Dapflome Extended-Release Tablet 10/1000 mg (Dapagliflozin Propanediol Hydrate, Metformin Hydrochloride)

Adult dose

This medication is generally administered once daily with dinner. The maximum dosage is once daily with dapagliflozin 10 mg/extended-release metformin 2000 mg, taken as 2 tablets of 5 mg/1000 mg. For initial therapy, the recommended starting dose is once daily with 1 tablet of either 5 mg/500 mg or 10 mg/500 mg. To reduce the gastrointestinal side effects of metformin, dosage should be adjusted gradually.

This medication contains two key components used to control blood sugar. The first component inhibits the reabsorption of sugar in the kidneys, helping to lower blood sugar by allowing sugar to be excreted in urine. The second component helps in blood sugar control by inhibiting sugar production in the liver and improving insulin sensitivity. This medication should not be used in patients with renal impairment, dehydration, severe infections, cardiac disease, or during pregnancy and breastfeeding. Serious metabolic complications such as severe lactic acidosis can occur rarely; therefore, if symptoms such as malaise, muscular pain, breathlessness, or abdominal pain appear during use, immediate consultation with a physician is necessary. When taken with insulin or sulfonylureas, symptoms of hypoglycemia may occur, necessitating dosage adjustments. During use, urinary tract and genital infections may occur, so prompt treatment should be sought for any infection symptoms. Monitoring renal function regularly is crucial, as this medication may affect kidney function. Excessive alcohol consumption may increase the risk of side effects. It is advised to stop taking this medication for a certain period before and after surgery or radiographic contrast tests, and ensure renal function is normal before resuming. This medication may cause a decrease in fluid volume and blood pressure, necessitating careful observation for especially elderly patients or those on diuretics. Additionally, this medication may lower vitamin B12 levels; hence, checking vitamin B12 levels is recommended for long-term users. Dizziness may occur while driving or operating machinery, so caution is advised. Keep out of reach of children, and store it in its original container to maintain quality.

Serious side effects

Severe lactic acidosis (lactic acidosis), severe hypoglycemia, severe edema (fluid volume depletion, dehydration, hypotension), diabetic ketoacidosis, urosepsis, pyelonephritis, acute kidney injury and renal function impairment, rash (severe skin reaction), Guillain-Barré syndrome, bacterial pneumonia, sialadenitis, chest pain, atrial fibrillation, acute cholecystitis, wrist fracture, perineal necrosis, severe allergic reactions (hives, severe swelling, chest tightness, difficulty breathing)

Mild side effects

• Vulvovaginitis
• balanitis
• urinary tract infection
• fungal infection
• hypoglycemia
• dry mouth
• dizziness
• constipation
• back pain
• dysuria

Store this medication in a tightly closed container to protect it from air and moisture, preferably at a temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the medication's effectiveness over time.

Appearance

Yellow oval-shaped extended-release film-coated tablet with both sides convex

Package unit

30 tablets/box [(10 tablets/PTP (Alu-Alu) x 3)]