Pagliflozin Tablets 10mg (Dapagliflozin Monohydrate Mixture)

Adult dose

The recommended dosage of this medication is 10 mg once daily for monotherapy and additional combination therapy with insulin and other glucose-lowering agents. When this medication is used in combination with insulin or insulin secretagogues such as sulfonylureas, lower doses of insulin or insulin secretagogues may be considered to reduce the risk of hypoglycemia. If there is no prior experience with diabetes medication therapy, metformin is recommended.

Child dose

The efficacy and safety of dapagliflozin in children under 18 years has not been established. There is no relevant data.

This medication should not be used in patients who have had an allergic reaction to the active ingredient or additives. It should not be administered to patients with type 1 diabetes or diabetic ketoacidosis. This medication contains anhydrous lactose, so it should not be given to patients with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. Patients undergoing renal dialysis should also not use this medication. It should be used cautiously in patients with decreased fluid volume or impaired kidney function, and attention should be paid to hypotension or changes in kidney function. In particular, elderly patients or those taking diuretics must closely monitor their blood pressure and fluid status. This medication contains colorants, Yellow No. 4 and Yellow No. 5, so those allergic to these components should exercise caution. The most common side effect of this medication is genital infections, which may occur more frequently in women. Hypoglycemic symptoms may occur more frequently when used with insulin or sulfonylureas, so blood glucose fluctuations should be carefully monitored. Dehydration or hypotension symptoms may result from decreased fluid volume, so hydration should be adequate, and medical consultation is advised if abnormal symptoms occur. Diabetic ketoacidosis may occur; thus, if symptoms such as vomiting, abdominal pain, or difficulty breathing arise, immediate hospital attention is necessary. The risk of urinary tract infections, including cystitis and pyelonephritis, may increase, so prompt treatment is necessary if pain or discomfort during urination occurs. In patients with reduced kidney function, creatinine levels may increase, necessitating regular blood tests. Severe infections such as perineal necrosis have been rarely reported, and patients should immediately inform medical personnel if pain, swelling, or fever around the genital area occurs. Pregnant or breastfeeding women should not use this medication, and treatment should be discontinued upon confirmation of pregnancy. The safety and efficacy of this medication in children have not been established, so it is not administered to this age group. In the case of overdose, specific antidotes are not available, so appropriate treatment should be administered according to symptoms. This medication may pose a risk of hypoglycemia when used with insulin or sulfonylureas, so dose adjustment and blood glucose monitoring are needed. Additionally, this medication does not significantly affect driving or machine operation, but caution should be exercised as hypoglycemic symptoms may occur.

Serious side effects

Rash, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash accompanied by high fever, blisters, skin sloughing, pain in oral/ocular mucous membranes, shortness of breath or difficulty breathing, asthma attacks, cough with fever presenting breathing difficulties, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning headache, seizures, confusion, visual disturbances, paralysis, and urination.

Mild side effects

Vulvovaginitis, glans inflammation and related genital infections, urinary tract infections, hypoglycemia, decreased fluid volume, dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, dyslipidemia, elevated blood urea, weight loss, itching, rash, cold sweats, palpitations, insomnia, hair loss, dermatitis, xerosis, allergic dermatitis, contact dermatitis, abnormal sweating, eczema, coin dermatitis, hyperkeratosis, skin lesions, muscle fiber pain, and limbs.

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture. It is essential to maintain storage temperatures between 1°C and 30°C at room temperature. This ensures the medication's efficacy is preserved and prevents degradation.

Appearance

Yellow, double-sided, convex, rhomboid film-coated tablets

Package unit

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