Medication info
Dapagliflozin Met Extended-Release Tablet 5/500 mg

Dapagliflozin Met Extended-Release Tablet 5/500 mg

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin citric acid›7.35mg / 1 tabletMetformin Hydrochloride with Colloidal Anhydrous Silica›505mg / 1 tablet
Manufacturer / importer
(주)동구바이오제약
Appearance
Orange, biconvex, oval film-coated tablet.
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202204356 · Approved 2022.12.05 · Insurance code 657308840

Summary

Main use
Effect on blood glucose 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, taken as 2 tablets of 5 mg/1000 mg. For initial therapy, the recommended starting dose is one tablet of 5 mg/500 mg or 10 mg/500 mg once daily. Gradual dosage adjustments are made to reduce gastrointestinal side effects from metformin.

Ingredients

Manufacturer
(주)동구바이오제약

Efficacy & effects

Effect on blood glucose control in type 2 diabetes and prevention of cardiovascular events.

  • Type 2 diabetes
  • blood glucose control disorders
  • cardiovascular diseases
  • cardiovascular risk factors.
View approved original text

This medication is used to improve blood glucose control in adult patients with type 2 diabetes when dapagliflozin and metformin are administered together. It is used as an adjunct to dietary and exercise therapy, particularly in patients who do not have sufficient blood glucose control. In addition, the effects of dapagliflozin on the occurrence of cardiovascular events should be carefully monitored in type 2 diabetes patients with cardiovascular disease or risk factors. Please consult professional information before use to ensure safe usage. This medication effectively improves blood glucose control in diabetic patients.

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, taken as 2 tablets of 5 mg/1000 mg. For initial therapy, the recommended starting dose is one tablet of 5 mg/500 mg or 10 mg/500 mg once daily. Gradual dosage adjustments are made to reduce gastrointestinal side effects from metformin.

Precautions

This medication is used for diabetes treatment and contains metformin and dapagliflozin. This medication should not be used in patients with poor kidney function or certain heart diseases and liver dysfunction. Before administration, kidney function and fluid status must be confirmed, and caution is especially needed in elderly patients or those with dehydration. Hypoglycemic symptoms may occur during treatment; therefore, dosage adjustments may be necessary when taken with insulin or other blood glucose-lowering agents. Lactic acidosis, a rare side effect, can be life-threatening, so if symptoms such as fatigue, muscle pain, or shortness of breath occur, immediate consultation with medical personnel is required. The risk of genital and urinary tract infections may increase, so prompt treatment should be sought if infection symptoms arise. Pregnant or breastfeeding women should not use this medication; if planning to become pregnant, consult a physician. The risk of side effects may increase when taking this medication with alcohol, so excessive drinking should be avoided. In cases of overdose, immediate medical attention is necessary; dialysis may be required. The safety and efficacy of this medication in children have not been established, so it should not be used in children. Regular monitoring of kidney function and serum vitamin B12 levels is recommended during treatment. Caution is required when driving or operating machinery as dizziness may occur.

Side effects and when to seek care immediately

Serious side effects

Lactic acidosis, severe hypoglycemia, severe allergic reactions, acute kidney injury, urinary tract sepsis, pyelonephritis, severe edema, severe skin adverse reactions (severe rashes, blisters, skin peeling, mucosal pain in mouth/eyes), liver abnormalities (jaundice), sudden and very severe headaches, seizures, altered consciousness, vision disturbances, paralysis, severe respiratory issues (shortness of breath, asthma attacks, respiratory abnormalities accompanied by coughing and fever), Guillain-Barré syndrome.

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia (when used with sulfonylurea or insulin), dry mouth, dizziness, constipation, back pain, dysuria, polyuria, nocturia, vulvar itching, genital itching, dyslipidemia, increased serum creatinine, increased serum urea, weight loss, headache, paresthesia, tremor, abdominal discomfort, dyspepsia, diarrhea,

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

Storage

This medication may be sensitive to air and moisture, so it must be stored in a tightly sealed container. It is recommended to maintain storage temperature between 1 degree and 30 degrees Celsius to safely preserve the effectiveness of the medication.

Appearance and packaging

Appearance

Orange, biconvex, oval film-coated tablet.

Package unit

30 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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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.