Medication info
Dangsiga Jeong 5 mg (Dapagliflozin Propanediol Hydrate)

Dangsiga Jeong 5 mg (Dapagliflozin Propanediol Hydrate)

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

MFDS item code 202203125 · Approved 2022.07.29 · Insurance code 649105610

Summary

Main use
Effect of blood sugar control in type 2 diabetes and reduction of cardiovascular risk
Who takes it
Adults · Children
Adult dose
The recommended dosage for this medication is 10 mg once daily for mono-therapy and additional combination therapy with insulin and other blood glucose-lowering agents. When used in combination with insulin or sulfonylureas, lower doses of insulin or insulin secretagogues should be considered. For initial combination therapy, the initial recommended dose of this medication is either 5 mg or 10 mg once daily.
Child dose
The efficacy and safety of dapagliflozin in children under 18 years of age have not been established.

Ingredients

Manufacturer
한국휴텍스제약(주)

Efficacy & effects

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

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

This medication is used to help control blood sugar levels in patients with type 2 diabetes. It can be used as an adjunct to diet and exercise. It can be used either as monotherapy or in combination with other diabetes medications, and is also appropriately prescribed to patients with cardiovascular disease or risk factors. This helps improve blood sugar control and reduce the risk of cardiovascular events. This medication is used for the treatment of type 2 diabetes.

How to take

Adult dose

The recommended dosage for this medication is 10 mg once daily for mono-therapy and additional combination therapy with insulin and other blood glucose-lowering agents. When used in combination with insulin or sulfonylureas, lower doses of insulin or insulin secretagogues should be considered. For initial combination therapy, the initial recommended dose of this medication is either 5 mg or 10 mg once daily.

Child dose

The efficacy and safety of dapagliflozin in children under 18 years of age have not been established.

Precautions

This medication should not be used in patients with a history of hypersensitivity, type 1 diabetes mellitus, diabetic ketoacidosis, or patients undergoing dialysis. It should be administered cautiously in patients with reduced fluid volume or renal dysfunction, and care must be taken to evaluate and monitor fluid status and kidney function due to the risk of hypotension or acute kidney injury. The efficacy of blood sugar control varies depending on kidney function, so it is not recommended for blood sugar control purposes in patients with moderate or severe kidney impairment. Adverse reactions such as genital infections, urinary tract infections, hypoglycemia, decreased fluid volume, and diabetic ketoacidosis may occur while taking this medication, and patients should consult healthcare professionals immediately if any symptoms arise. Particular caution is needed for the elderly and patients taking diuretics due to a higher risk of hypotension and decreased fluid volume. Pregnant or breastfeeding women should avoid using this medication, and if pregnancy is confirmed, administration should be stopped immediately. This medication may increase the risk of hypoglycemia when used with insulin or sulfonylureas, so dosage adjustments of these medications may be necessary. During treatment, blood sugar levels as well as symptoms of ketoacidosis should be closely monitored, and healthcare professionals should be notified immediately if symptoms of dehydration or hypotension occur. Additionally, this medication may increase urinary output, leading to reduced fluid volume, so regular checks on fluid status are necessary. In case of overdose, there is no specific antidote, so appropriate symptomatic treatment should be provided. Patients should be cautious of hypoglycemic symptoms when driving or operating machinery. Finally, this medication has not been established for safety and efficacy in children, so it should not be used and must be 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, pallor, severe rash with fever, blisters, skin peeling, mucosal pain in mouth/eyes, trouble breathing or shortness of breath, asthma attacks, cough + fever accompanied respiratory abnormalities, yellowing of skin or eyes (jaundice), profound drowsiness, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urine

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, interstitial nephritis, elevated hematocrit, reduced renal creatinine clearance at treatment initiation, dyslipidemia, elevated serum creatinine, elevated serum urea, weight loss, gastroesophageal reflux disease, upper abdominal pain, diverticulitis, bowel perforation, acute pancreatitis, chronic pancreatitis,

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. It is important to maintain storage temperatures between 1 and 30 degrees Celsius to safely retain the medication's efficacy.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

28 tablets/bottle, 30 tablets/bottle, 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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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.