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Dapagliflozin Bis L-proline 15.6mg
Tablet · Prescription medication
Hanmi Pharmaceutical Co., Ltd.

MFDS item code 202003735 · Approved 2020.05.22 · Insurance code 643508270
Treatment for blood sugar control in type 2 diabetes and reduction of cardiovascular risk in chronic heart failure and chronic kidney disease
This medication is used in conjunction with diet and exercise to assist in blood sugar control for patients with type 2 diabetes. It also reduces the risk of hospitalization and emergency visits due to heart failure in patients with chronic heart failure, and lowers the risk of death from cardiovascular disease. In patients with chronic kidney disease, it is used to lower risks associated with declining kidney function and reduce the risk of death from cardiovascular disease. This medication helps improve major health issues in patients with type 2 diabetes, chronic heart failure, and chronic kidney disease.
The recommended dosage for this medication is 10 mg once daily. When starting combination therapy, either 5 mg or 10 mg can be administered once daily. For patients with chronic heart failure and chronic kidney disease, 10 mg once daily is also recommended. The method of administration is oral, once daily, regardless of food intake, swallowing the tablet whole.
The efficacy and safety of this medication for children under 18 years of age have not been established. Therefore, there is no recommended dosage for pediatric patients.
This medication should not be used in patients who have had allergic reactions to the active ingredient or any excipients. It should not be administered to patients with type 1 diabetes or diabetic ketoacidosis. Patients with lactose intolerance or specific genetic issues should not receive this medication due to the lactose content. It should also not be used in patients undergoing dialysis. Patients with reduced fluid volume or kidney function issues should use this medication with caution. This medication can lower blood pressure and reduce blood volume, which can cause symptomatic hypotension or worsen kidney function. Particularly, elderly patients with reduced kidney function or those taking diuretics should be more cautious, and kidney function and blood pressure should be monitored before and during administration. This medication is not recommended for patients with very low kidney function. Taking this medication may commonly lead to genital infections; if related symptoms occur, immediate treatment is necessary. Symptoms of hypoglycemia may appear, especially when taken in conjunction with insulin or sulfonylureas, increasing the risk. Due to reduced fluid volume, dehydration or hypotension may occur, so hydration status should be carefully managed. Diabetic ketoacidosis, a serious metabolic anomaly, may rarely occur; if symptoms such as nausea, vomiting, abdominal pain, or difficulty breathing arise, immediate consultation with healthcare professionals is required. Urinary tract infections may also commonly occur, and rapid treatment is necessary if symptoms are present. As kidney function-related adverse reactions, creatinine levels may temporarily rise, so regular testing is needed. Very rarely, severe infections in the perineal area may occur; if there is pain, swelling, or fever in that area, healthcare professionals should be informed immediately. Patients with poor liver function or the elderly should use this medication with extra caution. Patients at risk of reduced fluid volume should closely monitor hydration status and blood pressure, and medication may be temporarily suspended if necessary. This medication increases urination, which may affect patients with bladder disorders, so caution is advised. Pregnant women or nursing mothers should refrain from using this medication, and if pregnancy is confirmed, it should be discontinued immediately. Safety and efficacy in pediatric patients have not yet been established. This medication may increase the risk of hypoglycemia when used with insulin or sulfonylureas, so adjustments of doses for these medications may be necessary. In case of overdose, there is no specific antidote, and symptomatic treatment should be provided, as it is not removed by dialysis. Lastly, during the use of this medication, caution should be exercised regarding the symptoms of hypoglycemia while driving or operating machinery. The medication should be kept out of the reach of children and stored in its original container.
Hives, severe swelling (angioedema), cold sweat, difficulty breathing, chest pain (chest tightness), rash, hives, angioedema, anaphylaxis (severe allergic response), severe rash with fever, blisters, skin peeling, mucosal pain in the mouth/eyes (severe skin adverse reactions), shortness of breath or difficulty breathing, asthma attacks, respiratory impairment accompanied by coughing and fever, yellowing of the skin or eyes (jaundice), systemic
Not everyone experiences these, and they can vary from person to person.
This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. The storage temperature should be maintained between 1 degree and 30 degrees Celsius at room temperature. Storing it this way ensures the safety of the medication's efficacy.
Yellow, double convex, diamond-shaped film-coated tablets
30 tablets/bottle
Even with the same ingredient, strength, dosage form and how it is taken can differ.
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Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.
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For anything that needs medical judgment, consult a doctor or pharmacist.
This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.