Medication info

Glufovi Tablet 10/100 mg

Prescription medicationTablet
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›113.4mg / 1 tabletDapagliflozin citric acid›14.7mg / 1 tablet
Manufacturer / importer
한올바이오파마(주)
Appearance
Yellow, rectangular film-coated tablet
Packaging
28 tablets/box [(7 tablets/Blister x 4)], 30 tablets/box [(10 tablets/Blister x 3)]
Approval status
Active

MFDS item code 202200495 · Approved 2022.01.28

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, administer 1 tablet once daily, regardless of meals. The tablet should be swallowed whole.

Ingredients

Manufacturer
한올바이오파마(주)

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 help patients with type 2 diabetes control their blood sugar. The combination of sitagliptin and dapagliflozin enhances blood sugar control, helping to improve management of blood sugar levels more effectively. It is used to improve blood sugar control through consistent usage and lifestyle modifications.

Dosage and Administration

Adult dosage

For patients receiving sitagliptin 100 mg and dapagliflozin 10 mg, administer 1 tablet once daily, regardless of meals. The tablet should be swallowed whole.

Precautions

This medication may cause severe allergic reactions. If symptoms such as skin rash, difficulty breathing, or swelling of the face or neck occur, discontinue use immediately and consult a doctor. This medication may cause a serious pancreatic inflammation called pancreatitis, so if sudden abdominal pain, nausea, or vomiting occurs, seek medical attention right away. Patients with allergies to any components or additives of this drug, individuals with type 1 diabetes, certain hereditary lactose intolerance, and those undergoing dialysis should not take this medication. Patients with impaired kidney function or decreased fluid volume should consult with a doctor before taking this medication, and blood pressure and kidney function should be monitored periodically during use. This medication can increase the risk of genital infections and urinary tract infections, so immediate treatment should be sought if infection symptoms appear. Due to the risk of hypoglycemia, especially when used alongside insulin or sulfonylureas, blood sugar levels should be checked frequently, and medication dosages may need adjustment as necessary. Women who are pregnant or planning to become pregnant should avoid using this medication, and it is also recommended that breastfeeding women do not use this medication. Safety and efficacy in children and adolescents under 18 have not been established, and use in these populations is not recommended. In elderly patients, kidney function may decline, so kidney function testing is needed before and during treatment. In case of overdose, there is no specific antidote, so appropriate treatment should be given based on symptoms, and blood dialysis may be considered if necessary. This medication does not significantly affect driving or operating machinery, but caution is advised due to the potential for hypoglycemic symptoms.

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 high fever, blisters, peeling skin, pain in oral/ocular mucous membranes, shortness of breath or difficulty breathing, asthma attack, respiratory distress with coughing and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, lightning-like headache, seizures, altered consciousness, visual disturbances, paralysis, urination changes

Mild side effects

  • Headache
  • nasopharyngitis
  • upper respiratory infections
  • diarrhea
  • abdominal pain
  • nausea
  • constipation
  • dry mouth
  • dizziness
  • back pain
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  • dysuria
  • nocturia
  • vulvar itching
  • genital itching
  • urinary tract infections
  • weight loss
  • weakness
  • fatigue
  • edema
  • itching
  • cold sweat
  • chest pain
  • increased blood triglycerides
  • dizziness
  • palpitations
  • anxiety disorders
  • insomnia
  • tinnitus
  • vaginal discharge
  • hair loss
  • dermatitis
  • dry skin
  • 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. It is advisable to maintain storage temperatures between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow, rectangular film-coated tablet

Package unit

28 tablets/box [(7 tablets/Blister x 4)], 30 tablets/box [(10 tablets/Blister 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.