Metformin ER 500mg 24hr Tabs

Metformin is a biguanide that improves glucose tolerance in patients with type 2 diabetes by lowering both basal and postprandial plasma glucose. Its primary mechanism of action is to decrease hepatic glucose production. It also decreases intestinal absorption of glucose and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.

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 any of these symptoms, call your doctor right away. For low blood sugar, follow your doctor's instructions, 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 is not an exhaustive list of possible side effects. If you have questions or concerns, 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.

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 allergic reaction you experienced, including any symptoms that occurred.
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 they have taken place 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 in conjunction with your other treatments and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.

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 directed by your doctor. Additionally, follow your doctor's instructions for regular blood work check-ups and discuss the results with them.

Be aware that stress, such as fever, infection, injury, or surgery, can affect your blood sugar control. Changes in physical activity, exercise, or diet can also impact 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 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. You may notice the appearance of a tablet in your stool, but this is a normal occurrence and not a cause for concern. If you have any questions or concerns, discuss them with your doctor.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Women of childbearing age who have not been ovulating may experience a return of fertility 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, inform your doctor, as they will need to discuss the potential benefits and risks of this medication to you and your baby.

• Iodinated contrast media (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 only if renal function is stable.)
• Severe renal impairment (eGFR <30 mL/min/1.73m²)
• Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.

• Alcohol (potentiates the effect of metformin on lactate metabolism, increasing 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 reducing renal clearance)

• Drugs that reduce metformin clearance (e.g., ranolazine, vandetanib, dolutegravir, cimetidine, isavuconazole, trimethoprim, cimetidine, verapamil, rifampin, cimetidine, quinidine, procainamide, amiloride, triamterene, furosemide, digoxin, morphine, probenecid, nifedipine) - may increase metformin levels and risk of lactic acidosis.
• Drugs that affect glycemic control (e.g., thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, isoniazid) - may cause hyperglycemia, requiring metformin dose adjustment.
• Sulfonylureas or insulin (increased risk of hypoglycemia when used concomitantly)

• Not available (most interactions are moderate to major due to potential for lactic acidosis or altered glucose control)

• Symptoms of lactic acidosis: malaise, myalgia, unusual somnolence, respiratory distress, abdominal distress, increased somnolence, hypothermia, hypotension, resistant bradyarrhythmias. Patients should be instructed to seek immediate medical attention if these symptoms occur.
• Symptoms of hypoglycemia (if used with insulin or sulfonylureas): sweating, tremor, dizziness, confusion, hunger, irritability.
• Symptoms of Vitamin B12 deficiency: peripheral neuropathy, anemia, fatigue.

Metformin is not approved for use in pregnancy by the FDA, but clinical guidelines (e.g., ACOG, ADA) suggest it may be considered in some cases of gestational diabetes or type 2 diabetes in pregnancy, particularly when insulin is not feasible or acceptable. Insulin is generally preferred for glycemic control during pregnancy. Risk vs. benefit should be carefully weighed.

Metformin is excreted into breast milk in low amounts. It is generally considered compatible with breastfeeding (Lactation Risk Category L2).

Metformin IR is approved for children 10 years and older with type 2 diabetes. Metformin ER is not typically recommended or approved for pediatric use due to limited studies and different dosing considerations.

Use with caution due to increased likelihood of decreased renal function in elderly patients. Renal function should be assessed more frequently. Start with a lower dose and titrate slowly to minimize adverse effects and lactic acidosis risk.

• Metformin is considered first-line pharmacologic therapy for type 2 diabetes, especially in overweight or obese patients, due to its efficacy, low risk of hypoglycemia (when used alone), and potential for weight neutrality or modest weight loss.
• Always take Metformin ER with the evening meal to optimize absorption and reduce gastrointestinal side effects.
• Patients should be educated on the symptoms of lactic acidosis and instructed to seek immediate medical attention if they occur.
• Regular monitoring of renal function is crucial, especially before initiation, annually, and whenever conditions that may affect renal function (e.g., dehydration, new medications) arise.
• Periodic monitoring of Vitamin B12 levels is recommended, as long-term metformin use can be associated with B12 deficiency.
• Temporarily discontinue metformin before or at the time of iodinated contrast imaging procedures and certain surgical procedures.

• Sulfonylureas (e.g., Glipizide, Glyburide)
• Thiazolidinediones (TZDs) (e.g., Pioglitazone)
• DPP-4 Inhibitors (e.g., Sitagliptin, Saxagliptin)
• SGLT2 Inhibitors (e.g., Canagliflozin, Dapagliflozin, Empagliflozin)
• GLP-1 Receptor Agonists (e.g., Liraglutide, Semaglutide, Dulaglutide)
• Insulin
• Alpha-glucosidase inhibitors (e.g., Acarbose)
• Meglitinides (e.g., Repaglinide)

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 your 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.