Medication info
Hyusiga 10 mg (Dapagliflozin Propanediol Monohydrate)

Hyusiga 10 mg (Dapagliflozin Propanediol Monohydrate)

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin Propanediol Hydrate›12.3mg / 1 tablet
Manufacturer / importer
(주)휴온스
Appearance
Yellow, double-convex, diamond-shaped, film-coated tablet
Packaging
28 tablets - 7 tablets/PTP[x 4]
Approval status
Active

MFDS item code 202300390 · Approved 2023.01.30 · Insurance code 670609040

Summary

Main use
Effect on blood sugar control in type 2 diabetes and suppression of cardiovascular risk
Who takes it
Adults · Children
Adult dose
The recommended dose for this medication, whether used alone or in combination with other hypoglycemic agents such as insulin, is 10 mg once daily. For initial combination therapy with metformin, the recommended starting dose is either 5 mg or 10 mg once daily. This medication can be administered orally once daily at any time, regardless of food intake. The tablet should be swallowed whole.
Child dose
The efficacy and safety of dapagliflozin in children under 18 years of age have not been established. There is no relevant data.

Ingredients

Manufacturer
(주)휴온스

Efficacy & effects

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

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

This medication is used to improve blood sugar control in patients with type 2 diabetes, supplementing diet and exercise therapy. It can be used alone or in combination with other medications. It can be safely used particularly in patients with type 2 diabetes who have cardiovascular disease or risk factors, where blood sugar control is challenging. This medication helps prevent complications of diabetes by controlling blood sugar levels and contributes to the overall health improvement of the patient. For detailed clinical trial information, please refer to the professional guidelines. In summary, this medication is used for blood sugar management in patients with type 2 diabetes and for improving cardiovascular health.

How to take

Adult dose

The recommended dose for this medication, whether used alone or in combination with other hypoglycemic agents such as insulin, is 10 mg once daily. For initial combination therapy with metformin, the recommended starting dose is either 5 mg or 10 mg once daily. This medication can be administered orally once daily at any time, regardless of food intake. The tablet should be swallowed whole.

Child dose

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

Precautions

This medication should not be used in patients who are allergic to the active ingredient or additives, as well as in patients with type 1 diabetes, diabetic ketoacidosis, and those on dialysis. It should be used cautiously in patients with restricted fluid volume or impaired kidney function, particularly those with low blood pressure or variables in kidney function requiring regular status assessment. This medication contains color additives Yellow No. 4 and Yellow No. 5, and patients allergic to these components should exercise caution. The most common side effects include genital infections and urinary tract infections. These are generally mild but can recur, so treatment should be sought immediately if symptoms occur. Hypoglycemic symptoms may occur, therefore blood sugar levels should be regularly monitored, especially when used with insulin or other hypoglycemic agents. Dehydration or hypotensive symptoms may occur due to decreased fluid volume, so those at risk of dehydration should be monitored closely, and medication may be temporarily discontinued if necessary. Serious metabolic disturbances like diabetic ketoacidosis can occur rarely; consult healthcare professionals immediately if symptoms like vomiting, abdominal pain, or shortness of breath arise. Patients with severely compromised liver function, elderly individuals, and those on diuretics should be particularly cautious when using this medication and should undergo regular kidney function tests. It is recommended that pregnant or breastfeeding women refrain from using this medication, and if pregnancy is confirmed, the medication should be discontinued immediately. This medication does not significantly affect driving or operating machinery, but caution is advised due to the risk of hypoglycemia. This medication should be stored in its original container, safely 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 high fever, blisters, skin peeling, oral/ocular mucosal pain, difficulty breathing or shortness of breath, asthma attack, cough with accompanying fever and respiratory abnormalities, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headaches, lightning-like headaches, seizures, altered consciousness, visual disturbances, paralysis, urinary

Mild side effects

  • Vulvovaginitis
  • balanitis and related genital infections
  • urinary tract infections
  • fungal infection
  • hypoglycemia
  • thirst
  • dizziness
  • constipation
  • dry mouth
  • back pain
Show 22 more
  • dysuria
  • polyuria
  • nocturia
  • increased hematocrit
  • elevated serum creatinine
  • dyslipidemia
  • elevated blood urea
  • weight loss
  • pruritus
  • cold sweat
  • dermatitis
  • skin dryness
  • hyperkeratosis
  • skin lesions
  • headache
  • sensory impairment
  • paresthesia
  • cough
  • shortness of breath
  • palpitations
  • insomnia
  • eating

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

Storage

This medication can be sensitive to air and moisture; therefore, it should be stored in a tightly sealed container. It is advised to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow, double-convex, diamond-shaped, film-coated tablet

Package unit

28 tablets - 7 tablets/PTP[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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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.