Dapagliflozin 10mg 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, Cardiovascular Agent, Renal Protectant
Pharmacologic Class
Sodium-glucose co-transporter 2 (SGLT2) inhibitor
Pregnancy Category
Not applicable (FDA has moved to narrative labeling)
FDA Approved
Jan 2014
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 people with heart failure and chronic kidney disease, helping to protect the heart and kidneys by reducing strain on these organs.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, take it exactly as directed by your doctor. 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, be sure to drink plenty of non-caffeinated liquids.
It's essential to continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better. This will help ensure that you receive the full benefits of the treatment.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication, store it at room temperature in a dry location, avoiding the bathroom. Keep all medications in a secure place, out of the reach of children and pets. When your medication is no longer needed or has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your doctor or pharmacist. If you have questions about the best way to dispose of your medication, consult with your pharmacist. You may also want to check if there are any 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. 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, take it exactly as directed by your doctor. 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, be sure to drink plenty of non-caffeinated liquids.
It's essential to continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better. This will help ensure that you receive the full benefits of the treatment.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication, store it at room temperature in a dry location, avoiding the bathroom. Keep all medications in a secure place, out of the reach of children and pets. When your medication is no longer needed or has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your doctor or pharmacist. If you have questions about the best way to dispose of your medication, consult with your pharmacist. You may also want to check if there are any 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. 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 a balanced diet as recommended by your healthcare provider.
- Engage in regular physical activity.
- Stay well-hydrated, especially when starting the medication or in hot weather, to prevent dehydration.
- Monitor blood sugar levels regularly if you have diabetes, as advised by your doctor.
- Practice good genital hygiene to reduce the risk of infections.
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:
5 mg orally once daily initially; may increase to 10 mg once daily based on efficacy and tolerability. For patients with eGFR < 45 mL/min/1.73 m², initiation is not recommended, but continuation may be considered if already on therapy and benefits outweigh risks.
Heart Failure (HFrEF):
10 mg orally once daily.
Chronic Kidney Disease (CKD):
10 mg orally once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (Safety and efficacy not established in pediatric patients < 18 years of age for T2DM, HF, or CKD indications).
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment needed (eGFR ≥ 60 mL/min/1.73 m²).
Moderate:
No dosage adjustment needed for eGFR 45 to < 60 mL/min/1.73 m². Initiation is not recommended for eGFR < 45 mL/min/1.73 m², but continuation may be considered if already on therapy and benefits outweigh risks. Discontinue if eGFR persistently falls below 25 mL/min/1.73 m².
Severe:
Initiation is not recommended for eGFR < 45 mL/min/1.73 m². Continuation may be considered if already on therapy and benefits outweigh risks. Discontinue if eGFR persistently falls below 25 mL/min/1.73 m².
Dialysis:
Contraindicated in patients on dialysis.
Hepatic Impairment:
Mild:
No dosage adjustment needed.
Moderate:
No dosage adjustment needed.
Severe:
No dosage adjustment needed.
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, leading to increased urinary glucose excretion (glucosuria) and a reduction in blood glucose levels. This mechanism is independent of insulin secretion and insulin sensitivity. Additionally, SGLT2 inhibition leads to osmotic diuresis, natriuresis, and a reduction in blood pressure, which contribute to its cardiovascular and renal benefits.
Pharmacokinetics
Absorption:
Bioavailability:
78%
Tmax:
2 hours (fasted state)
FoodEffect:
Food has a minimal effect on dapagliflozin pharmacokinetics; it can be taken with or without food.
Distribution:
Vd:
118 L
ProteinBinding:
91%
CnssPenetration:
Limited
Elimination:
HalfLife:
12.9 hours
Clearance:
Not available
ExcretionRoute:
Urine (75%), Feces (21%)
Unchanged:
Less than 2% (urine)
Pharmacodynamics
OnsetOfAction:
Within 30-60 minutes (glucosuric effect)
PeakEffect:
Approximately 2 hours (peak plasma concentration), glucosuric effect peaks within 24 hours.
DurationOfAction:
24 hours (allowing once-daily dosing)
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 fainting, increased thirst, seizures, feeling extremely tired or weak, decreased appetite, inability to pass urine or changes in urine output, dry mouth, dry eyes, or severe stomach upset or vomiting.
