Medication info
Udapaz 10 mg (Dapagliflozin Propanediol Hydrate)

Udapaz 10 mg (Dapagliflozin Propanediol Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin Propanediol Hydrate›Strength being verified
Manufacturer / importer
(주)유영제약
Appearance
Yellow, biconvex, diamond-shaped film-coated tablets
Packaging
10 tablets/box [10 tablets/PTP], 30 tablets/bottle
Approval status
Active

MFDS item code 202202237 · Approved 2022.05.25 · Insurance code 648204550

Summary

Main use
Blood sugar control in type 2 diabetes and reduction of cardiovascular risk
Who takes it
Adults · Children
Adult dose
The recommended dose of this medication for monotherapy and additional combination therapy with insulin and other blood sugar-lowering agents is 10 mg once daily. When this medication is used in combination with insulin or insulin secretagogues such as sulfonylureas, a lower dose of insulin or insulin secretagogues may be considered to reduce the risk of hypoglycemia. In initial combination therapy, if there is no prior experience with diabetes medication therapy, the initial recommended dose is either 5 mg once daily or 10 mg once daily.
Child dose
The efficacy and safety of dapagliflozin in pediatric patients under the age of 18 have not been established.

Ingredients

Manufacturer
(주)유영제약

Efficacy & effects

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 administered either as a monotherapy or in combination with other medications as an adjunct to dietary control and exercise therapy. It is especially used in patients with cardiovascular diseases or risk factors among those who do not achieve sufficient blood sugar control; detailed clinical trial information can be referenced in professional guidelines. This medication is effectively used for blood sugar management and the improvement of cardiovascular health in patients with type 2 diabetes.

How to take

Adult dose

The recommended dose of this medication for monotherapy and additional combination therapy with insulin and other blood sugar-lowering agents is 10 mg once daily. When this medication is used in combination with insulin or insulin secretagogues such as sulfonylureas, a lower dose of insulin or insulin secretagogues may be considered to reduce the risk of hypoglycemia. In initial combination therapy, if there is no prior experience with diabetes medication therapy, the initial recommended dose is either 5 mg once daily or 10 mg once daily.

Child dose

The efficacy and safety of dapagliflozin in pediatric patients under the age of 18 have not been established.

Precautions

This medication should not be used in patients with allergies to its active ingredients or excipients, in patients with type 1 diabetes, or in patients with diabetic ketoacidosis. Additionally, it should not be given to patients with lactose intolerance or specific genetic issues, as well as those undergoing dialysis. It must be used cautiously in patients with reduced fluid volume or kidney function problems, and fluid status and kidney function should be carefully monitored before and during administration. This medication can lower blood pressure or reduce intravascular volume, which may pose a risk of symptomatic hypotension or acute kidney injury, thus caution is warranted. The blood sugar control effect varies depending on kidney function, and effectiveness may decrease particularly in patients with moderate to severe renal impairment. Adverse reactions such as genital infections, urinary tract infections, hypoglycemia, fluid volume reduction, and diabetic ketoacidosis may occur during this medication's use, thus symptoms should be monitored. Genital infections tend to occur more frequently in females or in patients with a past history of infections. The risk of hypoglycemia may increase when combined with blood sugar-lowering agents such as insulin or sulfonylureas, necessitating careful dosage adjustments. If symptoms of dehydration or hypotension appear due to decreased fluid volume, immediate consultation with a healthcare professional is necessary. This medication is not recommended for patients with severely impaired liver function, women who are pregnant or breastfeeding, and should be discontinued if pregnancy is confirmed. Elderly patients or those on diuretics are at higher risk of fluid volume reduction and decline in kidney function, hence more caution should be taken. Glucose may be detected in urine tests conducted while on this medication, so this should be kept in mind when interpreting test results. Furthermore, this medication may interact with some drugs, so it is crucial to inform healthcare providers of any other medications being taken. There is no specific antidote for overdose, and appropriate treatment should be based on symptoms, with immediate medical attention sought if necessary. This medication does not significantly impact driving or machine operation, but caution is advised if hypoglycemia occurs. Finally, this medication should be stored out of reach of children and in its original container to maintain its quality.

Side effects and when to seek care immediately

Serious side effects

Rash, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, cough with fever accompanied respiratory abnormalities, jaundice (yellowing of skin or eyes), profound lethargy, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination abnormalities

Mild side effects

  • Vulvovaginitis
  • balanitis and related genital infections
  • urinary tract infections
  • hypoglycemia
  • dizziness
  • constipation
  • dry mouth
  • back pain
  • dysuria
  • polyuria
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  • nocturia
  • increased hematocrit
  • elevated serum creatinine
  • dyslipidemia
  • weight loss
  • rash
  • cold sweats
  • pruritus
  • headache
  • sensory loss
  • paresthesia
  • dyspepsia
  • nausea
  • diarrhea
  • vomiting
  • asthenia
  • hunger
  • vaginal discharge
  • chest pain
  • edema
  • facial swelling
  • facial pain
  • warmth
  • toxicosis

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 air or moisture ingress. The storage temperature should be kept at room temperature between 1 to 30 degrees Celsius to maintain its efficacy.

Appearance and packaging

Appearance

Yellow, biconvex, diamond-shaped film-coated tablets

Package unit

10 tablets/box [10 tablets/PTP], 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.