Medication info
Dapagliflozin 5 mg (Dapagliflozin Propanediol Hydrate)

Dapagliflozin 5 mg (Dapagliflozin Propanediol Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin Propanediol Hydrate›6.15mg / 1 tablet
Manufacturer / importer
(주)동구바이오제약
Appearance
Yellow round film-coated tablet
Packaging
Bottle - 28 tablets/bottle, Bottle - 30 tablets/bottle, Box - 28 tablets/box [7 tablets/Alu-Alu x 4]
Approval status
Active

MFDS item code 202200812 · Approved 2022.02.23 · Insurance code 657308660

Summary

Main use
Treatment to improve blood glucose control in Type 2 diabetes and reduce cardiovascular risk in chronic heart failure and kidney disease
Who takes it
Adults · Children
Adult dose
The recommended dose of this medication for both monotherapy and as an add-on to insulin or other hypoglycemic medications is 10 mg once daily. For initial combination therapy in cases where there has been no previous experience with other diabetes medications, the initial recommended dose is 5 mg or 10 mg once daily when administered with metformin. For patients with chronic heart failure and chronic kidney disease, the dose is also 10 mg once daily. For patients with liver dysfunction.
Child dose
The efficacy and safety of dapagliflozin in children under 18 years of age have not been established, and there are no related data.

Ingredients

Manufacturer
(주)동구바이오제약

Efficacy & effects

Treatment to improve blood glucose control in Type 2 diabetes and reduce cardiovascular risk in chronic heart failure and kidney disease

  • Type 2 diabetes
  • poor blood glucose control
  • cardiovascular diseases
  • cardiovascular risk factors
  • chronic heart failure
  • heart failure
  • chronic kidney disease
  • reduced glomerular filtration rate
  • end-stage kidney disease
View approved original text

This medication is used in conjunction with dietary and exercise therapy to help control blood glucose in patients with Type 2 diabetes. It is also effective in reducing the risk of death and hospitalization due to cardiovascular disease in patients with chronic heart failure. In patients with chronic kidney disease, it helps to lower risks associated with worsening kidney function. This drug is used in combination with standard treatment for cardiovascular risk or chronic heart failure and kidney disease. Overall, this medication is used to improve the health condition of patients with diabetes, heart failure, and kidney disease.

How to take

Adult dose

The recommended dose of this medication for both monotherapy and as an add-on to insulin or other hypoglycemic medications is 10 mg once daily. For initial combination therapy in cases where there has been no previous experience with other diabetes medications, the initial recommended dose is 5 mg or 10 mg once daily when administered with metformin. For patients with chronic heart failure and chronic kidney disease, the dose is also 10 mg once daily. For patients with liver dysfunction.

Child dose

The efficacy and safety of dapagliflozin in children under 18 years of age have not been established, and there are no related data.

Precautions

This medication should not be used in patients with allergies to the active ingredient or excipients, patients with Type 1 diabetes, those with diabetic ketoacidosis, and patients undergoing dialysis. It should be administered with caution in patients with reduced fluid volume or kidney function issues, and fluid status and kidney function should be carefully checked before administration. This medication can lower blood pressure and poses a risk of acute kidney injury, so elderly patients or those with decreased kidney function should be particularly cautious. The glucose control effect varies depending on kidney function and is not recommended for patients with heavily reduced kidney function. During the course of this medication, genital infections and urinary tract infections may occur, so if symptoms of infection appear, consulting healthcare professionals immediately is necessary. Additionally, hypoglycemia may occur, so dosage adjustments may be needed if taking medications such as insulin or sulfonylureas concurrently. Symptoms of dehydration or low blood pressure due to reduced fluid volume may occur, so if these symptoms are present, medication should be paused and a physician should be consulted. A serious metabolic disorder called diabetic ketoacidosis may occur, so if symptoms such as vomiting, abdominal pain, or difficulty breathing appear, visiting the hospital immediately is essential. It is safest not to use this medication in patients with severely impaired liver function, pregnant women, or nursing mothers. Elderly patients or those taking diuretics should have their kidney function and fluid status frequently monitored, and it is important to undergo regular blood glucose and kidney function tests during the course of this medication. Although this medication does not significantly affect driving or operating machinery, caution is necessary as hypoglycemia symptoms may occur. Lastly, the safety and efficacy of this medication in children have not been established, so it is not used in pediatric populations.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, skin peeling, pain in the mucous membranes of the mouth/eyes, difficulty breathing or shortness of breath, asthma attacks, abnormal breathing accompanied by coughing and fever, jaundice (yellowing of the skin or eyes), generalized severe weakness, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urination

Mild side effects

  • Vulvovaginitis
  • balanitis and related genital infections
  • urinary tract infections
  • fungal infections
  • hypoglycemia
  • thirst
  • dizziness
  • constipation
  • dry mouth
  • low back pain
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  • dysuria
  • polyuria
  • nocturia
  • interstitial nephritis
  • vulvar itching
  • genital itching
  • increased hematocrit
  • elevated blood creatinine
  • elevated blood urea
  • weight loss
  • rash
  • angioedema
  • gastrointestinal disorders
  • hyperglycemia
  • sensory disturbances
  • nerve compression
  • cerebral infarction
  • chest pain
  • weakness

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

Storage

This medication must be stored in a tightly sealed container to avoid exposure to air or moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius. This way, the effectiveness of the drug can be preserved for a long time.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

Bottle - 28 tablets/bottle, Bottle - 30 tablets/bottle, Box - 28 tablets/box [7 tablets/Alu-Alu 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.