Zenisiga 10mg (Dapagliflozin Anhydrous Mixture)

Adult dose

The recommended dosage is 10mg once daily for monotherapy and additional combination therapy with insulin or other antihyperglycemic agents. In the initial combination therapy, the recommended starting dose with metformin is either 5mg once daily or 10mg once daily. The recommended dosage for patients with chronic heart failure and chronic kidney disease is 10mg once daily. This medication can be taken orally once daily at any time, regardless of meals.

Child dose

Efficacy and safety of dapagliflozin in pediatric patients under 18 years have not been established. There is no relevant information.

This medication should not be used in patients who are allergic to the active ingredient or excipients. Do not administer to patients with type 1 diabetes or diabetic ketoacidosis. Contains anhydrous lactose and should not be used in patients with genetic conditions such as galactose intolerance, lactase deficiency, or glucose-galactose malabsorption. Should also not be given to patients undergoing dialysis. Administer cautiously in patients with reduced fluid volume or renal dysfunction, and monitor closely for changes in blood pressure or renal function. Especially in elderly patients, those with impaired renal function, or patients on diuretics, there is an increased risk of hypotension. Contains Yellow No. 4 and Yellow No. 5 dyes, so caution is advised for patients allergic to these components. The most common side effect reported in clinical trials and post-marketing is genital infections, which may occur more frequently in females. Symptoms of hypoglycemia may occur more frequently when used in conjunction with insulin or sulfonylureas, so caution is needed. Symptoms of dehydration or hypotension due to reduced fluid volume may develop, so medical consultation should be sought immediately if these symptoms arise. Diabetic ketoacidosis may rarely occur; if symptoms such as nausea, vomiting, abdominal pain, or difficulty breathing appear, immediate examination is required. The risk of urinary tract infections and pyelonephritis may increase; any associated symptoms should be promptly treated. Renal function may decline, so regular kidney function tests are necessary. Severe infections such as perineal necrosis have been reported rarely; if there is pain or swelling around the perineum or fever, inform healthcare professionals immediately. Use is not recommended during pregnancy, and nursing mothers should avoid taking this medication. The safety and efficacy in children have not been established. In cases of overdose, there is no specific antidote; appropriate treatment based on symptoms should be administered. When taking this medication, it may be necessary to adjust the doses of insulin or sulfonylureas to reduce the risk of hypoglycemia. It is important to regularly check fluid status, blood pressure, and renal function during treatment with this medication. Keep out of reach of children and store in the original container to maintain quality.

Serious side effects

Rash, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in the mucous membranes of the mouth/eyes, difficulty breathing or shortness of breath, asthma attacks, respiratory abnormalities accompanied by cough + fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headaches, thunderclap headaches, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia, dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, interstitial nephritis, elevated hematocrit, decreased serum creatinine clearance at treatment initiation, dyslipidemia, elevated serum creatinine, elevated blood urea, weight loss, acute pyelonephritis, chest pain, dyspepsia, nausea, diarrhea, vomiting, itching, rash,

Store this medication in a tightly closed container to protect it from air and moisture, and keep it at room temperature between 1 and 30 degrees Celsius. Storing it this way will help maintain the medication's effectiveness over time.

Appearance

Yellow, biconvex rhomboid film-coated tablets

Package unit

28 tablets/box [(14 tablets/PTP X 2)], 30 tablets/bottle