Medication info
Teravial Tablets 100 mg (Sitagliptin Hydrobromide Monohydrate)

Teravial Tablets 100 mg (Sitagliptin Hydrobromide Monohydrate)

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

MFDS item code 202101861 · Approved 2021.02.24 · Insurance code 698504760

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who takes it
Adults
Adult dose
This medicine is administered at a dose of 100 mg once a day for monotherapy or combination therapy, with a maximum daily dosage of 100 mg. It can be taken regardless of meals. For patients with renal impairment, administer 50 mg once a day if the glomerular filtration rate is 30–45 mL/min/1.73 m2. For patients with a glomerular filtration rate of 15–30 mL/min/1.73 m2 or those requiring hemodialysis or peritoneal dialysis due to end-stage renal disease, once a day

Ingredients

Manufacturer
(주)테라젠이텍스

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 medicine 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 for initial treatment, and in cases where blood sugar control is difficult with monotherapy and previous usage of anti-diabetic medications has not occurred, it is administered in combination with metformin. Additionally, when sufficient blood sugar control is not achieved with monotherapy of sulfonylureas, metformin, thiazolidinediones, or insulin, this medicine may be used in combination. The therapy effect can be enhanced by adding this medicine when controlling blood sugar is difficult even in combination with multiple medications. It is flexibly applied to improve blood sugar control in various scenarios.

How to take

Adult dose

This medicine is administered at a dose of 100 mg once a day for monotherapy or combination therapy, with a maximum daily dosage of 100 mg. It can be taken regardless of meals. For patients with renal impairment, administer 50 mg once a day if the glomerular filtration rate is 30–45 mL/min/1.73 m2. For patients with a glomerular filtration rate of 15–30 mL/min/1.73 m2 or those requiring hemodialysis or peritoneal dialysis due to end-stage renal disease, once a day

Precautions

This medicine may cause serious allergic reactions in some patients; therefore, if symptoms such as rash, hives, difficulty breathing, or swelling of the face or neck occur after use, discontinue the medication immediately and consult a physician. During the use of this medicine, symptoms of pancreatitis, inflammation of the pancreas, may occur; rapid medical attention should be sought if abdominal pain, vomiting, or loss of appetite occurs. This medicine should not be used in patients with type 1 diabetes or diabetic ketoacidosis, nor in patients with an allergy to this medicine or its ingredients. Patients with reduced kidney function may experience delayed excretion of this medicine, so the dosage may need adjustment by a physician, and kidney status should be checked. In clinical trials, side effects such as upper respiratory tract infections, pharyngitis, headache, etc. were primarily reported, and caution is needed as hypoglycemic symptoms can occur when taking it in conjunction with other anti-diabetic medications. The risk of hypoglycemia may increase when this medicine is taken in conjunction with insulin or sulfonylureas, which can induce hypoglycemia, so blood sugar levels should be checked frequently, and dosage adjustments may be necessary. If severe joint pain or blistering symptoms occur during drug intake, consult a doctor immediately to decide whether to discontinue the medication. Pregnant or breastfeeding women should avoid taking this medicine as its safety has not been established. Elderly patients may have decreased kidney function, so it is important to conduct kidney function tests before use and adjust the dosage according to the doctor's instructions. In case of overdose, seek medical attention immediately for appropriate treatment, as this medicine can be partially removed through hemodialysis, which may be considered if necessary. This medicine tends to have fewer interactions with other medications, but certain drug interactions may lead to changes in blood concentration; hence, all currently taken medications should be disclosed to the physician.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), rash, anaphylaxis, exfoliative skin disorders (including Stevens-Johnson syndrome), acute pancreatitis, cardiac arrest, severe and disabling joint pain, bullous pemphigoid, jaundice, acute renal failure, pneumonia, diabetes complications, metabolic acidosis, respiratory distress, severe neurological symptoms, severe hypoglycemia

Mild side effects

  • Pharyngitis
  • upper respiratory infections
  • headache
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • vomiting
  • muscle pain
  • limb pain
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  • back pain
  • pruritus
  • thrombocytopenia
  • severe hypoglycemia
  • indigestion
  • dizziness
  • increased ALT
  • increased AST
  • increased 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 medicine should be stored in a tightly sealed container to prevent air or moisture ingress, preferably at a temperature between 1 and 30 degrees Celsius room temperature. Storing it this way helps maintain the efficacy and prevent degradation of the medicine.

Appearance and packaging

Appearance

Bright brown, round, bilaterally convex film-coated tablets

Package unit

28 tablets/PTP [(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.