Medication info
Dapagliflozin M Extended-Release Tablet 10/500 mg

Dapagliflozin M Extended-Release Tablet 10/500 mg

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin Anhydrous Lactose Mixture›15.27mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
삼진제약(주)
Appearance
Pink, bilaterally convex, oval extended-release film-coated tablet
Packaging
30 tablets/box [(6 tablets/PTP*5)], 30 tablets/bottle, 200 tablets/bottle
Approval status
Active

MFDS item code 202301904 · Approved 2023.06.21 · Insurance code 647805640

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/2000 mg of extended-release metformin once daily, and 2 tablets of 5 mg/1000 mg. For those with no prior experience in diabetes medication treatment, the initial regimen is 5 mg/500 mg or 10 mg/500 mg one tablet once daily. To reduce gastrointestinal side effects of metformin, dosages are adjusted in stages.

Ingredients

Manufacturer
삼진제약(주)

Efficacy & effects

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

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

This medication is used to improve blood sugar control in adult patients with type 2 diabetes by combining dapagliflozin and metformin along with dietary and exercise therapy. Particularly, caution is necessary from medical professionals regarding the impact of dapagliflozin on the occurrence of cardiovascular events in type 2 diabetes patients who have insufficiently controlled blood sugar and have cardiovascular disease or risk factors. Therefore, this medication effectively assists in diabetes management and blood sugar control.

How to take

Adult dose

This medication is typically administered once daily with the evening meal. The maximum dosage is 10 mg of dapagliflozin/2000 mg of extended-release metformin once daily, and 2 tablets of 5 mg/1000 mg. For those with no prior experience in diabetes medication treatment, the initial regimen is 5 mg/500 mg or 10 mg/500 mg one tablet once daily. To reduce gastrointestinal side effects of metformin, dosages are adjusted in stages.

Precautions

This medication is used for treating diabetes and should not be administered to patients with reduced kidney function or certain health conditions. It may rarely cause a life-threatening metabolic complication known as lactic acidosis, so caution is required for patients with impaired kidney function or those experiencing severe infections, dehydration, etc. Also, when used in conjunction with insulin or sulfonylurea medications, the risk of hypoglycemia may increase, necessitating dosage adjustments. This medication may cause genital and urinary tract infections, and especially women or those with a history of infections should be vigilant about infection symptoms. Due to potential reduced fluid volume or symptoms of hypotension, elderly patients or those taking diuretics should regularly monitor their blood pressure and fluid status. This medication should not be used in patients with liver impairment, pregnant or nursing women, and those with lactose intolerance. It is advised to avoid alcohol while taking this medication, and if undergoing sudden surgery or contrast examinations, it should be temporarily discontinued. Blood levels of vitamin B12 may decrease, so regular blood tests are recommended for prolonged use. In case of overdose, immediate contact with a medical facility for proper treatment is essential, and while this medication has little influence on driving or machine operation, caution should be taken as dizziness may occur. Lastly, this medication should be kept out of reach of children and stored in its original container to prevent misuse or quality deterioration.

Side effects and when to seek care immediately

Serious side effects

Lactic acidosis, severe hypoglycemia, dehydration, hypovolemia, hypotension, diabetic ketoacidosis, urosepsis, pyelonephritis, acute kidney injury, renal dysfunction, Guillain-Barré syndrome, atrial fibrillation, acute cholecystitis, perineal necrosis, severe allergic reactions, severe skin adverse reactions, respiratory problems, liver abnormalities (jaundice), severe neurological symptoms, significant swelling or urination abnormalities.

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia, reduced fluid volume, thirst, dizziness, constipation, dry mouth, low back pain, dysuria, polyuria, nocturia, vulvar itching, genital itching, elevated hematocrit, initial decrease in renal creatinine clearance, dyslipidemia, initial increase in serum creatinine, elevated blood urea, weight loss, rash, diarrhea, nausea/vomiting, reduced/deficiency of vitamin B12, Guillain-Barré syndrome, bacterial.

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture, ideally at room temperature between 1 degrees and 30 degrees. By storing this way, the medication's efficacy can be maintained and safely used.

Appearance and packaging

Appearance

Pink, bilaterally convex, oval extended-release film-coated tablet

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.