Glipizide-Metformin 5mg/500mg Tabs
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 to you and adhere to the instructions. Take your medication with meals as directed. It's also essential to follow the diet and exercise plan recommended by your doctor. Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start feeling well.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you're unsure about the best way to dispose of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs available 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. Avoid taking two doses at the same time or taking extra doses.
Lifestyle & Tips
- Follow a balanced diet as recommended by your doctor or dietitian.
- Engage in regular physical activity (e.g., 30 minutes of moderate exercise most days of the week).
- Maintain a healthy weight.
- Monitor your blood sugar levels regularly as instructed by your healthcare provider.
- Limit or avoid alcohol consumption, as it can increase the risk of low blood sugar and a serious side effect called lactic acidosis.
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 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
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, although many people may not experience any or may only have mild symptoms. If you're bothered by any of the following side effects or if they don't go away, contact your doctor or seek medical help:
Dizziness or headache
Diarrhea, upset stomach, or vomiting
Stomach pain
Muscle pain
Signs of a common cold
This is not a comprehensive list of all 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, dizziness, confusion, hunger, irritability, fast heartbeat. Carry a source of fast-acting sugar (e.g., glucose tablets, fruit juice) to treat low blood sugar.
- Symptoms of lactic acidosis (a serious and rare side effect): unusual muscle pain, trouble breathing, unusual tiredness, stomach pain, dizziness, lightheadedness, slow or irregular heartbeat, feeling cold. Seek immediate medical attention if you experience these symptoms.
- 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. Never start, stop, or change the dose of any medication without first consulting your doctor.
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, consult with your doctor to discuss any potential risks or interactions.
Until you understand how this medication affects you, avoid driving and other activities that require alertness. Additionally, do not drive if you have experienced low blood sugar, as this can increase your risk of being involved in an accident.
If you have a deficiency in the enzyme glucose-6-phosphate dehydrogenase (G6PD), use caution when taking this medication, as it may increase your risk of developing anemia. Individuals of African, South Asian, Middle Eastern, and Mediterranean descent are more likely to have low G6PD levels.
Monitor your blood sugar levels as directed by your doctor. Regular blood tests will also be necessary to assess your condition; be sure to follow your doctor's instructions and discuss any concerns or questions you may have.
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 to discuss potential implications.
If you are taking colesevelam, take it at least 4 hours after taking this medication to minimize potential interactions.
There is a potential increased risk of death from heart disease associated with this medication; discuss this with your doctor to understand the benefits and risks.
During periods of stress, such as fever, infection, injury, or surgery, your blood sugar levels may be more challenging to control. Changes in physical activity, exercise, or diet can also affect your blood sugar levels.
If you experience diarrhea or vomiting, contact your doctor promptly, as you may need to increase your fluid intake to prevent dehydration.
In hot weather or during physical activity, be cautious and drink plenty of fluids to avoid fluid loss.
If you have been taking this medication for an extended period or at high doses, you may develop tolerance, reducing its effectiveness. If you notice a decrease in the medication's effectiveness, contact your doctor; do not take more than the prescribed dose.
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Overdose Information
Overdose Symptoms:
- Severe hypoglycemia (Glipizide component): profound weakness, confusion, seizures, coma.
- Lactic acidosis (Metformin component): severe abdominal pain, nausea, vomiting, diarrhea, rapid breathing, muscle pain, extreme tiredness, low blood pressure, hypothermia.
What to Do:
In case of suspected overdose, seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment for hypoglycemia may involve oral glucose or intravenous dextrose. Treatment for lactic acidosis involves supportive care and prompt hemodialysis to remove metformin.
