Empagliflozin 10 mg (Dapagliflozin Propanediol Hydrate)

Adult dose

The recommended dose of this medication for monotherapy and additional combination therapy with insulin and other antidiabetic agents is 10 mg once daily. In the case of initial combination therapy, if combined with metformin, the initial recommended dose is either 5 mg once daily or 10 mg once daily. This medication can be taken orally once daily at any time during the day, regardless of food intake, and the tablet must be swallowed whole.

Child dose

The efficacy and safety of dapagliflozin in children under 18 years of age have not been established. No related data is available.

This medication should not be used in patients with hypersensitivity to its active ingredient or excipients. It should also not be administered to patients with type 1 diabetes or diabetic ketoacidosis. Patients with genetic lactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not take this medication due to the lactose it contains. This drug should not be administered to patients undergoing dialysis. Patients who have reduced fluid volume or kidney function issues should use this medication with caution. This medication can lower blood pressure or decrease blood volume, so older patients or those on diuretics should carefully monitor their fluid status and kidney function. The blood sugar control effect of this medication may diminish in patients with moderate to severe kidney impairment, increasing the risk of serious side effects. When taking this medication, patients should watch for symptoms of side effects such as genital infections, urinary tract infections, hypoglycemia, reduced fluid volume, and diabetic ketoacidosis. Genital infections are more common in women, and patients with a history of infections are at higher risk of recurrence. Hypoglycemia can occur more frequently when used in combination with insulin or sulfonylurea, so caution should be exercised for signs of hypoglycemia and insulin dosage may need adjustment if taken together. If symptoms of reduced fluid volume or hypotension appear, immediate consultation with healthcare professionals is advised, and temporary cessation of medication may be necessary. Diabetic ketoacidosis can occur even when blood sugar levels are not high, so if symptoms such as vomiting, abdominal pain, or difficulty breathing appear, immediate examination is required. Patients with poor liver function or elderly patients should be particularly cautious when taking this medication, and regular checks of liver and kidney functions are advisable. Women who are pregnant or breastfeeding should not take this medication, and if pregnancy is confirmed, discontinuation should be immediate. The safety and efficacy of this medication in children have not been established, thus it should not be used. In cases of overdose, no specific antidote exists; therefore, it is important to receive appropriate treatment based on symptoms. This drug does not significantly affect the ability to drive or operate machinery, but caution should be exercised due to the risk of hypoglycemia. Lastly, this medication should be stored out of the reach of children and kept in its original container.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, paleness, severe rash with high fever, blisters, peeling skin, pain in the mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, cough combined with fever and breathing abnormalities, yellowing of the skin or eyes (jaundice), severe lethargy, sudden and severe headaches, thunderclap headaches, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia, dry mouth, dizziness, constipation, back pain, dysuria, polyuria, nocturia, elevated hematocrit, elevation of blood creatinine at treatment initiation, dyslipidemia, weight loss, rash, angioedema, paresthesia, headache, itching, sweating, palpitations, insomnia, dizziness, cough, dyspnea, orthostatic hypotension, asthenia, chest pain,

This medication may be sensitive to air or moisture; therefore, it must be stored in a tightly sealed container. It is recommended to keep the storage temperature between 1 to 30 degrees Celsius at room temperature. This will help maintain the drug's efficacy over time.

Appearance

Yellow, biconvex, diamond-shaped film-coated tablets

Package unit

PTP - 28 tablets/box [28 tablets (7 tablets/PTP x 4)], bottle - 30 tablets/bottle