Medication info
Dapaenmet Extended-Release Tablet 10/1000 mg (Dapagliflozin, Metformin)

Dapaenmet Extended-Release Tablet 10/1000 mg (Dapagliflozin, Metformin)

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin Anhydrous Lactose Mixture›15.27mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
에이치케이이노엔(주)
Appearance
Yellow, oval-shaped, bilayer, extended-release film-coated tablets
Packaging
30 tablets/box [(6 tablets/PTP*5)], 30 tablets/bottle, 200 tablets/bottle
Approval status
Active

MFDS item code 202300145 · Approved 2023.01.06

Summary

Main use
Effectiveness in controlling blood sugar in type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
This medication is generally taken once daily with the evening meal. The maximum dosage is once daily dapagliflozin 10 mg/extended-release metformin 2000 mg, taken as two tablets of 5 mg/1000 mg. When used as initial therapy, the recommended starting dosage is one tablet of 5 mg/500 mg or 10 mg/500 mg once daily. To reduce gastrointestinal side effects of metformin, dose adjustments should be made gradually.

Ingredients

Manufacturer
에이치케이이노엔(주)

Efficacy & effects

Effectiveness in controlling blood sugar in type 2 diabetes and prevention of cardiovascular events

  • Type 2 diabetes
  • poor blood sugar control
  • cardiovascular disease
  • cardiovascular risk factors
View approved original text

This medication is used to help adults with type 2 diabetes manage their blood sugar levels through the combination of dapagliflozin and metformin. It is administered as an adjunct to diet and exercise regimen and is effective even when blood sugar is not adequately controlled. Additionally, for patients with cardiovascular disease or risk factors, it is necessary to refer to expert clinical trial information regarding the use of this medication. Overall, this drug assists in blood sugar control and cardiovascular health for patients with type 2 diabetes.

How to take

Adult dose

This medication is generally taken once daily with the evening meal. The maximum dosage is once daily dapagliflozin 10 mg/extended-release metformin 2000 mg, taken as two tablets of 5 mg/1000 mg. When used as initial therapy, the recommended starting dosage is one tablet of 5 mg/500 mg or 10 mg/500 mg once daily. To reduce gastrointestinal side effects of metformin, dose adjustments should be made gradually.

Precautions

This medication helps manage blood sugar levels. Before taking it, kidney function must be checked. If renal function is poor, the drug may accumulate in the body, posing risks. It should not be used during acute illnesses such as severe infection, dehydration, heart problems, or acute myocardial infarction. It is not to be administered to pregnant or nursing women. This medication contains lactose, so patients with lactose intolerance should avoid taking it. When taken with insulin or sulfonylureas, the risk of hypoglycemia may increase, necessitating caution. During treatment, genital and urinary tract infections may develop, so immediate treatment is required if symptoms arise. Signs of reduced fluid volume or hypotension may occur, particularly if dehydrated. A rare side effect called lactic acidosis may occur; if symptoms like fatigue, muscle pain, shortness of breath, or abdominal pain arise, consult a physician immediately. Vitamin B12 levels may decrease; thus, regular blood tests are advised during long-term use. Alcohol can increase the risk of side effects, so excessive drinking should be avoided during treatment. Before undergoing surgery or imaging tests with contrast agents, the medication should be discontinued for a period, and it may be restarted once normal kidney function is confirmed. Older adults or those with diminished renal function require dose adjustments and monitoring of kidney function. In case of overdose, seek medical treatment immediately. The safety of this medication has not been established for children, so it should not be used in pediatric populations. Dizziness may occur during treatment, necessitating caution when driving or operating machinery. Keep this medication out of the reach of children and store it in its original container to prevent misuse and degradation of quality.

Side effects and when to seek care immediately

Serious side effects

  • Severe lactic acidosis
  • Severe hypoglycemia
  • Diabetic ketoacidosis
  • Urosepsis and pyelonephritis
  • Acute kidney injury and renal impairment
  • Severe allergic reactions (hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor)
  • Severe skin reactions (severe rash accompanied by fever, blistering, skin peeling, mouth/eye mucosa pain)
  • Respiratory issues (shortness of breath or difficulty breathing, asthma attacks, breathing difficulties associated with coughing and fever)

Mild side effects

  • Vulvovaginitis, balanitis and related genital infections
  • Urinary tract infection
  • Fungal infections
  • Hypoglycemia
  • Decreased fluid volume (dehydration, hypovolemia, hypotension)
  • Dizziness
  • Constipation
  • Dry mouth
  • Lower back pain
  • Dysuria
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  • Polyuria
  • Nocturia
  • Vulvar itching
  • Genital itching
  • Increased hematocrit
  • Decreased renal creatinine clearance in early treatment
  • Dyslipidemia
  • Elevated blood creatinine
  • Elevated blood urea
  • Weight loss
  • Diarrhea
  • Nausea/vomiting
  • Decreased/deficiency in vitamin B12
  • Abdominal pain
  • Digestive discomfort

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

Storage

This medication may be sensitive to air and moisture; therefore, it must be stored in a tightly sealed container. It is important to maintain storage temperatures between 1 to 30 degrees Celsius to preserve the medication's effectiveness and safety.

Appearance and packaging

Appearance

Yellow, oval-shaped, bilayer, extended-release film-coated tablets

Package unit

30 tablets/box [(6 tablets/PTP*5)], 30 tablets/bottle, 200 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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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.