Dafogin 10 mg (Dapagliflozin)

Adult dose

The recommended dosage is 10 mg once daily. For initial combination therapy, it is either 5 mg or 10 mg once daily. It can be taken orally once daily at any time of the day, regardless of meals, and the tablet should be swallowed whole.

Child dose

The efficacy and safety of dapagliflozin in pediatric patients under 18 years of age have not been established.

This drug must not be used in patients allergic to its active ingredient or excipients. It should also not be administered to patients with type 1 diabetes or diabetic ketoacidosis. Additionally, the drug should not be given to patients with inherited lactose intolerance or galactose intolerance, or those with certain lactose-degrading enzyme deficiencies. Patients undergoing dialysis should not use this drug. Use with caution in patients with reduced fluid volume or poor kidney function. This drug may cause low blood pressure or worsen kidney function, and fluid status and kidney function should be carefully monitored before and after administration. In patients with moderate to severe kidney impairment, blood sugar control effects may be diminished, and it is not recommended for use in patients with very severe kidney dysfunction. During treatment with this drug, there may be a risk of genital infections or urinary tract infections, and patients should seek immediate treatment if infection symptoms develop. There is a risk of hypoglycemia, so dosage adjustments may be necessary when used with insulin or sulfonylureas. Be cautious of dehydration or hypotension symptoms due to reduced fluid volume, and consider temporarily stopping use if symptoms appear. Serious metabolic disturbances such as diabetic ketoacidosis may occur, so if symptoms such as nausea, vomiting, abdominal pain, or breathing difficulties occur, an immediate hospital visit is required. Women who are pregnant or nursing should avoid using this drug, and administration should be discontinued if pregnancy is confirmed. Elderly patients or those with reduced kidney function should be particularly cautious, and regular kidney function tests are necessary. This drug does not significantly affect driving or operating machinery, but caution is needed due to the potential for hypoglycemic symptoms. There is no specific antidote for overdose, and appropriate treatment should be given according to symptoms, and hospitalization may be necessary if needed. This drug has not been established for safety and efficacy in children, so it is not prescribed for pediatric use. Regular consultation with a physician is crucial during treatment, and any abnormal symptoms must be immediately reported.

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, peeling skin, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, cough with fever and respiratory abnormalities, yellowing of skin or eyes (jaundice), extreme fatigue, sudden and severe headache, lightning-like headache, seizures, confusion, visual disturbances, paralysis, urination.

Mild side effects

Vulvitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia (when used with sulfonylureas or insulin), dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, interstitial nephritis, urethritis, increased hematocrit, decreased renal creatinine clearance at the beginning of treatment, dyslipidemia, weight loss, thirst, reduced fluid volume, urticaria, sweating, itching, edema, fever.

This drug should be stored in a tightly sealed container to protect it from air and moisture. Additionally, it should be kept away from excessively hot or cold areas and stored at room temperature between 1 to 30 degrees Celsius.

Appearance

Yellow, double convex, diamond-shaped film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP × 3]