Medication info
Sitasingul Tablet 50mg (Sitagliptin Hydrochloride Hydrate)

Sitasingul Tablet 50mg (Sitagliptin Hydrochloride Hydrate)

Prescription medicationTablet
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›56.69mg / 1 tablet
Manufacturer / importer
(주)씨엠지제약
Appearance
Bright yellow-orange round film-coated tablets
Packaging
Bottle packaging - 100 tablets/bottle, Bottle packaging - 30 tablets/bottle
Approval status
Active

MFDS item code 202301822 · Approved 2023.06.14 · Insurance code 648604560

Summary

Main use
Improvement in blood sugar control in type 2 diabetes
Who uses it
Adults
Adult dosage
This drug is administered once daily at a dose of 100 mg for either monotherapy or combination therapy, with a maximum daily dose of 100 mg. It can be taken independently of meals. For patients with renal impairment, - In mild to moderate renal impairment (eGFR 45 to less than 90), no dosage adjustment is necessary. - In moderate renal impairment (eGFR 30 to less than 45), the dose is 50 mg once daily. - In severe

Ingredients

Manufacturer
(주)씨엠지제약

Efficacy & effects

Improvement in blood sugar control in type 2 diabetes

  • Difficulty in blood sugar control in patients with type 2 diabetes
View approved original text

This drug is used in conjunction with dietary and exercise therapy to improve blood sugar control in patients with type 2 diabetes. It can be administered as monotherapy for patients starting treatment. However, if blood sugar control is difficult with monotherapy, it may be combined with Metformin. Additionally, it may be used in combination with other antidiabetic agents such as sulfonylureas, thiazolidinediones, and insulin. Even when adequate blood sugar control is difficult with various combination therapies, this drug can be added to effectively manage blood sugar. Therefore, this drug is widely used for the treatment of type 2 diabetes.

Dosage and Administration

Adult dosage

This drug is administered once daily at a dose of 100 mg for either monotherapy or combination therapy, with a maximum daily dose of 100 mg. It can be taken independently of meals. For patients with renal impairment, - In mild to moderate renal impairment (eGFR 45 to less than 90), no dosage adjustment is necessary. - In moderate renal impairment (eGFR 30 to less than 45), the dose is 50 mg once daily. - In severe

Precautions

This drug may cause allergic reactions, so if symptoms such as rash, difficulty breathing, or swelling of the face or neck occur after use, it should be discontinued immediately and medical consultation is necessary. Also, serious inflammation of the pancreas called pancreatitis may occur, so if symptoms such as abdominal pain, vomiting, or persistent nausea are present, medical attention should be sought immediately. This drug should not be used in patients with type 1 diabetes or diabetic ketoacidosis, and should not be administered to those with known hypersensitivity to this drug or its components. Patients with impaired kidney function should have their dosage adjusted, so regular kidney function tests are necessary and the drug should be taken as directed by a physician. Symptoms of hypoglycemia may occur during treatment with this drug, particularly when taken with other antidiabetic medications such as insulin or sulfonylureas, increasing the risk of hypoglycemia. Severe joint pain or blistering skin diseases may occur, so if these symptoms appear, consultation with a physician should be sought immediately. Pregnant or breastfeeding women are advised not to use this drug, and safety and efficacy have not been sufficiently established for children and adolescents under 18 years of age. In case of overdose, one should visit a hospital immediately for appropriate treatment, and this drug can be partially removed through hemodialysis, so hemodialysis may be considered if necessary.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (angioedema), anaphylaxis, severe allergic reactions, Stevens-Johnson syndrome, exfoliative skin disease, severe rash with fever, blisters, peeling skin, pain in oral/ocular mucosa, acute pancreatitis, severe skin adverse reactions, difficulty breathing or dyspnea, asthma attacks, respiratory abnormality accompanied by cough and fever, liver dysfunction (jaundice), increased liver enzyme levels, extreme lethargy, acute renal failure, severe

Mild side effects

  • Upper respiratory tract infection
  • nasopharyngitis
  • headache
  • dyspepsia
  • diarrhea
  • nausea
  • constipation
  • myalgia
  • limb pain
  • back pain
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  • interstitial lung disease
  • pruritus
  • thrombocytopenia
  • dizziness
  • increased triglycerides in the blood
  • increased low-density lipoprotein
  • hyperglycemia
  • weight loss
  • hypertension
  • hypernatremia
  • erectile dysfunction

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

Storage

This drug should be stored in a tightly sealed container to prevent air from entering, and it is safe to store at room temperature between 1 and 30 degrees Celsius. Storing it this way will help maintain the drug's effectiveness and prevent deterioration.

Appearance and packaging

Appearance

Bright yellow-orange round film-coated tablets

Package unit

Bottle packaging - 100 tablets/bottle, Bottle packaging - 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.