Medication info
Fosirinjenjeong 10 mg (Dapagliflozin Propanediol Monohydrate)

Fosirinjenjeong 10 mg (Dapagliflozin Propanediol Monohydrate)

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin Propanediol Hydrate›12.3mg / 1 tablet
Manufacturer / importer
위더스제약(주)
Appearance
Yellow, biconvex, diamond-shaped film-coated tablet
Packaging
28 tablets/box [14 tablets/PTP x 2]
Approval status
Active

MFDS item code 202201028 · Approved 2022.03.11 · Insurance code 660703740

Summary

Main use
Effect of blood sugar control and reduction of cardiovascular risk in type 2 diabetes
Who takes it
Adults · Children
Adult dose
The recommended dose of this medication is 10 mg once daily for monotherapy and additional combination therapy. In initial combination therapy with metformin, the dose is 5 mg or 10 mg once daily. There are dose adjustments based on renal impairment, liver impairment, and elderly patients. This medication can be taken orally once a day at any time during the day, regardless of meals, and 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.

Ingredients

Manufacturer
위더스제약(주)

Efficacy & effects

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

  • 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, and can be administered alone or in combination with other medications. It is particularly beneficial for patients whose blood sugar is not adequately controlled, as well as those with cardiovascular disease or risk factors. For detailed information regarding cardiovascular events, please refer to the professional guidance. Thus, this medication is effectively used to improve blood sugar control.

How to take

Adult dose

The recommended dose of this medication is 10 mg once daily for monotherapy and additional combination therapy. In initial combination therapy with metformin, the dose is 5 mg or 10 mg once daily. There are dose adjustments based on renal impairment, liver impairment, and elderly patients. This medication can be taken orally once a day at any time during the day, regardless of meals, and 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.

Precautions

This medication should not be used in certain patients. Patients allergic to the active ingredient or excipients should not take this medication. Additionally, patients with type 1 diabetes or diabetic ketoacidosis should not use this medication. Patients with genetic issues such as lactose intolerance or glucose-galactose malabsorption should also avoid this medication. Dialysis patients should not use this medication. Patients with decreased fluid volume or renal impairment should be administered this medication with caution. Since this medication may cause a decrease in blood pressure or sudden changes in kidney function, fluid status and kidney function must be thoroughly assessed before administration. Particular caution is needed for patients with impaired kidney function, the elderly, or those taking diuretics, as they are at a higher risk of hypotension. When taking this medication, it is important to observe for abnormal reactions such as genital infections, urinary tract infections, hypoglycemia, reduced fluid volume, and diabetic ketoacidosis. Genital infections are particularly common in women, and patients with a history of infection are at higher risk for recurrence. While this medication assists in blood sugar control, its effectiveness may be reduced in patients with severely impaired kidney function. Additionally, when combined with medications such as insulin or sulfonylureas that can cause hypoglycemia, the risk of hypoglycemia may increase, necessitating adjustments in the dosage of these medications. Pregnant or breastfeeding women are advised not to take this medication. If pregnancy is confirmed, this medication should be discontinued immediately, and its use should be avoided during breastfeeding. During the period of taking this medication, it is important to regularly monitor not only blood sugar levels but also fluid status, kidney function, and signs of infection. If unusual symptoms occur, medical consultation should be sought immediately. In case of overdose, there is no specific antidote, so appropriate treatment should be pursued based on symptoms, and hospitalization may be necessary if required. Lastly, the safety and efficacy of this medication in children have not been established, so it should not be used in pediatric patients. Keep this medication out of the reach of children and store it in its original container.

Side effects and when to seek care immediately

Serious side effects

Rash, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain of oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, cough+fever accompanied respiratory distress, skin or eye yellowing (jaundice), severe lethargy, sudden and severe headache, thunderclap headache, seizure, confusion, visual disturbances, paralysis, urination.

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infection, hypoglycemia, dry mouth, dizziness, constipation, back pain, dysuria, polyuria, nocturia, increased hematocrit, initial decrease in renal creatinine clearance, dyslipidemia, initial increase in serum creatinine, elevated blood urea, weight loss, rash, cold sweat, itching, chest pain, weakness, fatigue, pain, edema, foreign body sensation, facial swelling,

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

Storage

This medication may be sensitive to air and moisture, so it must be stored in a tightly sealed container. The recommended storage temperature is room temperature between 1 to 30 degrees Celsius. This will help maintain the effectiveness of the medication for a long time.

Appearance and packaging

Appearance

Yellow, biconvex, diamond-shaped film-coated tablet

Package unit

28 tablets/box [14 tablets/PTP x 2]

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.