Medication info
Daplogin 5 mg (Dapagliflozin Propanediol Monohydrate)

Daplogin 5 mg (Dapagliflozin Propanediol Monohydrate)

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

MFDS item code 202200929 · Approved 2022.03.04 · Insurance code 656005320

Summary

Main use
Effect on blood sugar control in type 2 diabetes and reduction of cardiovascular risk
Who takes it
Adults · Children
Adult dose
The recommended dosage of this drug is 10 mg once daily for monotherapy and as an adjunct to other blood sugar-lowering agents including insulin. In initial combination therapy, when administered with metformin, the daily dose may be 5 mg or 10 mg once daily. This drug can be taken orally at any time during the day, regardless of meals. The tablet should be swallowed whole.
Child dose
The safety and efficacy of Dapagliflozin in patients under 18 years of age have not been established.

Ingredients

Manufacturer
알리코제약(주)

Efficacy & effects

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

  • Type 2 diabetes
  • poor blood sugar control
  • cardiovascular diseases
  • cardiovascular risk factors
View approved original text

This drug is used in conjunction with diet and exercise to help control blood sugar in patients with type 2 diabetes. It can be used alone or in combination with other medications to control blood sugar. It is particularly helpful for patients whose blood sugar is poorly controlled and who have cardiovascular diseases or risk factors. This drug is used to improve blood sugar levels and reduce the risk of cardiovascular events.

How to take

Adult dose

The recommended dosage of this drug is 10 mg once daily for monotherapy and as an adjunct to other blood sugar-lowering agents including insulin. In initial combination therapy, when administered with metformin, the daily dose may be 5 mg or 10 mg once daily. This drug can be taken orally at any time during the day, regardless of meals. The tablet should be swallowed whole.

Child dose

The safety and efficacy of Dapagliflozin in patients under 18 years of age have not been established.

Precautions

This drug should not be used in certain patients. For example, it is not to be administered to those with allergies to the components or additives, patients with type 1 diabetes, diabetic ketoacidosis, or patients undergoing dialysis. Caution is required in patients with reduced fluid volume or impaired kidney function. This drug may lower blood pressure and affect kidney function, so fluid status and kidney function must be evaluated before administration, and symptoms of hypotension and changes in kidney function should be monitored after administration. In patients with moderate to severe kidney dysfunction, blood sugar control effects may decrease, and it is not recommended for patients with very low kidney function. Using this drug may lead to adverse reactions such as genital infections, urinary tract infections, hypoglycemia, decreased fluid volume, diabetic ketoacidosis, and rarely, Fournier's gangrene. Especially, genital and urinary tract infections appear more frequently in women and patients with a history of such infections. The risk of hypoglycemia may increase when used with other blood sugar-lowering agents such as insulin or sulfonylureas, and dosage adjustments may be required in such cases. Patients at risk of reduced fluid volume and hypotension, particularly the elderly or those on diuretics, should be more cautious, and should consult healthcare providers immediately if symptoms occur. Pregnant women or nursing mothers are advised not to use this drug, and should discontinue use if pregnancy is confirmed. The safety and efficacy of this drug in children have not been established, so it is not used in pediatric patients. In case of overdose, there is no specific antidote, so treatment should be received according to symptoms under medical supervision. This drug does not significantly affect driving or machine operation, but caution is needed in cases of hypoglycemia. Finally, this drug must 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

Urticaria, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, oral/ocular mucous membrane pain, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities with cough and fever, jaundice of the skin or eyes, extreme lethargy, sudden and severe headache, thunderclap headache, seizure, confusion, visual disturbances, paralysis, markedly reduced urine output

Mild side effects

  • Vulvitis
  • balanitis
  • genital infection
  • urinary tract infection
  • fungal infection
  • hypoglycemia
  • dry mouth
  • dizziness
  • constipation
  • dry mouth
Show 23 more
  • back pain
  • dysuria
  • polyuria
  • nocturia
  • elevated hematocrit
  • increased serum creatinine
  • dyslipidemia
  • weight loss
  • rash
  • gastroesophageal reflux disease
  • epigastric pain
  • diverticulitis
  • intestinal perforation
  • acute pancreatitis
  • chronic pancreatitis
  • hyperglycemia
  • paresthesia
  • nerve compression
  • weakness
  • pain
  • keratitis
  • chronic obstructive pulmonary disease
  • cough

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

Storage

This drug should be stored in a sealed container to protect it from air and moisture. The storage temperature should ideally be maintained between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

Box - 28 tablets/box [7 tablets/Alu-Alu x 4], Bottle - 28 tablets/bottle, Bottle - 30 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.