Kidney Problems: Inability to pass urine, changes in urine output, blood in the urine, or sudden weight gain.
Acidosis (Too Much Acid in the Blood): Confusion, rapid breathing, rapid heartbeat, irregular heartbeat, severe stomach pain, upset stomach, or vomiting, feeling extremely sleepy, shortness of breath, or extreme fatigue.
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: 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 become tender, red, or swollen, and you have a fever or feel unwell, seek medical help immediately.
Low Blood Sugar: Dizziness, headache, feeling sleepy or weak, shaking, rapid heartbeat, confusion, hunger, or sweating. If you experience any of these symptoms, contact your doctor right away. Follow your doctor's instructions for managing low blood sugar, which may include taking glucose tablets, liquid glucose, or some fruit juices.
Other Possible Side Effects
Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
Nose or throat irritation
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.
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 fainting, increased thirst, seizures, feeling extremely tired or weak, decreased appetite, inability to pass urine or changes in urine output, dry mouth, dry eyes, or severe stomach upset or vomiting.
Kidney Problems: Inability to pass urine, changes in urine output, blood in the urine, or sudden weight gain.
Acidosis (Too Much Acid in the Blood): Confusion, rapid breathing, rapid heartbeat, irregular heartbeat, severe stomach pain, upset stomach, or vomiting, feeling extremely sleepy, shortness of breath, or extreme fatigue.
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: 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 become tender, red, or swollen, and you have a fever or feel unwell, seek medical help immediately.
Low Blood Sugar: Dizziness, headache, feeling sleepy or weak, shaking, rapid heartbeat, confusion, hunger, or sweating. If you experience any of these symptoms, contact your doctor right away. Follow your doctor's instructions for managing low blood sugar, which may include taking glucose tablets, liquid glucose, or some fruit juices.
Other Possible Side Effects
Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
Nose or throat irritation
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:
- Signs of dehydration: feeling dizzy or lightheaded, especially when standing up, or feeling very thirsty.
- Signs of urinary tract infection: burning sensation when urinating, frequent urination, cloudy or bloody urine, or fever.
- Signs of genital yeast infection: itching, redness, swelling, or unusual discharge in the genital area.
- Signs of diabetic ketoacidosis (DKA): nausea, vomiting, stomach pain, unusual tiredness, or fruity-smelling breath. Seek immediate medical attention if these occur.
- Signs of Fournier's gangrene: severe pain, tenderness, redness, or swelling in the genital or anal area, accompanied by fever or feeling unwell. This is a rare but serious infection and requires immediate medical attention.
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. Be sure to describe the allergic reaction you experienced.
If you have type 1 diabetes, as this medication is not intended to treat this condition.
If you have a condition that causes acidic blood.
If you have kidney disease or are undergoing dialysis.
If you are dehydrated, as this may affect your treatment.
If you are taking or have recently taken immunosuppressive medications to treat kidney disease.
If you are pregnant or think you might be pregnant. Note that this medication should not be taken during the second or third trimester of pregnancy.
If you are breast-feeding, as you should not breast-feed while taking this medication.
Additionally, it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This includes any health problems you have, as they may interact with this medication. Always check with your doctor before starting, stopping, or changing the dose of any medication to ensure your safety.
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. Be sure to describe the allergic reaction you experienced.
If you have type 1 diabetes, as this medication is not intended to treat this condition.
If you have a condition that causes acidic blood.
If you have kidney disease or are undergoing dialysis.
If you are dehydrated, as this may affect your treatment.
If you are taking or have recently taken immunosuppressive medications to treat kidney disease.
If you are pregnant or think you might be pregnant. Note that this medication should not be taken during the second or third trimester of pregnancy.
If you are breast-feeding, as you should not breast-feed while taking this medication.
Additionally, it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This includes any health problems you have, as they may interact with this medication. Always check with your doctor before starting, stopping, or changing the dose of any medication to ensure your safety.
Precautions & Cautions
Important Warnings and Cautions
When taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists. Your doctor may advise you to stop taking this medication before certain surgical procedures, and will provide guidance on when to resume taking it after the procedure.
Low Blood Sugar and Driving
If you experience low blood sugar, do not drive, as this can increase your risk of being involved in an accident.
