Dapaquin 10 mg (Dapagliflozin Propanediol Hydrate)

Adult dose

The recommended dose of this medication is 10 mg once daily. In initial combination therapy, 5 mg or 10 mg can be administered once daily. It can be taken orally at any time of the day, regardless of food intake, and the tablet must be swallowed whole.

Child dose

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

This medication should not be administered to certain patients. For example, patients who are allergic to the active ingredient or excipients, type 1 diabetes patients, patients with diabetic ketoacidosis, and those undergoing dialysis should not take this medication. Careful administration is required for patients with reduced fluid volume or impaired kidney function. This medication can lower blood pressure or reduce intravascular blood volume, potentially leading to symptomatic hypotension or sudden changes in kidney function. Especially among patients with poor kidney function, elderly patients, or those taking diuretics, there is a higher risk of blood pressure reduction or fluid volume decrease; therefore, their condition should be closely monitored before and after administration. The blood sugar control effect of this medication may vary based on kidney function. For patients with moderate to severe renal impairment, the blood sugar control effect may be reduced, and it is not recommended for patients with severe renal impairment. The most common side effect when taking this medication is genital infection, which occurs more frequently in women, especially those with a history of genital infections, who may have a higher chance of recurrence. Most cases are mild to moderate and improve with appropriate treatment. Hypoglycemia may occur more frequently when this medication is used in conjunction with insulin or sulfonylureas, so dose adjustments may be necessary to reduce the risk of hypoglycemia when used in combination with these medications. Decreased fluid volume, dehydration, and symptoms of hypotension may also occur, so elderly patients or those taking diuretics should carefully monitor their fluid status. Serious metabolic disturbances such as diabetic ketoacidosis may arise, warranting immediate testing and treatment when symptoms or signs of ketoacidosis appear, even with normal blood sugar levels. The risk of urinary tract infections may also increase, so prompt medical attention is needed for any urinary-related symptoms. As this medication may affect kidney function, regular kidney function tests should be conducted during treatment. Rare serious infections such as perineal necrosis have been reported, and prompt consultation with healthcare professionals is necessary if symptoms such as pain, redness, or swelling in the perineum occur. Patients with liver disease may experience increased concentrations of this medication in the body, necessitating cautious use. Pregnant or breastfeeding women are advised not to use this medication, and discontinuation should occur if pregnancy is confirmed. The safety and effectiveness of this medication in children have not been established; thus, its use is not recommended. There is no specific antidote for overdose, and appropriate treatment should be administered based on clinical symptoms. This medication does not significantly affect driving or operating machinery, but caution is advised when taking it with insulin or sulfonylureas due to the risk of hypoglycemia.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, pain in the mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory distress with cough and fever, jaundice (yellowing of the skin or eyes), extreme lethargy, sudden and very severe headache, lightning headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination

Mild side effects

• Vulvovaginitis
• balanitis and related genital infections
• urinary tract infections
• fungal infections
• hypoglycemia
• thirst
• dizziness
• constipation
• dry mouth
• back pain

This medication should be stored in a tightly closed container to prevent exposure to air and moisture, and it should be kept at room temperature between 1 degree and 30 degrees Celsius. Proper storage can help maintain the medication's effectiveness for a prolonged period.

Appearance

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

Package unit

Bottle - 28 tablets/bottle, Bottle - 30 tablets/bottle, Box - 28 tablets/box [(7 tablets/Alu-Alu x 4)]