Medication info
Sitaren 50 mg (Sitagliptin Hydrochloride Hydrate)

Sitaren 50 mg (Sitagliptin Hydrochloride Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›56.7mg / 1 tablet
Manufacturer / importer
(주)넥스팜코리아
Appearance
Light yellow-pink, round, biconvex film-coated tablets
Packaging
30 tablets/box [(10 tablets/PTP x 3)]
Approval status
Active

MFDS item code 202005702 · Approved 2020.08.07 · Insurance code 662504570

Summary

Main use
Improvement in blood sugar control for type 2 diabetes
Who takes it
Adults
Adult dose
The recommended dosage is 100 mg once daily as monotherapy or in combination with other medications, with a maximum daily dosage of 100 mg. For patients with renal impairment, the dosage should be adjusted according to kidney function. - For mild and moderate renal impairment (eGFR above 45 but below 90), dosage adjustment is not necessary. - For moderate renal impairment (eGFR above 30 but below 45), administer 50 mg once daily. - Moderate

Ingredients

Manufacturer
(주)넥스팜코리아

Efficacy & effects

Improvement in blood sugar control for type 2 diabetes

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

This medication is used as an adjunct to diet and exercise to improve blood sugar control in patients with type 2 diabetes. It can be administered as monotherapy, and in cases where sufficient blood sugar control is difficult with monotherapy for patients who have not previously received antidiabetic drug treatment, it may be used in combination with metformin. Additionally, it can be combined with sulfonylureas, metformin, thiazolidinediones, or insulin in cases where blood glucose control is not sufficient through monotherapy. Furthermore, for patients who find blood glucose control challenging with multiple drug regimens, adding this medication can lead to further improved blood sugar control. Thus, this medication can be effectively utilized in various situations to aid in blood sugar control and diabetes treatment.

How to take

Adult dose

The recommended dosage is 100 mg once daily as monotherapy or in combination with other medications, with a maximum daily dosage of 100 mg. For patients with renal impairment, the dosage should be adjusted according to kidney function. - For mild and moderate renal impairment (eGFR above 45 but below 90), dosage adjustment is not necessary. - For moderate renal impairment (eGFR above 30 but below 45), administer 50 mg once daily. - Moderate

Precautions

This medication is used for diabetes treatment, and there are several precautions to observe when taking it. First, there is a possibility of a rare severe allergic reaction while taking this medication; if symptoms such as skin rash, difficulty breathing, or swelling of the face or neck occur, immediately discontinue use and consult a physician. Second, this medication may cause a serious side effect known as pancreatitis, which is inflammation of the pancreas; therefore, if there is abdominal pain, vomiting, or severe abdominal discomfort, it is essential to notify healthcare personnel immediately. Third, this medication should not be taken by patients with type 1 diabetes, diabetic ketoacidosis, or those who have hypersensitivity to this medication or its components. Fourth, patients with impaired kidney function should have their dosage adjusted, and kidney function tests should be performed before and during the medication. Fifth, when taken with sulfonylureas or insulin, there may be an increased risk of hypoglycemia, so patients should be vigilant for symptoms of low blood sugar and check their blood glucose frequently if necessary. Sixth, severe joint pain or blistering skin diseases may occur during treatment with this medication, and if these symptoms appear, it is crucial to inform a physician immediately and consider discontinuation of the medication. Seventh, it is not recommended for pregnant or breastfeeding women, and safety has not been confirmed for children under 18 years of age. Finally, in case of overdose, it is essential to visit a medical institution for appropriate treatment and monitoring, as some of the medication may be removed through hemodialysis. During the use of this medication, it is crucial to consult healthcare personnel if any of the above symptoms or abnormalities occur in order to receive appropriate measures.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, anaphylaxis, exfoliative skin disorders like Stevens-Johnson syndrome, acute pancreatitis, severe hypoglycemia, acute renal failure, severe arthralgia and complications with disability, bullous pemphigoid, pneumonia, diabetic complications, metabolic acidosis, falls, cardiac arrest, rash

Mild side effects

  • Headache
  • upper respiratory infection
  • nasopharyngitis
  • diarrhea
  • nausea
  • dyspepsia
  • dizziness
  • myalgia
  • limb pain
  • back pain
Show 12 more
  • increased serum triglycerides
  • increased low-density lipoprotein
  • hyperglycemia
  • hypernatremia
  • weight loss
  • hypertension
  • thrombocytopenia
  • elevated liver enzymes
  • interstitial lung disease
  • pruritus
  • constipation
  • vomiting

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

Storage

This medication should be stored in a tightly sealed container to prevent air exposure, and it is advisable to keep it at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness and prevent degradation.

Appearance and packaging

Appearance

Light yellow-pink, round, biconvex film-coated tablets

Package unit

30 tablets/box [(10 tablets/PTP 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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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.