Dapagliflo/metform 5mg-1000mg ER Tb
WARNING: Rarely, metformin may cause too much lactic acid in the blood (lactic acidosis). The risk is higher in people who have kidney problems, liver problems, heart failure, use alcohol, or take certain other drugs, including topiramate. The risk is also higher in people who are 65 or older and in people who are having surgery, an exam or test with contrast, or other procedures. If lactic acidosis happens, it can lead to other health problems and can be deadly. Kidney tests may be done while taking this drug.Do not take this drug if you have a very bad infection, low oxygen, or a lot of fluid loss (dehydration).Call your doctor right away if you have signs of too much lactic acid in the blood (lactic acidosis) like confusion; fast breathing; fast or slow heartbeat; a heartbeat that does not feel normal; very bad stomach pain, upset stomach, or throwing up; feeling very sleepy; shortness of breath; feeling very tired or weak; very bad dizziness; feeling cold; or muscle pain or cramps. @ COMMON USES: It is used to help control blood sugar in people with type 2 diabetes.It is used in certain people to lower the risk of death and having to go to the hospital because of heart failure.It is used in people with certain kidney problems to lower the risk of worsening kidney problems.
Drug Class
Antidiabetic, SGLT2 Inhibitor / Biguanide Combination
Pharmacologic Class
Sodium-glucose cotransporter 2 (SGLT2) inhibitor / Biguanide
Pregnancy Category
Category D
FDA Approved
Oct 2014
DEA Schedule
Not Controlled
Overview
What is this medicine?
This medication is a combination of two drugs, dapagliflozin and metformin, used to help control high blood sugar in adults with type 2 diabetes. Dapagliflozin works by helping your kidneys remove more sugar from your body through your urine. Metformin works by reducing the amount of sugar your liver makes and helping your body use insulin more effectively.
How to Use This Medicine
Taking Your Medication Correctly
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 food, preferably in the morning, and swallow the tablet whole without chewing, breaking, or crushing it. Stay hydrated by drinking plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.
It's essential to continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling better. This will help ensure that you receive the full benefits of the treatment.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom. Keep all medications in a safe and secure location, out of 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 by your doctor or pharmacist. Instead, check with your pharmacist for guidance on the best way to dispose of your medication, or look into local drug take-back programs.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. 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.
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 food, preferably in the morning, and swallow the tablet whole without chewing, breaking, or crushing it. Stay hydrated by drinking plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.
It's essential to continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling better. This will help ensure that you receive the full benefits of the treatment.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom. Keep all medications in a safe and secure location, out of 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 by your doctor or pharmacist. Instead, check with your pharmacist for guidance on the best way to dispose of your medication, or look into local drug take-back programs.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. 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 as recommended by your doctor or dietitian.
- Engage in regular physical activity as advised by your healthcare provider.
- Stay well-hydrated, especially when exercising or in hot weather, to reduce the risk of dehydration and kidney problems.
- Limit or avoid alcohol consumption, as it can increase the risk of lactic acidosis with metformin.
- Monitor your blood sugar levels regularly as instructed by your doctor.
- Inform your doctor if you are scheduled for any surgery or medical procedures, especially those involving iodinated contrast dye, as you may need to temporarily stop this medication.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Initial dose is typically Dapagliflozin 5 mg/Metformin ER 500 mg once daily, or based on current metformin dose. Max dose is Dapagliflozin 10 mg/Metformin ER 2000 mg once daily.
Dose Range:
5 - 2000 mg
Condition-Specific Dosing:
Type 2 Diabetes Mellitus:
Administer orally once daily in the morning with food. Swallow tablets whole, do not crush, cut, or chew.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment needed for eGFR ≥ 60 mL/min/1.73m². Monitor renal function.
Moderate:
Initiation not recommended if eGFR < 45 mL/min/1.73m². If eGFR falls persistently below 45 mL/min/1.73m² during treatment, discontinue. Metformin dose should not exceed 1000 mg/day if eGFR 30-45 mL/min/1.73m².
