Medication info
DapaHana 10mg (Dapagliflozin Propanediol Hydrate)

DapaHana 10mg (Dapagliflozin Propanediol Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin Propanediol Hydrate›12.3mg / 1 tablet
Manufacturer / importer
(주)에이프로젠바이오로직스
Appearance
Yellow, double convex, diamond-shaped 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 202200237 · Approved 2022.01.13 · Insurance code 645210640

Summary

Main use
Effect on controlling blood sugar in type 2 diabetes and preventing cardiovascular events
Who takes it
Adults · Children
Adult dose
The recommended dose of this medication is 10 mg once daily for monotherapy and additional combination therapy with insulin or other blood glucose-lowering agents. For initial combination therapy with metformin, the initial recommended doses are 5 mg once daily or 10 mg once daily. This medication can be taken once daily at any time during the day, irrespective of meals. The tablet must 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
(주)에이프로젠바이오로직스

Efficacy & effects

Effect on controlling blood sugar in type 2 diabetes and preventing cardiovascular events

  • Type 2 diabetes
  • abnormal blood sugar regulation
  • cardiovascular disease
  • cardiovascular risk factors
View approved original text

This medication is used in conjunction with dietary and exercise therapy to help control blood sugar levels in patients with type 2 diabetes. It can be used alone or in combination with other medications. Particularly, in patients who have difficulty controlling blood sugar and who have cardiovascular disease or risk factors, careful consideration should be given to the cardiovascular effects of the medication. Overall, this medication helps with blood sugar management and prevents related complications in patients with type 2 diabetes.

How to take

Adult dose

The recommended dose of this medication is 10 mg once daily for monotherapy and additional combination therapy with insulin or other blood glucose-lowering agents. For initial combination therapy with metformin, the initial recommended doses are 5 mg once daily or 10 mg once daily. This medication can be taken once daily at any time during the day, irrespective of meals. The tablet must 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 hypersensitivity to the active ingredient or excipients, type 1 diabetes, diabetic ketoacidosis, and patients undergoing dialysis. It should be administered with caution to patients with reduced fluid volume or renal dysfunction, as hypotension or rapid changes in kidney function may occur, requiring thorough monitoring of the patient's condition before and during administration. The blood sugar control effect of this medication differs based on renal function, and particularly in patients with moderate to severe impairment of kidney function, the blood sugar control effect may be reduced, necessitating caution. The most commonly reported side effect in clinical trials is genital infections, which may occur more frequently in women and patients with a history of infections. Additionally, hypoglycemia may occur, so when used with insulin or sulfonylureas and other blood glucose-lowering agents, dosage adjustment may be required to reduce the risk of hypoglycemia. Symptoms of dehydration or hypotension due to reduced fluid volume may occur, especially in elderly patients or those on diuretics, requiring additional caution; if symptoms appear, the medication may be temporarily discontinued. The risk of diabetic ketoacidosis is present, so if ketoacidosis symptoms appear regardless of blood glucose levels, immediate testing and treatment should be sought. This medication may increase the risk of urinary tract infections and pyelonephritis, thus rapid evaluation and treatment are necessary if infection symptoms occur. Serious infections such as Fournier's gangrene are rarely reported, and if symptoms such as pain, swelling, or redness in the genitals or perineum appear, medical attention should be sought immediately. Women who are pregnant or planning to become pregnant should not use this medication, and its use is also recommended against for nursing mothers. The safety and efficacy of this medication in children under 18 years of age have not been established and use is not recommended. In case of overdose, there is no specific antidote, so it is important to receive appropriate treatment based on symptoms. This medication does not significantly affect driving or machine operation, but caution is required if there is a risk of hypoglycemia. Lastly, this medication should be stored out of the reach of children, and kept in its original container to maintain quality.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash accompanied by fever, blisters, peeling skin, pain in oral/ocular mucosa, shortness of breath, asthma attack, respiratory abnormality with cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, lightning pain headache, seizures, confusion, visual disturbances, paralysis, urinary retention

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia, dry mouth, dizziness, constipation, back pain, dysuria, polyuria, nocturia, increased hematocrit, elevated serum creatinine, dyslipidemia, weight loss, rash, angioedema, gastrointestinal disorders (gastroesophageal reflux disease, epigastric pain, diverticulitis, intestinal perforation, acute pancreatitis, chronic pancreatitis, chronic gastritis, gastritis, gastrointestinal discomfort, abdominal discomfort, abdomen

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 best stored at room temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow, double convex, diamond-shaped 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.