Medication info
Dapagren Tablets 10 Milligrams (Dapagliflozin Propanediol Hydrate)

Dapagren Tablets 10 Milligrams (Dapagliflozin Propanediol Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin Propanediol Hydrate›12.3mg / 1 tablet
Manufacturer / importer
진양제약(주)
Appearance
Yellow diamond-shaped film-coated tablets
Packaging
Box - 28 tablets/box [(14 tablets/PTP (Alu-Alu) x 2)], Bottle - 30 tablets/bottle, Bottle - 300 tablets/bottle
Approval status
Active

MFDS item code 202300420 · Approved 2023.01.31 · Insurance code 650304460

Summary

Main use
Blood sugar control in type 2 diabetes and inhibition of progression of chronic kidney disease
Who takes it
Adults · Children
Adult dose
The recommended dosage for this medication is 10 mg once daily for monotherapy and additional combination therapy. In initial combination therapy, if there is no prior experience of diabetes medication, 5 mg once daily or 10 mg once daily is administered. For patients with chronic kidney disease, 10 mg once daily is also recommended. Patients with mild to moderate liver impairment do not require dosage adjustment, and patients with severe liver impairment are recommended to start with a dose of 5 mg.
Child dose
The efficacy and safety of this medication in children under 18 years of age have not been established, and it should not be used.

Ingredients

Manufacturer
진양제약(주)

Efficacy & effects

Blood sugar control in type 2 diabetes and inhibition of progression of chronic kidney disease

  • Type 2 diabetes
  • abnormal blood sugar control
  • cardiovascular disease
  • cardiovascular risk factors
  • chronic kidney disease
  • decreased estimated glomerular filtration rate
  • end-stage kidney disease
  • cardiovascular disease
  • risk of renal-related mortality
View approved original text

This medication is used as an adjunct to diet and exercise in the management of blood sugar levels in patients with type 2 diabetes. It should be used with caution in patients with cardiovascular diseases or risk factors. Furthermore, it helps reduce the risk associated with renal function decline in patients with chronic kidney disease and decreases the risk of cardiovascular disease and renal-related mortality. Therefore, this medication is effectively used in the treatment of both type 2 diabetes and chronic kidney disease.

How to take

Adult dose

The recommended dosage for this medication is 10 mg once daily for monotherapy and additional combination therapy. In initial combination therapy, if there is no prior experience of diabetes medication, 5 mg once daily or 10 mg once daily is administered. For patients with chronic kidney disease, 10 mg once daily is also recommended. Patients with mild to moderate liver impairment do not require dosage adjustment, and patients with severe liver impairment are recommended to start with a dose of 5 mg.

Child dose

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

Precautions

This medication should not be administered to certain patients. For example, patients with allergies to the active ingredient or additives of this medication, patients with type 1 diabetes, patients with diabetic ketoacidosis, and those with lactose intolerance or related genetic problems should not take this medication. Patients undergoing dialysis should also avoid using this medication. Patients with reduced fluid volume or kidney function issues should use this medication with caution. This medication can cause hypotension and worsen kidney function, so fluid status and kidney function should be monitored carefully before administration and continuously during treatment. Special care should be taken for the elderly or patients on diuretics as they have a higher risk of hypotension. During use of this medication, side effects such as genital infections, urinary tract infections, hypoglycemia, reduced fluid volume, and diabetic ketoacidosis may occur. Genital infections and urinary tract infections may be more common in women and patients with a history of previous infections; immediate treatment should be sought if symptoms develop. Hypoglycemia may occur more frequently when taken with medications like insulin or sulfonylureas, so dosage adjustments for these medications may be necessary. Additionally, this medication may have weight loss effects, and in rare cases, serious infections such as severe perineal necrosis may occur, so if any pain, swelling, or redness appears around the genital area, medical consultation should be sought immediately. Pregnant women should not use this medication, and if pregnancy is confirmed, administration should be stopped. It is also recommended that breastfeeding women do not take this medication. This medication can interact with other drugs, so especially when taken with diuretics, insulin, or sulfonylureas, discussions with healthcare professionals regarding appropriate dosage adjustments are necessary. Lastly, glucose may be detected in urine tests while on this medication, so this should be noted when interpreting test results. There is no special caution needed while driving or operating machinery, but awareness of hypoglycemic symptoms is essential.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, desquamation, pain in mucous membranes of mouth/eyes, difficulty breathing or breathlessness, asthma attacks, coughing with fever-related breathing difficulties, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, lightning-like headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination

Mild side effects

  • Vulvovaginal candidiasis
  • balanitis and related genital infections
  • urinary tract infections
  • fungal infections
  • hypoglycemia
  • dry mouth
  • dizziness
  • constipation
  • oral dryness
  • lower back pain
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  • dysuria
  • polyuria
  • nocturia
  • increased serum creatinine
  • dyslipidemia
  • weight loss
  • pruritus
  • urticaria
  • sweating
  • indigestion
  • nausea
  • diarrhea
  • vomiting
  • weakness
  • hunger
  • vaginal discharge
  • headache
  • chest pain
  • swelling
  • foreign body sensation
  • facial swelling
  • facial pain
  • warmth
  • flu-like symptoms

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 advisable to keep the storage temperature between 1 degree and 30 degrees Celsius at room temperature. This will help to safely maintain the medication's effectiveness.

Appearance and packaging

Appearance

Yellow diamond-shaped film-coated tablets

Package unit

Box - 28 tablets/box [(14 tablets/PTP (Alu-Alu) x 2)], Bottle - 30 tablets/bottle, Bottle - 300 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.