Metformin 625mg Tablets
Overview
What is this medicine?
How to Use This Medicine
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication with meals as directed.
It's essential to continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better. Don't stop taking your medication without consulting your doctor first.
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 take your next dose at the scheduled time, 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 dose.
Lifestyle & Tips
- Maintain a healthy diet as recommended by your doctor or dietitian.
- Engage in regular physical activity.
- 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.
Available Forms & Alternatives
Available Strengths:
- Metformin 1000mg Tablets
- Metformin 500mg Tablets
- Metformin 850mg Tablets
- Metformin ER 500mg 24hr Tabs
- Metformin ER 750mg 24hr Tabs
- Metformin ER 500mg Modified Tabs
- Metformin ER 1000mg Modified Tabs
- Metformin ER 500mg 24hr Tabs
- Metformin ER 500mg Osmotic Tabs
- Metformin ER 1000mg Osmotic Tabs
- Metformin ER 750mg 24hr Tabs
- Metformin ER 500mg Modified Tabs
- Metformin ER 1000mg Modified Tabs
- Metformin 500mg/5ml Solution
- Metformin 625mg Tablets
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Side Effects
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 list is not exhaustive, and you may experience other 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.
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, or a slow or irregular heartbeat. Seek immediate medical attention if these occur.
- Signs of low blood sugar (hypoglycemia) if taken with other diabetes medications: sweating, shaking, fast heartbeat, hunger, confusion, dizziness. Carry a source of sugar (e.g., glucose tablets, juice) to treat low blood sugar.
- Signs of vitamin B12 deficiency: unusual tiredness, weakness, numbness or tingling in hands or feet.
Before Using This Medicine
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 normally, which may be relevant before undergoing certain procedures or surgery
* Upcoming or recent exams or tests that involve contrast agents, particularly if they have taken place within the past 48 hours. Discuss this with your doctor to determine the best course of action.
This list is not exhaustive, and it is crucial to disclose all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues to your doctor and pharmacist. This will help ensure your safety while taking this medication. Always verify that it is safe to take this medication with your other drugs and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
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, 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 affect blood sugar control. Changes in physical activity, exercise, or diet can also impact 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 treatment with metformin may lead to low vitamin B-12 levels. If you have a history of low vitamin B-12 levels, consult 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. You will need to discuss the benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Lactic acidosis (most serious and common symptom)
- Hypoglycemia (if taken with other antidiabetic agents or in specific conditions)
- Gastrointestinal upset (nausea, vomiting, diarrhea)
What to Do:
Call 1-800-222-1222 (Poison Control Center) immediately. Emergency medical attention is required. Hemodialysis may be effective in removing metformin and lactate.
Drug Interactions
Contraindicated Interactions
- 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 procedure; restart metformin only if renal function is stable.)
- Severe renal impairment (eGFR <30 mL/min/1.73m²)
Major Interactions
- Alcohol (potentiates the effect of metformin on lactate metabolism, increasing the risk of lactic acidosis)
- Carbonic anhydrase inhibitors (e.g., topiramate, zonisamide, acetazolamide, dichlorphenamide) - may increase the risk of lactic acidosis by increasing serum bicarbonate levels and inducing non-anion gap metabolic acidosis.
- Cimetidine (increases metformin plasma concentration by reducing renal tubular secretion, increasing risk of lactic acidosis)
Moderate Interactions
- Drugs that reduce metformin clearance (e.g., ranolazine, vandetanib, dolutegravir, cimetidine, isavuconazonium) - may increase metformin levels and risk of lactic acidosis.
- Drugs that can cause hyperglycemia (e.g., thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blockers, isoniazid) - may require dose adjustment of metformin.
- Nifedipine (increases metformin absorption and excretion, but overall effect on glucose control is usually minor).
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Rationale: To assess baseline kidney function and determine appropriate dosing, as metformin is primarily renally eliminated and contraindicated in severe renal impairment.
Timing: Prior to initiation of therapy.
Rationale: To establish baseline glycemic control.
Timing: Prior to initiation of therapy.
Rationale: Metformin can decrease vitamin B12 levels.
Timing: Consider baseline, especially in patients at risk for B12 deficiency.
Routine Monitoring
Frequency: Every 3-6 months
Target: Individualized, typically <7% for most adults (ADA guidelines)
Action Threshold: If target not met, consider dose titration or addition of other agents.
Frequency: At least annually; more frequently (e.g., every 3-6 months) in elderly, those with risk factors for renal impairment, or during dose titration.
Target: >60 mL/min/1.73m² (adjust dose if <60, discontinue if <30)
Action Threshold: If eGFR falls below 45 mL/min/1.73m², reassess dose; if below 30 mL/min/1.73m², discontinue.
Frequency: Ongoing patient education and monitoring
Target: Absence of symptoms
Action Threshold: If suspected, discontinue metformin immediately and seek emergency medical attention.
Frequency: Periodically (e.g., every 1-2 years) or if megaloblastic anemia or neuropathy is suspected.
Target: Normal range
Action Threshold: Supplement B12 if levels are low.
Symptom Monitoring
- Symptoms of lactic acidosis: malaise, myalgia, somnolence, respiratory distress, abdominal distress, increased somnolence, hypothermia, hypotension, and resistant bradyarrhythmias.
- Symptoms of hypoglycemia (rare with monotherapy): sweating, tremor, dizziness, confusion, hunger.
- Gastrointestinal side effects: nausea, vomiting, diarrhea, abdominal discomfort, metallic taste.
Special Patient Groups
Pregnancy
Metformin is generally considered a reasonable option for managing gestational diabetes or type 2 diabetes in pregnancy, especially when insulin is not preferred or sufficient. However, insulin remains the preferred first-line agent for strict glycemic control during pregnancy.
Trimester-Specific Risks:
Lactation
Metformin is excreted into breast milk in low amounts. It is generally considered compatible with breastfeeding, and adverse effects in breastfed infants are not expected.
Pediatric Use
Approved for use in children 10 years of age and older for type 2 diabetes. Dosing for extended-release formulations like 625mg may need careful consideration and titration, as most pediatric data is with immediate-release.
Geriatric Use
Use with caution due to increased likelihood of decreased renal function in elderly patients. Renal function should be assessed more frequently. Start with lower doses and titrate slowly to minimize gastrointestinal side effects and lactic acidosis risk.
Clinical Information
Clinical Pearls
- Metformin is 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.
- Gastrointestinal side effects (nausea, diarrhea, abdominal discomfort) are common, especially at initiation. Starting with a low dose and titrating slowly, and taking with food (especially ER formulations), can help mitigate these.
- Extended-release formulations (like 625mg) are designed to improve gastrointestinal tolerability and allow for once-daily dosing.
- Patients should be educated on the symptoms of lactic acidosis and advised to seek immediate medical attention if they occur.
- Regular monitoring of renal function is crucial due to the risk of lactic acidosis in patients with impaired kidney function.
- Long-term metformin use can be associated with vitamin B12 deficiency; periodic monitoring and supplementation may be necessary.
Alternative Therapies
- Sulfonylureas (e.g., glipizide, glyburide, glimepiride)
- DPP-4 inhibitors (e.g., sitagliptin, saxagliptin, linagliptin)
- SGLT2 inhibitors (e.g., canagliflozin, dapagliflozin, empagliflozin)
- GLP-1 receptor agonists (e.g., liraglutide, semaglutide, dulaglutide)
- Thiazolidinediones (e.g., pioglitazone, rosiglitazone)
- Insulin therapy
- Alpha-glucosidase inhibitors (e.g., acarbose, miglitol)
- Meglitinides (e.g., repaglinide, nateglinide)