Daphaelson Tablets 5 mg (Dapagliflozin anhydrous mixture)

Adult dose

The recommended dosage for this medication is 10 mg once daily for monotherapy and additional combination therapy with insulin or other antidiabetic medications. For initial combination therapy when used with metformin, the recommended initial dosage is either 5 mg once daily or 10 mg once daily. There are specific dosage adjustment guidelines based on renal impairment, liver impairment, and elderly status, and the method of administration can be done at any time during the day, regardless of food intake.

Child dose

The effectiveness and safety of dapagliflozin in children under the age of 18 have not been established. There are no relevant data.

This medication should not be used in patients who have had allergic reactions to the active ingredients or excipients in this drug. It should also not be administered to patients with type 1 diabetes or diabetic ketoacidosis. Furthermore, patients with lactose intolerance or specific genetic issues leading to inability to digest lactose may have problems due to the included anhydrous lactose and thus should not receive this drug. This medication is not suitable for patients undergoing dialysis. For patients who have reduced fluid volume or issues with kidney function, this medication should be used with caution. It can cause hypotension or worsening of renal function, so these patients should have their fluid status and kidney function carefully monitored before and after administration. In particular, for patients with moderate to severe renal impairment, the effectiveness of blood sugar control may decrease, and it may be difficult to achieve blood sugar control with this medication alone. This medication contains coloring agents Yellow No. 4 and Yellow No. 5, so those who have allergies or hypersensitivity to these agents should use it cautiously. During the use of this medication, genital infections or urinary tract infections may occur, so if related symptoms arise, prompt treatment should be received. Hypoglycemic symptoms may also be present, especially when used with medications like insulin or sulfonylureas, where the risk may be heightened. Dehydration or hypotensive symptoms may occur due to decreased fluid volume, so if symptoms such as dizziness or dry mouth occur, consultation with healthcare professionals is necessary. There is a risk of serious metabolic abnormalities like diabetic ketoacidosis, so if symptoms such as vomiting, abdominal pain, or difficulty breathing occur, immediate medical attention should be sought. This medication may have renal-related adverse reactions like elevated blood creatinine due to changes in kidney function, so regular blood tests are necessary. Especially for the elderly or those with diminished kidney function, greater caution should be exercised when using this medication, and dosage adjustment or discontinuation should be considered as needed. It is recommended that women who are pregnant or breastfeeding do not use this medication, and if pregnancy is confirmed, it should be discontinued immediately. This medication does not significantly affect driving or the ability to operate machinery; however, caution is needed when used with drugs that have a risk of hypoglycemia.

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, pallor (severe allergic reaction), severe rash, blisters, skin peeling, pain in oral/ocular mucosa (severe skin reaction), shortness of breath or difficulty breathing, asthma attacks, cough with fever (respiratory issues), yellowing of skin or eyes (jaundice), extreme fatigue (liver abnormalities), sudden and severe headache.

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, hypoglycemia, decreased fluid volume, dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, genital itching, elevated hematocrit, decreased early-stage renal creatinine clearance, dyslipidemia, weight loss, gastrointestinal disorders (such as dyspepsia, nausea, diarrhea, vomiting, gastritis, abdominal discomfort, abdominal pain, etc.), urinary abnormalities, allergic dermatitis, contact dermatitis

This medication should be stored in a sealed container to protect it from air and moisture. It is best to maintain the storage temperature between 1 and 30 degrees Celsius at room temperature. This will help preserve the medication's effectiveness for a longer duration.

Appearance

Yellow, round, biconvex film-coated tablets

Package unit

28 tablets/box [14 tablets/PTP x 2, 7 tablets/PTP x 4]