Severe:
Contraindicated if eGFR < 30 mL/min/1.73m².
Dialysis:
Contraindicated in patients on dialysis.
Hepatic Impairment:
Mild:
No dose adjustment for dapagliflozin. Metformin: use with caution.
Moderate:
No dose adjustment for dapagliflozin. Metformin: use with caution, monitor for lactic acidosis.
Severe:
Metformin is contraindicated in severe hepatic impairment. Dapagliflozin: no specific adjustment, but caution due to increased dapagliflozin exposure.
Pharmacology
Mechanism of Action
Dapagliflozin is a selective and reversible inhibitor of sodium-glucose cotransporter 2 (SGLT2) in the kidney, reducing glucose reabsorption and increasing urinary glucose excretion. Metformin is a biguanide that decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
Pharmacokinetics
Absorption:
Bioavailability:
Dapagliflozin: ~78%; Metformin: ~50-60% (ER formulation)
Tmax:
Dapagliflozin: ~2 hours; Metformin: ~4-8 hours (ER formulation)
FoodEffect:
Dapagliflozin: Food has minimal effect on exposure. Metformin ER: Food increases absorption and Tmax.
Distribution:
Vd:
Dapagliflozin: ~118 L; Metformin: ~654 L
ProteinBinding:
Dapagliflozin: ~91%; Metformin: Negligible
CnssPenetration:
Limited for both
Elimination:
HalfLife:
Dapagliflozin: ~12.9 hours; Metformin: ~6.2 hours (plasma), ~17.6 hours (blood, ER formulation)
Clearance:
Dapagliflozin: ~207 mL/min; Metformin: Renal clearance is ~3.5 times greater than creatinine clearance
ExcretionRoute:
Dapagliflozin: Renal (75%), Fecal (21%); Metformin: Renal (unchanged)
Unchanged:
Dapagliflozin: <2% (renal); Metformin: ~90% (renal)
Pharmacodynamics
OnsetOfAction:
Dapagliflozin: Within hours; Metformin: Days to weeks for full effect
PeakEffect:
Dapagliflozin: ~4-6 hours; Metformin: ~2-3 weeks for maximal glucose lowering
DurationOfAction:
Dapagliflozin: 24 hours; Metformin: 24 hours (ER formulation)
Safety & Warnings
BLACK BOX WARNING
Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (>5 mmol/L), anion gap acidosis (without evidence of ketonuria or ketonemia), and an increased lactate/pyruvate ratio; metformin plasma levels generally >5 mcg/mL. If acidosis is suspected, discontinue Xigduo XR and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended. Risk factors include renal impairment, concomitant use of certain drugs (e.g., carbonic anhydrase inhibitors), age 65 years or greater, radiological studies with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, and hepatic impairment.
Side Effects
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 medical attention immediately:
Signs of an allergic reaction: 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, or swelling of the mouth, face, lips, tongue, or throat.
Signs of fluid and electrolyte problems: mood changes, confusion, muscle pain or weakness, fast or abnormal heartbeat, severe dizziness or fainting, increased thirst, seizures, feeling extremely tired or weak, decreased appetite, inability to urinate or changes in urine output, dry mouth, dry eyes, or severe stomach upset or vomiting.
Signs of kidney problems: inability to urinate, changes in urine output, blood in the urine, or significant weight gain.
Signs of a urinary tract infection (UTI): blood in the urine, burning or pain while urinating, frequent or urgent need to urinate, fever, lower abdominal pain, or pelvic pain.
Vaginal yeast infection: report itching, unpleasant odor, or discharge.
Yeast infection of the penis: report pain, swelling, rash, or discharge.
Severe stomach pain.
Stomach problems that occur later during treatment, such as upset stomach, vomiting, or diarrhea, which may be a sign of lactic acidosis (a condition where the blood becomes too acidic).
Rare but Serious Infections
A rare but potentially life-threatening infection can occur with medications like this one. Seek medical help immediately if you experience:
Tender, red, or swollen genitals or the area between your genitals and rectum, accompanied by fever or feeling unwell.
