Medication info
Aida Tablet 5 mg (Dapagliflozin Propanediol Hydrate)

Aida Tablet 5 mg (Dapagliflozin Propanediol Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin Propanediol Hydrate›6.15mg / 1 tablet
Manufacturer / importer
안국약품(주)
Appearance
Yellow, bilaterally convex, round film-coated tablets
Packaging
28 tablets/box [7 tablets/PTP X 4]
Approval status
Active

MFDS item code 202204325 · Approved 2022.12.02 · Insurance code 650205930

Summary

Main use
Effect of blood glucose control and reduction of cardiovascular risk in type 2 diabetes
Who takes it
Adults · Children
Adult dose
The recommended dosage of this medication is 10 mg once daily for both monotherapy and in addition to insulin or other hypoglycemic agents. In initial combination therapy with metformin, the dosage is either 5 mg once daily or 10 mg once daily. The method of administration is oral, at any time of the day regardless of meals, and the tablets should be swallowed whole.
Child dose
The efficacy and safety of dapagliflozin in children under 18 years have not been established. There is no relevant data.

Ingredients

Manufacturer
안국약품(주)

Efficacy & effects

Effect of blood glucose control and reduction of cardiovascular risk in type 2 diabetes

  • Type 2 diabetes
  • poor blood glucose control
  • cardiovascular disease
  • cardiovascular risk factors
View approved original text

This medication is used as an adjunct to diet and exercise to help control blood glucose in patients with type 2 diabetes. It can be administered alone or in combination with other medications. In addition, it is important to refer to clinical trial information guided by experts regarding the use of this medication in patients whose blood glucose is not adequately controlled and who have or are at risk for cardiovascular disease. Overall, this drug is used to improve patient health through effective management of blood glucose in type 2 diabetes.

How to take

Adult dose

The recommended dosage of this medication is 10 mg once daily for both monotherapy and in addition to insulin or other hypoglycemic agents. In initial combination therapy with metformin, the dosage is either 5 mg once daily or 10 mg once daily. The method of administration is oral, at any time of the day regardless of meals, and the tablets should be swallowed whole.

Child dose

The efficacy and safety of dapagliflozin in children under 18 years have not been established. There is no relevant data.

Precautions

This medication should not be used in patients with a history of allergic reactions, individuals with type 1 diabetes, and certain genetically lactose-intolerant patients. Additionally, it is advisable not to administer this medication to patients undergoing dialysis. Caution should be exercised in administering this medication to patients with reduced fluid volume or impaired kidney function, and fluid status and kidney function should be carefully evaluated before administration. This medication may lower blood pressure, and special attention is needed in older adults or patients on diuretics, as the risk of hypotension is higher. Serious metabolic disorders such as diabetic ketoacidosis may occur, so signs should be monitored, and testing should be done immediately if suspected. The risk of genital and urinary infections may increase, so treatment should be sought promptly if symptoms of infection arise. When used in combination with insulin or sulfonylureas, dosage adjustments may be necessary to reduce the risk of hypoglycemia. It is recommended that pregnant or breastfeeding women do not use this medication. The safety and effectiveness in children have not been established, so use is not recommended. In case of overdose, there is no specific antidote, so appropriate treatment should be given based on symptoms, and greater caution is needed if there are issues with kidney function. Regular check-ups and tests with healthcare professionals are vital to reduce the risks of fluid volume depletion, hypotension, infection, and ketoacidosis. Moreover, while this medication does not significantly impair driving or operating machinery, caution should be exercised for symptoms of hypoglycemia when taken with other hypoglycemic agents. Finally, store it out of reach of children and keep it in the original container to maintain quality.

Side effects and when to seek care immediately

Serious side effects

Rash, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweats, pallor, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, difficulty breathing, asthma attack, abnormal breathing accompanied by cough + fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, vision disturbances, paralysis, urination

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infection, fungal infection, hypoglycemia (when used with sulfonylureas or insulin), dry mouth, dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, renal tubular inflammation, increased hematocrit, elevated levels of serum creatinine, increased blood urea, weight loss, dyspepsia, nausea, diarrhea, vomiting, pruritus, rash, cold sweats, weakness, chest pain, fatigue,

Not everyone experiences these, and they can vary from person to person.

Storage

This medication must be stored in a tightly sealed container to prevent exposure to air and moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius, at room temperature.

Appearance and packaging

Appearance

Yellow, bilaterally convex, round film-coated tablets

Package unit

28 tablets/box [7 tablets/PTP X 4]

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.