Medication info
Poshuvet Tablet 5 mg (Dapagliflozin Propanediol Monohydrate)

Poshuvet Tablet 5 mg (Dapagliflozin Propanediol Monohydrate)

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin Propanediol Hydrate›6.15mg / 1 tablet
Manufacturer / importer
주식회사제뉴원사이언스
Appearance
Yellow, double convex, round film-coated tablet
Packaging
28 tablets (14 tablets/PTP × 2)
Approval status
Active

MFDS item code 202204690 · Approved 2022.12.29 · Insurance code 671707230

Summary

Main use
Treatment to control blood sugar in type 2 diabetes and reduce cardiovascular risks in chronic heart failure and kidney disease
Who takes it
Adults · Children
Adult dose
The recommended dosage of this medication is 10 mg once daily for both monotherapy and adjunct therapy. In initial combination therapy, it can be administered at 5 mg or 10 mg once daily with metformin. For patients with chronic heart failure and chronic kidney disease, 10 mg once daily is recommended. For patients with severe hepatic impairment, the starting dose is 5 mg, which may be increased to 10 mg if well tolerated. The method of administration is
Child dose
The efficacy and safety of dapagliflozin for children under 18 years of age have not been established; therefore, it is not administered.

Ingredients

Manufacturer
주식회사제뉴원사이언스

Efficacy & effects

Treatment to control blood sugar in type 2 diabetes and reduce cardiovascular risks in chronic heart failure and kidney disease

  • Type 2 diabetes
  • poor blood sugar control
  • chronic heart failure
  • cardiovascular disease
  • chronic kidney disease
  • estimated glomerular filtration rate reduction
  • end-stage kidney disease
View approved original text

This medication is used to help control blood sugar in patients with type 2 diabetes. Additionally, it contributes to maintaining health by reducing the risk of death and hospitalization in patients with chronic heart failure. In patients with chronic kidney disease, it helps reduce the risks associated with declining kidney function. This medication is used in conjunction with other standard treatment methods for each condition to enhance therapeutic effects. Overall, it is an effective drug for blood sugar management and improvement of cardiovascular and kidney health.

How to take

Adult dose

The recommended dosage of this medication is 10 mg once daily for both monotherapy and adjunct therapy. In initial combination therapy, it can be administered at 5 mg or 10 mg once daily with metformin. For patients with chronic heart failure and chronic kidney disease, 10 mg once daily is recommended. For patients with severe hepatic impairment, the starting dose is 5 mg, which may be increased to 10 mg if well tolerated. The method of administration is

Child dose

The efficacy and safety of dapagliflozin for children under 18 years of age have not been established; therefore, it is not administered.

Precautions

This medication should not be used by individuals with allergies to this medication's active ingredients or additives. Patients with type 1 diabetes or diabetic ketoacidosis should also not use this medicament. Patients with genetic lactose intolerance, such as galactose intolerance or Lapp lactase deficiency, and glucose-galactose malabsorption should not take this medication. Patients on dialysis should not use this medication. Caution should be exercised when using this medication in patients with reduced fluid volume or poor kidney function. This medication may lower blood pressure or reduce blood volume; thus, symptomatic hypotension or changes in kidney function may occur, requiring careful monitoring of fluid volume and kidney function before and during administration. Particularly, in patients with moderate to severe reduction in kidney function, blood sugar control effectiveness may decrease, and it is not recommended for patients with very low kidney function. While taking this medication, genital infections or urinary tract infections may occur; thus, immediate treatment should be sought if symptoms arise. When used with drugs that pose a risk of hypoglycemia, hypoglycemic symptoms may occur, necessitating adjustments to the doses of insulin or sulfonylureas. If symptoms of dehydration or hypotension occur due to reduced fluid volume, consultation with healthcare providers is necessary, and the use of this medication may need to be temporarily discontinued if necessary. This medication can cause a serious metabolic disturbance known as diabetic ketoacidosis; seek medical attention immediately if symptoms such as nausea, vomiting, abdominal pain, or difficulty breathing occur. Women who are pregnant or breastfeeding are advised not to use this medication, and if pregnancy is confirmed, administration should be stopped. Elderly patients or patients with reduced kidney function require special caution and should undergo regular kidney function testing during the use of this medication. This medication does not significantly impair the ability to operate vehicles or machinery, but caution is needed when taken with medications that pose a risk of hypoglycemia. Finally, this medication should be kept out of reach of children and stored in its original container to maintain quality.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria, severe swelling (edema), diaphoresis,
  • chest tightness,
  • difficulty breathing,
  • profound lethargy,
  • sudden and severe headache,
  • confusion,
  • paralysis,
  • generalized severe edema associated with elevated blood pressure,
  • diabetic ketoacidosis,
  • acute kidney injury,
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  • perineal necrosis (Fournier's gangrene),
  • urosepsis and pyelonephritis,
  • anaphylaxis,
  • severe skin reactions (severe rash with fever, blisters, peeling skin, mucosal pain in mouth/eyes)

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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  • urinary pain
  • polyuria
  • nocturia
  • interstitial nephritis
  • increased hematocrit
  • elevated blood creatinine
  • elevated blood urea
  • weight loss
  • dysesthesia
  • headache
  • dyspepsia
  • nausea
  • diarrhea
  • vomiting
  • asthenia
  • hunger
  • pruritus
  • urticaria
  • diaphoresis
  • arthralgia
  • musculoskeletal pain
  • limb pain

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture and kept at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the medication's efficacy over time.

Appearance and packaging

Appearance

Yellow, double convex, round film-coated tablet

Package unit

28 tablets (14 tablets/PTP × 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

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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.