Dapljinmet Controlled-Release Tablets 10/500 mg (Dapagliflozin Propanediol Hydrate, Metformin Hydrochloride)

Adult dose

This medication is generally administered once daily with the evening meal. The maximum dosage is dapagliflozin 10mg/extended-release metformin 2000mg once daily, taken as two tablets of 5mg/1000mg. When used as initial therapy, the recommended starting dose is one tablet of 5mg/500mg or 10mg/500mg once daily. This medication should be swallowed whole and should never be crushed, cut, or chewed.

This medication is used for the treatment of diabetes and contains two components that lower blood sugar. When taking this medication, it is essential to check that kidney function is normal. Patients with severely impaired kidney function or acute renal failure should not use it. Additionally, patients in states of dehydration, severe infections, cardiovascular issues, or acute myocardial infarction should avoid this medication. Pregnant or nursing women should not use this medication, and patients with lactose intolerance should also avoid it. The risk of hypoglycemia may increase when this medication is used in combination with insulin or sulfonylureas, hence caution is needed when used together, and insulin dosages may need adjustment if necessary. This medication can cause a decrease in blood volume or low blood pressure, so especially for the elderly or patients taking diuretics, blood pressure and fluid status should be monitored closely. During treatment, genital infections or urinary tract infections may occur, so if symptoms of infection appear, immediate consultation with a healthcare professional is advised. Furthermore, this medication carries a risk of serious metabolic complications such as lactic acidosis and ketoacidosis; thus, if symptoms such as fatigue, shortness of breath, or abdominal pain occur, immediate medical attention should be sought. It is advisable to avoid alcohol consumption while taking this medication and to temporarily discontinue it prior to surgery or contrast examinations, resuming only after verifying kidney function. Vitamin B12 deficiency may occur, so regular monitoring of serum vitamin B12 levels is required with prolonged use. Finally, special caution is needed for children and elderly patients over 80 years old, as the safety and efficacy of this medication have not been sufficiently established.

Serious side effects

Lactic acidosis (severe metabolic adverse reaction), severe hypoglycemia, acute kidney injury and renal impairment, ketoacidosis (serious metabolic acidosis), urosepsis and pyelonephritis (serious urinary infection), perineal necrosis (life-threatening), Guillain-Barré syndrome (neurological symptoms), atrial fibrillation, acute cholecystitis, severe allergic reactions (hives, severe swelling, chest tightness, shortness of breath, cold sweat, pallor), severe skin reactions (high fever and

Mild side effects

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

This medication may be sensitive to air and moisture, so it must be stored in a tightly sealed container. It is advisable to keep it at room temperature, between 1 to 30 degrees Celsius. This helps maintain the efficacy of the medication.

Appearance

Pink rectangular controlled-release film-coated tablet

Package unit

30 tablets/box [(6 tablets/PTP) x 5], 30 tablets/bottle