Neodapa Tablet 5mg (Dapagliflozin Propanediol Monohydrate)

Adult dose

The recommended dose for this medication is 10 mg once daily for monotherapy and combination therapy with other hypoglycemic agents such as insulin. In initial combination therapy, the dose is either 5 mg once daily or 10 mg once daily. Patients with chronic heart failure and chronic kidney disease are also recommended to take 10 mg once daily. For patients with mild to moderate liver impairment, dose adjustment is not necessary, whereas for patients with severe liver impairment, a starting dose of 5 mg is recommended.

Child dose

Efficacy and safety in children under 18 years have not been established; therefore, it is not administered.

This medication should not be used in certain patients. For instance, individuals allergic to the active ingredient or additives, type 1 diabetes patients or those with diabetic ketoacidosis, patients with genetic problems such as lactose intolerance or glucose-galactose malabsorption, and patients undergoing dialysis should not take this medication. Patients with reduced fluid volume or kidney function issues should take this medication cautiously. This medication can lower blood pressure or cause temporary changes in kidney function; hence fluid status and kidney function should be thoroughly checked before administration, and blood pressure and kidney function should be monitored continuously during use. This drug may increase the risk of genital infections and urinary tract infections; thus, if symptoms of infection appear, medical attention should be sought immediately. Additionally, symptoms of hypoglycemia may occur, particularly when used with medications such as insulin or sulfonylureas, hence caution is warranted. Dehydration symptoms or hypotension due to decreased fluid volume may occur, and immediate notification to medical personnel is required if such symptoms occur. This medication can cause a serious metabolic disorder known as diabetic ketoacidosis, so if symptoms such as nausea, vomiting, abdominal pain, or dyspnea occur, immediate examination and treatment are necessary. Patients with impaired kidney function or the elderly should be particularly cautious, as the drug's efficacy may vary based on kidney function. Pregnant or lactating women are advised not to take this medication, and if they become aware of taking it, they should stop immediately and consult healthcare professionals. In cases of overdose, there is no specific antidote, so appropriate treatment based on symptoms should be pursued, and hospitalization may be necessary if required. This medication may interact with other drugs, so it is essential to inform healthcare professionals of any current medications. Finally, caution is needed while driving or operating machinery during the use of this drug, especially if there is a risk of hypoglycemia. The safety and efficacy of this medication in children have not been established, thus it is not used for pediatric patients.

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blistering, skin peeling, pain in oral/eye mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory distress accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning headache, seizures, altered consciousness, visual disturbances, paralysis, urination.

Mild side effects

Vulvovaginitis, balanitis and associated genital infections, urinary tract infections, fungal infections, hypoglycemia, thirst, dizziness, constipation, dry mouth, back pain, pain during urination, polyuria, nocturia, dyslipidemia, weight loss, urticaria, itching, cold sweat, dermatitis, skin dryness, hyperkeratosis, skin lesions, arthralgia, musculoskeletal pain, limb pain, muscle weakness, myalgia, osteoarthritis, sprain, headache, urinary retention, chest pain, fatigue, pain, swelling.

This medication must be kept in a tightly sealed container to prevent exposure to air or moisture. It is advisable to maintain storage temperatures between 1 to 30 degrees Celsius.

Appearance

Yellow, bilaterally convex, round film-coated tablet

Package unit

PTP - 28 tablets/box [7 tablets/PTP x 4]