Medication info
Sitavia 50 mg Tablets (Sitagliptin Hydrochloride Monohydrate)

Sitavia 50 mg Tablets (Sitagliptin Hydrochloride Monohydrate)

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

MFDS item code 202102015 · Approved 2021.03.04 · Insurance code 645605580

Summary

Main use
Improvement of blood glucose control in type 2 diabetes
Who uses it
Adults
Adult dosage
The medication is administered as 100 mg once daily for monotherapy or in combination therapy, with a maximum daily dosage of 100 mg. It can be taken regardless of meals. For patients with renal impairment, dosage adjustment may be necessary according to renal function. In patients with mild to moderate renal impairment (eGFR ≥ 45 and < 60 mL/min/1.73 m2), no dosage adjustment is necessary. In patients with moderate renal impairment (eGFR ≥ 30 and <

Ingredients

Manufacturer
대화제약(주)

Efficacy & effects

Improvement of blood glucose control in type 2 diabetes

  • Type 2 diabetes
  • difficulty in blood glucose control
View approved original text

This medication is used along with diet and exercise to help control blood glucose levels in patients with type 2 diabetes. It can be administered as monotherapy, and in cases where monotherapy is insufficient for blood glucose control and the patient has no prior experience with diabetes medication, it can be used in conjunction with metformin. Additionally, this medication is combined with therapies such as sulfonylureas, metformin, thiazolidinediones, and insulin when control of blood glucose is inadequate with monotherapy. In cases where blood glucose control is difficult even with combination therapy, this drug can also be added to improve control. Therefore, this medication plays an important role in enhancing blood glucose control across various treatment stages.

Dosage and Administration

Adult dosage

The medication is administered as 100 mg once daily for monotherapy or in combination therapy, with a maximum daily dosage of 100 mg. It can be taken regardless of meals. For patients with renal impairment, dosage adjustment may be necessary according to renal function. In patients with mild to moderate renal impairment (eGFR ≥ 45 and < 60 mL/min/1.73 m2), no dosage adjustment is necessary. In patients with moderate renal impairment (eGFR ≥ 30 and <

Precautions

This medication may cause hypersensitivity reactions; if symptoms such as skin rash, itching, or difficulty breathing develop after administration, consult a physician immediately. This medication can induce acute pancreatitis; therefore, if symptoms such as abdominal pain, nausea, or vomiting occur, notify healthcare personnel immediately. This medication should not be used in patients with type 1 diabetes or diabetic ketoacidosis. It should not be administered if there is a history of allergy or hypersensitivity to this medication or its ingredients. Patients with impaired renal function should have their dosage adjusted and should undergo regular renal function tests. Since hypoglycemia may occur when this medication is used alone or in combination with other diabetes therapies, blood glucose changes should be closely monitored. Particular caution is needed if used with insulin or sulfonylurea drugs as the risk of hypoglycemia may increase. If severe joint pain or movement limitations occur, stop taking this medication and consult a physician. If any bullous skin diseases, skin rashes, or urticaria develop, discontinue medication immediately and seek dermatological care. This medication is not recommended for pregnant or nursing women, and safety has not been established for children under 18 years of age. In elderly patients, renal function may decline, thus dosage adjustment and regular kidney function testing are necessary. There are relatively fewer drug interactions when used with other medications, but caution is needed when taken with certain drugs, so it is important to inform a physician or pharmacist. In case of overdose, seek medical attention immediately for appropriate treatment, and if necessary, the drug may be removed by dialysis.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • angioedema
  • anaphylaxis
  • Stevens-Johnson syndrome
  • exfoliative dermatitis
  • acute pancreatitis
  • severe hypoglycemia
  • acute renal failure
  • severe and disabling arthralgia
  • bullous pemphigoid
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  • rhabdomyolysis
  • pneumonia
  • diabetic complications
  • metabolic acidosis
  • falls
  • cardiac arrest

Mild side effects

  • Nasopharyngitis
  • upper respiratory tract infection
  • headache
  • diarrhea
  • nausea
  • constipation
  • myalgia
  • limb pain
  • back pain
  • pruritus
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  • thrombocytopenia
  • dyspepsia
  • dizziness
  • increased liver enzyme levels
  • increased blood triglycerides
  • increased low-density lipoprotein
  • hyperglycemia
  • weight loss
  • hypernatremia
  • erectile dysfunction

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

Storage

Store this medication in a tightly closed container that allows for good air circulation, and keep at room temperature between 1°C and 30°C. This will help maintain the drug's effectiveness for a longer period.

Appearance and packaging

Appearance

Bright yellow-orange round film-coated tablets

Package unit

100 tablets/bottle, 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.