Dapagene Tablets 5mg (Dapagliflozin Anhydrous Mixture)

Adult dose

The recommended dosage for monotherapy and adjunct therapy for type 2 diabetes is 10 mg once daily. For initial combination therapy, the recommended dosages are 5 mg once daily or 10 mg once daily when administered with metformin. This drug can be taken orally 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 patients under 18 years of age have not been established. There is no related data.

This drug should not be used in patients who are allergic to the active ingredients or excipients of this drug. It is also not safe to administer to patients with type 1 diabetes or diabetic ketoacidosis. Patients with genetic conditions such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take this drug as it contains anhydrous lactose. Patients undergoing dialysis should also not use this drug. Caution should be exercised when administering to patients with low fluid volume or poor kidney function. This drug can cause hypotension or worsen kidney function due to reduced intravascular volume; therefore, assessment of fluid status and kidney function must be performed before administration. After administration, symptoms of hypotension and changes in kidney function should be regularly monitored. This drug contains specific dyes, Yellow No. 4 and Yellow No. 5, and should be used cautiously in patients with allergies or a history of hypersensitivity to these components. During the course of taking this drug, genital infections or urinary tract infections may occur, so immediate treatment is necessary if symptoms of infection arise. There may also be symptoms of hypoglycemia, so dosage adjustments may be needed when taken with insulin or sulfonylureas to reduce the risk of hypoglycemia. Dehydration symptoms or dry mouth may occur due to decreased fluid volume, so adequate fluid intake and symptom monitoring are important. In severe cases, drug administration may be temporarily suspended. This drug may increase the risk of diabetic ketoacidosis; therefore, if symptoms of ketoacidosis such as vomiting, abdominal pain, or difficulty breathing occur, immediate medical attention is required. Elderly patients or those with reduced kidney function may be particularly sensitive to side effects of this drug and require careful management and monitoring. It is advisable for pregnant or breastfeeding women to avoid using this drug, and if pregnancy is confirmed, administration should be immediately stopped. There is no specific antidote for overdose, so appropriate treatment and observation are required based on symptoms. This drug does not significantly affect driving or machinery operation, but caution is needed due to the risk of hypoglycemia.

Serious side effects

• Severe allergic reactions: Including urticaria, severe swelling (angioedema).
• Severe skin reactions: Severe rash with fever, blisters, skin peeling, mucosal pain.
• Respiratory issues: Breathlessness or difficulty breathing, asthma attacks, coughing with fever accompanied by respiratory abnormalities.
• Liver dysfunction (jaundice): Including yellowing of the skin or eyes.
• Severe neurological symptoms: Sudden, severe headache, thunderclap headache, seizures, altered consciousness.

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, hypoglycemia, dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, interstitial nephritis, vulvar itching, genital itching, elevated hematocrit, decreased renal creatinine clearance at the start of treatment, dyslipidemia, increased serum creatinine, increased blood urea, weight loss, rash, angioedema, gastroesophageal reflux disease, upper abdominal pain, diverticulitis,

This drug should be stored in a tightly sealed container to protect it from air and moisture. The storage temperature should be maintained between 1 and 30 degrees Celsius to preserve the drug's efficacy and safety for longer periods.

Appearance

Yellow, biconvex, round film-coated tablet

Package unit

28 Tablets/PTP[(7 Tablets/PTP×4, 14 Tablets/PTP×2)]