Posiglil Tablet 5 mg (Dapagliflozin Monohydrate and Lactose Mixture)

Adult dose

The recommended dosage for this medication is 10 mg once daily for both monotherapy and as additional therapy with insulin and other blood sugar-lowering medications. When this medication is used in combination with insulin or other insulin secretagogues such as sulfonylureas, lower doses of insulin or insulin secretagogues may be considered to reduce the risk of hypoglycemia. If the patient has no previous experience with diabetes medication treatment, the initial recommended dosage is 5 mg once daily or 10 mg once daily when administered with metformin.

Child dose

The efficacy and safety of dapagliflozin in children under 18 years of age have not been established. There is no relevant information.

This medication should not be administered to patients with an allergy to any of its components or excipients, or to patients with type 1 diabetes, diabetic ketoacidosis, genetic lactose-related disorders, or those undergoing dialysis. Caution should be exercised when administering this medication to patients with reduced fluid volume or impaired kidney function. Since this medication can cause blood pressure drops or rapid changes in kidney function, the patient’s condition should be thoroughly monitored before and after administration. This medication contains coloring agents Yellow No. 4 and Yellow No. 5, so patients with allergies or hypersensitivity to these components should be careful. Patients taking this medication may experience side effects such as genital infections, urinary tract infections, hypoglycemia, reduced fluid volume, and diabetic ketoacidosis, so symptoms should be closely monitored. Particularly, genital infections occur more frequently in women, and those with a history of infections may have a higher risk of recurrence. Additionally, serious side effects have been reported in some patients, such as renal function abnormalities or perineal necrosis, and if symptoms like fever or pain/swelling around the genital area occur, prompt consultation with healthcare professionals is necessary. Women who are pregnant or planning to become pregnant should not use this medication, and breastfeeding women are also advised against taking this medication. This medication may interact with other drugs; therefore, particularly when taking diuretics, insulin, or sulfonylureas, it is necessary to consult with a physician or pharmacist for dosage adjustments. Elderly patients or those with reduced kidney function need to be especially cautious while taking this medication and should regularly monitor kidney function and fluid status. Patients taking this medication should be aware of hypoglycemia symptoms and be careful when driving or operating machinery. Lastly, this medication should be kept out of the reach of children and stored in its original container to maintain product quality.

Serious side effects

Dehydration (dehydration, hypovolemia, hypotension), diabetic ketoacidosis, acute kidney injury, renal dysfunction, perineal necrosis (Fournier's gangrene), urosepsis, pyelonephritis, urticaria, angioedema, anaphylactic reactions, severe rash with fever, blisters, skin peeling, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthma attacks, respiratory complications accompanied by cough and fever, yellowing of the skin or eyes

Mild side effects

Vulvitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia (when used with sulfonylureas or insulin), dry mouth, dizziness, constipation, renal pain, dysuria, polyuria, nocturia, interstitial nephritis, increased hematocrit, initial decrease in kidney creatinine clearance, dyslipidemia, increased serum creatinine, increased blood urea, weight loss, angioedema, chest pain, none

This medication should be stored in a well-sealed container to prevent exposure to air and moisture, and it is recommended to store it at room temperature between 1 to 30 degrees Celsius. Storing it this way helps maintain the medication's effectiveness and safety.

Appearance

Yellow, bilaterally convex, round film-coated tablet

Package unit

28 tablets/box [(14 tablets/PTP×2, 7 tablets/PTP×4)]