Glipizide-Metformin 2.5mg/500mg Tab
Overview
What is this medicine?
How to Use This Medicine
To get the most benefit from your medication, it's essential to follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. Take your medication with meals as directed. Additionally, adhere to the diet and exercise plan recommended by your doctor. Continue taking your medication as prescribed by your doctor or healthcare provider, even if you're feeling well.
Storing and Disposing of Your Medication
To ensure your medication remains effective and safe, store it at room temperature in a dry place, avoiding the bathroom. Keep all medications in a secure location, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, consult with your pharmacist for guidance on the best disposal method. You may also want to explore drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember, with a meal. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Follow a healthy diet plan recommended by your doctor or dietitian.
- Engage in regular physical activity as advised by your healthcare provider.
- Monitor your blood sugar levels regularly as instructed.
- Limit alcohol intake, as it can increase the risk of low blood sugar and a serious side effect called lactic acidosis.
- Maintain good hydration, especially during illness or exercise.
Available Forms & Alternatives
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 medical attention immediately:
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
Feeling extremely tired or weak
Low blood sugar (hypoglycemia), which may be more likely when taking this medication with other diabetes drugs. Symptoms 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 and follow their instructions for managing low blood sugar, which may include taking glucose tablets, liquid glucose, or some fruit juices.
Stomach Problems
It's common to experience stomach issues like upset stomach, vomiting, or diarrhea when starting this medication. However, if you develop stomach problems later during treatment, contact your doctor immediately, as this could be a sign of a serious condition called lactic acidosis.
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. If you experience any of the following side effects or any other symptoms that bother you or don't go away, contact your doctor:
Dizziness or headache
Diarrhea, upset stomach, or vomiting
Stomach pain
Muscle pain
Signs of a common cold
Reporting Side Effects
This is not an exhaustive 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.
Seek Immediate Medical Attention If You Experience:
- Symptoms of low blood sugar (hypoglycemia): sweating, shaking, fast heartbeat, dizziness, hunger, confusion, irritability. Carry a source of sugar (e.g., glucose tablets, juice) to treat low blood sugar.
- Symptoms of lactic acidosis (a rare but serious side effect): unusual muscle pain, trouble breathing, stomach pain, unusual tiredness, dizziness, feeling cold, slow or irregular heartbeat. Seek immediate medical attention if these occur.
- Symptoms of allergic reaction: rash, itching, swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
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. Describe the allergic reaction you experienced, including the symptoms that occurred.
Certain health conditions, including:
+ Acidic blood problems
+ Kidney disease
+ Liver disease
+ Type 1 diabetes
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 (within the past 48 hours)
Additionally, if you:
Are pregnant or think you may be pregnant (do not take this medication if you are pregnant)
Are breast-feeding or plan to breast-feed
This medication can interact with other drugs and health conditions. Therefore, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Natural products and vitamins you are using
Any health problems you have
Your doctor will help you determine whether it is safe to take this medication with your other medications and health conditions. Do not start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
To ensure your safety, avoid driving and other activities that require alertness until you understand how this medication affects you. Additionally, do not drive if you have experienced low blood sugar, as this increases the risk of accidents.
If you have a deficiency of the enzyme G6PD, exercise caution, as you may be more prone to anemia. This enzyme deficiency is more common in individuals of African, South Asian, Middle Eastern, and Mediterranean descent.
Adhere to your doctor's instructions for monitoring your blood sugar levels and undergo blood tests as recommended by your doctor. It is crucial to discuss your test results with your doctor.
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 your doctor.
If you are also taking colesevelam, take it at least 4 hours after taking this medication. Be aware that this medication may increase the risk of heart disease-related death; discuss this with your doctor.
During periods of stress, such as fever, infection, injury, or surgery, it may be more challenging to control your blood sugar levels. Changes in physical activity, exercise, or diet can also impact your blood sugar levels.
If you experience diarrhea or vomiting, contact your doctor promptly, as you will need to drink more fluids to prevent excessive fluid loss. In hot weather or during physical activity, drink plenty of fluids to avoid dehydration.
Prolonged use of this medication or taking it at high doses may lead to tolerance, reducing its effectiveness. If you notice that the medication is no longer working as well, contact your doctor. Do not exceed the prescribed dose.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
Overdose Information
Overdose Symptoms:
- Severe hypoglycemia (extremely low blood sugar)
- Lactic acidosis (severe muscle pain, trouble breathing, stomach pain, dizziness, unusual tiredness, coldness)
- Gastrointestinal upset (nausea, vomiting, diarrhea)
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment may involve glucose administration for hypoglycemia and supportive care, potentially including hemodialysis for lactic acidosis.
