Il Yang Dapagliflozin 10 mg (Dapagliflozin Propanediol Hydrate)

Adult dose

The recommended dose of this medicine is 10 mg once daily. In initial combination therapy for those without prior experience of diabetes medication, it may be used with metformin at 5 mg or 10 mg once daily. Chronic kidney disease patients are also recommended to take 10 mg once daily. For patients with moderate to severe liver impairment, a starting dose of 5 mg is recommended, and if well tolerated, may be increased to 10 mg. This medicine can be taken without regard to meals, once daily.

Child dose

Efficacy and safety for children under 18 years have not been established, so it should not be used.

This medicine should not be administered to patients with hypersensitivity to the active ingredient or excipients, patients with type 1 diabetes, patients with diabetic ketoacidosis, patients with genetic issues such as lactose intolerance, and patients undergoing dialysis. It should be administered cautiously to patients with low fluid volume or impaired kidney function, and blood pressure and kidney function must be carefully monitored before and during treatment. This medicine is not recommended for patients with severely impaired kidney function, and especially for patients with low eGFR, consultation with a doctor is required before starting treatment. The most common side effects upon administration include genital infections, which may occur more frequently in women, so immediate treatment is required if any infection symptoms arise. Hypoglycemic symptoms may occur more frequently when this medicine is used in conjunction with insulin or sulfonylureas; therefore, dosage adjustments of these medications may be necessary. Dehydration or decreased fluid volume may occur, so elderly patients or those taking diuretics should be particularly aware of dehydration symptoms. Severe metabolic abnormalities, such as diabetic ketoacidosis, may rarely occur; therefore, immediate consultation with medical staff and testing is required if symptoms such as nausea, vomiting, abdominal pain, or difficulty breathing arise. Major urinary tract infections such as urinary tract infections and pyelonephritis have been reported, so prompt treatment is required if urinary tract infection symptoms are present. This medicine should be used with caution in patients with severely impaired liver function, and women who are pregnant or breastfeeding should avoid its use. Furthermore, this medicine may interact with certain drugs, so it is important to inform healthcare providers if other medications are being taken. There is no specific antidote for overdose, so appropriate treatment must be received based on symptoms, and caution should be taken regarding hypoglycemic risk when driving or operating machinery. Lastly, the safety and efficacy of this medicine has not been established in children, so it should not be used in pediatric patients.

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme fatigue, sudden and severe headache, lightning headache, seizures, confusion, abnormal vision, paralysis, urination difficulties

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia, dry mouth, dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, interstitial nephritis, vulvar itching, genital itching, increased hematocrit, reduced creatinine clearance at the start of treatment, dyslipidemia, elevated blood creatinine at the start of treatment, increased blood urea, weight loss, decreased fluid volume, headache, lightheadedness

This medicine may be sensitive to air or moisture, so it should be stored in a tightly closed container. It is recommended to maintain a storage temperature between 1 degree and 30 degrees at room temperature. Proper storage can help maintain the medication's effectiveness over time.

Appearance

Yellow, biconvex, diamond-shaped film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle, 28 tablets/box [(7 tablets/Alu-Alu)x4]