Dapaglinzi 10/4 mg

Adult dose

This medication may be administered to patients receiving glimepiride 4 mg and dapagliflozin 10 mg once daily, one tablet (as dapagliflozin/glimepiride 10mg/4mg) immediately before breakfast or the first meal of the day. It is very important not to skip meals after taking this medication. Patients who require a reduction in glimepiride should take separate preparations of each component. The tablets should be swallowed whole.

This medication should not be administered to certain patients. Firstly, patients with allergy to the main ingredients or excipients of this medication, or to sulfonylurea drugs should not take this medication. Furthermore, patients with type 1 diabetes, history of diabetic ketoacidosis, or diabetic coma should also not use this medication. As this medication contains anhydrous lactose, it should not be prescribed to patients with genetic disorders such as lactose intolerance, lactose enzyme deficiency, or glucose-galactose malabsorption. Patients with severe renal function or liver function impairment, pregnant women, or women who may become pregnant should not take this medication. Patients with severe infections, before or after surgery, or with severe trauma should prioritize insulin therapy and this medication should be used with caution. Patients with gastrointestinal disorders such as diarrhea or vomiting may have a risk of hypoglycemia due to impaired food absorption, so caution is needed. Dialysis patients should also avoid this medication. When using this medication, special care should be taken with patients whose kidney function or fluid volume is reduced. This medication can cause a drop in blood pressure or worsen kidney function, so patients with impaired kidney function, the elderly, or those taking diuretics should be thoroughly assessed before administration and their blood pressure and kidney function should be continuously monitored afterward. In patients whose kidney function is moderately impaired or worse, the blood sugar control effect may be diminished, so the decision to administer should be made carefully. In addition, when taking this medication along with sulfonylurea drugs, particularly at the beginning of treatment, the risk of hypoglycemia increases, thus blood sugar should be checked frequently. Elderly patients, those who are malnourished or have irregular meal intake, those who engage in excessive exercise, and those who consume alcohol should be especially cautious. If symptoms of hypoglycemia appear, sugar should be ingested immediately and if symptoms are severe, medical consultation should be sought. Common side effects of this medication include genital infections and urinary tract infections. Genital infections may occur more frequently in women, so treatment should be sought immediately if symptoms of infection appear. Hypoglycemia, decreased fluid volume, dizziness, dry mouth, dysuria, nocturia, increased hematocrit, elevated serum creatinine, dyslipidemia, weight loss, itching, cold sweats, hair loss, dermatitis, dry skin, allergic dermatitis, contact dermatitis, diabetic foot ulcers, abnormal sweating, eczema, coin dermatitis, and hyperkeratosis, and dermal lesions, flank pain, fibromyalgia have also been reported. This medication can potentially cause diabetic ketoacidosis, a serious metabolic condition, so if symptoms such as nausea, vomiting, abdominal pain, difficulty breathing, or fatigue occur, healthcare professionals should be notified immediately. Ketoacidosis can occur even if blood sugar levels are not high, so caution is required. Pregnant or breastfeeding women should not use this medication, and if pregnancy is planned, alternative treatments should be considered after discussing with a healthcare provider. The safety and efficacy for children and adolescents under 18 years of age have not been established, so it is not used in these populations. Elderly patients are at higher risk of decreased kidney function, so careful attention should be paid to dosage adjustments and monitoring of kidney function. In case of overdose, symptoms such as hypoglycemia, dehydration, and hypotension may occur, and immediate medical attention is needed. If hypoglycemia is severe, emergency treatment such as intravenous glucose may be necessary. During the use of this medication, be aware of symptoms of hypoglycemia and take care when driving or operating machinery. Keep the medication out of reach of children and store it in its original container.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urinary issues.

Mild side effects

• Vulvitis
• balanitis
• urinary tract infections
• fungal infections
• hypoglycemia
• dry mouth
• dizziness
• constipation
• oral dryness
• urinary pain

This medication should be stored in a tightly sealed container to protect it from air or moisture. It is best to maintain the storage temperature between 1 to 30 degrees Celsius at room temperature. Proper storage can help retain the drug's effectiveness for a long time.

Appearance

Yellow oval film-coated tablets

Package unit

Box - 28 tablets/box [(14 tablets/PTP x 2)], Bottle - 30 tablets/bottle, Bottle - 300 tablets/bottle, Bottle - 1000 tablets/bottle