Drug Interactions
Contraindicated Interactions
Major Interactions
- Cimetidine (increases metformin levels)
- Carbonic anhydrase inhibitors (e.g., topiramate, zonisamide, acetazolamide, dichlorphenamide - increased risk of lactic acidosis)
- Drugs that affect renal function (e.g., NSAIDs, ACE inhibitors, ARBs, diuretics - increased risk of metformin accumulation and lactic acidosis)
- Drugs that cause hyperglycemia (e.g., thiazides, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blockers, isoniazid)
- Drugs that cause hypoglycemia (e.g., beta-blockers, fluconazole, NSAIDs, salicylates, sulfonamides, probenecid, MAOIs, other antidiabetic agents)
Moderate Interactions
- Furosemide (increases metformin plasma concentration)
- Nifedipine (increases metformin plasma concentration)
- Digoxin (may increase glipizide levels)
- Warfarin (may alter anticoagulant effect)
- CYP2C9 inhibitors (e.g., fluconazole, amiodarone - may increase glipizide levels)
- CYP2C9 inducers (e.g., rifampin - may decrease glipizide levels)
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Rationale: To assess kidney function and determine appropriate metformin dosing, as metformin is renally excreted and contraindicated in severe renal impairment.
Timing: Prior to initiation
Rationale: To establish baseline glycemic control and guide initial therapy.
Timing: Prior to initiation
Rationale: To establish baseline glycemic control.
Timing: Prior to initiation
Rationale: To assess liver function, as metformin is contraindicated in hepatic impairment and glipizide is metabolized by the liver.
Timing: Prior to initiation
Rationale: Metformin can cause vitamin B12 deficiency.
Timing: Prior to initiation
Routine Monitoring
Frequency: Every 3-6 months
Target: <7% (individualized)
Action Threshold: If above target, consider dose adjustment or additional therapy.
Frequency: Daily (patient self-monitoring)
Target: 80-130 mg/dL (individualized)
Action Threshold: Persistent readings outside target range require dose adjustment or medical evaluation.
Frequency: At least annually; every 3-6 months if eGFR 30-59 mL/min/1.73 m2; more frequently in elderly or those at risk of renal impairment.
Target: >60 mL/min/1.73 m2 (for full metformin dose)
Action Threshold: If eGFR falls below 45 mL/min/1.73 m2, reassess metformin dose; if below 30 mL/min/1.73 m2, discontinue.
Frequency: Periodically (e.g., every 1-2 years) or if megaloblastic anemia is suspected.
Target: Normal range
Action Threshold: If low, consider supplementation.
Frequency: Ongoing patient education and self-monitoring
Target: N/A
Action Threshold: Treat immediately with fast-acting glucose; adjust medication if frequent.
Frequency: Ongoing patient education and monitoring
Target: N/A
Action Threshold: Seek immediate medical attention if suspected.
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)
- Signs of allergic reaction (e.g., rash, itching, swelling)
Special Patient Groups
Pregnancy
Category C. Not recommended for use during pregnancy. Insulin is generally preferred for glycemic control in pregnant women with diabetes.
Trimester-Specific Risks:
Lactation
Both glipizide and metformin are excreted into breast milk. Metformin is generally considered compatible with breastfeeding at typical doses, but glipizide may pose a risk of hypoglycemia in the infant. Use with caution; monitor breastfed infants 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 due to increased risk of hypoglycemia (glipizide) and lactic acidosis/renal impairment (metformin). Start with lower doses and titrate slowly. Closely monitor renal function.
Clinical Information
Clinical Pearls
- Always take Glipizide-Metformin with meals to reduce gastrointestinal side effects and minimize the risk of hypoglycemia.
- Patients should be educated on the symptoms of hypoglycemia and how to treat it.
- Metformin should be temporarily discontinued before any radiological procedure involving iodinated contrast media and for any surgical procedure requiring restricted food and fluid intake.
- Educate patients on the rare but serious risk of lactic acidosis, especially symptoms like unusual muscle pain, trouble breathing, or extreme tiredness, and to seek immediate medical attention if these occur.
- This medication is for Type 2 Diabetes Mellitus only and is not indicated 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 alone (diet, exercise)