Forxiga 5 mg (Dapagliflozin Propanediol Hydrate)

Adult dose

The recommended dosage for this medication is 10 mg once daily, both for monotherapy and in conjunction with other hypoglycemic agents such as insulin. For initial combination therapy with metformin, the initial recommended dose is 5 mg or 10 mg once daily. For chronic heart failure and chronic kidney disease, the dose is also 10 mg once daily. In patients with severe hepatic impairment, a starting dose of 5 mg is recommended, and if tolerated, it may be increased to 10 mg.

Child dose

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

This medication should not be used by individuals who are allergic to its active ingredient or any of its additives. It should not be administered to patients with type 1 diabetes or those with diabetic ketoacidosis. It contains anhydrous lactose, so individuals with genetic issues like galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take it. Patients on dialysis should not use this medication. Patients with dehydration or kidney function issues should use this medication with caution. This medication may lower blood pressure and reduce intravascular volume, posing a risk of symptomatic hypotension or acute kidney injury. Particularly in the elderly, patients on diuretics, or those with reduced kidney function, fluid status and kidney function should be carefully evaluated before administration. The medication is not recommended for patients with severely reduced kidney function, as its blood sugar control effects may be diminished. Infections such as genital infections and urinary tract infections may occur during treatment; any symptoms should be treated promptly. Hypoglycemic symptoms may appear; therefore, dosage adjustments may be necessary when taken with medications like insulin or sulfonylureas. Symptoms of dehydration such as decreased fluid volume, dry mouth, and dizziness may occur, highlighting the importance of fluid intake and monitoring for symptoms. Serious metabolic disorders such as diabetic ketoacidosis may develop; if symptoms like vomiting, abdominal pain, or difficulty breathing occur, immediate consultation with healthcare personnel is advised. This medication is not recommended for pregnant or breastfeeding women, and should be discontinued upon confirmation of pregnancy. It is not used in children, as safety and effectiveness have not been established. There is no specific antidote for overdose, so symptomatic treatment is crucial. This medication does not significantly affect driving or the operation of machinery, but caution is necessary due to the risk of hypoglycemia. Lastly, this medication should be stored out of reach of children and kept in its original container to maintain quality.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, peeling skin, pain in oral or ocular mucosa, difficulty breathing or shortness of breath, asthma attacks, cough with fever and respiratory distress, jaundice (yellowing of the skin or eyes), profound lethargy, sudden and severe headache, lightning headache, seizures, confused consciousness, vision disturbances, paralysis, urination.

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, hypoglycemia, thirst, dizziness, constipation, dry mouth, low back pain, dysuria, polyuria, nocturia, interstitial nephritis, increased hematocrit, elevated serum creatinine, dyslipidemia, weight loss, rash, gastrointestinal disorders (gastroesophageal reflux disease, abdominal pain, diverticulitis, intestinal perforation, acute pancreatitis, etc.), hyperglycemia, paresthesia, stroke, nerve compression, urinary tract infection.

This medication should be stored in a tightly sealed container to avoid contact with air or moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius to preserve the medication's effectiveness over time.

Appearance

Yellow, double-sided, convex, round film-coated tablet

Package unit

28 tablets (7 tablets/PTP × 4), 30 tablets (10 tablets/PTP × 3)