Podave Tablet 10mg (Dapagliflozin)

Adult dose

The recommended dose of this medication for both monotherapy and as an add-on to insulin or other glucose-lowering agents is 10 mg once daily. In cases of initial combination therapy, when there is no prior experience with diabetes medications, it can be administered at a dose of 5 mg or 10 mg once daily when taken with metformin. This medication can be taken orally at any time of the day, regardless of meals. The tablet should be swallowed whole.

Child dose

The efficacy and safety of this medication in pediatric patients under 18 years of age have not been established. There is no relevant data.

This medication should not be used in certain patients. Individuals allergic to the active ingredient or excipients, patients with type 1 diabetes, those with diabetic ketoacidosis, and those with lactose intolerance should not take this medication. Additionally, patients undergoing dialysis should not be administered this medication. Caution is advised for patients with dehydration or impaired kidney function. This medication can lower blood pressure or reduce blood volume, potentially causing hypotension or acute kidney injury, so renal function and fluid status should be adequately monitored prior to administration, and signs of hypotension and renal function should be continuously observed during treatment. Blood sugar control efficacy may diminish in patients with moderate to severe renal impairment. During treatment with this medication, side effects such as genital infections, urinary tract infections, hypoglycemia, reduced fluid volume, dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, interstitial nephritis, vulvar pruritus, genital itching, elevated hematocrit, decreased renal creatinine clearance at the start of treatment, dyslipidemia, elevated serum creatinine at the start of treatment, elevated blood urea, weight loss, urticaria, cold sweats, itching, cough, shortness of breath, palpitations, insomnia, tinnitus, and urinary retention may occur. Genital infections are more common in women, and the risk of recurrence is higher in those with a history of infections. Hypoglycemia may particularly occur when taken with insulin or sulfonylureas, so caution is needed. Reduced fluid volume may lead to symptoms of dehydration or hypotension, so immediate medical consultation is required if symptoms occur. This medication is not recommended for patients with severe liver impairment, and elderly patients or those taking diuretics should be cautious due to the higher risk of fluid volume depletion and hypotension. Furthermore, this medication may yield a positive result for glucose on urine tests, which should be considered when interpreting test results. Pregnant or breastfeeding women are advised not to use this medication, and it should be discontinued immediately if pregnancy is confirmed. This medication may interact with other drugs, requiring dose adjustments according to the physician's instructions, especially when taken with diuretics, insulin, or insulin secretagogues. In the event of an overdose, there are no specific antidotes, so appropriate treatment should be given based on symptoms, and methods for removing this medication by dialysis are not known. Finally, while this medication does not significantly impact driving or machinery operation, caution is needed due to the risk of hypoglycemia. Always store it out of reach of children and keep it in its original container for safety.

Serious side effects

• Perineal necrosis (Fournier's gangrene)
• Diabetic ketoacidosis
• Acute kidney injury
• Renal impairment
• Urosepsis
• Pyelonephritis
• Angioedema
• Rash
• Urticaria
• Cold sweats

Mild side effects

• Vulvovaginitis, balanitis, and related genital infections
• Urinary tract infection
• Hypoglycemia
• Reduced fluid volume
• Dizziness
• Constipation
• Dry mouth
• Back pain
• Dysuria
• Polyuria

This medication should be stored in a tightly sealed container to protect from air and moisture. It is best to maintain storage temperatures between 1 to 30 degrees Celsius.

Appearance

Yellow, double convex, rhombus-shaped film-coated tablet

Package unit

100 tablets/bottle, 8 tablets/Blister pack