Medication info
Sitagliflozin, Dapagliflozin, Metformin Extended-Release Tablets 5/50/1000 mg

Sitagliflozin, Dapagliflozin, Metformin Extended-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
동국제약(주)
Appearance
Orange oval extended-release film-coated tablets
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202401788 · Approved 2024.07.24 · Insurance code 653405800

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who takes it
Adults
Adult dose
The recommended dosage of this medication in antidiabetic therapy is dapagliflozin 10 mg, sitagliptin 100 mg, and extended-release metformin hydrochloride should not exceed 2000 mg, determined by each patient's current treatment regimen, efficacy, and tolerability. This medication is taken once daily in the evening with meals, and dosage adjustments for metformin hydrochloride should be done gradually as needed.

Ingredients

Manufacturer
동국제약(주)

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

View approved original text

This medication is prescribed to assist in blood sugar control for patients with type 2 diabetes when used in conjunction with dapagliflozin, sitagliptin, and metformin. It helps to effectively manage blood sugar levels alongside dietary and exercise regimens. This contributes to maintaining stable blood sugar levels and reducing the risk of complications associated with diabetes. It supports safe and effective blood sugar control considering the patient's lifestyle and concomitant medications. This medication improves blood sugar control in type 2 diabetes patients.

How to take

Adult dose

The recommended dosage of this medication in antidiabetic therapy is dapagliflozin 10 mg, sitagliptin 100 mg, and extended-release metformin hydrochloride should not exceed 2000 mg, determined by each patient's current treatment regimen, efficacy, and tolerability. This medication is taken once daily in the evening with meals, and dosage adjustments for metformin hydrochloride should be done gradually as needed.

Precautions

This medication contains three components: sitagliptin, dapagliflozin, and metformin, each of which is used for diabetes treatment. Sitagliptin may occasionally cause severe allergic reactions; if symptoms such as skin rash, difficulty breathing, or facial swelling occur within three months after administration, discontinue use immediately. Additionally, acute pancreatitis may occur, so if symptoms such as abdominal pain or vomiting arise, inform your doctor immediately. Dapagliflozin increases fluid excretion from the body and may cause blood pressure drop or dehydration; elderly patients or those with reduced kidney function should be carefully monitored. The risk of genital infections and urinary tract infections may increase during the use of this medication, so treatment should be sought immediately if infection symptoms appear. Rare infectious complications such as severe perineal necrosis (Fournier's gangrene) have also been reported, requiring immediate medical attention if symptoms arise. Metformin rarely causes a life-threatening metabolic disorder known as lactic acidosis; therefore, it should not be administered to patients with impaired kidney function or severe infections, dehydration, or liver dysfunction. Gastrointestinal disturbances (nausea, vomiting, diarrhea, etc.) may occur during use; caution is advised, and excessive alcohol consumption should be avoided. Regular kidney function checks are required while on this medication, and the medication should be discontinued if kidney function deteriorates. Additionally, discontinuation is recommended when surgery is planned or during severe infections or dehydration. Symptoms of hypoglycemia may occur, so particularly when used in combination with insulin or sulfonylureas, blood sugar levels should be monitored closely. It is important to consult healthcare providers immediately if any unusual symptoms or side effects are suspected while taking this medication.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, cough with fever and breathing abnormalities, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, vision problems, paralysis, urination

Mild side effects

  • Headache
  • hypoglycemia
  • nausea
  • diarrhea
  • constipation
  • dry mouth
  • back pain
  • dizziness
  • dermatitis
  • itching
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  • cold sweat
  • weight loss
  • dysuria
  • nocturia
  • myalgia
  • limb pain
  • fever
  • weakness
  • pain
  • blepharitis
  • vision impairment
  • insomnia
  • orthostatic hypotension
  • palpitations
  • dizziness
  • dyspepsia
  • nausea
  • vomiting
  • abdominal pain
  • decreased appetite
  • sensory disturbances
  • taste disturbances
  • drowsiness
  • menstrual irregularities
  • menorrhagia
  • hair loss
  • allergic dermatitis
  • contact dermatitis

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture, and the temperature should be maintained between 1 and 30 degrees Celsius at room temperature. Storing it this way helps maintain the medication's efficacy and safety.

Appearance and packaging

Appearance

Orange oval extended-release 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.