Low Blood Sugar
Low blood sugar can occur, especially when this medication is used with other diabetes medications. Signs of low blood sugar may include:
Dizziness, headache, feeling sleepy or weak, shaking, fast heartbeat, confusion, hunger, or sweating.
If you experience any of these symptoms, contact your doctor right away and follow their instructions for managing low blood sugar, which may include taking glucose tablets, liquid glucose, or certain fruit juices.
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or only minor ones. However, if you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical attention:
Diarrhea, upset stomach, or vomiting.
Headache.
Nose or throat irritation.
Reporting Side Effects
If you have questions about side effects or want to report any, you can:
Contact your doctor for medical advice about side effects.
Call the FDA at 1-800-332-1088.
* Report side effects online at https://www.fda.gov/medwatch.
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: 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, or swelling of the mouth, face, lips, tongue, or throat.
Signs of fluid and electrolyte problems: mood changes, confusion, muscle pain or weakness, fast or abnormal heartbeat, severe dizziness or fainting, increased thirst, seizures, feeling extremely tired or weak, decreased appetite, inability to urinate or changes in urine output, dry mouth, dry eyes, or severe stomach upset or vomiting.
Signs of kidney problems: inability to urinate, changes in urine output, blood in the urine, or significant weight gain.
Signs of a urinary tract infection (UTI): blood in the urine, burning or pain while urinating, frequent or urgent need to urinate, fever, lower abdominal pain, or pelvic pain.
Vaginal yeast infection: report itching, unpleasant odor, or discharge.
Yeast infection of the penis: report pain, swelling, rash, or discharge.
Severe stomach pain.
Stomach problems that occur later during treatment, such as upset stomach, vomiting, or diarrhea, which may be a sign of lactic acidosis (a condition where the blood becomes too acidic).
Rare but Serious Infections
A rare but potentially life-threatening infection can occur with medications like this one. Seek medical help immediately if you experience:
Tender, red, or swollen genitals or the area between your genitals and rectum, accompanied by fever or feeling unwell.
Low Blood Sugar
Low blood sugar can occur, especially when this medication is used with other diabetes medications. Signs of low blood sugar may include:
Dizziness, headache, feeling sleepy or weak, shaking, fast heartbeat, confusion, hunger, or sweating.
If you experience any of these symptoms, contact your doctor right away and follow their instructions for managing low blood sugar, which may include taking glucose tablets, liquid glucose, or certain fruit juices.
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or only minor ones. However, if you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical attention:
Diarrhea, upset stomach, or vomiting.
Headache.
Nose or throat irritation.
Reporting Side Effects
If you have questions about side effects or want to report any, you can:
Contact your doctor for medical advice about side effects.
Call the FDA at 1-800-332-1088.
* Report side effects online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Signs of lactic acidosis: unusual muscle pain, stomach discomfort, diarrhea, nausea, vomiting, weakness, unusual tiredness, dizziness, lightheadedness, rapid or difficult breathing, feeling cold.
- Signs of diabetic ketoacidosis (DKA): nausea, vomiting, stomach pain, excessive thirst, frequent urination, unusual tiredness, difficulty breathing, fruity smell on breath.
- Signs of dehydration: dizziness, lightheadedness, feeling faint, especially when standing up.
- Signs of urinary tract infection (UTI): burning sensation when urinating, frequent or urgent need to urinate, pain in the lower abdomen or pelvis, blood in urine, fever.
- Signs of genital yeast infection: itching or irritation in the genital area, discharge, rash.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following conditions or situations before starting this medication:
Any allergies you have, including allergies to this drug, its components, or other substances, and describe the symptoms you experienced.
If you have type 1 diabetes, as this medication is not intended to treat this condition.
If you have a condition that affects the acidity of your blood.
If you have kidney disease or are undergoing dialysis.
If you have liver disease.
If you have recently had a heart attack or stroke.
If you are experiencing difficulties with eating or drinking, including situations where you may be required to fast before a procedure or surgery.
