Medication info
Dapaglu Tablets 5 mg (Dapagliflozin Propanediol Hydrate)

Dapaglu Tablets 5 mg (Dapagliflozin Propanediol Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin Propanediol Hydrate›6.15mg / 1 tablet
Manufacturer / importer
삼익제약(주)
Appearance
Yellow, double convex, round film-coated tablet
Packaging
Bottle packaging - 30 tablets/bottle, Bottle packaging - 90 tablets/bottle
Approval status
Active

MFDS item code 202204518 · Approved 2022.12.16 · Insurance code 644004680

Summary

Main use
Effect on blood sugar control in type 2 diabetes and reduction of cardiovascular risks
Who takes it
Adults · Children
Adult dose
The recommended dose of this drug is 10 mg once daily for monotherapy and for combination therapy with insulin and other antihyperglycemic agents. When 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. This medication can be taken once daily at any time of the day, regardless of meals.
Child dose
The efficacy and safety of dapagliflozin have not been established in children under 18 years of age. There are no relevant data.

Ingredients

Manufacturer
삼익제약(주)

Efficacy & effects

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

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

This medication is used in conjunction with dietary and exercise therapy to assist in blood sugar control for patients with type 2 diabetes. It can also be used as monotherapy, and may be administered in combination with other medications as needed. It is particularly suitable for patients who have difficulty in managing blood sugar levels, especially those with cardiovascular disease or risk factors. This medication helps effectively manage blood sugar and reduce the risk of cardiovascular complications. Thus, it plays an important role in the treatment of type 2 diabetes and is used to improve patient health.

How to take

Adult dose

The recommended dose of this drug is 10 mg once daily for monotherapy and for combination therapy with insulin and other antihyperglycemic agents. When 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. This medication can be taken once daily at any time of the day, regardless of meals.

Child dose

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

Precautions

This medication should not be administered to certain patients. For example, individuals allergic to the components or excipients of this drug, patients with type 1 diabetes, those with diabetic ketoacidosis, individuals with lactose intolerance or certain genetic metabolic disorders, and patients undergoing dialysis may be at risk when taking this drug. Additionally, it should be used with caution in patients with reduced fluid volume or poor kidney function. This medication can lower blood pressure or affect kidney function, so it is essential to thoroughly check fluid status and kidney function before administration, and monitor for symptoms of hypotension or changes in kidney function after administration. During the use of this drug, the risk of genital infections or urinary tract infections may increase, so if symptoms of infection occur, immediate consultation with healthcare professionals is required. Hypoglycemia may occur, so especially when used with medications that can cause hypoglycemia such as insulin or sulfonylureas, blood sugar should be monitored regularly and dosages adjusted as necessary. This drug is not recommended for women who are pregnant or breastfeeding, and it should be discontinued immediately if pregnancy is confirmed. In case of overdose, there is no specific antidote, and appropriate treatment should be sought immediately at a hospital, as this drug may not be quickly eliminated from the body. Finally, caution is needed when driving or operating machinery while taking this medication, especially if there is a risk of hypoglycemia. The safety and efficacy of this drug have not been established for children, and it is recommended not to use it for this population. When storing this drug, keep it out of reach of children, and store it in its original container to maintain quality.

Side effects and when to seek care immediately

Serious side effects

Necrotizing fasciitis of the perineum (Fournier’s gangrene), diabetic ketoacidosis, acute kidney injury and renal impairment, reduction in fluid volume (including dehydration, hypovolemia, hypotension), anaphylaxis, angioedema, severe allergic reactions, severe skin adverse reactions, respiratory problems, hepatic abnormalities (jaundice), severe neurological symptoms, severe edema or urination abnormalities, urinary sepsis, pyelonephritis

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia, thirst, dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, increased hematocrit, initial treatment-related rise in serum creatinine, dyslipidemia, weight loss, rash, angioedema, chest pain, gastrointestinal disorders (such as dyspepsia, nausea, diarrhea, vomiting, gastritis, abdominal discomfort, abdominal pain, etc.), vaginal discharge, itching, urticaria,

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

Storage

This medication may be sensitive to air or moisture, so it must be stored in a tightly sealed container. It is recommended to maintain storage temperatures between 1 to 30 degrees Celsius to ensure the effectiveness of the drug and prevent degradation.

Appearance and packaging

Appearance

Yellow, double convex, round film-coated tablet

Package unit

Bottle packaging - 30 tablets/bottle, Bottle packaging - 90 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.