Fosiel Tablet 10mg (Dapagliflozin Propanediol Hydrate)

Adult dose

The recommended dose for this medication is 10 mg once daily for monotherapy and add-on therapy. For initial combination therapy with metformin, the dose is either 5 mg or 10 mg once daily. In cases of chronic heart failure and chronic kidney disease, the dose is 10 mg once daily. For patients with severe hepatic impairment, an initial dose of 5 mg is recommended, which can be increased to 10 mg if well tolerated. This medication can be taken regardless of food intake.

Child dose

The efficacy and safety of dapagliflozin in individuals under the age of 18 have not been established.

This medication should not be used in certain patients. Individuals who are allergic to the main ingredient or additives, patients with type 1 diabetes or diabetic ketoacidosis, individuals with genetic issues such as lactose intolerance, and those undergoing dialysis should not take this medication. Patients with dehydration or poor kidney function should use this medication cautiously. This medication may cause side effects related to blood pressure lowering or changes in kidney function; therefore, fluid status and kidney function should be carefully monitored before and during administration. The most common side effect of this medication is genital infections. Other reported side effects include hypoglycemia, dehydration, dizziness, thirst, constipation, back pain, dysuria, polyuria, nocturia, etc. Severe metabolic disorders such as diabetic ketoacidosis may rarely occur, so if related symptoms appear, immediate consultation with healthcare professionals is necessary. The risk of urinary tract infections and pyelonephritis may increase, and attention should be given to elevated creatinine levels associated with kidney function changes. A rare but severe infection called necrotizing fasciitis may occur; if there is pain, redness, or swelling in the perineum, immediate treatment is required. Elderly patients or those taking diuretics are at higher risk of dehydration and hypotension and should be monitored closely. It is recommended that women who are pregnant or breastfeeding do not use this medication, and if pregnancy is confirmed, therapy should be discontinued. This medication may increase the risk of hypoglycemia when used with other hypoglycemic agents such as insulin or sulfonylureas; therefore, dose adjustments of these medications may be necessary. There is no specific antidote for overdose; treatment should be symptomatic. Finally, this medication is not recommended for use in children as safety and efficacy have not been established.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, skin peeling, mucous membrane pain in the mouth/eyes, shortness of breath or difficulty breathing, asthma attack, cough with fever accompanied respiratory distress, yellowing of the skin or eyes (jaundice), severe lethargy, sudden and very severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urinary changes.

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia, dehydration, thirst, dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, interstitial nephritis, elevated hematocrit, decreased initial renal creatinine clearance, dyslipidemia, elevated blood creatinine in the initial stages of treatment, elevated blood urea, weight loss, sensory disturbances, headache, dyspepsia, nausea, diarrhea, vomiting.

This medication should be stored in a tightly closed container to protect it from air and moisture. It is advisable to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance

Yellow, biconvex rhomboid film-coated tablet

Package unit

28 tablets/PTP [14 tablets/PTP x 2]