Medication info

Glyfloem Controlled-Release Tablets 10/500 mg

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

MFDS item code 202301902 · Approved 2023.06.21

Summary

Main use
Effect on blood sugar control in type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
This medication is generally taken once a day with the evening meal. The maximum dosage is dapagliflozin 10 mg/metformin controlled-release 2000 mg taken once daily, or 2 tablets of 5 mg/1000 mg. The recommended starting dosage for initial therapy is 1 tablet of 5 mg/500 mg or 10 mg/500 mg once daily. To reduce gastrointestinal side effects of metformin, dosage should be adjusted gradually.

Ingredients

Manufacturer
대우제약(주)

Efficacy & effects

Effect on 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 as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes through the combined use of dapagliflozin and metformin. It is particularly administered to patients with type 2 diabetes whose blood sugar is inadequately controlled and who have cardiovascular diseases or risk factors. Refer to the professional guidelines for detailed information on cardiovascular event occurrences. This medication effectively improves blood sugar control, assisting in diabetes management.

How to take

Adult dose

This medication is generally taken once a day with the evening meal. The maximum dosage is dapagliflozin 10 mg/metformin controlled-release 2000 mg taken once daily, or 2 tablets of 5 mg/1000 mg. The recommended starting dosage for initial therapy is 1 tablet of 5 mg/500 mg or 10 mg/500 mg once daily. To reduce gastrointestinal side effects of metformin, dosage should be adjusted gradually.

Precautions

This medication is used in the treatment of diabetes and should not be used in patients with impaired kidney function or specific health conditions. It can rarely cause a serious condition called lactic acidosis, so caution is required in patients with decreased kidney function or those with heart disease or infections. When used with insulin or sulfonylureas, the risk of hypoglycemia may increase, so dosage adjustment may be necessary. Additionally, it should be administered carefully in patients at risk of dehydration or hypotension, with close monitoring of fluid status and kidney function before and during administration. The risk of genital infections and urinary tract infections may increase, so immediate treatment should be sought if symptoms of infection appear. Pregnant or breastfeeding women should not take this medication, and if pregnancy is confirmed, treatment should be discontinued. Elderly patients or those with impaired kidney function may need dosage adjustments, and regular kidney function tests are required. Excessive alcohol consumption should be avoided during treatment, and the medication should be temporarily suspended prior to any sudden surgeries or imaging tests involving contrast agents. In case of overdose, immediate medical attention should be sought for appropriate treatment, and the safety and efficacy of this medication in children have not been established. Lastly, this medication should be kept out of reach of children and stored in its original container to prevent degradation of quality.

Side effects and when to seek care immediately

Serious side effects

Severe lactic acidosis, severe hypoglycemia, severe allergic reactions (hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor), severe skin reactions (severe rash with fever, blistering, skin peeling, pain in oral/ocular mucosa), respiratory problems (shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever), liver abnormalities (jaundice, yellowing of skin or eyes, systemic symptoms).

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia (when used with sulfonylureas or insulin), reduced fluid volume (including dehydration, hypovolemia, hypotension), thirst, dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, vulvar itching, genital itching, increased hematocrit, initial decrease in renal creatinine clearance, dyslipidemia, initial increase in blood levels.

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

Storage

This medication must be stored in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain storage temperatures between 1 and 30 degrees Celsius. This will help preserve the medication's efficacy and safety.

Appearance and packaging

Appearance

Pink, oval, double convex, controlled-release film-coated tablets

Package unit

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