If you are scheduled to undergo an exam or test that involves contrast agents, or if you have had such a test within the past 48 hours, consult with your doctor.
If you are taking or have recently taken immunosuppressive medications to manage kidney disease.
If you are pregnant or think you might be pregnant. Do not take this medication during the second or third trimester of pregnancy.
* If you are breastfeeding. It is recommended that you do not breastfeed while taking this medication.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following conditions or situations before starting this medication:
Any allergies you have, including allergies to this drug, its components, or other substances, and describe the symptoms you experienced.
If you have type 1 diabetes, as this medication is not intended to treat this condition.
If you have a condition that affects the acidity of your blood.
If you have kidney disease or are undergoing dialysis.
If you have liver disease.
If you have recently had a heart attack or stroke.
If you are experiencing difficulties with eating or drinking, including situations where you may be required to fast before a procedure or surgery.
If you are scheduled to undergo an exam or test that involves contrast agents, or if you have had such a test within the past 48 hours, consult with your doctor.
If you are taking or have recently taken immunosuppressive medications to manage kidney disease.
If you are pregnant or think you might be pregnant. Do not take this medication during the second or third trimester of pregnancy.
* If you are breastfeeding. It is recommended that you do not breastfeed while taking this medication.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or adjust 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. Your doctor may advise you to stop taking this drug before certain surgical procedures, and if so, they will instruct you on when to resume taking it after the surgery or procedure.
To ensure your safety, avoid driving if you have experienced low blood sugar, as it increases the risk of accidents. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying down position, and be cautious when climbing stairs.
Regular blood work and lab tests are crucial, as ordered by your doctor. Be aware that this medication may affect the results of certain lab tests, so inform all your healthcare providers and lab personnel that you are taking this drug. Consult with your doctor to determine the most suitable glucose tests for you.
Monitor your blood sugar levels as directed by your doctor. Before consuming alcohol, discuss the potential risks with your doctor. Adhere to the diet and exercise plan recommended by your doctor. If you are on a low-salt or salt-free diet, consult with your doctor to ensure safe management.
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. In hot weather or during physical activity, drink plenty of fluids to prevent 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, discuss this with your doctor. A rare but serious condition called ketoacidosis (too much acid in the blood or urine) can occur with this medication, even if your blood sugar is below 250. This condition can be life-threatening and may require hospitalization. People with diabetes, pancreas problems, or those who are sick, dehydrated, or have undergone surgery are at a higher risk of developing ketoacidosis. Additionally, individuals who use insulin and take less than the prescribed dose or miss a dose are also at increased risk. Check your ketone levels as instructed by your doctor, and consult with them if you have any questions.
Severe urinary tract infections (UTIs) have been reported with this medication, and in some cases, hospitalization was necessary. Kidney problems can also occur, which may require hospitalization or dialysis. If you are unable to drink fluids or experience persistent vomiting, diarrhea, or stomach upset, contact your doctor to avoid dehydration, which can lead to low blood pressure or worsen kidney problems.
You may notice the tablet appearing in your stool, but this is a normal occurrence and not a cause for concern. If you have questions, consult with your doctor.
If you are 65 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 while taking this drug. If you become pregnant or suspect you are pregnant while taking this medication, contact your doctor immediately, as it may harm the unborn baby.
To ensure your safety, avoid driving if you have experienced low blood sugar, as it increases the risk of accidents. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying down position, and be cautious when climbing stairs.
Regular blood work and lab tests are crucial, as ordered by your doctor. Be aware that this medication may affect the results of certain lab tests, so inform all your healthcare providers and lab personnel that you are taking this drug. Consult with your doctor to determine the most suitable glucose tests for you.
Monitor your blood sugar levels as directed by your doctor. Before consuming alcohol, discuss the potential risks with your doctor. Adhere to the diet and exercise plan recommended by your doctor. If you are on a low-salt or salt-free diet, consult with your doctor to ensure safe management.
