Huons Dapagliflozin 10 mg (Dapagliflozin Anhydrous Mixture)

Adult dose

The recommended dosage for this medication is 10 mg once daily for monotherapy and additional combination therapy with other blood-glucose lowering agents such as insulin. For initial combination therapy, in cases where there is no prior experience with diabetes medications, the initial dose when co-administered with metformin is 5 mg or 10 mg once daily. This medication can be taken orally once daily at any time during the day, regardless of meals. The tablet should be swallowed whole.

Child dose

Efficacy and safety of dapagliflozin in children under the age of 18 have not been established.

This medication should not be used in patients with a history of allergic reactions to the active ingredient or excipients. It should not be administered to patients with type 1 diabetes or diabetic ketoacidosis. This medication contains anhydrous lactose, which should not be used in patients with problems in lactose metabolism or genetic issues such as galactose intolerance. Patients undergoing renal dialysis should not use this medication. Patients with reduced fluid volume or renal impairment should use this medication cautiously, and blood pressure and renal function should be monitored carefully before and during administration. Particularly, elderly patients or those on diuretics are at higher risk of hypotension or decreased fluid volume, so caution is needed. This medication contains colorants Yellow No. 4 and Yellow No. 5, and should be used with caution in patients with a history of allergic reactions. In clinical trials, the most common side effect was genital infections, occurring more frequently in women, particularly in those with a history of infections, where the likelihood of recurrence is increased. Hypoglycemia may occur when using this medication, particularly when used with insulin or sulfonylureas, and dosage adjustments may be needed. Symptoms of dehydration or hypotension due to reduced fluid volume can occur, and immediate consultation with healthcare personnel is advised if such symptoms arise. Diabetic ketoacidosis may rarely occur, so patients should seek immediate medical attention if symptoms such as vomiting, abdominal pain, or difficulty breathing appear. There may be an increased risk of urinary tract infections and pyelonephritis, and rapid treatment is necessary if there are any abnormal urination symptoms. In patients with impaired renal function, there may be a temporary increase in serum creatinine levels, thus regular monitoring of renal function is required. Severe infections such as necrotizing fasciitis have been rarely reported, so any pain, swelling, or redness in the genital area should be promptly reported to healthcare personnel. This medication is not recommended during pregnancy, and usage should be discontinued if pregnancy is confirmed. Lactating women are advised not to use this medication. Safety and efficacy in children and adolescents have not been established. There is no specific antidote for overdose, and treatment should be symptomatic as directed by a physician. This medication does not significantly affect driving or machine operation, but awareness of the risk of hypoglycemia should be recognized if used with insulin or sulfonylureas.

Serious side effects

Urticaria, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, cough with fever accompanied respiratory distress, yellowing of the skin or eyes (jaundice), profound lethargy, sudden and severe headache, thunderclap headache, seizures, confusional state, visual disturbances, paralysis, urine.

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, hypoglycemia, decreased fluid volume, dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, interstitial nephritis, increased hematocrit, decreased early treatment kidney creatinine clearance, dyslipidemia, increased serum creatinine, increased blood urea nitrogen, weight loss, rash, itching, cold sweat, dermatitis, urticaria, chest pain, fatigue.

This medication should be stored in a tightly closed container to protect it from air and moisture. Additionally, it is recommended to store the medication at room temperature between 1 degree and 30 degrees Celsius to maintain its efficacy and prevent degradation.

Appearance

Yellow, biconvex, diamond-shaped film-coated tablet

Package unit

28 tablets/box [7 tablets/PTPX 4]