Dizziness and Falls
To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying down position. Be cautious when climbing stairs.
Lab Tests and Monitoring
Regularly check your blood work and other lab tests 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.
Ketoacidosis
This medication can increase the risk of ketoacidosis (too much acid in the blood or urine), a potentially life-threatening condition. This risk is higher in people with diabetes, pancreas problems, or those who are sick, dehydrated, or have undergone surgery. Additionally, individuals taking insulin and missing doses or taking less than the prescribed dose are at increased risk. Monitor your ketone levels as directed by your doctor, and consult with your doctor if you have any questions or concerns.
Urinary Tract Infections and Kidney Problems
Severe urinary tract infections (UTIs) and kidney problems have been reported with this medication. In some cases, hospitalization or dialysis may be necessary. Be cautious in hot weather or during physical activity, and drink plenty of fluids to avoid dehydration.
Dehydration
If you are unable to eat or drink normally, including during illness, fasting, or certain medical procedures, consult with your doctor. If you experience persistent vomiting, diarrhea, or stomach upset, contact your doctor to avoid dehydration, which can lead to low blood pressure or worsen kidney problems.
Special Precautions
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Pregnancy
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 control. Monitor your blood sugar levels as directed by your doctor, and discuss the best glucose tests to use with your doctor.
When taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists. Your doctor may advise you to stop taking this medication before certain surgical procedures, and will provide guidance on when to resume taking it after the procedure.
Low Blood Sugar and Driving
If you experience low blood sugar, do not drive, as this can increase your risk of being involved in an accident.
Dizziness and Falls
To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying down position. Be cautious when climbing stairs.
Lab Tests and Monitoring
Regularly check your blood work and other lab tests 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.
Ketoacidosis
This medication can increase the risk of ketoacidosis (too much acid in the blood or urine), a potentially life-threatening condition. This risk is higher in people with diabetes, pancreas problems, or those who are sick, dehydrated, or have undergone surgery. Additionally, individuals taking insulin and missing doses or taking less than the prescribed dose are at increased risk. Monitor your ketone levels as directed by your doctor, and consult with your doctor if you have any questions or concerns.
Urinary Tract Infections and Kidney Problems
Severe urinary tract infections (UTIs) and kidney problems have been reported with this medication. In some cases, hospitalization or dialysis may be necessary. Be cautious in hot weather or during physical activity, and drink plenty of fluids to avoid dehydration.
Dehydration
If you are unable to eat or drink normally, including during illness, fasting, or certain medical procedures, consult with your doctor. If you experience persistent vomiting, diarrhea, or stomach upset, contact your doctor to avoid dehydration, which can lead to low blood pressure or worsen kidney problems.
Special Precautions
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Pregnancy
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 control. 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:
- Hypoglycemia (if taken with insulin or sulfonylureas)
- Volume depletion (dehydration, hypotension)
- Increased urinary glucose excretion
What to Do:
In case of overdose, contact a poison control center immediately (Call 1-800-222-1222). Treatment is supportive. Monitor for hypoglycemia and volume depletion and manage as appropriate.
Drug Interactions
Moderate Interactions
- Diuretics (e.g., loop diuretics, thiazide diuretics): Increased risk of dehydration and hypotension.
- Insulin and Insulin Secretagogues (e.g., sulfonylureas): Increased risk of hypoglycemia when used concomitantly with dapagliflozin. A lower dose of insulin or insulin secretagogue may be required.
- Lithium: SGLT2 inhibitors may decrease serum lithium concentrations due to increased urinary sodium excretion. Monitor lithium levels.
Monitoring
Baseline Monitoring
Renal function (eGFR)
Rationale: To assess baseline kidney function and guide dosing, as dapagliflozin efficacy is dependent on renal function and it is contraindicated in severe renal impairment/dialysis.
Timing: Prior to initiation
Electrolytes (e.g., sodium, potassium)
Rationale: To assess baseline electrolyte status, especially in patients at risk for volume depletion or on diuretics.
Timing: Prior to initiation
Glycated Hemoglobin (HbA1c)
Rationale: To establish baseline glycemic control for patients with Type 2 Diabetes Mellitus.
Timing: Prior to initiation
Routine Monitoring
Renal function (eGFR)
Frequency: At least annually, or more frequently in patients with impaired renal function or those receiving concomitant medications that affect renal function.
