B&CDapagliflozin 10 mg (Dapagliflozin Propanediol Monohydrate)

Adult dose

The recommended dose for this medication is 10 mg once daily for monotherapy and adjunct therapy. In the case of initial combination therapy, the dose can be either 5 mg once daily or 10 mg once daily. Dose adjustments may be needed for renal impairment, liver disorders, and seniors. Administration is oral, without regard to meals, once daily at any time of the day, and the tablets should be swallowed whole.

Child dose

Efficacy and safety in pediatric patients under 18 years of age have not been established; therefore, it is not recommended for use.

This medication should not be used in patients who are allergic to the active ingredients or excipients. It should also not be administered to patients with type 1 diabetes or diabetic ketoacidosis. In patients with genetic lactose intolerance or lactase deficiency, and glucose-galactose malabsorption disorders, administration may pose risks. This medication is also not used in patients undergoing dialysis treatment. It should be used cautiously in patients with reduced fluid volume or impaired kidney function. This medication can lower blood pressure and affect kidney function, therefore the fluid status and kidney function should be closely monitored before and during administration. In patients with moderate to severe renal impairment, the effectiveness in blood glucose control may be reduced, requiring careful attention. Various adverse reactions may occur, including genital infections, urinary tract infections, hypoglycemia, dehydration, diabetic ketoacidosis among others. Genital infections especially may occur more frequently in women and patients with a history of such infections. Hypoglycemia may occur more frequently when used with medications like insulin or sulfonylureas, necessitating dose adjustments. Dehydration or low blood pressure symptoms may appear due to reduced fluid volume, hence symptoms should be monitored closely. Diabetic ketoacidosis may occur even without high blood glucose levels; therefore, immediate examination and treatment are necessary if symptoms such as vomiting, abdominal pain, or breathing difficulties arise. This medication is not recommended for patients with severely impaired liver function. Elderly patients are at increased risk for decreased kidney function and fluid volume loss, and extra caution is warranted. Administration may cause glucose detection in urine tests affecting blood glucose control tests. To mitigate hypoglycemia risk when used with insulin or sulfonylureas, dose adjustments may be required. When used with certain diuretics, caution is warranted as risks of dehydration and low blood pressure may increase. Pregnant or nursing women should avoid this medication. There is no specific antidote for overdose, but appropriate treatment based on symptoms is advised. This medication does not significantly affect driving or operating machinery, but caution is necessary if hypoglycemia risk exists. Safety and efficacy have not been established in pediatric patients, and it is not used in this population. It should be stored out of reach of children and in the original container.

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blistering, skin peeling, mucosal pain in the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis.

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia, dizziness, constipation, dry mouth, back pain, painful urination, polyuria, nocturia, elevated hematocrit, increased serum creatinine levels at treatment initiation, dyslipidemia, weight loss, itching, cold sweats, headache, weakness, pain, edema, foreign body sensation, facial edema, facial pain, warmth, flu-like symptoms, menstrual irregularities, vaginal discharge, hair loss, dermatitis, and dry skin.

This medication should be stored in a tightly closed container to avoid exposure to air or moisture. The optimal storage temperature is between 1°C and 30°C at room temperature.

Appearance

Yellow, biconvex diamond-shaped film-coated tablets

Package unit

28 tablets/box [7 tablets/PTP (Alu-Alu) x 4]