Medication info
Sitagliptin Tablets 100 mg (Sitagliptin Hydrochloride Hydrate)

Sitagliptin Tablets 100 mg (Sitagliptin Hydrochloride Hydrate)

Prescription medicationTablet
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›113.4mg / 1 tablet
Manufacturer / importer
대우제약(주)
Appearance
Bright brown, round, bilayered, convex film-coated tablets
Packaging
28 tablets/box [(14 tablets/PTP x 2)]
Approval status
Active

MFDS item code 202101003 · Approved 2021.02.02 · Insurance code 649605970

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who uses it
Adults
Adult dosage
This medication is administered once a day at a dose of 100 mg for monotherapy or combination therapy, with a maximum daily dose of 100 mg. This medication can be taken without regard to meals. For patients with renal impairment: 1. Mild renal impairment (eGFR ≥ 60 and < 90 mL/min/1.73 m2) does not require dose adjustment. 2. Moderate renal impairment (eGFR ≥ 45 and < 60...

Ingredients

Manufacturer
대우제약(주)

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

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

This medication is used to improve blood sugar control in patients with type 2 diabetes in conjunction with diet and exercise. Initially, it is administered as monotherapy, and if blood sugar control is difficult with monotherapy, it can be used in combination with metformin. Additionally, this medication can be co-administered if adequate control is not achieved with sulfonylureas, metformin, thiazolidinediones, or insulin monotherapy. In cases where multiple medications are combined and blood sugar control is still insufficient, this medication can be added to enhance therapeutic efficacy. This flexible administration method helps effectively control patients' blood sugar.

Dosage and Administration

Adult dosage

This medication is administered once a day at a dose of 100 mg for monotherapy or combination therapy, with a maximum daily dose of 100 mg. This medication can be taken without regard to meals. For patients with renal impairment: 1. Mild renal impairment (eGFR ≥ 60 and < 90 mL/min/1.73 m2) does not require dose adjustment. 2. Moderate renal impairment (eGFR ≥ 45 and < 60...

Precautions

This medication may cause severe allergic reactions; therefore, if symptoms such as skin rash or difficulty breathing occur after administration, discontinue use immediately and seek medical attention. This medication can cause severe inflammation of the pancreas (pancreatitis), so if symptoms such as abdominal pain, nausea, or vomiting occur during use, notify a doctor immediately. This medication should not be used in patients with type 1 diabetes or diabetic ketoacidosis, and should also be avoided in individuals with allergies to this medication or its ingredients. Patients with decreased renal function may have delayed excretion of this medication, necessitating dose adjustment or careful use. Adverse reactions reported in clinical trials include upper respiratory infections, headaches, nasopharyngitis, diarrhea, among others. There may be an increased risk of hypoglycemia when taken with insulin or sulfonylureas. This medication has relatively few drug interactions, but caution is required when taken with cyclosporine or digoxin, and appropriate monitoring is advised. Its safety has not been established in pregnant or breastfeeding women, and its safety and efficacy in children under 18 have not been confirmed. In elderly patients, renal function decline is common, thus regular evaluation of renal function should be performed before and during administration of this medication. In case of overdose, general emergency treatments should be applied, and consideration can be given to blood dialysis since some may be removed by it if necessary. If any unusual symptoms occur during medication, such as joint pain or blisters on the skin, consult a doctor immediately for appropriate measures.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (angioedema)
  • anaphylaxis
  • rash
  • Stevens-Johnson syndrome
  • exfoliative skin disease
  • acute pancreatitis
  • acute renal failure
  • severe and disabling joint pain
  • bullous pemphigoid
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  • rhabdomyolysis
  • cardiac arrest

Mild side effects

  • Nasopharyngitis
  • upper respiratory infections
  • headache
  • diarrhea
  • nausea
  • constipation
  • muscle pain
  • limb pain
  • back pain
  • pruritus
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  • thrombocytopenia
  • indigestion
  • dizziness
  • increased triglycerides
  • gastritis
  • 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 tightly sealed container to prevent exposure to air or moisture and is best kept at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness.

Appearance and packaging

Appearance

Bright brown, round, bilayered, convex film-coated tablets

Package unit

28 tablets/box [(14 tablets/PTP x 2)]

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.