Dapagliflozin Propanediol Hydrate 5 mg Tablet

Adult dose

The recommended dose of this medication for monotherapy and additional combination therapy with insulin or other glucose-lowering agents is 10mg once daily. When using this medication in conjunction with insulin or insulin secretagogues such as sulfonylureas, lower doses of insulin or insulin secretagogues may be considered to reduce the risk of hypoglycemia. For initial combination therapy, the initial recommended dose of this medication is 5mg once daily or 10mg once daily if the patient has no previous experience with diabetes medication.

Child dose

The efficacy and safety of Dapagliflozin in pediatric patients under 18 years of age have not been established.

This medication should not be administered to specific patients. For example, individuals allergic to any components or additives of this medication, patients with type 1 diabetes or diabetic ketoacidosis, and those undergoing dialysis should not take this medication. Caution should be exercised when using this medication in patients with low fluid volume or impaired renal function. This medication may lower blood pressure or cause temporary changes in renal function, therefore, particular attention is needed in elderly patients with impaired renal function or those taking diuretics. Fluid status and renal function should be evaluated before starting this medication, and during treatment, low blood pressure symptoms and renal function should be monitored closely. The effectiveness of this medication in blood glucose control may vary based on renal function, and in patients with moderate to severe renal impairment, the efficacy in blood glucose control may be reduced. This medication is not recommended for patients with severe renal impairment for blood glucose control purposes. Common side effects that may occur include genital infections and urinary tract infections, which may occur more frequently in women or patients with previous infection experiences. Additionally, symptoms of hypoglycemia may appear, especially when taken with medications that induce hypoglycemia such as insulin or sulfonylureas, necessitating dose adjustments. Dehydration or hypotension may occur due to reduced fluid volume, and in rare cases, serious metabolic disorders such as diabetic ketoacidosis may arise; therefore, careful monitoring for these symptoms is necessary. Ketoacidosis can occur even when blood sugar levels are not elevated, so if symptoms such as nausea, vomiting, abdominal pain, or shortness of breath appear, immediate testing and treatment must be sought. This medication can occasionally cause a serious infection such as Fournier's gangrene; thus, if there is pain, swelling, or redness in the genital or perineal area, immediate medical attention should be sought. Elderly patients or those with impaired renal function should exercise extra caution while taking this medication, especially when combined with diuretics, as the risk of dehydration or hypotension may increase. Pregnant or breastfeeding women should refrain from taking this medication for safety, and if pregnancy is confirmed, they should discontinue use immediately. Patients taking this medication along with insulin or sulfonylureas may need to adjust the doses of these medications to reduce the risk of hypoglycemia. During treatment, fluid status, blood pressure, renal function, blood glucose, and ketone levels should be regularly monitored, and if any unusual symptoms occur, immediate consultation with healthcare professionals is advised. This medication does not affect driving or operating machinery, but caution is needed in cases of hypoglycemia risk. Lastly, the safety and efficacy of this medication have not been established in children, thus it should not be used.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor (severe allergic reaction), high fever with severe rash, blisters, peeling skin, pain on the mucous membranes of mouth/eyes (severe skin reactions), shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities associated with cough and fever, yellowing of skin or eyes (jaundice), extreme fatigue (liver dysfunction), sudden and severe headache.

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, hypoglycemia, dry mouth, dizziness, constipation, back pain, dysuria, polyuria, nocturia, interstitial nephritis, increased hematocrit, decreased renal creatinine clearance at the start of treatment, dyslipidemia, increased serum creatinine, elevated blood urea, weight loss, gastrointestinal disorders (gastroesophageal reflux disease, upper abdominal pain, diverticulitis, intestinal perforation, acute pancreatitis, chronic pancreatitis

This medication should be stored in a tightly closed container to protect it from air and moisture. It should be stored at a temperature between 1 degree and 30 degrees Celsius. This helps to ensure the medication's effectiveness is maintained safely.

Appearance

Yellow round film-coated tablet

Package unit

28 tablets/box [7 tablets/Alu-Alu*4], 28 tablets/bottle, 30 tablets/bottle