Dapagliflozin Metformin Sustained Release Tablet 5/500 mg

Adult dose

This medication is generally administered once daily with the evening meal. The maximum dose is 10 mg of dapagliflozin/2000 mg of sustained-release metformin per day, administered as 2 tablets of 5 mg/1000 mg. When used as initial therapy, the recommended starting dosage is one tablet of either 5 mg/500 mg or 10 mg/500 mg once daily. Dosing should be titrated gradually to reduce gastrointestinal side effects of metformin.

This medication is used for the treatment of diabetes and contains metformin and dapagliflozin. This medication should not be administered to patients with impaired renal function or liver issues, and caution is also needed in cases of acute infections, dehydration, or cardiac problems. During the course of this medication, a rare but serious side effect known as lactic acidosis may occur; therefore, if symptoms such as fatigue, muscle pain, or difficulty breathing appear, consult a doctor immediately. Moreover, this medication may cause hypoglycemia, so when used with insulin or other hypoglycemic agents, blood sugar changes should be carefully monitored, and dosage adjustment may be necessary. This medication may cause decreased fluid volume and low blood pressure; hence, especially elderly patients or those on diuretics should frequently check their blood pressure and fluid status. The risk of genital infections and urinary tract infections may increase, so if symptoms of infection appear, prompt treatment should be sought. Women who are pregnant or breastfeeding should not use this medication, and those planning a pregnancy or confirming pregnancy must discontinue use immediately. This drug may cause vitamin B12 deficiency, so it is advisable to monitor blood levels of vitamin B12 during prolonged use. In case of overdose, immediate medical attention is required; dizziness may occur as a side effect, so caution is advised while driving or operating machinery. Finally, this medication should be kept out of reach of children and stored in its original container to prevent quality degradation and misuse.

Serious side effects

• Lactic acidosis (severe metabolic complication)
• Severe allergic reactions (history of hypersensitivity)
• Severe renal impairment and acute renal failure
• Diabetic ketoacidosis
• Severe skin adverse reactions (rash, blisters, skin peeling, pain in mucous membranes of mouth/eyes)
• Severe edema (including decreased fluid volume, dehydration, hypovolemia, hypotension)
• Difficulty breathing and respiratory abnormalities
• Perineal necrosis (life-threatening severe perineal necrosis)
• Urosepsis and pyelonephritis
• Acute kidney injury

Mild side effects

• Vulvovaginitis, balanitis and related genital infections
• Urinary tract infection
• Fungal infection
• Hypoglycemia
• Thirst
• Dizziness
• Constipation
• Dry mouth
• Back pain
• Dysuria

This medication should be stored in a tightly closed container to prevent air or moisture from entering. It is best to store at room temperature between 1°C and 30°C. Proper storage helps maintain the effectiveness of the medication for a longer duration.

Appearance

Orange to dark orange rectangular film-coated double-layer tablet consisting of immediate-release layer and sustained-release layer

Package unit

30 tablets/bottle