Dapagliflozin 5mg Tablets
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 urgent hospital visits, hospital stays, and death because of heart failure.It is used in people with certain kidney problems to lower the risk of worsening kidney problems, hospital stays, and death.
Drug Class
Antidiabetic agent, Cardiovascular agent, Renal protectant
Pharmacologic Class
Sodium-glucose co-transporter 2 (SGLT2) inhibitor
Pregnancy Category
Not available
FDA Approved
Jan 2012
DEA Schedule
Not Controlled
Overview
What is this medicine?
Dapagliflozin is a medication that helps your kidneys remove more sugar from your body through your urine. This helps lower blood sugar levels in people with type 2 diabetes. It also has benefits for the heart and kidneys, even in people without diabetes, by helping to reduce the risk of heart failure and slow down kidney disease progression.
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. You can take this medication with or without food. Unless your doctor advises you to limit your fluid intake, drink plenty of non-caffeinated liquids to stay hydrated. Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry location, avoiding the bathroom. Keep all medications in a safe place, 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 by your doctor or pharmacist. If you have questions about disposing of your medication, consult with your pharmacist, who may be aware of 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. 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. You can take this medication with or without food. Unless your doctor advises you to limit your fluid intake, drink plenty of non-caffeinated liquids to stay hydrated. Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry location, avoiding the bathroom. Keep all medications in a safe place, 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 by your doctor or pharmacist. If you have questions about disposing of your medication, consult with your pharmacist, who may be aware of 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. 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
- Maintain adequate hydration by drinking plenty of fluids, especially during illness, exercise, or in hot weather, to reduce the risk of dehydration.
- Follow a healthy diet and exercise plan as recommended by your doctor.
- Practice good personal hygiene, especially in the genital area, to reduce the risk of infections.
- Monitor blood sugar levels regularly if you have diabetes, as advised by your healthcare provider.
- Be aware of the symptoms of low blood sugar (hypoglycemia) if you are also taking insulin or other medications that can lower blood sugar.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
10 mg orally once daily
Dose Range:
5 - 10 mg
Condition-Specific Dosing:
Type 2 Diabetes Mellitus:
Initial: 5 mg orally once daily. May increase to 10 mg orally once daily if additional glycemic control is needed and tolerated. Not recommended for glycemic control if eGFR <45 mL/min/1.73m2.
Heart Failure (HFrEF or HFpEF):
10 mg orally once daily. Initiate if eGFR >=25 mL/min/1.73m2. Continue if eGFR falls below 25 mL/min/1.73m2.
Chronic Kidney Disease (CKD):
10 mg orally once daily. Initiate if eGFR >=25 mL/min/1.73m2. Continue if eGFR falls below 25 mL/min/1.73m2.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for Type 2 Diabetes Mellitus in patients <10 years of age. For Heart Failure and Chronic Kidney Disease: 10 mg orally once daily for patients 10 years of age and older.
Adolescent:
For Heart Failure and Chronic Kidney Disease: 10 mg orally once daily for patients 10 years of age and older.
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment required (eGFR 60-89 mL/min/1.73m2).
Moderate:
No dose adjustment required for Heart Failure or CKD (eGFR 25-59 mL/min/1.73m2). For Type 2 Diabetes Mellitus, initiation is not recommended if eGFR <45 mL/min/1.73m2, but may be continued if already on therapy and eGFR falls to 30-44 mL/min/1.73m2.
Severe:
Initiation is not recommended for any indication if eGFR <25 mL/min/1.73m2. For Heart Failure or CKD, if already on therapy, continue 10 mg once daily if eGFR >=25 mL/min/1.73m2. Discontinue if eGFR falls below 25 mL/min/1.73m2 and patient is on dialysis.
Dialysis:
Contraindicated in patients on dialysis.
Hepatic Impairment:
Mild:
No dose adjustment required.
Moderate:
No dose adjustment required.
Severe:
Not studied; use is not recommended.
Pharmacology
Mechanism of Action
Dapagliflozin is a highly potent, selective, and reversible inhibitor of sodium-glucose co-transporter 2 (SGLT2). SGLT2 is expressed in the proximal renal tubules and is responsible for the reabsorption of approximately 90% of filtered glucose from the tubular lumen. By inhibiting SGLT2, dapagliflozin reduces glucose reabsorption and lowers the renal threshold for glucose (RTG), leading to increased urinary glucose excretion (glucosuria). This results in a reduction in blood glucose concentrations independent of insulin secretion and action. In heart failure and chronic kidney disease, SGLT2 inhibition also provides cardiovascular and renal benefits through mechanisms beyond glycemic control, including osmotic diuresis, natriuresis, reduced intraglomerular pressure, improved renal oxygenation, and effects on myocardial metabolism and fibrosis.
