Medication info
Newpham Dapagliflozin 10mg (Dapagliflozin Propanediol Hydrate)

Newpham Dapagliflozin 10mg (Dapagliflozin Propanediol Hydrate)

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

MFDS item code 202202179 · Approved 2022.05.23 · Insurance code 053601720

Summary

Main use
Blood sugar control for type 2 diabetes and reduction of cardiovascular risk
Who takes it
Adults · Children
Adult dose
The recommended dose of this medication is 10mg once daily for both monotherapy and additional combination therapy. In the case of initial combination therapy, the dosage may be 5mg once daily or 10mg once daily. This medication can be taken orally at any time of the day, independent of meals. Tablets should be swallowed whole.
Child dose
The efficacy and safety of dapagliflozin in pediatric patients under 18 years of age have not been established. No related data are available.

Ingredients

Manufacturer
안국뉴팜(주)

Efficacy & effects

Blood sugar control for type 2 diabetes and reduction of cardiovascular risk

  • Type 2 diabetes
  • abnormal blood sugar control
  • cardiovascular diseases
  • cardiovascular risk factors
View approved original text

This medication is used to assist in blood sugar control for patients with type 2 diabetes. It can be administered alone or in combination with other medications along with dietary and exercise therapies. Patients, especially those with cardiovascular diseases or risk factors, should ensure to check for any cardiovascular event warnings. Overall, this medication is effective in improving blood sugar control for type 2 diabetes.

How to take

Adult dose

The recommended dose of this medication is 10mg once daily for both monotherapy and additional combination therapy. In the case of initial combination therapy, the dosage may be 5mg once daily or 10mg once daily. This medication can be taken orally at any time of the day, independent of meals. Tablets should be swallowed whole.

Child dose

The efficacy and safety of dapagliflozin in pediatric patients under 18 years of age have not been established. No related data are available.

Precautions

This medication should not be administered to those with allergies to the active ingredient or excipients, patients with type 1 diabetes, diabetic ketoacidosis, or genetic disorders such as lactose intolerance. Patients undergoing dialysis should not use this medication. Patients with low fluid volume or kidney function issues should use this medication with caution and blood pressure and kidney function should be carefully monitored before and after dosage. Particularly in elderly patients or those taking diuretics, there is a heightened risk of hypotension or reduced blood volume, thus caution is warranted. This medication may cause side effects such as genital infections, urinary tract infections, hypoglycemia, reduced fluid volume, diabetic ketoacidosis, etc., so it is essential to consult a healthcare professional immediately if symptoms occur. Patients with poor liver function should also exercise caution when using this medication, and those with low blood pressure or at risk of reduced fluid volumes require closer monitoring. Pregnant women are advised not to use this medication, and breastfeeding women should also avoid taking this medication. When used together with insulin or sulfonylureas, the risk of hypoglycemia is increased, so dosage adjustments of these medications may be necessary. In case of overdose, there is no specific antidote available, so treatment should be symptomatic. Finally, caution is advised during driving or operating machinery while on this medication, and it should be stored out of reach of children.

Side effects and when to seek care immediately

Serious side effects

  • Rash, severe swelling (edema), chest tightness, difficulty breathing, cold sweat → severe allergic reaction
  • Severe rash with high fever, blisters, peeling skin, pain in oral/ocular mucosa → severe skin adverse reaction
  • Shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough and fever → respiratory problems
  • Yellowing of skin or eyes (jaundice), extreme lethargy → liver issues (jaundice)
  • Sudden and extremely severe...

Mild side effects

Vulvitis, balanitis and related genital infections, urinary tract infections, hypoglycemia, dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, increased hematocrit, decreased renal creatinine clearance at the beginning of treatment, dyslipidemia, elevated serum creatinine at the start of treatment, increased urea in the blood, weight loss, reduced fluid volume, dry mouth, rash, cold sweat, itching, chest pain, weakness, fatigue, pain, swelling, foreign body sensation

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 degree and 30 degrees Celsius. This will help preserve the efficacy of the medication for a longer period.

Appearance and packaging

Appearance

Yellow, double-convex, diamond-shaped film-coated tablets

Package unit

PTP - 28 tablets/box [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.