Medication info

Sitagliptin Tablet 100 mg (Sitagliptin Phosphate Hydrate)

Prescription medicationTablet경구Expired
Ingredient · strength
Sitagliptin Phosphate Hydrate›128.5mg / 1 tablet
Manufacturer / importer
신풍제약(주)
Appearance
Beige, round, biconvex film-coated tablet
Packaging
100 tablets/box [(10 tablets/PTP × 10)]
Approval status
Expired

MFDS item code 201500229 · Approved 2015.01.16

This product's status changed to Expired on 2025.01.16. 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
The usual dosage is 100 mg once daily, either alone or in combination therapy, with a maximum daily dosage of 100 mg. This medication can be taken regardless of meals. Dosage adjustment for patients with renal impairment: 1. In patients with mild renal impairment (eGFR ≥ 60 mL/min/1.73 m2 and < 90 mL/min/1.73 m2), no dosage adjustment is needed. 2. In patients with moderate renal impairment (eGFR ≥ 45 mL/min/1.73 m2 and < 60 mL/min/1.73 m2), no dosage adjustment is needed.

Ingredients

Manufacturer
신풍제약(주)

Efficacy & effects

Improvement in 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 in conjunction with diet and exercise to improve blood sugar control in patients with type 2 diabetes. It can be administered as monotherapy, and in cases where there is no prior experience with diabetes medication and blood sugar control is difficult with monotherapy, it is combined with metformin. Additionally, it is used in conjunction with sulfonylureas, metformin, thiazolidinediones, and in cases where insulin alone is insufficient for blood sugar control. Furthermore, it can be added to various combination therapies when blood sugar control remains inadequate. In these diverse scenarios, this medication assists in blood sugar regulation.

How to take

Adult dose

The usual dosage is 100 mg once daily, either alone or in combination therapy, with a maximum daily dosage of 100 mg. This medication can be taken regardless of meals. Dosage adjustment for patients with renal impairment: 1. In patients with mild renal impairment (eGFR ≥ 60 mL/min/1.73 m2 and < 90 mL/min/1.73 m2), no dosage adjustment is needed. 2. In patients with moderate renal impairment (eGFR ≥ 45 mL/min/1.73 m2 and < 60 mL/min/1.73 m2), no dosage adjustment is needed.

Precautions

This medication may cause serious allergic reactions in some patients; therefore, if symptoms such as skin rash, difficulty breathing, or swelling of the face or neck occur within three months of first use, the medication should be stopped immediately and medical consultation should be sought. This medication may cause a serious inflammation of the pancreas called pancreatitis, and if severe abdominal pain, vomiting, or loss of appetite occurs, the healthcare provider should be notified immediately. This medication should not be used in patients with type 1 diabetes or diabetic ketoacidosis, and it should not be administered if there is a known allergy to this medication or its components. Patients with impaired kidney function may need dose adjustments, and particularly those with low glomerular filtration rates or those undergoing dialysis should strictly follow the physician's instructions. This medication can be used alone or in combination with other diabetes treatments, but some patients may experience side effects such as cold symptoms, headaches, and gastrointestinal disturbances. When taken with insulin or sulfonylureas, the risk of hypoglycemia may increase; therefore, blood sugar levels should be monitored regularly, and dosages of other medications should be adjusted as necessary. Pregnant or breastfeeding women are advised not to use this medication, and the safety for children or adolescents under 18 years has not been established. Elderly patients may experience reduced kidney function, so kidney function testing before and during treatment is recommended. In case of overdose, general symptomatic treatment should be initiated, and some of this medication can be removed via dialysis. If during treatment, unusual symptoms such as joint pain or skin blisters occur, it is important to consult a doctor immediately. Additionally, while drug interactions with this medication are limited, caution is required when used in combination with digoxin, so all medications currently being taken should be reported to the healthcare provider.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), anaphylaxis, angioedema, severe allergic reactions, Stevens-Johnson syndrome, exfoliative dermatitis, severe rash with high fever, blisters, skin peeling, pain in mucosal membranes of mouth/eyes, severe skin adverse reactions, difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, respiratory issues, yellowing of skin or eyes (jaundice), liver abnormalities, sudden and severe headaches

Mild side effects

  • Nasopharyngitis
  • upper respiratory infections
  • headaches
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • vomiting
  • muscle pain
  • limb pain
Show 14 more
  • back pain
  • pruritus
  • thrombocytopenia
  • blistering dermatitis
  • severe and disabling joint pain
  • dyspepsia
  • dizziness
  • increased blood triglycerides
  • increased low-density lipoprotein
  • 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 tightly sealed container to protect it from air and moisture. It is recommended to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

Beige, round, biconvex film-coated tablet

Package unit

100 tablets/box [(10 tablets/PTP × 10)]

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.