Dapagliflozin and Metformin Extended-Release Tablets 5/1000 mg

Adult dose

This medication is generally administered once daily with the evening meal. The maximum dosage is 10 mg of Dapagliflozin/2000 mg of extended-release Metformin once daily, administered as 2 tablets of 5 mg/1000 mg. For patients with no previous experience of diabetes medication treatment, the initial regimen is 1 tablet of 5 mg/500 mg or 10 mg/500 mg once daily. To reduce the gastrointestinal side effects of Metformin, dosage should be titrated gradually.

This medication is used to aid blood glucose control in patients with type 2 diabetes. It should not be administered to patients with impaired kidney function, and caution should be exercised in cases of moderate to severe kidney impairment. Avoid administering this medication to patients with severe infections, dehydration, cardiovascular collapse, acute myocardial infarction, and it should be temporarily discontinued during certain periods before and after surgery. Pregnant or breastfeeding women should not use this medication, nor should it be given to patients with hypersensitivity to any ingredient included in it. As this medication carries a risk of hypoglycemia, caution should be taken for symptoms of hypoglycemia when used with insulin or sulfonylureas, and dosage adjustments may be necessary. A rare but serious side effect known as lactic acidosis may occur, so if symptoms such as malaise, muscle pain, respiratory distress, or abdominal pain appear during use, consult a physician immediately. This medication may increase the risk of genital and urinary tract infections, so if infection symptoms arise, prompt treatment is necessary. Vitamin B12 deficiency may occur, so regular monitoring of blood vitamin B12 levels is recommended during prolonged use. Alcohol may increase the risk of side effects from this medication, so excessive drinking should be avoided during therapy. Elderly patients or those with reduced kidney function should particularly adjust their dosage with caution and monitor their kidney function regularly. This medication may lead to weight loss and caution should be exercised for dehydration symptoms due to increased urination. Serious infections such as necrotizing fasciitis have been reported rarely, so if symptoms such as pain, swelling, or redness in that area appear, inform medical personnel immediately. During the use of this medication, beware of symptoms like dizziness when driving or operating machinery. It is important to consult a physician or pharmacist about possible interactions with other medications before and after use of this drug.

Serious side effects

Lactic acidosis, severe hypoglycemia, ketoacidosis, urosepsis, pyelonephritis, acute kidney injury, renal impairment, severe allergic reactions (hives, severe swelling, tightness in the chest, difficulty breathing, cold sweats, paleness), severe skin reactions (severe rash, blisters, skin peeling, pain in mucous membranes of mouth/eyes associated with high fever), respiratory issues (shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever), liver

Mild side effects

• Vulvovaginitis
• balanitis
• genital infections
• urinary tract infections
• fungal infections
• hypoglycemia
• dry mouth
• dizziness
• constipation
• back pain

This medication should be stored in a tightly closed container to prevent exposure to air or moisture, and it is recommended to keep it at room temperature between 1 to 30 degrees Celsius. Storing it this way helps maintain its potency and prevents degradation.

Appearance

Pink to dark pink elliptical film-coated bilayer tablets consisting of immediate-release and extended-release layers

Package unit

30 tablets per bottle