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The following safety information outlines the potential risks and necessary precautions when using Steglatro (ertugliflozin). It is important to carefully consider these warnings and discuss any concerns with your healthcare provider.

• Low Blood Pressure: Steglatro may lead to fluid loss, which could result in low blood pressure. Be alert for symptoms such as dizziness, lightheadedness, fatigue, or blurred vision. Those most at risk include individuals with kidney problems, older adults, those with existing low blood pressure, and those taking diuretics.

• Ketoacidosis: In rare cases, Steglatro can cause ketoacidosis, a serious condition marked by high ketone levels. Discontinue use and seek immediate medical attention if you experience symptoms like severe dehydration, nausea, vomiting, stomach pain, fatigue, or shortness of breath. Factors that increase risk include high doses of the medication, reduced insulin doses, sudden fever, low-calorie intake, surgery, pancreatic issues, and alcohol abuse.

• Sudden Kidney Problems: The medication can cause fluid loss, potentially leading to kidney damage, especially in individuals with low blood volume, existing kidney or heart conditions, or those taking diuretics, ACE inhibitors, ARBs, or NSAIDs. Notify your healthcare provider if you experience significant dietary changes, fluid loss, or symptoms like reduced urine output, leg swelling, nausea, fatigue, or shortness of breath.

• Serious Genital or Urinary Tract Infections: Steglatro may increase the risk of urinary tract infections, genital yeast infections, and Fournier's gangrene, a severe, life-threatening condition. Seek medical advice if you notice symptoms such as painful urination, blood in urine, fever, itching, pain, redness, or swelling in the genital area. Immediate emergency help is necessary for severe symptoms like fever above 100.4ºF, or extreme weakness or discomfort.

• Leg and Foot Amputations: Although uncommon, there is a potential risk of lower limb amputations, particularly affecting toes or feet. Monitor your legs and feet for signs of infections, such as new pain, tenderness, sores, or ulcers. Those at higher risk include individuals with a history of amputation, blood circulation issues, foot ulcers, males, and those with high baseline A1C or taking diuretics or insulin.

• Low Blood Sugar: When used with insulin or medications that increase insulin levels (e.g., sulfonylureas or glinides), Steglatro can cause low blood sugar. Symptoms may include headache, sleepiness, hunger, irritability, dizziness, confusion, sweating, shakiness, weakness, or a fast heartbeat. Your healthcare provider may adjust your medication dosage to mitigate this risk. Risks are heightened for insulin users, older adults, and those consuming alcohol or undernourished.

Contraindications:

Do not use Steglatro if you have any of the following conditions, as it may result in serious health complications:

• Severe kidney problems
• End-stage kidney disease (ESRD)
• Dialysis

Always consult your healthcare provider if you have any questions or need clarification regarding the use of this medication.

When taking this medication, some individuals may experience common side effects such as frequent urination, headaches, and thirst. Female and male yeast infections, urinary tract infections, and vaginal itching are also reported, but these are generally mild. If these effects persist or worsen, it's advisable to consult a healthcare provider.

There are other side effects that might occur, including symptoms of a common cold, back pain, weight loss, and an increase in bad cholesterol levels. These effects should be monitored and discussed with a healthcare professional if they become concerning.

Serious side effects, though rare, require immediate medical attention. These include signs of ketoacidosis, characterized by severe dehydration, nausea, vomiting, stomach pain, tiredness, or shortness of breath. Another rare, but serious, condition is Fournier's gangrene, identified by fever, discomfort, and pain or swelling in the genital area. Acute kidney injury, indicated by low urine production, swelling in legs or feet, nausea, tiredness, or shortness of breath, is also a critical concern.

Additionally, the medication may increase the risk of lower limb amputation, especially in individuals with poor blood flow or previous amputations. Regular foot checks are recommended to detect new pain or sores. The risk of low blood sugar is typically low unless combined with other diabetes medications, insufficient caloric intake, or excessive physical activity. Symptoms of low blood sugar include sweating, shaking, fast heartbeat, and dizziness, and should be treated promptly.

Dehydration is another risk, potentially leading to serious kidney damage, so it is important to stay hydrated. Severe allergic reactions are rare but require urgent medical help if symptoms like rash, severe dizziness, or trouble breathing occur. Always communicate any unusual symptoms with your healthcare provider.