Pharmacokinetics
Absorption:
Bioavailability:
78%
Tmax:
0.5 to 2 hours
FoodEffect:
Food has a minimal effect on dapagliflozin pharmacokinetics; can be taken with or without food.
Distribution:
Vd:
118 L
ProteinBinding:
Approximately 91%
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 12.9 hours
Clearance:
Not available
ExcretionRoute:
Renal (approximately 75%), Fecal (approximately 21%)
Unchanged:
<2% (in urine)
Pharmacodynamics
OnsetOfAction:
Within hours (glucosuric effect)
PeakEffect:
1 to 2 hours (plasma concentration), maximal glucosuric effect within 24 hours
DurationOfAction:
24 hours
Safety & Warnings
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:
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.
Fluid and Electrolyte Problems: Mood changes, confusion, muscle pain or weakness, fast or abnormal heartbeat, severe dizziness or passing out, increased thirst, seizures, feeling very tired or weak, decreased appetite, unable to pass urine or change in the amount of urine produced, dry mouth, dry eyes, or severe upset stomach or vomiting.
Kidney Problems: Unable to pass urine, change in how much urine is passed, blood in the urine, or a significant weight gain.
Acidosis (Too Much Acid in the Blood): Confusion, fast breathing, fast heartbeat, irregular heartbeat, severe stomach pain, upset stomach, or vomiting, feeling very sleepy, shortness of breath, or feeling very tired or weak.
Urinary Tract Infection (UTI): Blood in the urine, burning or pain when passing urine, frequent or urgent need to urinate, fever, lower stomach pain, or pelvic pain.
Vaginal Yeast Infection: Itching, bad odor, or discharge. Report these symptoms to your doctor.
Yeast Infection of the Penis: Pain, swelling, rash, or discharge. Report these symptoms to your doctor.
Rare but Serious Infection: If your genitals or the area between your genitals and rectum becomes tender, red, or swollen, and you have a fever or do not feel well, seek medical help immediately.
Low Blood Sugar: Dizziness, headache, feeling sleepy or weak, shaking, fast heartbeat, confusion, hunger, or 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.
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 report any concerns to your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Nose or throat irritation
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, call your doctor. You can also report side effects to the FDA at 1-800-332-1088 or 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:
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.
Fluid and Electrolyte Problems: Mood changes, confusion, muscle pain or weakness, fast or abnormal heartbeat, severe dizziness or passing out, increased thirst, seizures, feeling very tired or weak, decreased appetite, unable to pass urine or change in the amount of urine produced, dry mouth, dry eyes, or severe upset stomach or vomiting.
Kidney Problems: Unable to pass urine, change in how much urine is passed, blood in the urine, or a significant weight gain.
Acidosis (Too Much Acid in the Blood): Confusion, fast breathing, fast heartbeat, irregular heartbeat, severe stomach pain, upset stomach, or vomiting, feeling very sleepy, shortness of breath, or feeling very tired or weak.
Urinary Tract Infection (UTI): Blood in the urine, burning or pain when passing urine, frequent or urgent need to urinate, fever, lower stomach pain, or pelvic pain.
Vaginal Yeast Infection: Itching, bad odor, or discharge. Report these symptoms to your doctor.
Yeast Infection of the Penis: Pain, swelling, rash, or discharge. Report these symptoms to your doctor.
Rare but Serious Infection: If your genitals or the area between your genitals and rectum becomes tender, red, or swollen, and you have a fever or do not feel well, seek medical help immediately.
Low Blood Sugar: Dizziness, headache, feeling sleepy or weak, shaking, fast heartbeat, confusion, hunger, or 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.
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 report any concerns to your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Nose or throat irritation
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, call 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 dehydration: dizziness, lightheadedness, feeling faint, dry mouth, excessive thirst.
- Signs of urinary tract infection: burning sensation when urinating, frequent urination, cloudy urine, pelvic pain.
- Signs of genital yeast infection: itching, redness, swelling, or discharge in the genital area.
- Signs of diabetic ketoacidosis (DKA): nausea, vomiting, stomach pain, unusual tiredness, trouble breathing, fruity smell to breath.
- Signs of Fournier's gangrene (a rare but serious infection): tenderness, redness, or swelling in the genital or perineal area, fever, feeling unwell.
- Signs of kidney problems: decreased urination, swelling in legs or feet.
