Newsig 10 mg (Dapagliflozin Propanediol Monohydrate)

Adult dose

The recommended dosage for this medication is 10 mg once daily for monotherapy and additional combination therapy. For initial combination therapy, it is 5 mg or 10 mg once daily. This medication can be taken orally at any time of the day regardless of food intake. The tablet should be swallowed whole.

Child dose

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

This medication should not be used in certain patients. For example, patients with allergies to the active ingredient or excipients, those with type 1 diabetes, patients with diabetic ketoacidosis, patients with lactose intolerance or specific genetic issues, and patients undergoing dialysis should not take this medication. It should be administered cautiously to patients with reduced fluid volume or renal function issues. This medication may lower blood pressure or affect kidney function, so blood pressure and renal function should be closely monitored before and during administration. Special care is needed for the elderly or patients taking diuretics. Taking this medication may cause genital infections or urinary tract infections, and immediate treatment should be sought if infection symptoms occur. Additionally, hypoglycemia may occur, and dosage adjustment may be necessary to reduce the risk of hypoglycemia if taking medications like insulin or sulfonylureas. This medication can induce a reduction in fluid volume, and if symptoms of dehydration or hypotension occur, a temporary cessation of administration may be discussed with a physician. There is also a risk of serious metabolic disorders known as diabetic ketoacidosis, so careful monitoring for related symptoms or risk factors is essential. Patients with impaired liver function or the elderly must also take care when using this medication and should understand that glucose may be detected in urine tests during treatment. Pregnant or breastfeeding women are advised not to use this medication. The safety and efficacy in children have not yet been established. As there is no specific antidote in case of overdose, appropriate treatment should be administered according to symptoms, and measures should be taken per a physician's instructions if necessary. Finally, this medication does not significantly affect the ability to drive or operate machinery; however, caution should be exercised regarding the risk of hypoglycemia when combined with other antidiabetic agents. Store the medication out of the reach of children and keep it in its original container for safety.

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with fever, blisters, skin peeling, mucosal pain in mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough + fever, yellowing of skin or eyes (jaundice), profound lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urine

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, hypoglycemia, dry mouth, dizziness, constipation, dry mouth, lumbar pain, dysuria, polyuria, nocturia, interstitial nephritis, elevated hematocrit, decreased renal creatinine clearance at treatment initiation, dyslipidemia, elevated serum creatinine, elevated blood urea, weight loss, dermatitis, itching, sweating, musculoskeletal pain, dry skin, hair loss, urticaria, sweating,

This medication should be stored in a tightly sealed container to protect it from air and moisture, and it is safe to keep it at room temperature between 1 to 30 degrees Celsius. Storing it this way helps maintain the medication's effectiveness.

Appearance

Yellow, double convex diamond-shaped film-coated tablets

Package unit

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