DapaRizin 5mg (Dapagliflozin Monohydrate)

Adult dose

The recommended dose for this medication is 10 mg once daily for monotherapy and additional combination therapy with other blood sugar-lowering agents, including insulin. In initial combination therapy with metformin for patients who have no previous experience with diabetes medications, the daily recommended doses are 5 mg or 10 mg once daily. Dosage adjustments for special populations vary according to renal impairment, liver dysfunction, and elderly individuals and are made as necessary. This medication can be taken regardless of food intake.

Child dose

The efficacy and safety of Dapagliflozin in pediatric patients under 18 years of age have not been established. There is no relevant data.

This medication should not be used in patients who have had allergic reactions to the active ingredient or excipients. It should also not be administered to patients with type 1 diabetes or diabetic ketoacidosis. Patients with genetic disorders that prevent lactose breakdown should avoid this medication, as the included anhydrous lactose may cause problems. This medication is not administered to patients undergoing dialysis. This medication should be used cautiously in patients who have reduced fluid volume or kidney function issues. It may lower blood pressure and reduce blood volume, which can lead to symptomatic hypotension or kidney function deterioration. Patients with impaired kidney function, elderly patients, and those on diuretics are at greater risk, and their conditions should be closely monitored before and after administration. Caution is also necessary for patients with allergies to specific pigment components. During treatment, genital infections or urinary tract infections may occur, so immediate treatment is necessary if any infection symptoms arise. Symptoms of hypoglycemia may appear, especially when taken with insulin or sulfonylureas, so dosage adjustment may be necessary. Dehydration symptoms, dry mouth, and dizziness due to reduced fluid volume may occur, so adequate hydration and monitoring of symptoms are important. Severe metabolic instability known as diabetic ketoacidosis may rarely occur, so if symptoms such as abdominal pain, vomiting, or shortness of breath occur, immediate consultation with healthcare professionals is required. Regular kidney function tests are necessary as this medication may affect kidney function, and there may be an increase in creatinine levels. Rare but serious side effects, such as severe perineal necrosis (Fournier's gangrene), have been reported; if pain, swelling, or redness occurs around the genital area, inform a physician immediately. Women who are pregnant or nursing are advised against using this medication. This medication may increase the risk of hypoglycemia when used with other blood sugar-lowering agents; interactions with other medications being taken must be confirmed. There is no specific antidote for overdose; it is crucial to seek symptomatic treatment, and appropriate measures should be taken based on health status. Caution should be observed while driving or operating machinery during the course of this medication, especially in combination with insulin or sulfonylureas, due to the risk of hypoglycemia. Store this medication out of reach of children, and keep it in its original container to maintain quality.

Serious side effects

• Rash, severe swelling (edema), sweating
• Diabetic ketoacidosis
• Acute kidney injury and renal dysfunction
• Perineal necrosis (Fournier's gangrene)
• Anaphylactic reactions
• Rash: severe rash with high fever, blistering, skin peeling, pain in mouth/eye mucosa
• Shortness of breath or difficulty breathing, asthma attack, cough+fever accompanied respiratory problems
• Skin or eyes turning yellow (jaundice)
• Sudden and severe headache, seizures, altered consciousness, vision changes

Mild side effects

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

This medication should be stored in a sealed container to prevent exposure to air or moisture, and it is advisable to keep it at room temperature between 1°C and 30°C. This storage helps maintain the medication's effectiveness over time.

Appearance

Yellow, double convex, round film-coated tablet

Package unit

28 tablets/box [(7 tablets/PTP x 4, 14 tablets/PTP x 2)]