Medication info
Dapagliflozin and Metformin Extended-Release Tablets 10/1000 Milligrams

Dapagliflozin and Metformin Extended-Release Tablets 10/1000 Milligrams

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin Anhydrous Lactose Mixture›15.27mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
에이치엘비제약(주)
Appearance
Yellow, bilaterally convex, oval-shaped 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 202300150 · Approved 2023.01.06 · Insurance code 647304520

Summary

Main use
Blood sugar control in type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
This medication is generally administered once daily with the evening meal. The maximum dosage is 10 mg of dapagliflozin and 2000 mg of extended-release metformin taken once daily, which equates to two tablets of 5 mg/1000 mg. If there is no previous experience with diabetes medication, the starting dose for initial therapy can be one tablet of 5 mg/500 mg or 10 mg/500 mg taken once daily. To reduce gastrointestinal side effects of metformin, gradual dose titration is recommended.

Ingredients

Manufacturer
에이치엘비제약(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 helps improve blood sugar control in adult patients with type 2 diabetes by using dapagliflozin and metformin together. It is especially prescribed as an adjunct therapy for patients who are also following a dietary and exercise regimen. Caution is necessary for adult type 2 diabetes patients who are not achieving adequate blood sugar control and who have or are at risk for cardiovascular disease, and further information on this is available in professional clinical trial data. This medication effectively improves blood sugar control.

How to take

Adult dose

This medication is generally administered once daily with the evening meal. The maximum dosage is 10 mg of dapagliflozin and 2000 mg of extended-release metformin taken once daily, which equates to two tablets of 5 mg/1000 mg. If there is no previous experience with diabetes medication, the starting dose for initial therapy can be one tablet of 5 mg/500 mg or 10 mg/500 mg taken once daily. To reduce gastrointestinal side effects of metformin, gradual dose titration is recommended.

Precautions

This medication is used for the treatment of diabetes, and while very rare, it can cause a severe condition known as lactic acidosis. Lactic acidosis is characterized by an excessive buildup of lactic acid in the body, and if symptoms occur, immediate medical attention is required. Additionally, there is a risk of hypoglycemia when used in combination with insulin or sulfonylureas, so caution is advised. Symptoms of hypoglycemia include dizziness, tremors, and cold sweats. Patients with impaired kidney function, especially those with moderate to severe impairment, should not use this medication. Regular kidney function tests should be conducted as kidney function can deteriorate rapidly. In cases of acute conditions such as dehydration, severe infection, acute myocardial infarction, or shock, this medication should not be administered, and administration should be suspended for a certain period before and after surgery. Women who are pregnant or breastfeeding should not use this medication, and patients with specific genetic diseases such as lactose intolerance should avoid administration. This medication can cause a decrease in fluid volume and low blood pressure, so elderly patients and those taking diuretics should be especially cautious. Blood pressure and fluid status should be frequently monitored. During the course of treatment with this medication, symptoms of genital and urinary tract infections may occur, requiring immediate treatment if symptoms arise. There is also a possibility of vitamin B12 deficiency; therefore, monitoring serum vitamin B12 levels is recommended during long-term treatment. Excessive alcohol consumption should be avoided as it can increase the risk of lactic acidosis. This medication may affect certain tests (e.g., blood glucose tests), so it is important to inform healthcare professionals about its use during testing. Finally, the safety of this medication in children has not been established, and dosage adjustments may be necessary due to the risk of renal function decline in the elderly. It is crucial to consult with healthcare professionals if any unusual symptoms occur during treatment and to strictly adhere to the prescribed dosage and regimen.

Side effects and when to seek care immediately

Serious side effects

Lactic acidosis, severe allergic reactions (hypersensitivity), acute kidney injury, renal impairment, diabetic ketoacidosis, urinary sepsis, pyelonephritis, acute cholecystitis, Guillain-Barré syndrome, atrial fibrillation, perineal necrosis, serious skin adverse reactions (severe rash, blisters, skin peeling, mucosal pain)

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia, reduced fluid volume (including dehydration, hypovolemia, hypotension), dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, vulvar itching, itching, elevated hematocrit, reduced initial renal creatinine clearance, dyslipidemia, elevated serum creatinine, elevated blood urea, weight loss, diarrhea, nausea/vomiting, flatulence

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture, and it is advisable to keep it at room temperature between 1 degree and 30 degrees Celsius. Storing it this way will help maintain the effectiveness of the medication for a longer period.

Appearance and packaging

Appearance

Yellow, bilaterally convex, oval-shaped 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.

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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.