Medication info

Hallym Sitagliptin Tablets 100mg (Sitagliptin Phosphate Hydrate)

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Sitagliptin Phosphate Hydrate›128.5mg / 1 tablet
Manufacturer / importer
한림제약(주)
Appearance
Beige, round, film-coated tablets with both sides convex
Packaging
28 tablets (14 tablets per PTP packaging × 2)
Approval status
Approval withdrawn

MFDS item code 201503151 · Approved 2015.05.26

This product's status changed to Approval withdrawn on 2024.03.06. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement in blood sugar control in type 2 diabetes
Who takes it
Adults
Adult dose
This medication is administered once daily at a dose of 100 mg, with a maximum daily dosage of 100 mg in monotherapy or combination therapy. It can be taken without regard to meals. For patients with renal impairment, dosage adjustment is necessary based on kidney function. - Mild renal impairment (eGFR 60 or more but less than 90): No dosage adjustment needed. - Moderate renal impairment (eGFR 45 or more but less than 60): No dosage adjustment needed. - Moderate renal impairment (eGFR 30 or more but less than 45): Administer 50 mg once daily. - Severe renal impairment (eGFR less than 30) or End-stage renal disease (ESRD) requiring hemodialysis or peritoneal dialysis: Administer 25 mg once daily. This medication can be taken regardless of dialysis timing.

Ingredients

Manufacturer
한림제약(주)

Efficacy & effects

Improvement in blood sugar control in type 2 diabetes

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

This medication is used to improve blood sugar control in patients with type 2 diabetes. It can be administered alone as an adjunct to dietary therapy and exercise therapy, and in patients without prior experience of diabetes medication, it is co-administered with metformin if blood sugar control is difficult. Furthermore, in cases where blood sugar control is inadequate with monotherapy using sulfonylureas, metformin, thiazolidinediones, or insulin, this medication is used in combination. It helps effectively manage blood sugar by adding this medication when blood sugar control is insufficient with various combination therapies. This medication plays a significant role in enhancing blood sugar control.

How to take

Adult dose

This medication is administered once daily at a dose of 100 mg, with a maximum daily dosage of 100 mg in monotherapy or combination therapy. It can be taken without regard to meals. For patients with renal impairment, dosage adjustment is necessary based on kidney function. - Mild renal impairment (eGFR 60 or more but less than 90): No dosage adjustment needed. - Moderate renal impairment (eGFR 45 or more but less than 60): No dosage adjustment needed. - Moderate renal impairment (eGFR 30 or more but less than 45): Administer 50 mg once daily. - Severe renal impairment (eGFR less than 30) or End-stage renal disease (ESRD) requiring hemodialysis or peritoneal dialysis: Administer 25 mg once daily. This medication can be taken regardless of dialysis timing.

Precautions

This medication may cause allergic reactions. If signs such as skin rash, difficulty breathing, or swelling of the face or neck occur, discontinue use immediately and consult a doctor. While taking this medication, inflammation of the pancreas (pancreatitis) may occur, so if you experience severe abdominal pain or vomiting, notify your healthcare provider immediately. Patients with type 1 diabetes or diabetic ketoacidosis should not use this medication. Patients with decreased kidney function need to have their dosage adjusted, and it is important to undergo kidney function tests periodically. During treatment, symptoms such as headaches, upper respiratory infections, nasopharyngitis, diarrhea, etc., may appear; if symptoms are severe, consult your doctor. The risk of hypoglycemia may increase when used with insulin or sulfonylureas, so blood sugar levels should be closely monitored. If symptoms of severe joint pain or skin blisters occur, discontinue the medication and inform your doctor immediately. Pregnant women should avoid this medication as its safety has not been established. Breastfeeding women are also recommended not to take this medication as it may be excreted in breast milk. In children and adolescents, the safety and efficacy of this medication have not been established, so it is not used. Elderly patients may have reduced kidney function requiring dosage adjustments and kidney function testing. In cases of overdose, seek appropriate treatment immediately at a medical institution. This medication may be partially removed by hemodialysis. This medication may interact with other drugs, so it is essential to inform the doctor or pharmacist of any medications currently being taken. Clinical trial results on cardiovascular safety have confirmed that this medication does not increase the risk of cardiovascular diseases.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • angioedema
  • anaphylaxis
  • Stevens-Johnson syndrome
  • severe allergic reactions
  • acute pancreatitis
  • acute kidney failure
  • severe and disabling joint pain
  • bullous pemphigoid
  • thrombocytopenia
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  • hypoglycemia
  • pneumonia
  • diabetes complications
  • metabolic acidosis
  • cardiac arrest

Mild side effects

  • Nasopharyngitis
  • upper respiratory infection
  • headache
  • diarrhea
  • nausea
  • constipation
  • muscle pain
  • limb pain
  • back pain
  • pruritus
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  • thrombocytopenia
  • indigestion
  • dizziness
  • increased triglycerides in blood
  • gastritis
  • weight loss
  • hypertension
  • hypernatremia
  • erectile dysfunction

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

Storage

Store this medication in a tightly sealed container to prevent air exposure, at a temperature between 1°C and 30°C. This is to maintain the medication's effectiveness and prevent deterioration.

Appearance and packaging

Appearance

Beige, round, film-coated tablets with both sides convex

Package unit

28 tablets (14 tablets per PTP packaging × 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.