Medication info

Foglime Met Sustained Release Tablet 10/500 mg

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Dapagliflozin citric acid›14.7mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
한국프라임제약(주)
Appearance
Pink, oval, film-coated tablets with a biconvex shape on both sides
Packaging
30 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 202204060 · Approved 2022.11.10

This product's status changed to Approval withdrawn on 2023.10.18. It may no longer be sold, so consult a doctor or pharmacist before taking it.

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 administered once a day with the evening meal. The maximum dosage is 10 mg of dapagliflozin/2000 mg of extended-release metformin once daily, administered as 2 tablets of 5 mg/1000 mg. In cases where the patient has no prior experience with diabetes treatment and adequate blood sugar control cannot be achieved with monotherapy, initial therapy can begin with 5 mg/500 mg or 10 mg/500 mg once daily.

Ingredients

Manufacturer
한국프라임제약(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 to improve blood sugar control in adult patients with type 2 diabetes by combining dapagliflozin and metformin. It is particularly used as an adjunct to insulin and exercise therapy in patients who cannot achieve adequate blood sugar control alone. Additionally, for patients with type 2 diabetes whose blood sugar is not adequately controlled and have cardiovascular disease or risk factors, the effects of this medication on cardiovascular events should refer to healthcare professionals. This medication effectively assists in the treatment of type 2 diabetes and improves blood sugar management.

How to take

Adult dose

This medication is generally administered once a day with the evening meal. The maximum dosage is 10 mg of dapagliflozin/2000 mg of extended-release metformin once daily, administered as 2 tablets of 5 mg/1000 mg. In cases where the patient has no prior experience with diabetes treatment and adequate blood sugar control cannot be achieved with monotherapy, initial therapy can begin with 5 mg/500 mg or 10 mg/500 mg once daily.

Precautions

This medication is used for the treatment of diabetes and helps to control blood sugar levels. Rarely, during the use of this medication, a serious condition called lactic acidosis may occur. If symptoms such as difficulty breathing, muscle pain, or fatigue appear, consult a doctor immediately. When taking other diabetes medications, hypoglycemic symptoms may occur, so blood sugar levels should be monitored closely. Patients with impaired kidney function, dehydration, severe infections, or heart-related problems should not take this medication, and the drug should be discontinued around the time of surgery or radiological examinations. Women who are pregnant or breastfeeding should not take this medication for safety. Elderly individuals or those with decreased kidney function should consult a doctor before taking this medication, and kidney function should be regularly monitored during treatment. This medication can cause genital infections or urinary tract infections in some patients, so treatment should be sought immediately if infection symptoms arise. Patients with reduced fluid volume or risk of low blood pressure should take caution while using this medication, and may temporarily stop it if necessary. During treatment, watch for signs of hypoglycemia, and dose adjustments may be required when used with insulin or other hypoglycemic agents. Patients with underlying conditions such as liver or kidney disease, or heart failure should use this medication only under medical supervision. In cases of overdose, seek immediate medical attention for appropriate treatment; the safety of this medication in children has not been established. This medication does not significantly affect driving or machine operation, but caution is needed as symptoms like dizziness may occur. Store this medication out of reach of children, and keep it in the original container to maintain quality.

Side effects and when to seek care immediately

Serious side effects

Lactic acidosis, severe hypoglycemia, severe allergic reactions (hypersensitivity), acute kidney injury, renal impairment, acute myocardial infarction, shock, acute or chronic metabolic acidosis, diabetic pre-coma, congestive heart failure, acute cholecystitis, Guillain-Barré syndrome, atrial fibrillation, perineal necrosis, urinary sepsis, pyelonephritis, acute kidney injury, severe edema (systemic edema), severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, hypoglycemia, reduced fluid volume, thirst, diabetic ketoacidosis, dizziness, constipation, dry mouth, back pain, pain during urination, polyuria, nocturia, vulvar itching, genital itching, increased hematocrit, decreased creatinine clearance in the early treatment phase, dyslipidemia, elevated serum creatinine in the early treatment phase, elevated blood urea, weight loss, abdominal pain, dyspepsia,

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

Storage

Store this medication in a tightly closed container to prevent air or moisture from entering. It is recommended to maintain a storage temperature between 1 degree and 30 degrees Celsius. This way, the effectiveness of the medication is maintained and degradation can be avoided.

Appearance and packaging

Appearance

Pink, oval, film-coated tablets with a biconvex shape on both sides

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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.