Fasiga 10 mg Tablets (Dapagliflozin)

Adult dose

The recommended dosage of this drug is 10 mg once daily for monotherapy and additional combination therapy with insulin or other glucose-lowering agents. In the case of initial combination therapy when no previous diabetes medications have been received, the doses with metformin can be either 5 mg once daily or 10 mg once daily. The method of administration is oral intake once daily at any time of the day, regardless of food intake, and the tablet should be swallowed whole.

Child dose

The efficacy and safety of dapagliflozin in children under 18 years have not been established. No relevant data are available.

This drug should not be used in patients with allergies to its ingredients or excipients. It should also not be administered to patients with type 1 diabetes or those with diabetic ketoacidosis. It contains anhydrous lactose, making it unsuitable for patients with galactose intolerance, Lapp lactase deficiency, or genetic disorders related to glucose-galactose absorption. Patients undergoing dialysis should not use this drug. This drug should be used cautiously in patients who are volume-depleted or have impaired kidney function, as hypotension or changes in kidney function may occur; therefore, the patient's condition should be closely monitored before and after administration. In patients with moderate or severe renal impairment, the blood glucose control effect may be reduced, requiring caution. During treatment with this drug, genital infections or urinary tract infections may occur, particularly in women or those with a history of past infections, with a higher recurrence risk. Symptoms of hypoglycemia may occur but are more common when taken with medications such as insulin or sulfonylureas. Dehydration or hypotension may occur due to volume depletion, so fluid status must be managed well, and symptoms should be reported immediately. Diabetic ketoacidosis may rarely occur, so if symptoms of ketoacidosis appear regardless of blood sugar levels, medical attention should be sought promptly. This drug may affect kidney function, so regular kidney function tests are important. Severe infections such as Fournier's gangrene have been rarely reported, so if symptoms such as pain, tenderness, redness, or swelling occur in the genital or perineal area, medical attention should be sought immediately. Pregnant or breastfeeding women are advised not to use this drug, and administration should be discontinued upon confirmation of pregnancy. Elderly patients or those with impaired kidney function should be closely monitored due to increased risks of volume depletion and hypotension. When using this drug, precautions should be taken while driving or operating machinery for symptoms of hypoglycemia, and the risk of hypoglycemia may increase when used in combination with insulin or sulfonylureas. Due to drug interactions, when taken with diuretics, the risk of dehydration and hypotension may be increased, necessitating dose adjustments and monitoring as per the physician's instructions. There is no specific antidote in case of overdose, so appropriate treatment based on symptoms should be received. The safety and efficacy of this drug in pediatric patients have not been established; therefore, it is not recommended for children.

Serious side effects

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

Mild side effects

Vulvovaginitis, balanitis, genital infections, urinary tract infections, hypoglycemia, volume depletion, dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, interstitial nephritis, vulvar itching, genital itching, increased hematocrit, decreased serum creatinine clearance at treatment initiation, dyslipidemia, increased creatinine, elevated blood urea, weight loss, gastrointestinal disturbances, hyperglycemia, sensory disturbances, weakness, pain,

This medicine must be stored in a tightly sealed container to avoid exposure to air or moisture. Additionally, it should be kept at room temperature between 1 to 30 degrees Celsius, avoiding places that are too hot or too cold.

Appearance

Yellow, double convex, diamond-shaped film-coated tablet

Package unit

8 tablets/PPT [(8 tablets/Alu-Alu)], 100 tablets/bottle