Medication info
Diphyton 10 mg (Dapagliflozin Propanediol Hydrate)

Diphyton 10 mg (Dapagliflozin Propanediol Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin Propanediol Hydrate›12.3mg / 1 tablet
Manufacturer / importer
(주)다림바이오텍
Appearance
Yellow, biconvex, diamond-shaped film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle, 28 tablets/box[((7 tablets/Alu-Alu)×4)]
Approval status
Active

MFDS item code 202300038 · Approved 2023.01.04 · Insurance code 664602780

Summary

Main use
Treatment for glycemic control in type 2 diabetes and reduction of cardiovascular risk in chronic heart failure and kidney disease
Who takes it
Adults · Children
Adult dose
The recommended dosage of this medication for monotherapy and as an add-on therapy with other antidiabetic agents such as insulin is 10 mg once daily. If there is no prior experience with antidiabetic medication, when used in combination with metformin, the initial dosage is either 5 mg once daily or 10 mg once daily. For patients with chronic heart failure and chronic kidney disease, the dosage is 10 mg once daily. Dosage adjustments may be made for renal impairment, liver impairment, and the elderly.
Child dose
The efficacy and safety of dapagliflozin in children under 18 years of age have not been established. There is no relevant data.

Ingredients

Manufacturer
(주)다림바이오텍

Efficacy & effects

Treatment for glycemic control in type 2 diabetes and reduction of cardiovascular risk in chronic heart failure and kidney disease

  • Type 2 diabetes
  • abnormal blood sugar control
  • 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 in conjunction with dietary and exercise therapies to help control blood sugar in patients with type 2 diabetes. It also helps reduce the risk of death and hospitalization from cardiovascular disease in patients with chronic heart failure. In patients with chronic kidney disease, it is effective in reducing the risk of kidney function decline and death from cardiovascular disease. This medication is used alongside other standard treatments for each condition to enhance therapeutic effect. Overall, it is beneficial in the treatment of diabetes, chronic heart failure, and chronic kidney disease.

How to take

Adult dose

The recommended dosage of this medication for monotherapy and as an add-on therapy with other antidiabetic agents such as insulin is 10 mg once daily. If there is no prior experience with antidiabetic medication, when used in combination with metformin, the initial dosage is either 5 mg once daily or 10 mg once daily. For patients with chronic heart failure and chronic kidney disease, the dosage is 10 mg once daily. Dosage adjustments may be made for renal impairment, liver impairment, and the elderly.

Child dose

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

Precautions

This medication should not be administered to certain patients. People with allergies to the active ingredients or excipients of this medication, type 1 diabetes patients, patients with diabetic ketoacidosis, individuals with genetic lactose intolerance, and patients undergoing dialysis should not use this medication. Caution should be exercised in patients with decreased fluid volume or impaired kidney function. In particular, patients with significantly impaired kidney function, the elderly, and those taking diuretics may be at increased risk for hypotension or kidney damage, so their condition should be closely monitored before and during administration. This medication may increase the risk of genital and urinary tract infections, so if symptoms of such infections appear, medical personnel should be informed immediately. When used with insulin or sulfonylureas that have a risk of hypoglycemia, hypoglycemic symptoms should be closely monitored, and if necessary, the dose of such medications should be adjusted. Due to the potential for dehydration or hypotension from decreased fluid volume, particularly elderly patients or those taking antihypertensive medications should regularly check their blood pressure and fluid status. This medication can cause a serious metabolic disorder known as diabetic ketoacidosis, so if symptoms such as vomiting, abdominal pain, or difficulty breathing occur, immediate medical care should be sought. Pregnant or breastfeeding women are advised not to use this medication, and if pregnancy is confirmed, administration should be immediately discontinued. In children, the safety and efficacy of dapagliflozin have not been sufficiently established, so it is not used. In case of overdose, there are no specific antidotes, but appropriate treatment is needed based on symptoms, and rapid treatment should be administered for dehydration or hypotension. Finally, this medication should be stored out of the reach of children and maintained in its original container to preserve quality.

Side effects and when to seek care immediately

Serious side effects

Rash, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, peeling skin, pain in mouth/eyes mucosa, shortness of breath or difficulty breathing, asthma attacks, cough accompanied by fever, respiratory abnormalities, jaundice (yellowing of the skin or eyes), severe lethargy, sudden and severe headache, lightning 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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  • pain during urination
  • polyuria
  • nocturia
  • elevated hematocrit
  • initial elevated serum creatinine
  • increased blood urea
  • weight loss
  • rash
  • itching
  • cold sweat
  • weakness
  • chest pain
  • fatigue
  • pain
  • peripheral edema
  • generalized edema
  • hunger
  • vaginal discharge
  • menstrual irregularities
  • hair loss
  • dermatitis
  • skin

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a sealed container. Additionally, to maintain the drug's effectiveness, it is important to store it at a cool room temperature, specifically between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow, biconvex, diamond-shaped film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle, 28 tablets/box[((7 tablets/Alu-Alu)×4)]

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.