Medication info
Sitagliptin, Dapagliflozin, Metformin Sustained-Release Tablets 5/50/1000 mg

Sitagliptin, Dapagliflozin, Metformin Sustained-Release Tablets 5/50/1000 mg

Prescription medicationTablet경구
Ingredient · strength
Metformin Hydrochloride›1000mg / 1 tabletSitagliptin Phosphate Hydrate›64.25mg / 1 tabletDapagliflozin Propanediol Hydrate›6.15mg / 1 tablet
Manufacturer / importer
(주)녹십자
Appearance
Orange, oval-shaped sustained-release film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202401791 · Approved 2024.07.24 · Insurance code 643606750

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who takes it
Adults
Adult dose
The recommended dosage of this medication is 10 mg of dapagliflozin and 100 mg of sitagliptin, while sustained-release metformin hydrochloride is determined within the range not exceeding 2000 mg based on each patient's treatment regimen, efficacy, and tolerability. This medication is taken once daily with meals in the evening, and if dosage adjustment of metformin hydrochloride is necessary, it should be adjusted stepwise. Taking 10/100/1000 mg sustained-release tablets.

Ingredients

Manufacturer
(주)녹십자

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

View approved original text

This medication is used in conjunction with diet and exercise to more effectively help patients with type 2 diabetes control their blood sugar levels. The three components, dapagliflozin, sitagliptin, and metformin, act together to help stabilize blood sugar levels. This combination therapy is particularly suitable for cases where blood sugar management is difficult and contributes to the overall health condition of the patient. When combined with consistent medication adherence and lifestyle changes, it shows positive effects in treating diabetes. Therefore, this medication is used to enhance blood sugar control in patients with type 2 diabetes.

How to take

Adult dose

The recommended dosage of this medication is 10 mg of dapagliflozin and 100 mg of sitagliptin, while sustained-release metformin hydrochloride is determined within the range not exceeding 2000 mg based on each patient's treatment regimen, efficacy, and tolerability. This medication is taken once daily with meals in the evening, and if dosage adjustment of metformin hydrochloride is necessary, it should be adjusted stepwise. Taking 10/100/1000 mg sustained-release tablets.

Precautions

This medication is used for the treatment of diabetes and requires several precautions during use. First, one of the ingredients in this medication may cause allergic reactions, so if symptoms such as skin rash, itching, or difficulty breathing occur, stop taking the medication immediately and consult a doctor. Second, pancreatitis, a serious inflammation of the pancreas, can occur rarely, so if abdominal pain, vomiting, or fever presents, seek medical attention immediately. Third, some components of this medication are not suitable for patients with reduced kidney function, and in case of diminished renal function, use should be avoided or dosage adjusted under a doctor's guidance. Fourth, the metformin component may rarely cause life-threatening lactic acidosis, particularly in cases of dehydration, severe infection, or heart disease, and symptoms may include lethargy, difficulty in breathing, and abdominal pain. Fifth, this medication can induce hypoglycemia, so caution should be exercised when skipping meals or engaging in excessive exercise, and if hypoglycemic symptoms (dizziness, trembling, cold sweat, etc.) occur, sugars should be consumed immediately. Sixth, patients at risk of fluid volume reduction or hypotension, especially elderly patients or those taking diuretics, should have their blood pressure and fluid status monitored regularly. Seventh, this medication can increase the risk of genital infections and urinary tract infections, so prompt treatment is necessary if infection symptoms appear. Eighth, prior to surgery or imaging examinations with contrast agents, use of this medication must be temporarily suspended, and it should be resumed only after renal function has restored normally. Ninth, patients with liver dysfunction or those who consume alcohol excessively should avoid taking this medication, and regular liver function tests are recommended. Finally, if unusual symptoms such as joint pain, skin rash, or blistering diseases appear during the use of this medication, it is necessary to consult a doctor immediately, and discontinuation of the medication may be required. This medication should be used safely according to the individual's health status, and consultation with a doctor prior to use is essential.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty in breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory distress accompanying cough + fever, jaundice (yellowing of the skin or eyes), severe malaise, sudden and severe headache, lightning headache, seizures, confusion, vision abnormalities, paralysis, urination issues

Mild side effects

  • Vulvovaginitis
  • balanitis and related genital infections
  • urinary tract infections
  • fungal infections
  • hypoglycemia
  • dizziness
  • constipation
  • dry mouth
  • low back pain
  • dysuria
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  • polyuria
  • nocturia
  • genital itching
  • increased hematocrit
  • elevated serum creatinine
  • dyslipidemia
  • weight loss
  • dyspepsia
  • nausea
  • diarrhea
  • vomiting
  • headache
  • itching
  • cold sweat
  • edema
  • foreign body sensation
  • facial edema
  • facial pain
  • warm sensation
  • flu-like symptoms
  • insomnia
  • orthostatic hypotension

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

Storage

This medication may be sensitive to air and humidity, so it should be stored in a tightly sealed container. It is recommended to store at room temperature between 1 to 30 degrees Celsius. This will help maintain the effectiveness of the medication for a long time.

Appearance and packaging

Appearance

Orange, oval-shaped sustained-release 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.