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 to ensure safe treatment:
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.
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, as this may impact the medication's effectiveness and safety.
If you are dehydrated, as this can affect the medication's absorption and increase the risk of side effects. Discuss your dehydration with your doctor to determine the best course of action.
If you are taking or have recently taken immunosuppressive medications to treat kidney disease, as these medications can interact with this drug.
If you are pregnant or think you might be pregnant. Do not take this medication during the second or third trimester of pregnancy, as it may harm the fetus.
If you are breastfeeding, as it is recommended to avoid breastfeeding while taking this medication to prevent potential harm to the baby.
Additionally, it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any existing health problems, to your doctor and pharmacist. This information will help them assess potential interactions and ensure it is safe for you to take this medication. Never start, stop, or change the dose of any medication without consulting your doctor first.
It is essential to inform your doctor about the following conditions to ensure safe treatment:
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.
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, as this may impact the medication's effectiveness and safety.
If you are dehydrated, as this can affect the medication's absorption and increase the risk of side effects. Discuss your dehydration with your doctor to determine the best course of action.
If you are taking or have recently taken immunosuppressive medications to treat kidney disease, as these medications can interact with this drug.
If you are pregnant or think you might be pregnant. Do not take this medication during the second or third trimester of pregnancy, as it may harm the fetus.
If you are breastfeeding, as it is recommended to avoid breastfeeding while taking this medication to prevent potential harm to the baby.
Additionally, it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any existing health problems, to your doctor and pharmacist. This information will help them assess potential interactions and ensure it is safe for you to take this medication. Never start, stop, or change the dose of any medication without consulting your doctor first.
Precautions & Cautions
Important Warnings and Cautions
Before taking this medication, inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug. Your doctor may instruct you to stop taking this medication before certain surgical procedures. If you need to stop taking this medication, your doctor will advise you on when to resume taking it after your surgery or procedure.
Driving and Blood Sugar Levels
Do not drive if your blood sugar levels are low, as this can increase your risk of being involved in an accident.
Preventing Dizziness and Falls
To minimize the risk of feeling dizzy or passing out, get up slowly from a sitting or lying down position. Be cautious when climbing stairs.
Lab Tests and Monitoring
Regularly have your blood work and other lab tests checked as directed by your doctor. This medication may affect certain lab test results, so inform all your healthcare providers and lab personnel that you are taking this medication.
Alcohol Consumption
Discuss your alcohol consumption with your doctor before drinking.
Diet and Exercise
Follow the diet and exercise plan recommended by your doctor. If you are on a low-salt or salt-free diet, consult with your doctor.
Risk of Ketoacidosis
This medication can increase the risk of ketoacidosis (too much acid in the blood or urine), a potentially life-threatening condition that may require hospitalization. This risk is higher in people with diabetes or pancreas problems, as well as those who are sick, dehydrated, or cannot eat or drink normally. Additionally, the risk of ketoacidosis is increased in people who skip meals, follow a ketogenic diet, or have surgery. If you use insulin, taking less than the normal dose or missing a dose can also increase the risk of ketoacidosis. Check your ketone levels as directed by your doctor, and consult with your doctor if you have any questions.
Urinary Tract Infections and Kidney Problems
This medication can increase the risk of severe urinary tract infections (UTIs) and kidney problems, which may require hospitalization or dialysis. Be cautious in hot weather or during physical activity, and drink plenty of fluids to prevent dehydration.
Dehydration and Fluid Loss
If you are unable to eat or drink normally, including during illness, fasting, or certain procedures or surgery, consult with your doctor. If you experience vomiting, diarrhea, or stomach upset that does not resolve, contact your doctor to prevent dehydration, which can lead to low blood pressure or worsen kidney problems.
Special Considerations
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Pregnancy and Breastfeeding
This medication may harm an unborn baby if taken during pregnancy. If you become pregnant or are planning to become pregnant, inform your doctor immediately.
High Blood Sugar
During times of stress, such as fever, infection, injury, or surgery, it may be more challenging to control blood sugar levels. Changes in physical activity, exercise, or diet can also affect blood sugar levels. Monitor your blood sugar levels as directed by your doctor, and discuss the best glucose tests to use with your doctor.
Before taking this medication, inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug. Your doctor may instruct you to stop taking this medication before certain surgical procedures. If you need to stop taking this medication, your doctor will advise you on when to resume taking it after your surgery or procedure.
Driving and Blood Sugar Levels
Do not drive if your blood sugar levels are low, as this can increase your risk of being involved in an accident.