Drug Interactions
Contraindicated Interactions
- Iodinated contrast media (temporarily discontinue metformin at time of or prior to procedure)
- Severe renal impairment (eGFR <30 mL/min/1.73m2)
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis
Major Interactions
- Alcohol (increased risk of lactic acidosis with metformin)
- Carbonic anhydrase inhibitors (e.g., topiramate, acetazolamide, zonisamide, dichlorphenamide) (increased risk of lactic acidosis with metformin)
- Cimetidine (increases metformin plasma concentration)
- Drugs that affect renal function (e.g., NSAIDs, ACE inhibitors, ARBs, diuretics) (may increase metformin accumulation and lactic acidosis risk)
- Sulfonylurea potentiators (e.g., fluconazole, miconazole, sulfonamides, NSAIDs, salicylates, probenecid, chloramphenicol, coumarins) (increased risk of hypoglycemia with glipizide)
- Beta-blockers (may mask symptoms of hypoglycemia)
Moderate Interactions
- Corticosteroids, thiazide diuretics, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blockers, isoniazid (may cause hyperglycemia, requiring dose adjustment of glipizide/metformin)
- Colesevelam (may decrease glipizide absorption)
- Digoxin (glipizide may increase digoxin levels)
Minor Interactions
- Chromium (may enhance glucose-lowering effect)
Monitoring
Baseline Monitoring
Rationale: To establish baseline glycemic control.
Timing: Prior to initiation
Rationale: To establish baseline glycemic control.
Timing: Prior to initiation
Rationale: To assess kidney function, critical for metformin dosing and safety.
Timing: Prior to initiation
Rationale: To assess hepatic function, relevant for glipizide metabolism and metformin lactic acidosis risk.
Timing: Prior to initiation
Rationale: To establish baseline, as long-term metformin use can be associated with B12 deficiency.
Timing: Prior to initiation
Routine Monitoring
Frequency: Every 3-6 months
Target: Individualized, typically <7%
Action Threshold: Above target, consider dose adjustment or additional therapy
Frequency: Daily (patient self-monitoring) or as clinically indicated
Target: FPG: 80-130 mg/dL; PPG: <180 mg/dL
Action Threshold: Persistent readings outside target range, consider dose adjustment
Frequency: At least annually; more frequently (every 3-6 months) in elderly, those with impaired renal function, or those at risk of renal impairment.
Target: eGFR >60 mL/min/1.73m2 (ideally)
Action Threshold: eGFR <45 mL/min/1.73m2 requires dose adjustment or discontinuation; eGFR <30 mL/min/1.73m2 is a contraindication.
Frequency: Annually or every 2-3 years, or if symptoms of deficiency occur.
Target: Normal range
Action Threshold: Low levels, consider supplementation.
Symptom Monitoring
- Symptoms of hypoglycemia (e.g., sweating, tremor, dizziness, confusion, hunger, irritability)
- Symptoms of lactic acidosis (e.g., malaise, myalgia, respiratory distress, somnolence, abdominal distress, unusual fatigue)
- Gastrointestinal side effects (e.g., nausea, vomiting, diarrhea, abdominal discomfort)
- Symptoms of vitamin B12 deficiency (e.g., peripheral neuropathy, anemia)
Special Patient Groups
Pregnancy
Generally not recommended during pregnancy. Insulin is typically the preferred treatment for glycemic control in pregnant women with diabetes. Poorly controlled diabetes during pregnancy increases the risk of maternal and fetal complications. If used, monitor blood glucose closely.
Trimester-Specific Risks:
Lactation
Metformin is excreted into breast milk in small amounts and is generally considered compatible with breastfeeding by many experts, though long-term data are limited. Glipizide is also excreted into breast milk and carries a risk of hypoglycemia in the infant. Weigh the benefits of breastfeeding against the potential risks to the infant. Monitor the infant for signs of hypoglycemia.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients. Not recommended for use in children.
Geriatric Use
Use with caution in elderly patients due to increased risk of renal impairment (which increases metformin accumulation and lactic acidosis risk) and increased susceptibility to hypoglycemia with glipizide. Start with lower doses and titrate slowly. Monitor renal function more frequently.
Clinical Information
Clinical Pearls
- Always take Glipizide-Metformin with meals to minimize gastrointestinal side effects and reduce the risk of hypoglycemia.
- Educate patients thoroughly on the symptoms and management of hypoglycemia and the rare but serious symptoms of lactic acidosis.
- Ensure patients are well-hydrated, especially during illness, exercise, or hot weather, to reduce the risk of lactic acidosis.
- Metformin should be temporarily discontinued before or at the time of iodinated contrast imaging procedures and for any surgical procedures requiring restricted food/fluid intake, and not restarted until renal function is stable and normal.
- Long-term metformin use can lead to vitamin B12 deficiency; consider periodic monitoring and supplementation if needed.
- This combination is not for type 1 diabetes or diabetic ketoacidosis.
Alternative Therapies
- Other oral antidiabetic agents (e.g., DPP-4 inhibitors, SGLT2 inhibitors, GLP-1 receptor agonists, TZDs, alpha-glucosidase inhibitors, meglitinides)
- Insulin therapy
- Lifestyle modifications (diet, exercise)