Medication info
Posiro 5 mg (Dapagliflozin Propanediol Hydrate)

Posiro 5 mg (Dapagliflozin Propanediol Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin Propanediol Hydrate›6.15mg / 1 tablet
Manufacturer / importer
(주)대웅제약
Appearance
Yellow round film-coated tablet
Packaging
28 tablets/box[(7 tablets/Alu-Alu*4)], 30 tablets/bottle, 28 tablets/bottle
Approval status
Active

MFDS item code 202200919 · Approved 2022.03.03 · Insurance code 641607920

Summary

Main use
Control of blood sugar in type 2 diabetes and treatment for reducing cardiovascular risks of chronic heart failure and kidney disease
Who takes it
Adults · Children
Adult dose
This drug can be taken orally once daily at any time of day, regardless of food intake. The tablet must be swallowed whole.
Child dose
The efficacy and safety of dapagliflozin in children under 18 years have not been established. There is no relevant data.

Ingredients

Manufacturer
(주)대웅제약

Efficacy & effects

Control of blood sugar in type 2 diabetes and treatment for reducing cardiovascular risks of chronic heart failure and kidney disease

  • Type 2 diabetes
  • impaired blood sugar control
  • chronic heart failure
  • chronic kidney disease
  • estimated decreased glomerular filtration rate
  • end-stage kidney disease
  • cardiovascular diseases
View approved original text

This drug is used as an adjunct to help control blood sugar in patients with type 2 diabetes. Additionally, in patients with chronic heart failure, it is administered with other treatments to reduce the risk of death and hospitalization due to cardiovascular diseases. In patients with chronic kidney disease, this drug helps slow the decline in kidney function and reduces the risk of cardiovascular and kidney-related mortality. Thus, this drug plays an important role not only in blood sugar control but also in preventing complications related to heart failure and kidney disease. Therefore, it is used in the treatment of type 2 diabetes, chronic heart failure, and chronic kidney disease.

How to take

Adult dose

This drug can be taken orally once daily at any time of day, regardless of food intake. The tablet must be swallowed whole.

Child dose

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

Precautions

This drug should not be used in patients who are allergic to the active ingredient or excipients. It is also not safe for patients with type 1 diabetes, diabetic ketoacidosis, or those on dialysis. Patients with decreased fluid volume or renal impairment should use this drug with caution, and blood pressure and renal function should be closely monitored before and during treatment. This drug may lower blood pressure and cause decreased body fluid volume, which can lead to symptomatic hypotension or worsening of renal function. In patients with moderate renal impairment, the blood sugar control effect may be reduced, thus it is not recommended for patients with significantly impaired renal function. Taking this drug may lead to various side effects such as genital infections, urinary tract infections, hypoglycemia, decreased body fluid volume, and ketoacidosis, so if any unusual symptoms occur, immediate consultation with a physician is required. Genital infections are more common in women and have a higher chance of recurrence in patients with a history of prior infections. The risk of hypoglycemia is higher when this drug is used with insulin or sulfonylureas, and dosage adjustments may be necessary in such cases. In cases of severe fluid volume reduction, dehydration or hypotensive symptoms may occur, so careful monitoring of the patient's condition and adequate fluid intake are necessary. Diabetic ketoacidosis can occur even when blood sugar levels are not high, so if symptoms such as vomiting, abdominal pain, fatigue, or difficulty breathing occur, immediate medical attention should be sought. This drug has limited experience in use among patients with severe hepatic impairment, so caution is warranted, and elderly patients or those taking diuretics are at higher risk of fluid volume reduction and require more careful monitoring. Furthermore, while taking this drug, glucose may be detected in urine tests, so this should be noted. It is recommended that pregnant or breastfeeding women do not use this drug, and if pregnancy is confirmed, use should be discontinued immediately. There is no specific antidote for overdose, so appropriate treatment based on symptoms is crucial. This drug does not significantly affect driving or operating machinery, but caution should be exercised for the risk of hypoglycemia when used in combination with insulin or sulfonylureas. Finally, it is important to store this drug out of the reach of children and in its original container to maintain product quality.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with high fever, blisters, peeling skin, mucosal pain in mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, cough with fever accompanied respiratory abnormalities, yellowing of the skin or eyes (jaundice), extreme tiredness throughout the body, sudden severe headache, thunderclap headache, seizures, consciousness confusion, visual disturbances, paralysis, urination

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia, dry mouth, dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, elevated hematocrit, increased serum creatinine, reduced initial renal creatinine clearance, dyslipidemia, weight loss, hives, sweating, itching, dyspepsia, nausea, diarrhea, vomiting, headache, chest pain, fatigue, pain, edema, foreign body sensation

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

Storage

This drug may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is also best to store the drug at room temperature between 1 and 30 degrees Celsius, avoiding excessively hot or cold places.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

28 tablets/box[(7 tablets/Alu-Alu*4)], 30 tablets/bottle, 28 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.