Medication info
Sitalen 100 mg (Sitagliptin Hydrochloride Monohydrate)

Sitalen 100 mg (Sitagliptin Hydrochloride Monohydrate)

Prescription medicationTablet경구
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›113.4mg / 1 tablet
Manufacturer / importer
(주)넥스팜코리아
Appearance
Light orange, round, double convex film-coated tablets
Packaging
30 tablets/box [(10 tablets/PTP x 3)]
Approval status
Active

MFDS item code 202005703 · Approved 2020.08.07 · Insurance code 662504560

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who takes it
Adults
Adult dose
The medication is administered once daily at a dose of 100 mg for monotherapy or combination therapy with a maximum daily dose of 100 mg. It can be taken regardless of meals. In patients with renal impairment, dosage adjustment is necessary based on kidney function. - Mild to moderate renal impairment (eGFR 45 to <90): No dosage adjustment is needed. - Moderate renal impairment (eGFR 30 to <45): Administer 50 mg once daily.

Ingredients

Manufacturer
(주)넥스팜코리아

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

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

This medication is used to assist blood sugar control in patients with type 2 diabetes. Initially, it can be administered alone, but if adequate blood sugar control is difficult with monotherapy, it is administered in combination with metformin. Additionally, when blood sugar control is difficult with monotherapy of sulfonylurea, metformin, thiazolidinedione, or insulin, this medication can be used in combination to enhance therapeutic effects. Furthermore, when sufficient blood sugar control cannot be achieved even with combination therapies of sulfonylurea and metformin, thiazolidinedione and metformin, or insulin and metformin, this medication can be added to improve blood sugar control. Therefore, this medication plays a role in improving blood sugar control in various treatment situations.

How to take

Adult dose

The medication is administered once daily at a dose of 100 mg for monotherapy or combination therapy with a maximum daily dose of 100 mg. It can be taken regardless of meals. In patients with renal impairment, dosage adjustment is necessary based on kidney function. - Mild to moderate renal impairment (eGFR 45 to <90): No dosage adjustment is needed. - Moderate renal impairment (eGFR 30 to <45): Administer 50 mg once daily.

Precautions

This medication can cause severe allergic reactions; if symptoms such as skin rash or difficulty breathing occur, discontinue use immediately and consult a doctor. This medication can cause a serious pancreatic inflammation called pancreatitis, so if symptoms such as abdominal pain or vomiting occur while taking it, notify medical staff promptly. Do not use in patients with type 1 diabetes or diabetic ketoacidosis, and also should not be administered in cases of allergy to the drug or its components. Patients with impaired kidney function may have difficulty excreting this medication, so dosage adjustments are necessary according to kidney function, and use must be done cautiously. Hypoglycemic symptoms can occur while taking this medication, especially when used together with insulin or sulfonylurea, so blood sugar levels should be checked frequently and hypoglycemia should be monitored. This medication may cause side effects such as upper respiratory infections, headaches, indigestion, and diarrhea, so if symptoms persist or worsen, consult with medical staff. It is advisable for pregnant or breastfeeding women not to use this medication, and safety and efficacy have not been established for children or adolescents under 18 years of age. Elderly patients should be assessed for potential kidney function decline before administration, and dosage adjustment may be necessary. In case of overdose, immediately visit a medical facility for appropriate treatment, and blood dialysis may be performed based on medical judgment as some may be removed during dialysis. This medication may have interactions with other hypoglycemic agents or specific medications, so all medications being taken should be reported to the medical staff.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, severe skin reactions (such as Stevens-Johnson syndrome), shortness of breath or difficulty breathing, asthma attacks, cough and breathing abnormalities accompanied by fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache

Mild side effects

  • Nasopharyngitis
  • upper respiratory infection
  • headache
  • diarrhea
  • abdominal pain
  • nausea
  • constipation
  • muscle pain
  • limb pain
  • back pain
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  • pruritus
  • thrombocytopenia
  • indigestion
  • dizziness
  • increased blood triglycerides
  • increased low-density lipoproteins
  • hyperglycemia
  • weight loss
  • hypertension
  • hypernatremia
  • erectile dysfunction

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

Storage

This medication should be stored in a sealed container to prevent air exposure and kept at a temperature between 1 to 30 degrees Celsius. Storing it this way helps maintain the effectiveness of the medication for a longer period.

Appearance and packaging

Appearance

Light orange, round, double convex 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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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.