Medication info
Dapljin Met Extended-release Tablet 10/1000 mg

Dapljin Met Extended-release Tablet 10/1000 mg

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin Propanediol Hydrate›12.3mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
동국제약(주)
Appearance
Yellow, oval, double convex extended-release film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202300353 · Approved 2023.01.27 · Insurance code 653405290

Summary

Main use
Blood sugar control in type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
This medication is typically administered once daily with the evening meal. The maximum dosage is 10 mg of dapagliflozin and 2000 mg of extended-release metformin once daily, administered as two tablets of 5 mg/1000 mg. In cases where there is no previous experience with diabetes drug therapy, the initial regimen should be 5 mg/500 mg or 10 mg/500 mg once daily. To reduce gastrointestinal side effects of metformin, the dosage should be increased gradually.

Ingredients

Manufacturer
동국제약(주)

Efficacy & effects

Blood sugar control in type 2 diabetes and prevention of cardiovascular events

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

This medication is used in combination with dapagliflozin and metformin as an adjunct to dietary and exercise therapy to help control blood sugar levels in adults with type 2 diabetes. In particular, in patients with type 2 diabetes who have poor blood sugar control and have cardiovascular disease or risk factors, further information from a specialist regarding the impact of dapagliflozin on cardiovascular events should be referred to. This medication is used to improve blood sugar control in patients with type 2 diabetes.

How to take

Adult dose

This medication is typically administered once daily with the evening meal. The maximum dosage is 10 mg of dapagliflozin and 2000 mg of extended-release metformin once daily, administered as two tablets of 5 mg/1000 mg. In cases where there is no previous experience with diabetes drug therapy, the initial regimen should be 5 mg/500 mg or 10 mg/500 mg once daily. To reduce gastrointestinal side effects of metformin, the dosage should be increased gradually.

Precautions

This medication can rarely cause a serious condition known as lactic acidosis; therefore, if any unusual symptoms occur during treatment, consult a physician immediately. There is a risk of hypoglycemia when this medication is used with other diabetes treatments, so caution is required. Patients with poor kidney function, dehydration, severe infections, acute myocardial infarction, or any condition that may affect kidney function should not take this medication. Pregnant or breastfeeding women should not use this medication, and patients with genetic issues such as lactose intolerance should also avoid it. This medication should be administered cautiously to patients with decreased fluid volume or impaired kidney function, and renal function and blood pressure should be regularly monitored before and during treatment. Adverse reactions such as genital infections, urinary tract infections, hypoglycemia, reduced fluid volume, ketoacidosis, and others may occur, so symptoms should be reported to a physician immediately. Vitamin B12 levels may decrease, so regular blood tests are recommended if used for an extended period. Alcohol consumption may increase the risk of adverse reactions from this medication, so avoid excessive drinking during treatment. This medication may interact with other drugs; therefore, inform your physician or pharmacist about any other medications you are taking. Elderly patients often have decreased kidney function, so careful dose adjustment and regular monitoring of kidney function are needed while using this medication. In the case of overdose, seek immediate medical attention; dialysis treatment may be required as necessary. This medication does not significantly affect driving or operating machinery, but caution is necessary as dizziness may occur. Always keep this medication out of reach of children and store it in its original container to maintain quality.

Side effects and when to seek care immediately

Serious side effects

  • Lactic acidosis
  • Ketoacidosis
  • Urosepsis and pyelonephritis
  • Acute renal injury and kidney dysfunction
  • Severe allergic reactions (hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor)
  • Severe skin reactions (severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa)
  • Respiratory issues (difficulty breathing, asthma attack, respiratory issues accompanied by cough and fever)
  • Liver abnormalities (jaundice) (skin

Mild side effects

  • Vulvovaginitis, balanitis, and associated genital infections
  • Urinary tract infection
  • Hypoglycemia
  • Reduced fluid volume (dehydration, hypovolemia, hypotension)
  • Dizziness
  • Constipation
  • Dry mouth
  • Lumbago
  • Polyuria
  • Nocturia
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  • Vulvar pruritus
  • Genital pruritus
  • Increased hematocrit
  • Decreased renal creatinine clearance at the start of treatment
  • Dyslipidemia
  • Increased serum creatinine
  • Increased blood urea
  • Weight loss
  • Decreased/deficiency of vitamin B12
  • Upper abdominal pain, dyspepsia, abdominal discomfort, diarrhea, abdominal pain

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. Additionally, it is advisable to store it at room temperature between 1 and 30 degrees Celsius to maintain its effectiveness.

Appearance and packaging

Appearance

Yellow, oval, double convex extended-release film-coated tablet

Package unit

30 tablets/bottle, 100 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.

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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.