Dapagliflozin Propanediol Hydrate 5 mg Tablet

Adult dose

The recommended dosage of this medication is 10 mg once daily for both monotherapy and add-on therapy with other glucose-lowering agents such as insulin. When used in combination with insulin or insulin secretagogues like sulfonylureas, the dosages of those medications may be reduced to lower the risk of hypoglycemia. For initial combination therapy with metformin, the initial recommended doses are 5 mg or 10 mg once daily.

Child dose

The safety and efficacy of dapagliflozin in patients under 18 years of age have not been established, and therefore, it is not recommended.

This medication should not be administered to certain patients. For example, patients allergic to this medication's active ingredient or excipients, type 1 diabetes patients, patients with diabetic ketoacidosis, and those undergoing dialysis should not use this medication. This medication should be used cautiously in patients with reduced fluid volume or impaired kidney function. It may lower blood pressure or temporarily worsen kidney function, so fluid status and kidney function should be evaluated before administration, and periodic monitoring should be conducted during treatment. The blood sugar control effect of this medication may decrease in patients with moderate to severe kidney impairment, and it is not recommended for patients with severe kidney dysfunction. During the use of this medication, the risk of genital infections and urinary tract infections may increase, so patients should consult a healthcare professional immediately if any symptoms of infection occur. When used in combination with insulin or sulfonylureas, which have a risk of hypoglycemia, caution should be taken for signs of hypoglycemia, and the dosage of those medications should be adjusted if necessary. This medication may cause side effects related to reduced fluid volume; therefore, patients should inform their healthcare provider immediately if they experience symptoms of dehydration or low blood pressure, and medications may need to be temporarily discontinued if necessary. Severe metabolic disorders such as diabetic ketoacidosis may occur, so if symptoms like nausea, vomiting, abdominal pain, or difficulty breathing appear, the patient should visit the hospital immediately. Women who are pregnant or planning to become pregnant are advised not to use this medication, and it should be discontinued immediately if pregnancy is confirmed. It is also considered safe for breastfeeding women not to take this medication. Elderly patients should be monitored more closely because they have a higher risk of changes in kidney function and reduced fluid volume. During the use of this medication, glucose may be detected in urine tests, so it is advisable to use different tests to evaluate blood sugar control. There is no specific antidote for overdose, so receiving appropriate treatment based on symptoms is important. This medication does not significantly affect driving or machine operation, but caution is necessary when used with drugs that carry a risk of hypoglycemia. Finally, the safety and efficacy of this medication in children have not been established, so it should not be used.

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with cough + fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headaches, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia, dry mouth, dizziness, constipation, back pain, painful urination, polyuria, nocturia, interstitial nephritis, elevated hematocrit, increased blood creatinine at the start of treatment, dyslipidemia, weight loss, abnormal sensations, drowsiness, tension headache, carpal tunnel syndrome, cerebral infarction, diabetic neuropathy, unconsciousness, nerve compression, neuralgia, peripheral neuropathy

This medication should be stored in a tightly sealed container to protect it from air and moisture and should be kept at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness.

Appearance

Yellow round film-coated tablet

Package unit

Bottle - 28 tablets/bottle [Bottle: HDPE/Caps: PP], Bottle - 30 tablets/bottle [Bottle: HDPE/Caps: PP], Box - 28 tablets/box [7 tablets/Alu-Alu*4]