing
DurationOfAction: Approximately 12 hours (immediate-release); 24 hours (extended-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 were generally >5 mcg/mL. If metformin-associated lactic acidosis is suspected, discontinue metformin and institute general supportive measures promptly in a hospital setting. Prompt hemodialysis is recommended. 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 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.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when 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 may be more likely when this medication is used with other diabetes medications. Symptoms of low blood sugar may include:
+ Dizziness
+ Headache
+ Feeling sleepy or weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating

If you experience any of these symptoms, call your doctor right away. Follow your doctor's instructions for managing low blood sugar, 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. Many people may not experience any side effects or may only have mild side effects. However, if you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:

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

This is not a complete list of possible side effects. If you have questions or concerns about side effects, contact 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:

  • Unusual muscle pain (not related to exercise)
  • Feeling very tired or sleepy (somnolence)
  • Trouble breathing or shortness of breath
  • Stomach pain, nausea, vomiting, or diarrhea
  • Feeling cold, especially in your hands or feet
  • Slow or irregular heartbeat
  • Feeling dizzy or lightheaded
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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, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
Certain health conditions, including:
+ Acidic blood problems
+ Kidney disease
+ Liver disease
Recent medical events, such as a heart attack or stroke
Any difficulties with eating or drinking, including situations where you may be required to fast before a procedure or surgery
* Upcoming or recent 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 issues 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 adjust 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, avoid driving, as it increases the risk of accidents. Monitor your blood sugar levels as instructed by your doctor. Additionally, follow your doctor's recommendations for regular blood tests to ensure your health is not affected.

Be aware that stress, such as fever, infection, injury, or surgery, can impact your blood sugar control. Changes in physical activity, exercise, or diet can also affect your blood sugar levels. 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 fluid intake to prevent excessive fluid loss. In hot weather or during physical activity, drink plenty of fluids to avoid dehydration.

Long-term use of metformin may lead to low vitamin B-12 levels. If you have a history of low vitamin B-12 levels, consult your doctor. Individuals 65 years or older should use this medication with caution, as they may be more susceptible to side effects.

Women of childbearing age who have not been ovulating may be at risk of pregnancy while taking this medication. To avoid pregnancy, use birth control measures while taking this drug. If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks with your doctor to ensure the best possible outcome for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Lactic acidosis (severe metabolic acidosis with elevated lactate levels)
  • Hypoglycemia (rare when used alone, but possible with co-ingestion of other agents or in specific conditions)
  • Severe gastrointestinal upset

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment involves supportive care, correction of acidosis, and hemodialysis to remove metformin and lactate from the blood.

Drug Interactions

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Contraindicated Interactions

  • Iodinated contrast agents (temporarily discontinue metformin at the time of or prior to the procedure in patients with an eGFR between 30 and 60 mL/min/1.73 m2; in patients with a history of liver disease, alcoholism, or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure; restart metformin if renal function is stable.)
  • Severe renal impairment (eGFR <30 mL/min/1.73m²)
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Major Interactions

  • Alcohol (increases risk of lactic acidosis)
  • Carbonic anhydrase inhibitors (e.g., topiramate, zonisamide, acetazolamide, dichlorphenamide - may increase risk of lactic acidosis)
  • Cimetidine (increases metformin plasma concentration by decreasing renal clearance)
  • Drugs that reduce metformin clearance (e.g., ranolazine, vandetanib, dolutegravir, cimetidine, isavuconazole, trimethoprim, or crizotinib - may increase metformin accumulation and risk of lactic acidosis)
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Moderate Interactions

  • Diuretics (thiazide and loop diuretics - may increase blood glucose, requiring metformin dose adjustment)
  • Corticosteroids (systemic and inhaled - may increase blood glucose, requiring metformin dose adjustment)
  • Sympathomimetics (e.g., decongestants, bronchodilators - may increase blood glucose)
  • Phenothiazines (may increase blood glucose)
  • Niacin (may increase blood glucose)
  • Calcium channel blockers (some may affect glucose control)
  • Thyroid products (may affect glucose control)
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Minor Interactions

  • Not specifically categorized as minor, but general caution with drugs affecting glucose levels.

Monitoring

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Baseline Monitoring

Renal function (eGFR)

Rationale: To assess kidney function and determine appropriate dosing, as metformin is renally eliminated and contraindicated in severe renal impairment.

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 has been associated with decreased vitamin B12 levels.

Timing: Prior to initiation, especially in patients at risk for B12 deficiency.

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Routine Monitoring

HbA1c

Frequency: Every 3-6 months

Target: Individualized, typically <7% for most adults

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

Renal function (eGFR)

Frequency: At least annually; more frequently (every 3-6 months) in patients with eGFR 30-59 mL/min/1.73m² or those at risk for renal impairment.

Target: >60 mL/min/1.73m² for full dose; adjust or discontinue based on guidelines.

Action Threshold: If eGFR falls below 45 mL/min/1.73m², reassess dose; if below 30 mL/min/1.73m², discontinue.

Vitamin B12 levels

Frequency: Periodically, especially if symptoms of neuropathy or anemia develop.

Target: Normal range (e.g., >200 pg/mL)

Action Threshold: If low, consider supplementation.

Signs and symptoms of lactic acidosis

Frequency: Ongoing patient education and monitoring

Target: N/A

Action Threshold: Immediate medical attention if suspected.

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Symptom Monitoring

  • Unusual muscle pain (myalgia)
  • Somnolence (sleepiness)
  • Respiratory distress (shortness of breath)
  • Abdominal distress (abdominal pain, nausea, vomiting, diarrhea)
  • Hypothermia
  • Arrhythmias
  • Malaise
  • Weakness

Special Patient Groups

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Pregnancy

Metformin is often continued during pregnancy for women with gestational diabetes or pre-existing type 2 diabetes, especially if diet and exercise are insufficient. It is considered a reasonable option due to its efficacy and relatively low risk profile. However, insulin is often preferred for strict glycemic control.

Trimester-Specific Risks:

First Trimester: Limited data, but no clear evidence of increased risk of congenital malformations.
Second Trimester: Generally considered safe and effective for glycemic control.
Third Trimester: Generally considered safe and effective for glycemic control.
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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. It is generally considered compatible with breastfeeding.

Infant Risk: Low risk. Monitor infant for gastrointestinal upset (diarrhea, gas) or poor feeding, though these are rare.
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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 the higher likelihood of decreased renal function. Renal function should be assessed more frequently, and the lowest effective dose should be used to minimize the risk of lactic acidosis.

Clinical Information

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Clinical Pearls

  • Metformin is considered first-line pharmacologic therapy for most patients with type 2 diabetes.
  • It is weight-neutral or can cause modest weight loss, and does not typically cause hypoglycemia when used as monotherapy.
  • Always take with food to minimize gastrointestinal side effects (nausea, diarrhea, abdominal discomfort), which are common, especially at initiation.
  • Temporarily discontinue metformin before or at the time of iodinated contrast imaging procedures and certain surgical procedures (e.g., major surgery, procedures with restricted food/fluid intake) to reduce the risk of lactic acidosis.
  • Educate patients on the symptoms of lactic acidosis and the importance of seeking immediate medical attention if they occur.
  • Long-term use may be associated with vitamin B12 deficiency; consider periodic monitoring and supplementation if needed.
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Alternative Therapies

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

Average Cost: Typically $10-$50 per 30 tablets (1000mg)
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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.