Daewoo Dapagliflozin 10mg (Dapagliflozin Monohydrate Mixture)

Adult dose

The recommended dosage for this medication is 10mg, taken once daily, for both monotherapy and additional combination therapy with insulin or other hypoglycemic agents. For initial combination therapy, when administered with metformin, the initial recommended dosage is either 5mg once daily or 10mg once daily. This medication can be taken orally at any time of day regardless of food intake and must be swallowed whole.

This medication should not be administered to certain patients. For example, it should not be used by patients who are allergic to any components of this medication, individuals with type 1 diabetes, patients suffering from diabetic ketoacidosis, those with lactose intolerance, or patients undergoing dialysis. Careful use of this medication is required for patients with insufficient fluid volume or poor kidney function. This medication can lower blood pressure or affect kidney function, so extra caution is especially necessary for the elderly or patients taking diuretics. Prior to administration, fluid status and kidney function must be verified, and during use, continuous observation of symptoms of hypotension and changes in kidney function is crucial. Furthermore, this medication contains yellow pigments, Yellow No. 4 and Yellow No. 5, and care should be taken when administering it to patients with a history of allergies to these substances. During the medication period, genital infections and urinary tract infections may occur, so if symptoms of infection arise, immediate consultation with medical personnel is advised. Additionally, symptoms of hypoglycemia may appear, requiring dose adjustments when used concurrently with insulin or sulfonylureas, which may induce hypoglycemia. Reports of dehydration or hypotension due to reduced fluid volume have also been noted, so patients with dehydration or low blood pressure should exercise caution. Severe metabolic abnormalities known as diabetic ketoacidosis may rarely occur, so if symptoms such as nausea, vomiting, abdominal pain, or difficulty breathing arise, immediate medical attention is necessary. Use during pregnancy is not recommended, and if pregnancy is confirmed, the medication should be discontinued immediately. It is also advisable for breastfeeding women to avoid this medication. There is no specific antidote for overdose; therefore, appropriate treatment according to symptoms is important. This medication does not significantly affect driving or operating machinery, but caution is necessary in cases of hypoglycemia. Finally, the safety and efficacy of this medication in children have not been established, so it should not be used in pediatric patients.

Serious side effects

• Urticaria, severe swelling (edema), cold sweat → severe allergic reactions
• Severe rash with high fever, blisters, skin peeling, pain in mouth/eyes mucosa → severe skin adverse reactions
• Shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough+fever → respiratory problems
• Yellowing of skin or eyes (jaundice), profound lethargy → liver abnormalities (jaundice)
• Sudden and severe headache, thunderclap headache, seizures,

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia, reduced fluid volume, dizziness, constipation, dry mouth, back pain, pain during urination, polyuria, nocturia, genital itching, increased hematocrit, reduced initial renal creatinine clearance, dyslipidemia, increased serum creatinine, increased blood urea, weight loss, rash, urticaria, cold sweat, itching, vomiting, diarrhea, headache, cough,

This medication should be stored in a tightly closed container to protect it from air and moisture, and it is best stored at room temperature between 1 and 30 degrees Celsius. Storing it this way will help maintain the medication's efficacy and prevent degradation.

Appearance

Yellow, double convex rhomboid film-coated tablets

Package unit

28 tablets/box [(14 tablets/PTP x 2, 7 tablets/PTP x 4)]