Medication info

Dapagutine Tablet 5mg (Dapagliflozin Propanediol Hydrate)

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Dapagliflozin Propanediol Hydrate›6.15mg / 1 tablet
Manufacturer / importer
신풍제약(주)
Appearance
Yellow round film-coated tablet
Packaging
28 tablets/box (7 tablets/Alu-Alu*4), 28 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 202200980 · Approved 2022.03.08

This product's status changed to Approval withdrawn on 2024.05.30. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Effects on blood sugar control in type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dosage of this drug is 10 mg once daily for monotherapy and as an additional combination therapy with insulin and other blood glucose lowering agents. If this medication is used in combination with insulin or insulin secretagogues such as sulfonylureas, lower doses of insulin or insulin secretagogues may be considered to reduce the risk of hypoglycemia. For initial combination therapy with metformin, the initial recommended dose is 5 mg once daily or 10 mg once daily.

Ingredients

Manufacturer
신풍제약(주)

Efficacy & effects

Effects on blood sugar control in type 2 diabetes and prevention of cardiovascular events

View approved original text

This medication helps patients with type 2 diabetes effectively control their blood sugar while following dietary and exercise regimens. It can be used alone or in combination with other diabetes medications. It can be safely used by patients with type 2 diabetes who have cardiovascular disease or risk factors, but it is advisable to refer to a healthcare professional for related precautions. This drug improves blood sugar control and aids in maintaining cardiovascular health, thereby enhancing diabetes management.

How to take

Adult dose

The recommended dosage of this drug is 10 mg once daily for monotherapy and as an additional combination therapy with insulin and other blood glucose lowering agents. If this medication is used in combination with insulin or insulin secretagogues such as sulfonylureas, lower doses of insulin or insulin secretagogues may be considered to reduce the risk of hypoglycemia. For initial combination therapy with metformin, the initial recommended dose is 5 mg once daily or 10 mg once daily.

Precautions

This drug should not be used in patients who have had an allergic reaction to the active ingredient or excipients, in patients with type 1 diabetes, or in patients undergoing dialysis. Care should be taken when used in patients with decreased fluid volume or poor kidney function, as hypotension or worsening kidney function may occur, so conditions should be carefully monitored before and after administration. The blood sugar control effect of this drug varies according to kidney function, so it is not recommended for patients with severely impaired kidney function. The most common side effect is genital infection, which may occur more frequently in women or patients with a history of infection, requiring caution. Hypoglycemic symptoms may appear, so especially when used with medications such as insulin or sulfonylureas, blood sugar changes should be closely monitored. Dehydration or symptoms of hypotension due to decreased body fluid may occur, so elderly patients or those taking diuretics should be particularly cautious. Severe metabolic disorder, known as diabetic ketoacidosis, may occur, so if related symptoms appear, immediate consultation with medical staff is required. Serious urinary infections such as urinary tract infection and pyelonephritis may occur, so prompt treatment is necessary if infection symptoms are present. The safety of this drug has not been sufficiently established for patients with severely impaired liver function, so caution is needed. Pregnant or breastfeeding women should avoid using this medication, and treatment should be discontinued immediately upon confirmation of pregnancy. For children, the safety and effectiveness of this drug have not been established, thus use is not recommended. In cases of overdose, there are no specific antidotes, so treatment should be symptomatic and follow medical staff instructions. Finally, this drug should be stored in its original container and kept out of reach of children.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucous membranes, shortness of breath or difficulty breathing, asthma attacks, respiratory complications with cough and fever, yellowing of the skin or eyes (jaundice), extreme fatigue, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination.

Mild side effects

  • Vulvar vaginitis
  • balanitis and related genital infections
  • urinary tract infection
  • hypoglycemia
  • thirst
  • dizziness
  • constipation
  • dry mouth
  • back pain
  • dysuria
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  • polyuria
  • nocturia
  • increased hematocrit
  • initial increase in serum creatinine
  • increased blood urea
  • weight loss
  • rash
  • gastroesophageal reflux disease
  • abdominal pain
  • chronic gastritis
  • diverticulosis
  • gastrointestinal disorders
  • abdominal discomfort
  • abdominal pain
  • dyspepsia
  • nausea
  • diarrhea
  • vomiting
  • vaginal discharge
  • itching
  • urticaria.

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

Storage

This medication should be stored in a container that is tightly sealed to avoid exposure to air or moisture and should be kept at room temperature between 1 degree and 30 degrees Celsius. Proper storage will maintain the drug's effectiveness and safety.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

28 tablets/box (7 tablets/Alu-Alu*4), 28 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.