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. In hot weather or during physical activity, drink plenty of fluids to prevent 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, discuss this with your doctor. A rare but serious condition called ketoacidosis (too much acid in the blood or urine) can occur with this medication, even if your blood sugar is below 250. This condition can be life-threatening and may require hospitalization. People with diabetes, pancreas problems, or those who are sick, dehydrated, or have undergone surgery are at a higher risk of developing ketoacidosis. Additionally, individuals who use insulin and take less than the prescribed dose or miss a dose are also at increased risk. Check your ketone levels as instructed by your doctor, and consult with them if you have any questions.
Severe urinary tract infections (UTIs) have been reported with this medication, and in some cases, hospitalization was necessary. Kidney problems can also occur, which may require hospitalization or dialysis. If you are unable to drink fluids or experience persistent vomiting, diarrhea, or stomach upset, contact your doctor to avoid dehydration, which can lead to low blood pressure or worsen kidney problems.
You may notice the tablet appearing in your stool, but this is a normal occurrence and not a cause for concern. If you have questions, consult with your doctor.
If you are 65 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 while taking this drug. If you become pregnant or suspect you are pregnant while taking this medication, contact your doctor immediately, as it may harm the unborn baby.
Overdose Information
Overdose Symptoms:
- Lactic acidosis (severe metabolic acidosis, hypothermia, hypotension, resistant bradyarrhythmias)
- Hypoglycemia (if taken with insulin or sulfonylureas)
- Renal impairment
- Dehydration
What to Do:
Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is symptomatic and supportive. Hemodialysis is effective for removing metformin and may be considered for dapagliflozin in severe cases.
Drug Interactions
Contraindicated Interactions
Major Interactions
- Carbonic anhydrase inhibitors (e.g., topiramate, acetazolamide, zonisamide, dichlorphenamide) - increased risk of lactic acidosis with metformin
- Diuretics (loop or thiazide) - increased risk of dehydration and hypotension with dapagliflozin, potential for increased lactic acidosis risk with metformin
- Insulin and insulin secretagogues (e.g., sulfonylureas) - increased risk of hypoglycemia
Moderate Interactions
- Drugs that reduce metformin clearance (e.g., ranolazine, cimetidine, dolutegravir, isavuconazole, trimethoprim, vandetanib) - increased metformin levels
- Lithium - dapagliflozin may decrease lithium levels
- ACE inhibitors/ARBs - increased risk of hypotension and renal impairment with dapagliflozin
Minor Interactions
- Corticosteroids, sympathomimetics, diuretics, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, calcium channel blockers, isoniazid (may cause hyperglycemia, requiring dose adjustment of antidiabetics)
Monitoring
Baseline Monitoring
Renal function (eGFR)
Rationale: To assess eligibility for treatment and guide dosing, as both drugs are renally cleared and have contraindications/precautions based on eGFR.
Timing: Prior to initiation
HbA1c
Rationale: To establish baseline glycemic control.
Timing: Prior to initiation
Blood glucose (fasting and postprandial)
Rationale: To establish baseline glycemic control.
Timing: Prior to initiation
Routine Monitoring
Renal function (eGFR)
Frequency: At least annually, or more frequently in patients at risk for renal impairment (e.g., elderly, those on diuretics)
Target: Maintain eGFR ≥ 45 mL/min/1.73m² for continued use; discontinue if < 30 mL/min/1.73m²
Action Threshold: If eGFR falls below 45 mL/min/1.73m², consider discontinuation or dose adjustment of metformin. Discontinue if eGFR < 30 mL/min/1.73m².
HbA1c
Frequency: Every 3-6 months
Target: Individualized, typically < 7%
Action Threshold: If target not met, consider dose adjustment or addition of other agents.
Blood glucose (fasting and postprandial)
Frequency: Daily or as directed by healthcare provider
Target: Fasting: 80-130 mg/dL; Postprandial: <180 mg/dL
Action Threshold: Persistent readings outside target range may indicate need for dose adjustment or lifestyle modification.
Signs/symptoms of lactic acidosis
Frequency: Ongoing patient education and monitoring
Target: N/A
Action Threshold: If suspected (e.g., malaise, myalgia, respiratory distress, abdominal pain), discontinue immediately and seek emergency medical attention.
