Neodapa Tablet 10 mg (Dapagliflozin Propanediol Hydrate)

Adult dose

The recommended dosage of this medicine is 10 mg once daily for both monotherapy and additional combination therapy with insulin and other antihyperglycemic agents. In initial combination therapy, if there is no prior experience with diabetes medication, the initial dosage is either 5 mg once daily or 10 mg once daily when used in combination with metformin. For chronic heart failure and chronic kidney disease, the dosage is 10 mg once daily. Separate dosing adjustments may be needed for patients with kidney impairment, liver impairment, and the elderly.

Child dose

The efficacy and safety of dapagliflozin in children under the age of 18 have not been established, and therefore it should not be used.

This medicine should not be used in patients who are allergic to the active ingredient or excipients. It should also not be administered to patients with type 1 diabetes or diabetic ketoacidosis. Patients with genetically related lactose intolerance or related diseases should not use this medicine due to the presence of anhydrous lactose. Patients undergoing dialysis should also not use this medicine. Caution should be exercised when administering this medicine to patients with low fluid volume or impaired kidney function. This medicine can lower blood pressure and may affect kidney function, so fluid status and kidney function must be checked before administration. Particularly in elderly patients or those taking diuretics, there is a higher risk of hypotension or reduced blood volume, so care is needed. Patients with severely impaired kidney function may have decreased blood sugar regulating effects, and administration is not recommended. Taking this medicine may cause adverse reactions such as genital infections, urinary tract infections, hypoglycemia, dehydration, diabetic ketoacidosis, among others. Genital infections, in particular, may occur more frequently in women and in patients with a history of previous infections. The risk of hypoglycemia may be higher when taken with insulin or sulfonylurea, and dosage adjustments may be necessary. Symptoms of fluid volume depletion should be reported immediately, and the medication may need to be discontinued temporarily if necessary. This medicine can rarely cause a serious infection known as Fournier's gangrene, so if there is pain, swelling, or redness around the perineum, immediate medical attention should be sought. It is advisable not to use this medicine during pregnancy or breastfeeding. Elderly patients should have their kidney function monitored more frequently and should be alert to the risk of hypotension or fluid volume depletion. This medicine may interact with insulin, sulfonylureas, diuretics, etc., so adjustments with other medications being taken may be necessary. In case of overdose, there is no specific antidote, so treatment should be provided according to symptoms, and measures should be taken as directed by a physician if needed. When driving or operating machinery, caution should be exercised considering the risk of hypoglycemia. This medicine should be kept out of the reach of children and stored in its original container.

Serious side effects

• Severe allergic reactions: rash, sweating
• Severe skin reactions: rash, blistering, peeling skin, mouth/eye mucosal pain
• Respiratory issues: difficulty breathing, asthma attacks, breathing problems with cough and fever
• Liver abnormalities (jaundice): yellowing of skin or eyes (jaundice), extreme fatigue
• Severe neurological symptoms: sudden and severe headache, lightning-like headache, seizures, confusion, vision abnormalities, paralysis
• Severe

Mild side effects

• Vulvovaginitis
• balanitis and related genital infections
• urinary tract infections
• hypoglycemia
• dry mouth
• dizziness
• constipation
• back pain
• dysuria
• polyuria

This medicine should be stored in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance

Yellow, biconvex, diamond-shaped film-coated tablet

Package unit

PTP) 28 tablets/box (28 tablets (7 tablets/PTP x 4)), bottle) 30 tablets/bottle