Medication info
Podag 10 mg (Dapagliflozin Propanediol Hydrate)

Podag 10 mg (Dapagliflozin Propanediol Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin Propanediol Hydrate›12.3mg / 1 tablet
Manufacturer / importer
이연제약(주)
Appearance
Yellow, convex, diamond-shaped film-coated tablets
Packaging
PTP - 28 tablets/box [28 tablets (7 tablets/PTP x 4)], bottle - 30 tablets/bottle
Approval status
Active

MFDS item code 202202288 · Approved 2022.05.30 · Insurance code 658604760

Summary

Main use
Effectiveness in blood sugar control in type 2 diabetes and reduction of cardiovascular risk
Who takes it
Adults · Children
Adult dose
The recommended dose of this medication is 10 mg once daily. For initial combination therapy, it is 5 mg or 10 mg once daily. It can be taken orally at any time during the day regardless of food consumption, and the tablet should be swallowed whole.
Child dose
The efficacy and safety of Dapagliflozin in pediatric patients under the age of 18 have not been established, and there are no recommendations for administration.

Ingredients

Manufacturer
이연제약(주)

Efficacy & effects

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

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

This medication helps patients with type 2 diabetes more effectively control their blood sugar levels while following diet and exercise regimens. It can be used alone or in combination with other medications and is particularly useful for patients whose blood sugar control is inadequate. Additionally, for patients with cardiovascular disease or risk factors for such disease, this medication may help reduce the occurrence of cardiovascular events, so it should be used safely according to a doctor's instructions. This medication is used to improve blood sugar control in type 2 diabetes.

How to take

Adult dose

The recommended dose of this medication is 10 mg once daily. For initial combination therapy, it is 5 mg or 10 mg once daily. It can be taken orally at any time during the day regardless of food consumption, and the tablet should be swallowed whole.

Child dose

The efficacy and safety of Dapagliflozin in pediatric patients under the age of 18 have not been established, and there are no recommendations for administration.

Precautions

This medication should not be used in patients with an allergy to its active ingredients or additives. It should not be administered to patients with type 1 diabetes or diabetic ketoacidosis. This medication contains lactose; therefore, patients with lactose intolerance, galactose intolerance, lactose deficiency or glucose-galactose malabsorption should not take it. Patients undergoing dialysis should not be administered this medication. It should be used cautiously in patients with decreased fluid volume or impaired kidney function. This medication can lower blood pressure or decrease intravascular volume, potentially causing symptomatic hypotension or acute kidney injury; thus, fluid status and kidney function must be evaluated prior to administration and monitored periodically during treatment. Particularly, elderly patients, those with reduced kidney function, or those on diuretics are at higher risk for hypotension or volume depletion and require careful monitoring. The blood sugar control effect of this medication varies depending on kidney function; therefore, it is advisable not to use it for blood sugar control in patients with severe renal impairment. During the drug treatment, genital infections or urinary tract infections may occur, so immediate treatment should be sought if symptoms of infection arise. Hypoglycemic symptoms may occur, although this is more frequently seen when used in conjunction with insulin or sulfonylureas; thus, dose adjustments may be necessary to mitigate the risk of hypoglycemia when used with these medications. Symptoms of fluid volume depletion or dehydration may arise, so patients with fluid loss, especially due to gastrointestinal disorders, should be closely monitored and may need to temporarily discontinue this medication if necessary. This medication can cause serious metabolic acidosis known as diabetic ketoacidosis; therefore, patients with related symptoms or risk factors should be carefully monitored and treatment should be sought immediately if symptoms are suspected. There is limited experience using this medication in patients with severe hepatic impairment; thus, it should be administered cautiously in patients with liver dysfunction. Elderly patients are at higher risk of reduced kidney function and fluid volume depletion, requiring special caution. Pregnant women should avoid using this medication and should discontinue it immediately if pregnancy is confirmed. Breastfeeding women should also not take this medication, as it may pass into breast milk and affect infants. In cases of overdose, since there is no specific antidote, appropriate treatment according to symptoms should be undertaken and consultation with healthcare providers is recommended if necessary. This medication does not significantly affect the ability to drive or operate machinery, but caution should be exercised regarding hypoglycemia when used in conjunction with insulin or sulfonylureas. Finally, this medication has not been established for safety and efficacy in children, so it is advisable not to use it in this population.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities with cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urinary issues.

Mild side effects

  • Vulvovaginitis
  • balanitis
  • and associated genital infections
  • urinary tract infections
  • fungal infections
  • hypoglycemia
  • dry mouth
  • dizziness
  • constipation
  • back pain
Show 22 more
  • dysuria
  • polyuria
  • nocturia
  • interstitial nephritis
  • elevated hematocrit
  • increased serum creatinine
  • dyslipidemia
  • weight loss
  • rash
  • angioedema
  • chest pain
  • fatigue
  • pain
  • itching
  • urticaria
  • cold sweat
  • vertigo
  • cough
  • dyspnea
  • palpitations
  • insomnia
  • fatty liver.

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture, at a temperature between 1 to 30 degrees Celsius. Storing it this way will help maintain its effectiveness for a longer period.

Appearance and packaging

Appearance

Yellow, convex, diamond-shaped film-coated tablets

Package unit

PTP - 28 tablets/box [28 tablets (7 tablets/PTP x 4)], bottle - 30 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.