Medication info
Dapaone M Extended-Release Tablet 10/1000 milligrams

Dapaone M Extended-Release Tablet 10/1000 milligrams

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin citric acid›14.7mg / 1 tabletMetformin Hydrochloride with Colloidal Anhydrous Silica›1010mg / 1 tablet
Manufacturer / importer
대원제약(주)
Appearance
Yellow or dark yellow bilaterally convex oval film-coated tablets
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202204123 · Approved 2022.11.16 · Insurance code 671807570

Summary

Main use
Efficacy in blood sugar control and prevention of cardiovascular events in type 2 diabetes
Who takes it
Adults
Adult dose
This medication is generally administered once daily with the evening meal. The maximum dosage is 10mg of dapagliflozin/2000mg of extended-release metformin taken as 2 tablets of 5mg/1000mg once daily. The recommended starting dose for initial therapy is 1 tablet of either 5mg/500mg or 10mg/500mg taken once daily. The dosage should be titrated gradually to minimize gastrointestinal side effects of metformin.

Ingredients

Manufacturer
대원제약(주)

Efficacy & effects

Efficacy in blood sugar control and prevention of cardiovascular events in type 2 diabetes

  • 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 help control blood sugar in adults with type 2 diabetes. It specifically aids in effectively lowering blood sugar when dapagliflozin and metformin are administered together. Furthermore, for type 2 diabetes patients who do not achieve sufficient blood sugar control and have cardiovascular disease or risk factors, it's necessary to refer to the expert's attention regarding the cardiovascular impact of dapagliflozin. This medication contributes to improved blood sugar control and the prevention of diabetes-related complications.

How to take

Adult dose

This medication is generally administered once daily with the evening meal. The maximum dosage is 10mg of dapagliflozin/2000mg of extended-release metformin taken as 2 tablets of 5mg/1000mg once daily. The recommended starting dose for initial therapy is 1 tablet of either 5mg/500mg or 10mg/500mg taken once daily. The dosage should be titrated gradually to minimize gastrointestinal side effects of metformin.

Precautions

This medication can very rarely cause a serious condition known as lactic acidosis, so attention should be paid to these symptoms. Care should be taken as hypoglycemia may occur when used with other diabetes medications. Patients with severely impaired kidney function or conditions affecting the kidneys such as dehydration or severe infections should not use this medication. Pregnant or nursing women should also refrain from taking this medication. Elderly patients or those with slightly impaired kidney function should regularly monitor kidney function and fluid status while using this medication. This medication may increase the risk of genital and urinary tract infections, so if signs of infection occur, consult healthcare professionals immediately. Prolonged use may lead to vitamin B12 deficiency, so it is advisable to check blood levels if taking for an extended period. If planning for surgery or radiological imaging with contrast agents, discontinue this medication in advance and restart after confirming normal kidney function. Alcohol may increase the risk of side effects associated with this medication; therefore, excessive drinking should be avoided during use. Dizziness or hypotension may occur while taking this medication, so caution is needed when driving or operating machinery. If any unusual symptoms occur while taking this medication, consult a doctor immediately for appropriate measures.

Side effects and when to seek care immediately

Serious side effects

  • Severe lactic acidosis
  • severe hypoglycemia
  • acute deterioration of kidney function
  • cardiopulmonary disease
  • septicemia
  • ketosis
  • lactic acidosis
  • severe allergic reactions
  • urinary sepsis
  • pyelonephritis
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  • acute kidney injury
  • kidney dysfunction
  • Guillain-Barré syndrome
  • bacterial pneumonia
  • sialadenitis
  • chest pain
  • atrial fibrillation
  • acute cholecystitis
  • perineal necrosis
  • fever
  • pain around the genital or perineal area
  • ulceration
  • erythema or swelling
  • hives
  • severe swelling (edema)
  • chest pain

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, hypoglycemia, thirst, dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, vulvar itching, genital itching, increased hematocrit, reduced renal creatinine clearance at the start of treatment, dyslipidemia, increased serum creatinine at the start of treatment, elevated blood urea, weight loss, diarrhea, nausea/vomiting, vitamin B12 reduction/deficiency, abdominal pain

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

Storage

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

Appearance and packaging

Appearance

Yellow or dark yellow bilaterally convex oval film-coated tablets

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.