Dapagliflozin 5mg Tablets (Dapagliflozin Propanediol Hydrate)

Adult dose

The recommended dosage of this medication is 10mg once daily for monotherapy and additional combination therapy. In initial combination therapy, 5mg or 10mg may be given once daily. For chronic heart failure and chronic kidney disease, 10mg is taken once daily. In patients with severe liver impairment, a starting dose of 5mg is recommended, and if well tolerated, it can be increased to 10mg. Administration can be done regardless of food intake.

Child dose

The efficacy and safety of dapagliflozin in pediatric patients under 18 years of age are not established, so it should not be administered.

This medication should not be used in patients with a history of allergic reactions, those with type 1 diabetes, or individuals with certain genetic lactose intolerance disorders. It is particularly contraindicated in patients undergoing dialysis. Patients with reduced fluid volume or impaired kidney function must use this medication with caution. This drug may lower blood pressure and affect kidney function, so fluid status and kidney function should be monitored closely before and during treatment. The most commonly reported side effect in clinical trials is genital infections, which may occur more frequently in women. Other possible symptoms include hypoglycemia, dehydration, dry mouth, dizziness, and urinary tract infections. This medication can cause serious metabolic disturbances known as diabetic ketoacidosis; if relevant symptoms or signs occur, consult a healthcare professional immediately. Elderly patients or those taking diuretics are at a higher risk of dehydration and hypotension and should be monitored more closely. Pregnant women or nursing mothers are advised against using this medication, and it should be discontinued if pregnancy is confirmed. This drug may increase the risk of hypoglycemia when used in conjunction with insulin or sulfonylureas, thus dosage adjustments for these medications may be necessary. During treatment, it is important to regularly check blood sugar control status as well as fluid status and kidney function periodically. This medication has not been confirmed for safety and efficacy in children and should not be used in this population. In case of overdose, there is no specific antidote, and appropriate treatment should be provided based on symptoms. Finally, caution should be exercised during driving or operating machinery due to possible side effects such as hypoglycemia.

Serious side effects

Urticaria, severe swelling (angioedema), chest tightness, difficulty breathing, diaphoresis, pallor, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), profound lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis,

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia, reduced fluid volume, dry mouth, dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, increased hematocrit, reduced creatinine clearance initially after treatment, dyslipidemia, elevated creatinine levels initially after treatment, elevated blood urea, weight loss, urticaria, pruritus, diaphoresis, rash, angioedema, asthenia, pain,

This medication may be sensitive to air and moisture, so it should be stored in a tightly closed container. The recommended storage temperature is room temperature between 1 degree and 30 degrees Celsius. This helps maintain the drug's effectiveness and safety.

Appearance

Yellow, biconvex, round film-coated tablet

Package unit

PTP - 28 tablets/box [7 tablets/PTP x 4]