Medication info
Dapagliflozin Metformin Extended-Release Tablet 10/1000 mg

Dapagliflozin Metformin Extended-Release Tablet 10/1000 mg

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin Propanediol Hydrate›12.3mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
(주)비보존제약
Appearance
Yellow, oval-shaped, double-convex extended-release film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202300354 · Approved 2023.01.27 · Insurance code 658204720

Summary

Main use
Efficacy in controlling blood sugar in type 2 diabetes and preventing cardiovascular events
Who takes it
Adults
Adult dose
This medication is generally administered once daily with the evening meal. The maximum dose is once daily dapagliflozin 10 mg/extended-release metformin 2000 mg, taken as 2 tablets of 5 mg/1000 mg. If there is no prior experience with diabetes medications, the initial regimen should be one tablet of 5 mg/500 mg or 10 mg/500 mg once daily. To reduce gastrointestinal side effects associated with metformin, dose adjustments may be made.

Ingredients

Manufacturer
(주)비보존제약

Efficacy & effects

Efficacy in controlling blood sugar in type 2 diabetes and preventing cardiovascular events

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

This medication is used to assist in the control of blood sugar in adult patients with type 2 diabetes who require a combination of dapagliflozin and metformin. It is especially effective in managing blood sugar when used in conjunction with dietary control and exercise. It may also be used in type 2 diabetes patients who have cardiovascular disease or risk factors associated with cardiovascular disease when blood sugar control is challenging. Detailed information regarding the occurrence of cardiovascular events can be referenced in professional materials. This medication is intended to help improve blood sugar regulation.

How to take

Adult dose

This medication is generally administered once daily with the evening meal. The maximum dose is once daily dapagliflozin 10 mg/extended-release metformin 2000 mg, taken as 2 tablets of 5 mg/1000 mg. If there is no prior experience with diabetes medications, the initial regimen should be one tablet of 5 mg/500 mg or 10 mg/500 mg once daily. To reduce gastrointestinal side effects associated with metformin, dose adjustments may be made.

Precautions

This medication helps in the management of blood sugar levels. Caution is required as there is a rare possibility of severe lactic acidosis being a side effect when taking this medication. If taken with other diabetes medications, there may be a risk of hypoglycemia. This medication should not be used in specific patients. For instance, patients with severely impaired kidney function, those with dehydration or severe infections, type 1 diabetes patients, heart failure patients, women who are pregnant or nursing, and those with lactose intolerance should not take this medication. Additionally, caution is required for patients with mildly reduced kidney function or low fluid volume. Elderly patients or those on diuretics also need to be cautious. Symptoms of hypotension or changes in kidney function should be closely monitored during treatment with this medication. Genital infections or urinary tract infections may occur frequently while taking this medication. If symptoms of infection appear in the genitals or urinary tract, immediate treatment is necessary. Additionally, hypoglycemic symptoms may occur, thus maintaining proper blood sugar management is important. This medication can lead to dehydration or hypotension due to reduced fluid volume, so fluid status should be well managed, and in necessary cases, discontinuation of the medication may be required. Rarely, serious metabolic disturbances such as diabetic ketoacidosis may occur, so if symptoms like abdominal pain, vomiting, or breathing difficulties occur, consult a healthcare professional immediately. This medication may lower vitamin B12 levels, so it is advisable to check for vitamin B12 deficiency if used for a long period. Alcohol consumption may increase the risk of side effects associated with this medication and should be avoided. Pregnant or nursing women should not use this medication, and use should be discontinued upon confirmation of pregnancy. Elderly patients should be aware that declining kidney function is common; therefore, renal function should be regularly monitored before and after use, and dosage adjustments may be necessary. In case of overdose, appropriate treatment should be administered, particularly since the metformin component can be removed through dialysis. This medication does not significantly affect driving or machinery operation, but caution is advised due to the possibility of dizziness. Finally, this medication should be kept out of the reach of children and maintained in its original container to preserve quality.

Side effects and when to seek care immediately

Serious side effects

  • Lactic acidosis
  • severe hypoglycemia
  • ketoacidosis
  • acute kidney injury
  • impaired kidney function
  • urosepsis
  • pyelonephritis
  • rash
  • severe skin reactions
  • Guillain-Barré syndrome
Show 18 more
  • chest pain
  • pneumonia
  • acute cholecystitis
  • atrial fibrillation
  • perineal necrosis
  • severe edema
  • hypotension
  • hypovolemia
  • urticaria
  • severe swelling
  • chest tightness
  • shortness of breath
  • cold sweat
  • pallor
  • severe rash with high fever
  • blisters
  • skin peeling
  • pain in mucous membranes of mouth/eyes

Mild side effects

Vulvitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia, thirst, dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, pruritus of the vulva, pruritus of the genitalia, elevated hematocrit, reduced initial renal creatinine clearance, dyslipidemia, elevated blood creatinine, elevated blood urea, weight loss, diarrhea, nausea/vomiting, decreased vitamin B12/deficiency

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

Storage

Store this medication in a tightly closed container to avoid contact with air or moisture. It is recommended to maintain a storage temperature between 1 to 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

Yellow, oval-shaped, double-convex extended-release film-coated tablets

Package unit

30 tablets/bottle, 100 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.