Preventing Dizziness and Falls
To minimize the risk of feeling dizzy or passing out, get up slowly from a sitting or lying down position. Be cautious when climbing stairs.
Lab Tests and Monitoring
Regularly have your blood work and other lab tests checked as directed by your doctor. This medication may affect certain lab test results, so inform all your healthcare providers and lab personnel that you are taking this medication.
Alcohol Consumption
Discuss your alcohol consumption with your doctor before drinking.
Diet and Exercise
Follow the diet and exercise plan recommended by your doctor. If you are on a low-salt or salt-free diet, consult with your doctor.
Risk of Ketoacidosis
This medication can increase the risk of ketoacidosis (too much acid in the blood or urine), a potentially life-threatening condition that may require hospitalization. This risk is higher in people with diabetes or pancreas problems, as well as those who are sick, dehydrated, or cannot eat or drink normally. Additionally, the risk of ketoacidosis is increased in people who skip meals, follow a ketogenic diet, or have surgery. If you use insulin, taking less than the normal dose or missing a dose can also increase the risk of ketoacidosis. Check your ketone levels as directed by your doctor, and consult with your doctor if you have any questions.
Urinary Tract Infections and Kidney Problems
This medication can increase the risk of severe urinary tract infections (UTIs) and kidney problems, which may require hospitalization or dialysis. Be cautious in hot weather or during physical activity, and drink plenty of fluids to prevent dehydration.
Dehydration and Fluid Loss
If you are unable to eat or drink normally, including during illness, fasting, or certain procedures or surgery, consult with your doctor. If you experience vomiting, diarrhea, or stomach upset that does not resolve, contact your doctor to prevent dehydration, which can lead to low blood pressure or worsen kidney problems.
Special Considerations
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Pregnancy and Breastfeeding
This medication may harm an unborn baby if taken during pregnancy. If you become pregnant or are planning to become pregnant, inform your doctor immediately.
High Blood Sugar
During times of stress, such as fever, infection, injury, or surgery, it may be more challenging to control blood sugar levels. Changes in physical activity, exercise, or diet can also affect blood sugar levels. Monitor your blood sugar levels as directed by your doctor, and discuss the best glucose tests to use with your doctor.
Overdose Information
Overdose Symptoms:
- Hypotension (low blood pressure)
- Volume depletion (dehydration)
- Hypoglycemia (if taken with insulin or sulfonylureas)
What to Do:
In case of overdose, contact a poison control center immediately (e.g., 1-800-222-1222 in the US) or seek emergency medical attention. Treatment is supportive, focusing on correcting volume depletion and electrolyte imbalances. Glucosuria will persist for approximately 24 hours.
Drug Interactions
Moderate Interactions
- Diuretics (e.g., loop diuretics, thiazide diuretics)
- Insulin and insulin secretagogues (e.g., sulfonylureas)
- ACE inhibitors/Angiotensin Receptor Blockers (ARBs)
Monitoring
Baseline Monitoring
Renal Function (eGFR)
Rationale: To assess baseline kidney function and guide dosing, especially for initiation and in patients with CKD.
Timing: Prior to initiation of therapy.
Volume Status/Blood Pressure
Rationale: To assess risk of hypotension, especially in patients on diuretics or with pre-existing volume depletion.
Timing: Prior to initiation of therapy.
Electrolytes (e.g., potassium, sodium)
Rationale: To assess baseline electrolyte balance, especially in patients at risk for imbalances (e.g., on diuretics, renal impairment).
Timing: Prior to initiation of therapy.
Routine Monitoring
Renal Function (eGFR)
Frequency: At least annually, or more frequently in patients with impaired renal function or those at risk for acute kidney injury.
Target: Maintain eGFR >=25 mL/min/1.73m2 for continued use in HF/CKD. For T2DM, consider discontinuation if eGFR <30 mL/min/1.73m2.
Action Threshold: Significant decline in eGFR, eGFR <25 mL/min/1.73m2 (consider discontinuation or dose adjustment based on indication).
Volume Status/Blood Pressure
Frequency: Periodically, especially during intercurrent illness or changes in diuretic dose.
Target: Normotensive, no signs of orthostasis.
Action Threshold: Symptomatic hypotension, orthostasis, signs of dehydration.
Blood Glucose (HbA1c, FBG)
Frequency: Every 3-6 months (HbA1c) for T2DM patients; as clinically indicated for FBG.
Target: Individualized glycemic targets.
Action Threshold: Persistent hyperglycemia or hypoglycemia (if on concomitant insulin/sulfonylurea).