Target: Maintain eGFR ≥ 25 mL/min/1.73 m² for continuation.
Action Threshold: Discontinue if eGFR persistently falls below 25 mL/min/1.73 m².
Electrolytes
Frequency: Periodically, especially in patients at risk for volume depletion (e.g., elderly, those on diuretics).
Target: Within normal limits.
Action Threshold: Address imbalances, consider dose adjustment of diuretics or dapagliflozin.
Blood Glucose (Fasting Plasma Glucose, HbA1c)
Frequency: HbA1c every 3-6 months for T2DM; daily self-monitoring of blood glucose as needed.
Target: Individualized glycemic targets.
Action Threshold: Adjust antidiabetic therapy if targets not met or if hypoglycemia occurs.
Signs and symptoms of volume depletion
Frequency: Routinely, especially during initiation or dose titration.
Target: Not applicable.
Action Threshold: If symptoms occur (e.g., dizziness, orthostatic hypotension), assess hydration status and consider temporary interruption or dose reduction.
Symptom Monitoring
- Signs and symptoms of dehydration (dizziness, lightheadedness, orthostatic hypotension)
- Symptoms of urinary tract infection (dysuria, frequent urination, urgency, fever)
- Symptoms of genital mycotic infection (itching, redness, discharge)
- Symptoms of diabetic ketoacidosis (nausea, vomiting, abdominal pain, rapid breathing, unusual fatigue, fruity breath odor)
- Symptoms of Fournier's gangrene (pain, tenderness, erythema, swelling in the genital or perineal area, fever, malaise)
- Symptoms of hypoglycemia (sweating, tremor, confusion, hunger, irritability) if used with insulin or sulfonylureas
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. 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 developmental toxicity at clinically relevant exposures.
Second Trimester:
Potential for adverse renal developmental effects in the fetus (due to SGLT2 inhibition affecting fluid and electrolyte homeostasis).
Third Trimester:
Potential for adverse renal developmental effects in the fetus (due to SGLT2 inhibition affecting fluid and electrolyte homeostasis).
Lactation
Not recommended during breastfeeding. It is unknown if dapagliflozin is excreted in human milk. Due to the potential for serious adverse reactions in a breastfed infant (e.g., renal developmental effects), 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:
Potential for serious adverse reactions (e.g., renal developmental effects, hypoglycemia).
Pediatric Use
Safety and effectiveness have not been established in pediatric patients under 18 years of age for any indication (Type 2 Diabetes Mellitus, Heart Failure, Chronic Kidney Disease).
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly (≥65 years) and younger patients. However, elderly patients may be at increased risk for volume depletion and renal impairment. Monitor renal function and hydration status more frequently.
Clinical Information
Clinical Pearls
- Dapagliflozin offers benefits beyond glycemic control, including significant reductions in cardiovascular death and hospitalization for heart failure, and progression of kidney disease, independent of diabetes status.
- Patients should be advised to maintain adequate hydration to minimize the risk of volume depletion, especially during periods of illness, hot weather, or increased physical activity.
- Educate patients on the symptoms of diabetic ketoacidosis (DKA), even if blood glucose levels are not significantly elevated (euglycemic DKA), and to seek immediate medical attention if symptoms occur.
- Emphasize the importance of good personal hygiene to reduce the risk of genital mycotic infections.
- Renal function should be assessed before initiating therapy and periodically thereafter, as efficacy is dependent on eGFR and the drug is contraindicated in severe renal impairment or dialysis.
Alternative Therapies
- Other SGLT2 inhibitors (e.g., empagliflozin, canagliflozin, ertugliflozin)
- For Type 2 Diabetes: Metformin, GLP-1 receptor agonists, DPP-4 inhibitors, sulfonylureas, insulin, thiazolidinediones, alpha-glucosidase inhibitors, meglitinides.
- For Heart Failure: ACE inhibitors/ARBs/ARNI, beta-blockers, MRAs, diuretics.
- For Chronic Kidney Disease: ACE inhibitors/ARBs, finerenone.
Cost & Coverage
Average Cost:
$500 - $650 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 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 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 is a crucial patient fact sheet. Please read it carefully and review it again whenever you receive a refill. 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. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.