Dapljin 10 mg (Dapagliflozin Propanediol Hydrate)

Adult dose

The recommended dose for this medication is 10 mg once daily for monotherapy or adjunctive therapy. For initial adjunctive therapy, it is administered as either 5 mg once daily or 10 mg once daily. Dosing adjustments are indicated for renal impairment, hepatic impairment, and elderly patients. The method of administration is oral intake once daily, at any time regardless of food intake, swallowing the tablet whole.

Child dose

The efficacy and safety in children under 18 years of age have not been established.

This medication should not be administered to certain patients. For example, patients allergic to the active ingredient or excipients, patients with type 1 diabetes, patients with diabetic ketoacidosis, and patients with lactose intolerance should not use this medication. Additionally, patients undergoing dialysis should also not take this medication. Patients with reduced fluid volume or renal dysfunction should use this medication with caution. This medication can lower blood pressure or reduce blood volume, which could lead to symptomatic hypotension or acute kidney injury. Especially in patients with impaired renal function, the elderly, and patients taking diuretics, fluid status and renal function should be closely evaluated before administration, and symptoms of hypotension and renal function should be continuously monitored during treatment. The most common side effect during the use of this medication is genital infection. Other reported side effects include urinary tract infections, hypoglycemia, reduced fluid volume, dizziness, dry mouth, dysuria, polyuria, hypotension, and others. Particularly, hypoglycemia may occur more frequently when used in combination with drugs such as insulin or sulfonylureas, hence caution is necessary. This medication should be used with caution in patients with poor liver function, and elderly patients should also be more closely monitored for fluid volume reduction or changes in renal function. Moreover, as this medication may cause glucose to be detected in urine tests, this should be taken into account. The risk of hypoglycemia may increase when used with insulin secretagogues, so adjustment of insulin or sulfonylurea dosing may be necessary. Use of this medication is not recommended during pregnancy, and administration should be stopped immediately if pregnancy is confirmed. Lactating women are also advised not to take this medication. In the case of overdose, there are no specific antidotes, so appropriate treatment based on clinical symptoms should be administered, and removal of this medication through dialysis has not been studied. This medication does not significantly affect the ability to drive or operate machinery; however, the risk of hypoglycemia should be acknowledged when taken with insulin or sulfonylureas. Finally, this medication should be stored out of reach of children and kept in its original container for safety.

Serious side effects

• Hives
• severe swelling (edema)
• chest tightness
• difficulty breathing
• cold sweats
• pale skin
• severe rash with fever
• blisters
• skin peeling
• pain in oral/ocular mucosa

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, increased hematocrit, increased blood creatinine at treatment initiation, elevated blood urea, weight loss, rash, angioedema, gastrointestinal disorders (gastroesophageal reflux disease, upper abdominal pain, diverticulitis, bowel perforation, acute pancreatitis, chronic pancreatitis, chronic gastritis,

This medication may degrade due to air or moisture, so it should be stored in a tightly sealed container. Furthermore, it is important to store it at room temperature between 1°C and 30°C to maintain its effectiveness.

Appearance

Yellow, double-sided convex diamond-shaped film-coated tablet

Package unit

30 tablets/bottle, 90 tablets/bottle