Signs/Symptoms of Genital Mycotic Infections (GMI) or Urinary Tract Infections (UTI)
Frequency: At each visit, or as symptoms arise.
Target: Absence of symptoms.
Action Threshold: Presence of itching, discharge, dysuria, frequency, urgency, fever.
Signs/Symptoms of Diabetic Ketoacidosis (DKA)
Frequency: At each visit, or as symptoms arise.
Target: Absence of symptoms.
Action Threshold: Nausea, vomiting, abdominal pain, fatigue, shortness of breath, fruity breath odor.
Symptom Monitoring
- Signs of dehydration (dizziness, lightheadedness, dry mouth, excessive thirst)
- Symptoms of urinary tract infection (burning sensation when urinating, frequent urination, cloudy urine, pelvic pain)
- Symptoms of genital yeast infection (itching, redness, swelling, discharge)
- Symptoms of diabetic ketoacidosis (nausea, vomiting, abdominal pain, excessive thirst, rapid breathing, fruity breath odor, unusual fatigue)
- Symptoms of Fournier's gangrene (tenderness, redness, or swelling in the genital or perineal area, fever, malaise)
- Symptoms of hypoglycemia (sweating, tremor, dizziness, confusion, hunger, irritability) if used with insulin or sulfonylureas
Special Patient Groups
Pregnancy
Use is not recommended during the second and third trimesters of pregnancy due to potential adverse effects on renal development in the fetus. Limited data on first trimester use. Discuss risks and benefits with a healthcare provider.
Trimester-Specific Risks:
First Trimester:
Limited human data; animal studies do not indicate direct teratogenicity at clinically relevant exposures.
Second Trimester:
Animal studies show adverse renal developmental effects (renal pelvic and tubule dilatations) at exposures higher than clinical. Human data are insufficient, but potential for similar effects exists.
Third Trimester:
Animal studies show adverse renal developmental effects. Use is generally avoided due to potential for fetal renal dysfunction.
Lactation
Not recommended during breastfeeding. Dapagliflozin is excreted in the milk of lactating rats. It is unknown if it is excreted in human milk. Due to the potential for serious adverse reactions in a breastfed infant (e.g., renal dysfunction, hypoglycemia), a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
Risk level L3 (Moderately Safe, but generally not recommended due to potential for adverse effects in infant).
Pediatric Use
Approved for Heart Failure and Chronic Kidney Disease in patients 10 years of age and older. Not indicated for Type 2 Diabetes Mellitus in patients younger than 10 years of age. Safety and effectiveness for T2DM in pediatric patients <10 years have not been established.
Geriatric Use
No dose adjustment is required based on age. However, elderly patients may be at increased risk for volume depletion and hypotension due to age-related decline in renal function and increased susceptibility to adverse effects of volume depletion. Monitor renal function and volume status more frequently.
Clinical Information
Clinical Pearls
- Dapagliflozin offers significant cardiovascular and renal benefits beyond glycemic control, making it a cornerstone therapy for patients with Type 2 Diabetes Mellitus, Heart Failure (HFrEF and HFpEF), and Chronic Kidney Disease.
- Patients should be educated on the importance of hydration to mitigate the risk of volume depletion and hypotension.
- Counsel patients on symptoms of genital mycotic infections and urinary tract infections, and emphasize good hygiene.
- Be vigilant for signs and symptoms of euglycemic diabetic ketoacidosis (DKA), which can occur even with normal or mildly elevated blood glucose levels. Consider temporary discontinuation during acute illness, surgery, or prolonged fasting.
- While the risk of lower limb amputation is lower with dapagliflozin compared to canagliflozin, it's still important to monitor for foot complications, especially in patients with pre-existing peripheral vascular disease or neuropathy.
- Dapagliflozin can cause a transient decrease in eGFR upon initiation, which typically stabilizes. Persistent or significant decline warrants further investigation.
Alternative Therapies
- Other SGLT2 inhibitors (e.g., Empagliflozin, Canagliflozin, Ertugliflozin)
- Other antidiabetic agents (e.g., Metformin, GLP-1 receptor agonists, DPP-4 inhibitors, Sulfonylureas, Insulin)
- For Heart Failure: ACE inhibitors, ARBs, ARNI (Sacubitril/Valsartan), Beta-blockers, MRAs (Spironolactone, Eplerenone)
- For Chronic Kidney Disease: ACE inhibitors, ARBs, Finerenone
Cost & Coverage
Average Cost:
$500 - $650 per 30 tablets (10mg)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (Preferred Brand or Non-Preferred Brand, depending on plan formulary)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult 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. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.