Medication info
Sitagliptin Hydrochloride Hydrate Tablets 100 mg

Sitagliptin Hydrochloride Hydrate Tablets 100 mg

Prescription medicationTablet경구
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›113.37mg / 1 tablet
Manufacturer / importer
신풍제약(주)
Appearance
Bright yellow-orange round film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202102485 · Approved 2021.03.22 · Insurance code 648508110

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who takes it
Adults
Adult dose
This medication is administered once daily at a dosage of 100 mg for both monotherapy and combination therapy, with a maximum daily dose of 100 mg. It can be taken regardless of meals. For patients with renal impairment, dosage adjustment is required based on kidney function. For mild to moderate renal impairment (eGFR between 45 and 90), no dosage adjustment is necessary.

Ingredients

Manufacturer
신풍제약(주)

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

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

This medication is used in conjunction with dietary control and exercise to assist with blood sugar control in patients with type 2 diabetes. Patients who have never received diabetes medication treatment may take this medication alone. If blood sugar control is difficult with monotherapy, it can be used in combination with other diabetes medications such as metformin. Additionally, if blood sugar control is insufficient with monotherapy of sulfonylureas, metformin, thiazolidinediones, or insulin, this medication can be used in combination. In cases where blood sugar control is difficult with the combination of multiple medications, this medication can be added to assist in blood sugar management. Therefore, this medication is effectively used to improve blood sugar control in patients with type 2 diabetes.

How to take

Adult dose

This medication is administered once daily at a dosage of 100 mg for both monotherapy and combination therapy, with a maximum daily dose of 100 mg. It can be taken regardless of meals. For patients with renal impairment, dosage adjustment is required based on kidney function. For mild to moderate renal impairment (eGFR between 45 and 90), no dosage adjustment is necessary.

Precautions

This medication can cause serious allergic reactions, although rarely. These reactions may include anaphylaxis, swelling of the face or neck, and severe skin disorders. Such symptoms may occur within the first three months after starting the medication, so caution is needed. This medication may cause inflammation of the pancreas, known as acute pancreatitis, so if symptoms of pancreatitis occur, the medication should be discontinued immediately. Symptoms of pancreatitis include severe abdominal pain, vomiting, and nausea. This medication should not be used in patients with type 1 diabetes or diabetic ketoacidosis, and it should not be given to individuals allergic to this medication or its components. Patients with impaired kidney function may have delayed excretion of this medication, so dosage adjustment is necessary, and regular kidney function tests are important. While taking this medication, side effects such as cold-like symptoms, headache, indigestion, and diarrhea may occur. Additionally, if taken together with insulin or sulfonylureas, the risk of hypoglycemia may increase, so thorough blood sugar management is essential. If severe joint pain or skin blistering symptoms occur, it is important to consult a doctor immediately, and discontinuation of the medication may be necessary. It is advisable for pregnant or breastfeeding women not to take this medication, and safety in children or adolescents under 18 years of age has not been fully established. In case of overdose, immediate medical attention should be sought, and this medication can be partially removed through dialysis if needed. There is also a potential for drug interactions while taking this medication, so it's important to consult a doctor or pharmacist about all medications being taken.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), anaphylaxis, severe skin adverse reactions (Stevens-Johnson syndrome, exfoliative dermatitis), acute pancreatitis, severe and disabling joint pain, blistering dermatitis, liver abnormalities due to increased liver enzymes (including jaundice symptoms), acute renal failure, cardiac arrest, pneumonia, diabetes complications, metabolic acidosis, severe allergic reactions, angioedema, difficulty breathing, thrombocytopenia, rhabdomyolysis

Mild side effects

  • Upper respiratory tract infection
  • nasopharyngitis
  • headache
  • diarrhea
  • nausea
  • constipation
  • muscle pain
  • limb pain
  • back pain
  • itching
Show 11 more
  • thrombocytopenia
  • hypoglycemia
  • indigestion
  • dizziness
  • increased serum triglycerides
  • increased LDL cholesterol
  • 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 from entering, and it is best kept at room temperature between 1 to 30 degrees Celsius. This will help maintain the effectiveness of the medication and prevent degradation.

Appearance and packaging

Appearance

Bright yellow-orange round film-coated tablets

Package unit

30 tablets/bottle, 100 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.