Signs/symptoms of ketoacidosis
Frequency: Ongoing patient education and monitoring
Target: N/A
Action Threshold: If suspected (e.g., nausea, vomiting, abdominal pain, thirst, polyuria, fatigue, difficulty breathing), discontinue immediately and seek emergency medical attention.
Volume status/blood pressure
Frequency: Periodically, especially in patients prone to hypotension or on diuretics
Target: N/A
Action Threshold: If symptomatic hypotension occurs, manage volume status.
Symptom Monitoring
- Unusual muscle pain
- Stomach discomfort
- Diarrhea
- Nausea
- Vomiting
- Weakness
- Unusual tiredness
- Dizziness
- Lightheadedness
- Rapid or difficult breathing
- Decreased urination
- Signs of urinary tract infection (burning, frequent, urgent urination, pain in lower abdomen)
- Signs of genital yeast infection (itching, redness, discharge)
- Increased thirst
- Increased urination
- Fruity breath odor (ketoacidosis)
Special Patient Groups
Pregnancy
Not recommended during the second and third trimesters of pregnancy due to potential adverse effects on renal development in the fetus from dapagliflozin. Metformin is generally considered safer in pregnancy for type 2 diabetes, but the combination product is contraindicated due to the dapagliflozin component.
Trimester-Specific Risks:
First Trimester:
Limited human data for dapagliflozin. Metformin is often continued in the first trimester if already on it.
Second Trimester:
Dapagliflozin: Potential for adverse renal developmental effects (animal data). Avoid use.
Third Trimester:
Dapagliflozin: Potential for adverse renal developmental effects (animal data). Avoid use.
Lactation
Both dapagliflozin and metformin are excreted into human milk. Due to the potential for serious adverse reactions in a breastfed infant (e.g., renal dysfunction, hypoglycemia), breastfeeding is not recommended during treatment.
Infant Risk:
L3 (Moderate risk - potential for renal dysfunction, hypoglycemia, and unknown long-term effects from dapagliflozin; low risk for metformin but combination is not recommended).
Pediatric Use
Safety and effectiveness have not been established in pediatric patients. Not recommended for use in patients younger than 18 years of age.
Geriatric Use
Increased risk of volume depletion, hypotension, and renal impairment, especially in patients ≥ 65 years of age. More frequent monitoring of renal function is recommended. Increased risk of lactic acidosis with metformin in elderly patients due to potential for decreased renal function.
Clinical Information
Clinical Pearls
- Always take Xigduo XR in the morning with food to reduce gastrointestinal side effects of metformin and ensure proper absorption of the ER formulation.
- Swallow the tablet whole; do not crush, cut, or chew, as this will affect the extended-release properties.
- Patients may notice a tablet shell in their stool; this is normal and does not mean the medication was not absorbed.
- Educate patients on the signs and symptoms of lactic acidosis and diabetic ketoacidosis, emphasizing the importance of seeking immediate medical attention if these occur.
- Ensure adequate hydration, especially during illness, exercise, or in hot weather, to minimize the risk of volume depletion and acute kidney injury.
- Temporarily discontinue this medication before any radiological procedure involving iodinated contrast media or any surgical procedure requiring restricted food/fluid intake.
- Regular monitoring of renal function (eGFR) is crucial, as dose adjustments or discontinuation may be necessary based on kidney function.
Alternative Therapies
- Other SGLT2 inhibitors (e.g., empagliflozin, canagliflozin, ertugliflozin)
- Other biguanides (Metformin monotherapy)
- DPP-4 inhibitors (e.g., sitagliptin, saxagliptin)
- GLP-1 receptor agonists (e.g., liraglutide, semaglutide)
- Sulfonylureas (e.g., glipizide, glyburide)
- Thiazolidinediones (e.g., pioglitazone)
- Insulin
Cost & Coverage
Average Cost:
Varies widely, typically $500-$700 per 30 tablets
Insurance Coverage:
Tier 2 or 3 (preferred or non-preferred brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.