Ilyang Dapagliflozin 5 mg Tablets (Dapagliflozin Monohydrate)

Adult dose

The recommended dosage of this medication for monotherapy and adjunctive therapy with other blood sugar-lowering agents, including insulin, is 10 mg once daily. In initial combination therapy, it may be 5 mg once daily or 10 mg once daily. This medication can be taken orally at any time of day, regardless of food intake. Tablets should be swallowed whole.

Child dose

The efficacy and safety of dapagliflozin in pediatric patients under 18 years of age have not been established.

This medication should not be used in patients who have experienced allergic reactions to the active ingredients or excipients. It may pose risks for patients with type 1 diabetes or diabetic ketoacidosis. Since it contains anhydrous lactose, it should not be used in patients with genetic issues such as galactose intolerance, lactase deficiency, or glucose-galactose malabsorption. This medication is also not recommended for patients undergoing dialysis. In patients with reduced fluid volume or impaired kidney function, it may cause blood pressure reduction or kidney damage, so the patient's condition should be meticulously checked before administration and carefully monitored afterward. This medication contains certain colorants, Tartrazine and Sunset Yellow, so caution should be exercised in patients allergic to these substances. During the use of this medication, genital infections or urinary tract infections may occur; patients should immediately inform their healthcare provider if infection symptoms appear. There is a risk of hypoglycemia; therefore, when used with blood sugar-lowering agents such as insulin or sulfonylureas, blood sugar reduction symptoms should be closely monitored. Dehydration or hypotension symptoms may occur due to reduced fluid volume, so adequate fluid intake and careful observation of symptoms are essential. Serious metabolic abnormalities like diabetic ketoacidosis may occur; symptoms such as vomiting, abdominal pain, or difficulty breathing require immediate hospital attention. Blood sugar control effectiveness varies based on kidney function, so it is advisable to avoid use in patients with severe kidney impairment. Pregnant women or those planning to become pregnant should preferably not use this medication, and breastfeeding women should also avoid its use. Elderly patients or those with weakened kidney functions require special caution and, if necessary, blood pressure and kidney functions should be checked frequently. While taking this medication, caution should be exercised regarding hypoglycemic symptoms when driving or operating machinery. In case of overdose, there is no specific antidote, so appropriate treatment based on symptoms is important. This medication should be stored safely and kept out of the reach of children.

Serious side effects

• Decreased fluid volume
• hypotension
• diabetic ketoacidosis
• acute kidney injury
• renal impairment
• liver dysfunction (jaundice)
• perineal necrosis (Fournier's gangrene)
• urosepsis
• pyelonephritis
• hives

Mild side effects

• Vulvovaginitis
• balanitis
• genital infection
• urinary tract infection
• fungal infection
• hypoglycemia
• dizziness
• constipation
• dry mouth
• back pain

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture, ideally at room temperature between 1 to 30 degrees Celsius. This helps maintain the drug's effectiveness over time.

Appearance

Yellow, round, film-coated tablet with convex sides on both sides

Package unit

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