Metformin 500mg/5ml Solution

Metformin is a biguanide that improves glycemic control by decreasing hepatic glucose production (gluconeogenesis), 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 in monotherapy.

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 may be more likely when this medication is used with other diabetes medications. Symptoms of low blood sugar 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. 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 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.

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. Discuss these situations with your doctor to ensure your safety.

This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all the medications you are taking, including:
Prescription and over-the-counter (OTC) drugs
Natural products
Vitamins
* Any health problems you are experiencing

Your doctor and pharmacist need this information to assess the safety of taking this medication with your other medications and health conditions. Never start, stop, or change 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, avoid driving, as it increases the risk of accidents. Monitor your blood sugar levels as directed by your doctor. Additionally, follow your doctor's instructions for regular blood tests to ensure your health is being properly tracked.

Be aware that stress, such as fever, infection, injury, or surgery, can affect 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 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 decreased 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.

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, discuss the benefits and risks with your doctor to ensure the best possible outcome for you and your baby.

• Iodinated contrast media (temporarily discontinue at time of or prior to procedure, and for 48 hours after, re-evaluate renal function before restarting)
• Alcohol (excessive acute or chronic intake due to increased risk of lactic acidosis)
• Cimetidine (significant increase in metformin plasma levels)

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

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

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

• Symptoms of lactic acidosis (malaise, myalgia, respiratory distress, somnolence, abdominal distress, hypothermia, hypotension, resistant bradyarrhythmias)
• Symptoms of hypoglycemia (if used in combination with insulin or sulfonylureas)
• Gastrointestinal side effects (nausea, vomiting, diarrhea, abdominal discomfort)
• Symptoms of vitamin B12 deficiency (fatigue, weakness, peripheral neuropathy, cognitive changes)

Metformin is generally considered safe for use during pregnancy when clinically indicated for gestational diabetes or type 2 diabetes. It crosses the placenta. Current guidelines suggest it can be continued or initiated if benefits outweigh risks, especially if insulin therapy is not preferred or effective.

Metformin is excreted into breast milk in small amounts. It is generally considered compatible with breastfeeding. Monitor breastfed infants for signs of hypoglycemia or gastrointestinal upset, though these are rare.

Approved for use in children 10 years of age and older for type 2 diabetes. Dosing is weight-based and titrated. Monitor renal function and vitamin B12 levels.

Use with caution due to increased likelihood of decreased renal function in older adults, which increases the risk of lactic acidosis. Renal function should be assessed more frequently. Start with lower doses and titrate slowly.

• Metformin is often the first-line pharmacologic agent for type 2 diabetes, especially in overweight or obese patients, due to its efficacy, low risk of hypoglycemia (as monotherapy), and potential for weight neutrality or modest weight loss.
• Always advise patients to 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.
• Counsel patients on the symptoms of lactic acidosis and the importance of seeking immediate medical attention if they occur.
• GI side effects (nausea, diarrhea, abdominal discomfort) are common, especially at initiation. Taking metformin with meals and titrating the dose slowly can help mitigate these effects. Extended-release formulations may also reduce GI side effects.
• Periodic monitoring of vitamin B12 levels should be considered, especially in patients with risk factors for deficiency or those on long-term therapy, as metformin can decrease B12 absorption.

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

If your symptoms or health issues persist or worsen, it is 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 it is a good idea to check with your pharmacist. If you have any questions or concerns about this medication, consult with 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 information about the medication taken, the amount, and the time it occurred.