Pagliflozin Tablets 5 mg (Dapagliflozin Monohydrate Combination)

Adult dose

The recommended dose of this medication for both monotherapy and additional combination therapy with other hypoglycemic agents such as insulin is 10 mg once daily. For initial combination therapy with metformin, the recommended starting dose is 5 mg once daily or 10 mg once daily. In patients with severe liver impairment, a starting dose of 5 mg is recommended and can be increased to 10 mg based on tolerability. This medication can be taken once daily regardless of food intake.

Child dose

The efficacy and safety of this medication in children under 18 years of age have not been established.

This medication should not be used in certain patients. First, patients allergic to the active ingredient or excipients should not take this medication. Second, it should not be administered to patients with type 1 diabetes or diabetic ketoacidosis. Third, patients with problems in lactose digestion or genetic conditions such as galactose intolerance should not take this medication. Fourth, it is not used in patients undergoing dialysis. This medication should be administered cautiously to patients with low fluid volume or poor kidney function. It may lower blood pressure or affect kidney function, so caution is particularly warranted in the elderly or patients taking diuretics. Before administration, the patient's fluid status and kidney function should be assessed, and blood pressure and kidney function should be continuously monitored during treatment. This medication contains colorants Yellow No. 4 and Yellow No. 5, and patients allergic to these components should be cautious. During the treatment, side effects such as genital infections, urinary tract infections, hypoglycemia, low fluid volume, and diabetic ketoacidosis may occur. Genital infections are particularly more common in women, and if symptoms of infection develop, immediate treatment should be sought. Hypoglycemia may occur more frequently when taken alongside insulin or sulfonylureas, so be attentive to hypoglycemic symptoms when using these medications in combination. Dehydration or low blood pressure may develop due to decreased fluid volume, so symptoms of dehydration or changes in blood pressure should be closely monitored. Diabetic ketoacidosis may occur even when blood sugar is not significantly elevated, so if symptoms such as nausea, vomiting, abdominal pain, or difficulty breathing appear, immediate consultation with healthcare professionals is advised. This medication may affect kidney function, so patients with impaired kidney function should have their renal status evaluated before administration and should undergo regular kidney function tests during treatment. Pregnant or breastfeeding women are advised not to take this medication, and if pregnancy is confirmed, it should be discontinued immediately. In the case of overdose, there is no specific antidote, so it is necessary to receive appropriate treatment based on symptoms. Caution may be needed for hypoglycemia while driving or operating machinery during the use of this medication, so symptoms should be well monitored. The medicine should be stored out of reach of children and kept in its original container for safety.

Serious side effects

Rash, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, high fever with severe rash, blisters, skin peeling, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthma attacks, abnormal respiratory symptoms accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination

Mild side effects

• Vulvovaginitis
• balanitis
• genital infections
• urinary tract infections
• hypoglycemia
• decreased fluid volume
• dizziness
• constipation
• dry mouth
• back pain

This medication should be stored in an airtight container to prevent entry of air or moisture. The storage temperature should be maintained at room temperature between 1 to 30 degrees. This will help preserve the medication's effectiveness over time.

Appearance

Yellow, round, film-coated tablets that are convex on both sides

Package unit

28 tablets/box [7 tablets/PTP X 4]