Medication info
Therabia Tablets 50 mg (Sitagliptin Hydrochloride Hydrate)

Therabia Tablets 50 mg (Sitagliptin Hydrochloride Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›56.7mg / 1 tablet
Manufacturer / importer
(주)테라젠이텍스
Appearance
Light apricot-colored, round, biconvex film-coated tablets
Packaging
28 tablets/PTP [(14 tablets/PTP x 2)]
Approval status
Active

MFDS item code 202101859 · Approved 2021.02.24 · Insurance code 698504740

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who takes it
Adults
Adult dose
For monotherapy or combination therapy, administer 100 mg once daily, with a maximum daily dose of 100 mg. In patients with renal impairment, dosage adjustment is required based on kidney function. - In patients with mild to moderate renal impairment (eGFR 45 to less than 90), no dosage adjustment is necessary. - In patients with moderate renal impairment (eGFR 30 to less than 45), administer 50 mg once daily. - In patients with severe renal impairment

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 medication is used in combination with dietary and exercise therapy to help control blood sugar in patients with type 2 diabetes. It can be administered alone for patients using it for the first time, and if blood sugar control is difficult with monotherapy, it can be combined with Metformin. Additionally, when blood sugar control is insufficient with monotherapy of sulfonylureas, Metformin, thiazolidinediones, or insulin, this medication can be combined to enhance therapeutic effects. Even when it is difficult to control blood sugar with multiple medications, this drug can be used additionally. This medication improves blood sugar control in type 2 diabetes patients across various treatment scenarios.

How to take

Adult dose

For monotherapy or combination therapy, administer 100 mg once daily, with a maximum daily dose of 100 mg. In patients with renal impairment, dosage adjustment is required based on kidney function. - In patients with mild to moderate renal impairment (eGFR 45 to less than 90), no dosage adjustment is necessary. - In patients with moderate renal impairment (eGFR 30 to less than 45), administer 50 mg once daily. - In patients with severe renal impairment

Precautions

This medication is used for the treatment of diabetes and helps in blood sugar control. Points to be cautious about during usage include the possibility of allergic reactions to this medication; therefore, if there are symptoms such as skin rash, breathing difficulties, or swelling of the face or neck, immediately discontinue the medication and consult a doctor. Furthermore, serious pancreatic inflammation known as pancreatitis may occur, so if symptoms such as abdominal pain, nausea, or vomiting appear after taking this medication, inform medical personnel immediately. It should not be used in patients with type 1 diabetes or diabetic ketoacidosis, and those with hypersensitivity to this drug or its components should also avoid taking it. Patients with impaired kidney function may require dosage adjustments due to increased drug concentration, and regular kidney function checks before and during treatment are advisable. Hypoglycemia may occur during the use of this medication; therefore, when taken with other hypoglycemic agents like insulin or sulfonylureas, attention should be paid to hypoglycemic symptoms, and dosage adjustments of other medications may be necessary. Additionally, rare side effects such as severe joint pain or bullous pemphigoid, which causes blisters on the skin, may occur, and symptoms should be reported to a doctor immediately if they arise. The use of this medication is not recommended during pregnancy or breastfeeding, and safety has not been established in children and adolescents under 18 years of age. In the event of overdose, gastrointestinal removal of the drug and clinical monitoring including ECG may be necessary, and in some cases, blood dialysis may be required to eliminate some of the medication. Finally, this medication has been reported to pose no cardiovascular safety issues and does not increase the risk of heart disease or heart failure.

Side effects and when to seek care immediately

Serious side effects

  • Hives, severe swelling (angioedema), tightness in the chest, difficulty breathing, cold sweat, pallor (severe allergic reaction)
  • Severe rash with high fever, blisters, skin shedding, pain in oral/ocular mucosa (severe skin abnormal reactions)
  • Difficulty breathing or shortness of breath, asthma attacks, cough + abnormal breathing with fever
  • Yellowing of skin or eyes (jaundice), extreme lethargy (liver abnormality)
  • Sudden and very severe headache, lightning-like pain

Mild side effects

  • Upper respiratory tract infection
  • nasopharyngitis
  • constipation
  • vomiting
  • headache
  • muscle pain
  • limb pain
  • back pain
  • pruritus
  • diarrhea
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  • nausea
  • dyspepsia
  • dizziness
  • increased blood triglycerides
  • increased low-density lipoprotein
  • hyperglycemia
  • weight loss
  • 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 air and moisture from entering, and it is advisable to keep it at a temperature between 1 degrees Celsius and 30 degrees Celsius at room temperature. Storing it this way will help maintain the effectiveness of the medication for a long period.

Appearance and packaging

Appearance

Light apricot-colored, round, biconvex 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.