Medication info
Dapa Tablet 5mg (Dapagliflozin Citrate)

Dapa Tablet 5mg (Dapagliflozin Citrate)

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin citric acid›7.35mg / 1 tablet
Manufacturer / importer
대원제약(주)
Appearance
Yellow, double-convex, round film-coated tablet
Packaging
28 tablets/box [(14 tablets/PTPX 2)]
Approval status
Active

MFDS item code 202007550 · Approved 2020.11.04 · Insurance code 671807210

Summary

Main use
Control of blood sugar in type 2 diabetes and treatment to reduce cardiovascular risks in chronic heart failure and kidney disease
Who takes it
Adults · Children
Adult dose
The recommended dose of this medication is 10mg once daily for monotherapy and additional combination therapy. In initial combination therapy, the dose is 5mg or 10mg once daily. For patients with chronic heart failure and chronic kidney disease, the dose is 10mg once daily. This medication can be taken orally at any time of the day, regardless of food intake. The tablet should be swallowed whole.
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
대원제약(주)

Efficacy & effects

Control of blood sugar in type 2 diabetes and treatment to reduce cardiovascular risks in chronic heart failure and kidney disease

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

This medication is used in conjunction with dietary and exercise therapy to help control blood sugar in patients with type 2 diabetes. Additionally, in patients with chronic heart failure, it helps reduce the risk of death and hospitalization due to cardiovascular diseases. In chronic kidney disease patients, it is used to lower the risk of worsening kidney function and death from cardiovascular disease. This medication improves overall therapeutic effectiveness when administered in combination with standard treatments for each condition. In summary, this medication is effectively used for managing type 2 diabetes, chronic heart failure, and chronic kidney disease.

How to take

Adult dose

The recommended dose of this medication is 10mg once daily for monotherapy and additional combination therapy. In initial combination therapy, the dose is 5mg or 10mg once daily. For patients with chronic heart failure and chronic kidney disease, the dose is 10mg once daily. This medication can be taken orally at any time of the day, regardless of food intake. The tablet should be swallowed whole.

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 used in patients with allergies to its active ingredients or excipients, type 1 diabetes mellitus, patients with diabetic ketoacidosis, patients with genetic issues such as lactose intolerance or glucose-galactose malabsorption, and patients on dialysis. It should be administered with caution in patients with volume depletion or impaired kidney function. This medication may cause a decrease in blood pressure or abrupt changes in kidney function, so fluid status and kidney function should be carefully monitored and observed before and during administration. The most common side effect while taking this medication is genital infection. Other reported side effects include urinary tract infection, hypoglycemia, volume depletion, dizziness, dry mouth, constipation, and back pain. Hypoglycemia, especially, may occur more frequently if used with insulin or sulfonylureas, so caution is required. This medication may reduce the effectiveness of blood sugar control in patients with decreased kidney function and is not recommended for patients with very low kidney function. Women who are pregnant or breastfeeding are advised not to use this medication, and it should be discontinued immediately upon confirmation of pregnancy. Elderly patients are advised to be particularly cautious when taking this medication due to the higher risk of impaired kidney function and volume depletion. When used with other diuretics, this medication may increase the risk of dehydration and hypotension, so if taken together, careful observation of fluid status is necessary. Additionally, this medication has the action of increasing urination, which may worsen the condition in patients with bladder-related diseases, so caution is needed. Serious metabolic acidosis called ketoacidosis may occur during the use of this medication, so if symptoms such as vomiting, abdominal pain, difficulty breathing, or lethargy occur, immediate consultation with a healthcare professional is advised. This medication may affect the results of certain tests for blood sugar control, so it is advisable to discuss the testing methods with healthcare professionals. There are no specific antidotes for overdose, so appropriate treatment should be administered depending on symptoms while monitoring the patient's progress. Lastly, this medication is not recommended for use in children due to a lack of established safety and efficacy.

Side effects and when to seek care immediately

Serious side effects

  • Severe swelling (edema)
  • cold sweat
  • hives
  • diabetic ketoacidosis
  • volume depletion
  • low blood pressure
  • acute kidney injury
  • renal dysfunction
  • perineal necrosis (Fournier's gangrene)
  • urinary sepsis
Show 14 more
  • pyelonephritis
  • angioedema
  • liver abnormalities (jaundice)
  • sudden and severe headache
  • confusion
  • paralysis
  • vision disturbances
  • seizures
  • markedly reduced urine output
  • increased blood pressure
  • severe edema
  • chest tightness
  • difficulty breathing
  • asthma attack

Mild side effects

  • Vulvovaginal candidiasis
  • balanitis and related genital infections
  • urinary tract infection
  • fungal infection
  • hypoglycemia
  • dry mouth
  • dizziness
  • constipation
  • dry mouth
  • back pain
Show 17 more
  • dysuria
  • polyuria
  • nocturia
  • vulvar itching
  • genital itching
  • increased hematocrit
  • decreased renal creatinine clearance
  • dyslipidemia
  • increased serum creatinine
  • increased blood urea
  • weight loss
  • rash
  • angioedema
  • gastroesophageal reflux disease
  • epigastric pain
  • diverticulitis
  • intestinal perforation

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

Storage

This medication must be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain the storage temperature between 1°C and 30°C. Proper storage will help to maintain the effectiveness of the medication over time.

Appearance and packaging

Appearance

Yellow, double-convex, round film-coated tablet

Package unit

28 tablets/box [(14 tablets/PTPX 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.