Medication info
Poglizin Tablet 5 mg (Dapagliflozin Propanediol Hydrate)

Poglizin Tablet 5 mg (Dapagliflozin Propanediol Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin Propanediol Hydrate›6.15mg / 1 tablet
Manufacturer / importer
한국프라임제약(주)
Appearance
Yellow, biconvex, round film-coated tablets
Packaging
28 tablets/box [(14 tablets/PTP×2)]
Approval status
Active

MFDS item code 202300407 · Approved 2023.01.31 · Insurance code 663608710

Summary

Main use
Treatment for blood sugar control in type 2 diabetes and reduction of cardiovascular risks in chronic heart failure and kidney disease
Who takes it
Adults · Children
Adult dose
For monotherapy and additional combination therapy in type 2 diabetes: Take 10 mg once daily. For initial combination therapy (when used with metformin): Take either 5 mg or 10 mg once daily. For patients with chronic heart failure and chronic kidney disease: Take 10 mg once daily. For special populations (patients with severe liver impairment): Start with a dosage of 5 mg, and if well tolerated, it can be increased to 10 mg. Administration method:
Child dose
The efficacy and safety of this medication in children under 18 years of age have not been established, so it should not be administered.

Ingredients

Manufacturer
한국프라임제약(주)

Efficacy & effects

Treatment for blood sugar control in type 2 diabetes and reduction of cardiovascular risks in chronic heart failure and kidney disease

  • Type 2 diabetes
  • blood sugar control disorders
  • cardiovascular diseases
  • cardiovascular risk factors
  • chronic heart failure
  • heart failure
  • chronic kidney disease
  • reduced glomerular filtration rate
  • end-stage kidney disease
View approved original text

This medication is used to help control blood sugar in patients with type 2 diabetes, along with diet and exercise. It is also used in patients with chronic heart failure to reduce the risk of death and hospitalization due to cardiovascular disease, in combination with other standard treatments for heart failure. In patients with chronic kidney disease, this medication helps to slow the decline in kidney function and reduce the risk of death related to cardiovascular disease. Thus, this medication is effectively used in the treatment of type 2 diabetes, chronic heart failure, and chronic kidney disease.

How to take

Adult dose

For monotherapy and additional combination therapy in type 2 diabetes: Take 10 mg once daily. For initial combination therapy (when used with metformin): Take either 5 mg or 10 mg once daily. For patients with chronic heart failure and chronic kidney disease: Take 10 mg once daily. For special populations (patients with severe liver impairment): Start with a dosage of 5 mg, and if well tolerated, it can be increased to 10 mg. Administration method:

Child dose

The efficacy and safety of this medication in children under 18 years of age have not been established, so it should not be administered.

Precautions

This medication should not be used in patients who are allergic to the active ingredient or other excipients. It should also not be administered to patients with type 1 diabetes or diabetic ketoacidosis. Patients with lactose intolerance, certain genetic issues, and those undergoing dialysis should also refrain from using this medication. It should be used cautiously in patients with low fluid volume or poor kidney function. This medication may cause side effects such as low blood pressure or changes in kidney function, so these patients should be carefully monitored before and after administration. In patients with significantly impaired kidney function, blood sugar control effectiveness may decrease, necessitating careful attention. Side effects like genital infections, urinary tract infections, hypoglycemia, reduced fluid volume, and diabetic ketoacidosis may occur when taking this medication. Especially women, or patients with a history of previous infections, are at higher risk of infections. There may be a risk of hypoglycemia, so dose adjustments may be needed when used with insulin or sulfonylureas. Pregnant or breastfeeding women are advised not to use this medication, and it should be discontinued immediately if pregnancy is confirmed. Elderly patients or those taking multiple medications should be cautious regarding drug interactions and changes in kidney function. This medication can increase urine output, potentially causing reduced fluid volume or low blood pressure, so fluid status should be checked frequently. In case of overdose, there is no specific antidote, and appropriate treatment should be provided based on symptoms. Finally, during the course of taking this medication, blood sugar and ketone levels should be monitored regularly, and any unusual symptoms should lead to immediate consultation with a healthcare professional.

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, pain of oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, abnormal respiratory symptoms accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

  • Vulvovaginitis
  • balanitis and related genital infections
  • urinary tract infections
  • fungal infections
  • hypoglycemia
  • thirst
  • dizziness
  • constipation
  • dry mouth
  • back pain
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  • dysuria
  • polyuria
  • nocturia
  • interstitial nephritis
  • increased hematocrit
  • elevated blood creatinine
  • increased blood urea
  • weight loss
  • rash
  • angioedema
  • chest pain
  • asthenia
  • pain
  • edema
  • foreign body sensation
  • facial edema
  • facial pain
  • warmth
  • flu-like symptoms
  • menstrual irregularities
  • genital edema

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is recommended to maintain a storage temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the drug's effectiveness and safety.

Appearance and packaging

Appearance

Yellow, biconvex, round film-coated tablets

Package unit

28 tablets/box [(14 tablets/PTP×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.