Medication info
Dapagreen Tablet 5 mg (Dapagliflozin Propanediol Hydrate)

Dapagreen Tablet 5 mg (Dapagliflozin Propanediol Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin Propanediol Hydrate›6.15mg / 1 tablet
Manufacturer / importer
진양제약(주)
Appearance
Yellow, bilaterally convex, round, film-coated tablet
Packaging
Box - 28 tablets/box [14 tablets/PTP (Alu-Alu) x 2], Bottle - 30 tablets/bottle, Bottle - 300 tablets/bottle
Approval status
Active

MFDS item code 202300421 · Approved 2023.01.31 · Insurance code 650304450

Summary

Main use
Effect on blood sugar control in type 2 diabetes and inhibition of progression of chronic kidney disease
Who takes it
Adults · Children
Adult dose
This medication can be taken orally once daily at any time regardless of food intake. The tablet should be swallowed whole. The recommended dose for monotherapy and add-on therapy is 10 mg once daily. For those with no previous experience in diabetes medication treatment, when administered in combination with metformin, the initial recommended dose is either 5 mg once daily or 10 mg once daily. For chronic kidney disease patients, the dose is once daily.
Child dose
The efficacy and safety of dapagliflozin in children under 18 years have not been established. There are no relevant data.

Ingredients

Manufacturer
진양제약(주)

Efficacy & effects

Effect on blood sugar control in type 2 diabetes and inhibition of progression of chronic kidney disease

  • Type 2 diabetes
  • blood sugar control disorder
  • cardiovascular disease
  • cardiovascular risk factors
  • chronic kidney disease
  • estimated glomerular filtration rate reduction
  • end-stage kidney disease
  • death from cardiovascular disease
  • risk of renal-related death
View approved original text

This medication is used to improve blood sugar control in patients with type 2 diabetes. It can be administered either alone or in combination as an adjunct to dietary and exercise therapy. It is also applicable to patients with type 2 diabetes who are at risk of cardiovascular disease. Additionally, in patients with chronic kidney disease, it slows the progression of reduced kidney function and decreases the risk of cardiovascular and kidney-related mortality. In this case, it is used in conjunction with other chronic kidney disease treatments. In summary, this medication helps improve the main symptoms and complications of patients with type 2 diabetes and chronic kidney disease.

How to take

Adult dose

This medication can be taken orally once daily at any time regardless of food intake. The tablet should be swallowed whole. The recommended dose for monotherapy and add-on therapy is 10 mg once daily. For those with no previous experience in diabetes medication treatment, when administered in combination with metformin, the initial recommended dose is either 5 mg once daily or 10 mg once daily. For chronic kidney disease patients, the dose is once daily.

Child dose

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

Precautions

This medication should not be used in patients who have had allergic reactions to its active ingredients or excipients. Additionally, it should not be administered to patients with type 1 diabetes or diabetic ketoacidosis. This medication contains anhydrous lactose, so patients with genetic issues such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take it. Patients undergoing dialysis should also avoid using this medication. Patients with reduced fluid volume or kidney function issues should use this medication with caution, and blood pressure and kidney function must be carefully monitored before and after administration. In particular, in patients with moderate or more severe kidney impairment, the blood sugar control effect of this medication may be reduced, so consultation with a specialist is advised. During the use of this medication, genital infections or urinary tract infections may occur, so immediate treatment is necessary if symptoms of infection arise. There may be symptoms of hypoglycemia, so when used with insulin or sulfonylureas, dosage adjustment may be required. This medication can cause dehydration or low blood pressure, so if reduced fluid volume is suspected, temporary cessation of use may be necessary. Severe metabolic abnormalities, such as diabetic ketoacidosis, can occur, so if symptoms like vomiting, abdominal pain, or shortness of breath occur, healthcare professionals should be notified immediately. Patients with severely impaired liver function, pregnant women, and breastfeeding women should avoid taking this medication. Elderly patients are at a higher risk of kidney impairment and reduced fluid volume, so extra caution is needed. Also, the safety and efficacy of this medication have not been established in children, so it should not be used in pediatric patients. In case of overdose, seek immediate medical attention, and while this medication does not significantly affect driving or operating machinery, caution is advised considering the risk of hypoglycemia. Finally, this medication should be stored in its original packaging and kept out of reach of children.

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, peeling skin, pain in oral/ocular mucous membranes, shortness of breath or difficulty breathing, asthma attacks, breathing problems accompanied by cough and fever, yellowing of skin or eyes (jaundice), profound lethargy, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urine

Mild side effects

Vulvovaginal inflammation, glansitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia, dry mouth, dizziness, constipation, oral dryness, back pain, dysuria, polyuria, nocturia, vulvar itching, genital itching, increased hematocrit, elevated blood creatinine, dyslipidemia, weight loss, rash, angioedema, gastrointestinal disorders (gastroesophageal reflux disease, abdominal pain, diverticulitis, bowel perforation, acute pancreatitis, chronic pancreatitis, chronic gastritis,

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

Storage

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

Appearance and packaging

Appearance

Yellow, bilaterally convex, round, film-coated tablet

Package unit

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

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.