Medication info
Dapagliflozin and Sitagliptin Tablets 10/100 mg

Dapagliflozin and Sitagliptin Tablets 10/100 mg

Prescription medicationTablet
Ingredient · strength
Dapagliflozin Propanediol Hydrate›12.3mg / 1 tabletSitagliptin Phosphate Hydrate›128.5mg / 1 tablet
Manufacturer / importer
명문제약(주)
Appearance
Bright yellow rectangular film-coated tablets
Packaging
Box - 28 tablets/box [(7 tablets/PTP (Alu-Alu) x 4)], Box - 30 tablets/box [(10 tablets/PTP (Alu-Alu) x 3)]
Approval status
Active

MFDS item code 202200067 · Approved 2022.01.04 · Insurance code 649808150

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who uses it
Adults
Adult dosage
For patients receiving sitagliptin 100 mg and dapagliflozin 10 mg, one tablet may be administered once daily, regardless of meal times. The tablet should be swallowed whole.

Ingredients

Manufacturer
명문제약(주)

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

View approved original text

This medication is used to help control blood sugar levels in patients with type 2 diabetes. It is particularly effective when taken in conjunction with dietary therapy and exercise, and is recommended for patients for whom the combination of sitagliptin and dapagliflozin is appropriate. This helps improve blood sugar levels and supports healthy blood sugar management.

Dosage and Administration

Adult dosage

For patients receiving sitagliptin 100 mg and dapagliflozin 10 mg, one tablet may be administered once daily, regardless of meal times. The tablet should be swallowed whole.

Precautions

This medication contains the active ingredients sitagliptin and dapagliflozin, which are used in the treatment of diabetes. First, this medication may cause hypersensitivity reactions, so it must be discontinued immediately if allergic reactions occur. Caution is especially needed as anaphylaxis, angioedema, and serious skin conditions may arise. Additionally, acute pancreatitis has been reported rarely, so if abdominal pain, vomiting, or other symptoms occur, consult a doctor immediately. This medication should not be used in patients with type 1 diabetes or those undergoing dialysis, and patients with impaired renal function may require dose adjustment. The dapagliflozin component may induce decreased fluid volume and hypotension; therefore, elderly patients and those taking diuretics should have their blood pressure and fluid status monitored regularly. There may be an increased risk of hypoglycemia when used in conjunction with insulin or sulfonylureas for blood sugar control, necessitating dose adjustment. This medication may increase the risk of genital infections and urinary tract infections, so appropriate treatment should be obtained if infection symptoms appear. It is recommended that women who are pregnant or breastfeeding do not use this medication, and safety in children under 18 years has not been established. There is no specific antidote for overdose, so appropriate treatment should be administered based on symptoms, and some components may be removed by dialysis. There is a risk of hypoglycemia when driving or operating machinery, so caution is advised. Finally, this medication should be stored in its original container, out of reach of children.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, anaphylaxis, angioedema, Stevens-Johnson syndrome, rash, blisters, skin peeling, pain in oral/ocular mucosa, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attacks, cough with fever respiratory anomalies, yellowing of skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice), sudden and severe

Mild side effects

  • Headache
  • nasopharyngitis
  • upper respiratory infection
  • diarrhea
  • vomiting
  • dizziness
  • constipation
  • thirst
  • hypoglycemia
  • back pain
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  • dysuria
  • polyuria
  • nocturia
  • vulvar itching
  • genital itching
  • increased hematocrit
  • elevated serum creatinine
  • dyslipidemia
  • nausea
  • indigestion
  • abdominal pain
  • chest pain
  • fatigue
  • pain
  • edema
  • foreign body sensation
  • hunger
  • itching
  • cold sweat
  • chest discomfort
  • palpitations
  • insomnia
  • tinnitus
  • menstrual irregularities
  • vaginal discharge
  • face

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

Storage

This medication must be stored in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius. This will ensure the medication's effectiveness is preserved safely.

Appearance and packaging

Appearance

Bright yellow rectangular film-coated tablets

Package unit

Box - 28 tablets/box [(7 tablets/PTP (Alu-Alu) x 4)], Box - 30 tablets/box [(10 tablets/PTP (Alu-Alu) x 3)]

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.