Medication info
Pashiga Jeng 10mg (Dapagliflozin Propanediol Hydrate)

Pashiga Jeng 10mg (Dapagliflozin Propanediol Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin Propanediol Hydrate›12.3mg / 1 tablet
Manufacturer / importer
(주)한국파비스제약
Appearance
Yellow, biconvex, rhomboid film-coated tablets
Packaging
28 tablets/box [14 tablets/Alu-Alu*2]
Approval status
Active

MFDS item code 202301304 · Approved 2023.04.21

Summary

Main use
Blood sugar control in type 2 diabetes, reduced cardiovascular risk in chronic heart failure, and inhibition of chronic kidney disease progression
Who takes it
Adults · Children
Adult dose
The recommended dosage for this medication is once daily 10 mg for monotherapy and additional combination therapy with insulin and other hypoglycemic agents. In the case of initial combination therapy with metformin, the initial recommended dose is either 5 mg or 10 mg once daily. The recommended dosage for patients with chronic heart failure and chronic kidney disease is 10 mg once daily. Dose adjustments may be necessary in patients with renal and hepatic impairment.
Child dose
The efficacy and safety of dapagliflozin in pediatric patients under 18 years of age have not been established, and its use is not recommended.

Ingredients

Manufacturer
(주)한국파비스제약

Efficacy & effects

Blood sugar control in type 2 diabetes, reduced cardiovascular risk in chronic heart failure, and inhibition of chronic kidney disease progression

  • Type 2 diabetes
  • blood sugar control disorders
  • cardiovascular diseases
  • cardiovascular risk factors
  • chronic heart failure
  • heart failure
  • chronic kidney disease
  • reduced estimated glomerular filtration rate
  • end-stage renal disease
View approved original text

This medication is used along with dietary and exercise therapy to help control blood sugar levels in patients with type 2 diabetes. It also aids in reducing the occurrence of cardiovascular events in patients at risk of cardiovascular diseases. In patients with chronic heart failure, it is used alongside other treatments to lower the risk of death and hospitalization due to cardiovascular diseases. It is also utilized to decrease the risk of kidney function decline and related risks in patients with chronic kidney disease. This medication is effective in blood sugar control, heart failure management, and kidney protection.

How to take

Adult dose

The recommended dosage for this medication is once daily 10 mg for monotherapy and additional combination therapy with insulin and other hypoglycemic agents. In the case of initial combination therapy with metformin, the initial recommended dose is either 5 mg or 10 mg once daily. The recommended dosage for patients with chronic heart failure and chronic kidney disease is 10 mg once daily. Dose adjustments may be necessary in patients with renal and hepatic impairment.

Child dose

The efficacy and safety of dapagliflozin in pediatric patients under 18 years of age have not been established, and its use is not recommended.

Precautions

This medication should not be used in patients who are allergic to the active ingredient or excipients, in patients with type 1 diabetes, diabetic ketoacidosis patients, patients with lactose intolerance, or patients undergoing dialysis. Caution is required when used in patients with reduced fluid volume or impaired kidney function due to the risk of low blood pressure or kidney damage. This medication may cause side effects such as genital infections, urinary tract infections, hypoglycemia, dehydration, dizziness, constipation, dry mouth, back pain, etc. Especially, genital infections and urinary tract infections may occur more frequently in women and patients with a history of previous infections, hence prompt treatment is required when symptoms arise. In severe cases, serious infections such as perineal necrosis may occur, so immediate medical attention should be sought if pain or swelling occurs around the perineum. Additionally, this medication can cause serious metabolic disturbances known as ketoacidosis, so immediate examination should be undertaken if symptoms like nausea, vomiting, abdominal pain, or difficulty breathing develop. Elderly patients or those taking diuretics face a higher risk of decreased fluid volume and hypotension, requiring closer monitoring. Women who are pregnant or breastfeeding should avoid using this medication, and discontinuation should occur if pregnancy is confirmed. This medication may increase the risk of hypoglycemia when used with insulin or sulfonylureas, requiring possible dosage adjustments of those drugs. In case of overdose, there is no specific antidote, so appropriate treatment should be administered according to symptoms, and rapid consultation with medical personnel is important. During the use of this medication, caution should be exercised for symptoms of hypoglycemia when driving or operating machinery. Finally, the safety and efficacy of this medication in children have not been established, so it should not be used, and it should be kept out of the reach of children.

Side effects and when to seek care immediately

Serious side effects

Perineal necrosis (Fournier's gangrene), reduced fluid volume, diabetic ketoacidosis, acute kidney injury, renal dysfunction, severe swelling, increased blood pressure, severe rash with fever, blisters, peeling skin, pain in oral/ocular mucosa, chest tightness, difficulty breathing, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of the skin or eyes), profound fatigue, sudden and severe headache, thunderclap headache.

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia, dry mouth, dizziness, constipation, back pain, dysuria, polyuria, nocturia, genital itching, increased hematocrit, elevated serum creatinine levels at the beginning of treatment, dyslipidemia, weight loss, rash, angioedema, chest pain, weakness, pain, swelling, foreign body sensation, facial swelling, facial pain, warmth, flu-like symptoms, menstrual irregularities, dermatitis

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. Additionally, it is best stored at room temperature between 1 to 30 degrees Celsius. Caution should be taken as storing the medication in extremely hot or cold places can diminish its effectiveness.

Appearance and packaging

Appearance

Yellow, biconvex, rhomboid film-coated tablets

Package unit

28 tablets/box [14 tablets/Alu-Alu*2]

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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.