Kacey Family 10 Milligrams (Dapagliflozin Propanediol Hydrate)

Adult dose

Administer 10 mg orally once a day as monotherapy or additional combination therapy. During initial combination therapy, administer either 5 mg or 10 mg orally once a day. It can be taken at any time of the day, regardless of food intake, and the tablet should be swallowed whole.

Child dose

The safety and efficacy of dapagliflozin in pediatric patients under 18 years of age have not been established, so its use is not recommended.

This medication should not be administered to certain patients. Individuals allergic to the active ingredient or excipients, those with type 1 diabetes, or those with diabetic ketoacidosis should not use it. Additionally, due to the presence of anhydrous lactose, individuals with genetic issues such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should also avoid it. Patients undergoing dialysis should not take this medication. Patients with reduced fluid volume or kidney function issues should use this medication with caution. There is a risk of low blood pressure or rapid deterioration of kidney function; thus, fluid volume and kidney function should be properly assessed before administration. This is particularly important for elderly patients or those taking certain diuretics, who should be closely monitored for symptoms of low blood pressure and changes in kidney function during treatment. In patients with moderate to severe kidney function impairment, blood sugar control efficacy may decrease. This medication may cause side effects such as genital infections, urinary tract infections, hypoglycemia, reduction in fluid volume, and diabetic ketoacidosis. Genital infections are particularly more common in women, and appropriate treatment should be sought if symptoms occur. Hypoglycemia may occur more frequently when used in combination with medications like insulin or sulfonylureas, so dosage adjustments may be necessary. Due to reduced fluid volume, symptoms of dehydration or low blood pressure may arise, which should be monitored. Diabetic ketoacidosis can occur even when blood sugar levels are not elevated, so immediate testing and treatment are necessary if related symptoms appear. In patients with compromised liver function or elderly patients, caution is advised when using this medication, and regular testing is necessary if there is a risk of reduced fluid volume. During the use of this medication, urine tests may show positive results for glucose, which should be noted. When taken with insulin or sulfonylureas, there is a risk of hypoglycemia, so dosage adjustments for these medications may be necessary. Additionally, the use of this medication in combination with certain diuretics may increase the risk of dehydration and low blood pressure, necessitating caution. Pregnant women are advised not to use this medication, and it should be discontinued immediately if pregnancy is confirmed. Nursing mothers should also avoid this medication as safety has not been established. The safety and efficacy of this medication have not been established in pediatric patients, so its use is not recommended. There is no specific antidote for overdose; appropriate supportive treatment should be provided based on the patient’s condition. This medication does not significantly affect the ability to drive or operate machinery; however, caution is required when taken with insulin or sulfonylureas due to the risk of hypoglycemia. Lastly, this medication should be stored out of reach of children, kept in its original container, and container changes should be avoided to maintain product quality.

Serious side effects

Urticaria, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with high fever, blisters, skin peeling, mucosal pain in the mouth/eyes, shortness of breath or difficulty breathing, asthma attack, cough with fever-related breathing abnormalities, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headaches, thunderclap headaches, seizures, confusion, visual disturbances, paralysis.

Mild side effects

• Vulvovaginitis
• balanitis
• related genital infections
• urinary tract infections
• fungal infections
• hypoglycemia
• dry mouth
• dizziness
• constipation
• dry mucous membranes

This medication should be stored in a sealed container to protect it from air and moisture. It is recommended to maintain storage temperatures between 1 and 30 degrees Celsius. Proper storage will help maintain the efficacy and safety of the medication.

Appearance

Yellow, biconvex, diamond-shaped film-coated tablet

Package unit

PTP packaging - 28 tablets/box [(7 tablets/PTP × 4)]