MDapa Tablet 5 mg (Dapagliflozin Propanediol Hydrate)

Adult dose

The recommended dosage for this medication is 10 mg once daily. For initial combination therapy, it is 5 mg once daily or 10 mg once daily. This can be taken orally at any time of the day irrespective of food intake, and the tablet should be swallowed whole.

Child dose

The efficacy 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, individuals with allergies to the active ingredients or excipients, patients with type 1 diabetes, those with diabetic ketoacidosis, and patients with lactose intolerance or related genetic issues should not take this medication. Also, patients undergoing dialysis should avoid using this medication. Patients with a reduced fluid volume or impaired kidney function should use this medication with caution as it may lower blood pressure or cause temporary changes in kidney function. Especially, patients with moderate to severe renal impairment or elderly patients, or individuals taking diuretics should be thoroughly evaluated for fluid status and kidney function before administering this medication, and periodic checks for symptoms of hypotension or kidney function should be performed after administration. When taking this medication, infections such as genital infections and urinary tract infections may occur, so if symptoms of infection manifest, consult a doctor immediately. Additionally, hypoglycemia may occur, so particularly for patients taking insulin or sulfonylureas, it may be necessary to adjust the medication dosage to reduce the risk of hypoglycemia. Dehydration or symptoms of hypotension may occur due to decreased fluid volume, so if these symptoms arise, consult medical personnel immediately, and temporarily discontinue medication if necessary. This medication can cause severe metabolic acidosis, such as ketoacidosis, so if symptoms like vomiting, abdominal pain, difficulty breathing, or fatigue appear, visit a hospital immediately. Ketoacidosis can occur even if blood sugar is not high, so caution is warranted. Pregnant or breastfeeding women should not take this medication, and if pregnancy is confirmed, the medication should be discontinued immediately. Elderly patients or those with impaired kidney function require special caution when taking this medication, and fluid status and kidney function should be checked frequently. This medication, when taken with other diuretics, may increase the risk of dehydration and hypotension, so caution is advised in such cases. Additionally, when taken with insulin or insulin secretagogues, the risk of hypoglycemia may increase, necessitating possible dosage adjustments. In case of overdose, there are no specific antidotes, so appropriate treatment should be provided based on the patient's condition, and if symptoms are severe, medical attention should be sought immediately. During treatment, caution should be exercised when driving or operating machinery due to the risk of hypoglycemia, and it should be kept out of reach of children.

Serious side effects

Decreased fluid volume (including dehydration, hypovolemia, hypotension), diabetic ketoacidosis, necrotizing fasciitis of the perineum (Fournier's gangrene), acute kidney injury, renal dysfunction, urinary sepsis, pyelonephritis, severe allergic reactions (hives, angioedema, anaphylaxis), severe skin reactions (severe rash with fever, blistering, peeling skin, mucosal pain in the mouth/eyes), respiratory issues (shortness of breath or difficulty breathing, asthma attack,

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia, thirst, dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, elevated hematocrit, increased serum creatinine at the start of treatment, increased serum urea, weight loss, itching, hives, sweating, edema, chest pain, fatigue, foreign body sensation, facial swelling, facial pain, warmth sensation, flu-like symptoms, menstrual irregularities, vaginal discharge, hair loss,

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

Appearance

Yellow, round, biconvex, film-coated tablet

Package unit

PTP - 28 tablets/box [28 tablets (7 tablets/PTP x 4)], bottle - 30 tablets/bottle