Medication info

DapaRin Tablets 5mg (Dapagliflozin Propanediol Hydrate)

Prescription medicationTablet경구Approval revoked
Ingredient · strength
Dapagliflozin Propanediol Hydrate›6.15mg / 1 tablet
Manufacturer / importer
일성아이에스(주)
Appearance
Yellow round film-coated tablet
Packaging
Bottle - 28 tablets/bottle, Bottle - 30 tablets/bottle, Box - 28 tablets/box [(7 tablets/Alu-Alu × 4)]
Approval status
Approval revoked

MFDS item code 202200885 · Approved 2022.02.28

This product's status changed to Approval revoked on 2024.04.09. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Effect of blood sugar control and prevention of cardiovascular events in type 2 diabetes
Who takes it
Adults · Children
Adult dose
The recommended dosage for this medication as a monotherapy and as an additional combination therapy with other hypoglycemic agents such as insulin is 10 mg once daily. In the case of initial combination therapy with metformin, the initial recommended dose is 5 mg once daily or 10 mg once daily. This medication can be taken orally at any time during the day, regardless of meals. 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. No relevant data are available.

Ingredients

Manufacturer
일성아이에스(주)

Efficacy & effects

Effect of blood sugar control and prevention of cardiovascular events in type 2 diabetes

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

This medication is used alone or in combination with diet and exercise therapy to help control blood sugar levels in patients with type 2 diabetes. It can also be administered to patients with type 2 diabetes who have cardiovascular disease or risk factors and whose blood sugar control is insufficient. By stably managing blood sugar through treatment, it helps prevent complications of diabetes and improves overall blood sugar control.

How to take

Adult dose

The recommended dosage for this medication as a monotherapy and as an additional combination therapy with other hypoglycemic agents such as insulin is 10 mg once daily. In the case of initial combination therapy with metformin, the initial recommended dose is 5 mg once daily or 10 mg once daily. This medication can be taken orally at any time during the day, regardless of meals. 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. No relevant data are available.

Precautions

This medication should not be used in patients with allergies to the main ingredient or excipients, type 1 diabetes patients, patients with diabetic ketoacidosis, and those undergoing dialysis. Caution should be exercised when administering this medication to patients with low fluid volume or poor kidney function. This medication can lower blood pressure and affect kidney function, so the fluid status and kidney function should be thoroughly checked before and after administration. The blood sugar control effect of this medication may vary depending on kidney function, and it is not recommended for patients with severely reduced kidney function. While taking this medication, symptoms such as genital infections, urinary tract infections, hypoglycemia, decreased fluid volume, and diabetic ketoacidosis may occur, so attention should be paid to symptoms. Particularly, genital infections may occur more commonly in women, and immediate treatment should be sought when infection symptoms appear. Due to the risk of hypoglycemia, dose adjustments may be necessary when taken with medications such as insulin or sulfonylureas. If signs of reduced fluid volume or hypotension appear, administration of this medication should be temporarily discontinued and the condition observed. Diabetic ketoacidosis can occur even if blood glucose levels are not high, so immediate hospitalization is required if symptoms of ketoacidosis such as vomiting, abdominal pain, or respiratory distress occur. This medication is not recommended for use in patients with severely impaired liver function, pregnant women, or breastfeeding women. Additionally, special caution is needed when prescribing this medication to the elderly or patients with reduced kidney function. This medication may interact with other drugs, so it is essential to consult with a doctor or pharmacist if any other medications are being taken. There are no specific antidotes for overdose; thus, treatment should be symptomatic. Finally, while taking this medication, be cautious of hypoglycemic symptoms when driving or operating machinery, and keep it out of reach of children.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities with cough+fever, yellowing of skin or eyes (jaundice), severe lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urination changes.

Mild side effects

Vulvitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia, dry mouth, dizziness, constipation, back pain, dysuria, polyuria, nocturia, increased hematocrit, initial treatment reduction in renal creatinine clearance, dyslipidemia, increased blood creatinine, increased blood urea, weight loss, rash, gastrointestinal disturbances (dyspepsia, nausea, diarrhea, vomiting), vaginal discharge, itching, urticaria, taste.

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

Storage

This medication can be sensitive to air or moisture, so it must be stored in a tightly sealed container. It is best to maintain room temperature between 1 degree and 30 degrees. This will help maintain the efficacy of the medication and prevent deterioration.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

Bottle - 28 tablets/bottle, Bottle - 30 tablets/bottle, Box - 28 tablets/box [(7 tablets/Alu-Alu × 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.