Podag Tablet 5 mg (Dapagliflozin Propanediol Hydrate)

Adult dose

The recommended dosage of this medication is 10 mg once daily for both monotherapy and additional combination therapy with other antidiabetic agents such as insulin. When using this medication in combination with insulin or sulfonylureas, which stimulate insulin secretion, consideration can be given to a lower dose of insulin or insulin secretagogues to reduce the risk of hypoglycemia. For initial combination therapy, if no previous antidiabetic drug treatment has been experienced, the initial recommended dose of this medication is 5 mg once daily or 10 mg once daily in combination with metformin. Special populations: Renal impairment - eGFR less than 45 mL/min/1.73m2: It is not recommended to administer this medication for the purpose of improving blood sugar control. - Patients on dialysis: This medication should not be administered. Hepatic impairment No dose adjustment is necessary for patients with mild or moderate hepatic impairment. For patients with severe hepatic impairment, a starting dose of 5 mg is recommended. If well tolerated, this dose can be increased to 10 mg. Elderly (≥ 65 years) Dose adjustment based on age is not recommended. Pediatric The safety and efficacy of dapagliflozin in patients under 18 years of age have not been established. There are no relevant data available. Administration method This medication can be taken orally regardless of food intake, once daily at any time of the day. The tablets should be swallowed whole.

This medication should not be used in specific patients. For example, patients who are allergic to the active ingredients or additives of this medication, patients with type 1 diabetes or diabetic ketoacidosis, and patients with genetic lactose intolerance problems should not take this medication. Additionally, this medication should not be used in patients undergoing dialysis. In patients with decreased fluid volume or reduced kidney function, this medication should be used with caution. This medication can lower blood pressure and affect kidney function, so the patient’s fluid status and kidney function should be thoroughly evaluated prior to administration, and symptoms of hypotension and changes in kidney function should be periodically monitored after administration. Caution is needed in patients with moderate to severe kidney impairment as the effectiveness in controlling blood sugar levels may be reduced. Using this medication can result in side effects such as genital infections, urinary tract infections, hypoglycemia, decreased fluid volume, and diabetic ketoacidosis. Genital infections occur more frequently in women, and patients who have experienced such infections in the past have a higher risk of recurrence. Hypoglycemia may occur more frequently when used in conjunction with insulin or sulfonylureas, and dose adjustments may be necessary when combined with these medications. Furthermore, during treatment with this medication, dehydration or hypotension symptoms may occur due to decreased fluid volume, so patients should consult healthcare professionals immediately if such symptoms arise. Rarely, serious infections like Fournier's gangrene, which can be life-threatening, have been reported; therefore, if pain, swelling, or redness occurs around the perineum, treatment should be sought immediately. It is advisable for pregnant or breastfeeding women to avoid using this medication. If pregnancy is confirmed, the use of this medication should be discontinued immediately, and it should not be taken while breastfeeding. This medication can interact with other drugs; therefore, caution is necessary when taken with diuretics, insulin, sulfonylureas, etc. Patients should always consult with a doctor or pharmacist before taking any medication, and should seek advice immediately if any unusual symptoms arise during use. Lastly, the safety and efficacy of this medication in children have not been established; thus, it should not be used in minors. In the case of overdose, appropriate treatment should be sought immediately from a medical institution.

Serious side effects

Decreased fluid volume (dehydration, hypovolemia, hypotension), diabetic ketoacidosis, acute kidney injury, renal impairment, urosepsis, pyelonephritis, Fournier's gangrene (necrotizing fasciitis), anaphylaxis, urticaria, severe edema, chest tightness, difficulty breathing, cold sweats, pallor, severe rash with fever, blisters, skin peeling, mucosal pain in the mouth/eyes, shortness of breath or difficulty breathing, asthma attack, cough

Mild side effects

Vulvitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia, dry mouth, dizziness, constipation, dry mouth, low back pain, dysuria, polyuria, nocturia, vulvar pruritus, genital pruritus, dyslipidemia, weight loss, rash, angioedema, gastrointestinal disorders (gastroesophageal reflux disease, epigastric pain, diverticulitis, intestinal perforation, acute pancreatitis, chronic pancreatitis, chronic gastritis, intragastric air retention, frequent bowel movement, gastritis, large intestine disorders)

This medication may be sensitive to air and moisture, so it should be stored in a sealed container. Additionally, it is advisable to avoid extremely hot or cold places and to store it at room temperature between 1°C and 30°C.

Appearance

Yellow, biconvex, round film-coated tablets

Package unit

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