Dapagliflozin 10 mg Tablets (Dapagliflozin Monohydrate Blend)

Adult dose

The recommended dose of this medication is 10 mg once daily for both monotherapy and as an adjunct to other glucose-lowering agents such as insulin. In cases of initial combination therapy without prior experience of diabetes medication, when used in combination with metformin, the initial recommended dose is 5 mg once daily or 10 mg once daily. This medication can be taken orally at any time of the day, regardless of meals, and should be swallowed whole.

Child dose

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

This medication should not be used in patients with hypersensitivity to the active ingredient or excipients, patients with type 1 diabetes, patients with diabetic ketoacidosis, patients with certain genetic lactose-related disorders, and patients undergoing dialysis. Caution should be exercised when used in patients with reduced fluid volume or impaired kidney function, especially in elderly patients or those taking diuretics, as they should be closely monitored for blood pressure drops and changes in kidney function. This medication contains Yellow No. 4 and Yellow No. 5 dyes, so patients with a history of allergies to these components should be administered with caution. During use, side effects such as genital infections, urinary tract infections, hypoglycemia, reduced fluid volume, and diabetic ketoacidosis may occur, so it is important to consult medical staff immediately if symptoms develop. Particularly, diabetic ketoacidosis can occur even when blood sugar levels are not high, so it is important to undergo testing promptly if symptoms like nausea, vomiting, abdominal pain, or difficulty breathing arise. This medication can increase fluid excretion from the body, potentially lowering blood pressure, so patients with a history of hypotension or dehydration risk should frequently assess their fluid status and may need to temporarily suspend medication if necessary. It is advisable for pregnant or nursing women to avoid using this medication, and it should be discontinued immediately upon confirmation of pregnancy. The safety and efficacy in children have not been established, therefore it should not be used in pediatric patients. When used in conjunction with other diabetes medications, the risk of hypoglycemia may be increased, so dosage adjustments of insulin or sulfonylureas may be necessary. In case of overdose, while there is no specific antidote, appropriate treatment according to the symptoms should be followed under the guidance of medical staff. This medication does not significantly affect the ability to drive or operate machinery; however, caution is needed as hypoglycemic symptoms may occur. Lastly, it is important to store this medication out of the reach of children and to keep it in its original container to maintain product quality.

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with high fever, blisters, peeling skin, pain in mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by coughing and fever, jaundice, extreme lethargy, sudden and severe headache, lightning headache, seizures, confusion, vision abnormalities, paralysis,

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia, thirst, dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, interstitial nephritis, increased hematocrit, decreased renal creatinine clearance in early treatment, dyslipidemia, weight loss, dyspepsia, nausea, diarrhea, vomiting, weakness, chest pain, fatigue, generalized edema, itching, urticaria, sweating, palpitations,

This medication should be stored in a tightly closed container to prevent air or moisture from entering, and safely stored at room temperature between 1 to 30 degrees Celsius. Proper storage helps maintain the effectiveness of the medication and prevents deterioration.

Appearance

Yellow, biconvex rhomboid film-coated tablets

Package unit

PTP - 28 Tablets/PTP [14 Tablets/PTP×2, 7 Tablets/PTP×4], Bottle - 30 Tablets/Bottle