Medication info
Sitagliptin Phosphate Hydrate 100 mg (Sitagliptin Phosphate Monohydrate)

Sitagliptin Phosphate Hydrate 100 mg (Sitagliptin Phosphate Monohydrate)

Prescription medicationTablet경구
Ingredient · strength
Sitagliptin Phosphate Hydrate›128.5mg / 1 tablet
Manufacturer / importer
(주)종근당
Appearance
Beige round film-coated tablets
Packaging
PTP - 30 tablets/box [10 tablets/PTP x 3]
Approval status
Active

MFDS item code 201503476 · Approved 2015.05.29 · Insurance code 643307090

Summary

Main use
Improvement of blood glucose control in type 2 diabetes
Who takes it
Adults
Adult dose
The medication is administered once daily at a dosage of 100 mg for monotherapy or combination therapy, with a maximum daily dosage of 100 mg. It can be taken regardless of meals. For renal impairment patients, dose adjustments are necessary according to kidney function. No dose adjustment is needed for mild and moderate renal impairment (eGFR 45 mL/min/1.73 m² or greater).

Ingredients

Manufacturer
(주)종근당

Efficacy & effects

Improvement of blood glucose control in type 2 diabetes

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

This medication is used in conjunction with diet and exercise to improve blood glucose control in patients with type 2 diabetes. It can be used alone; however, if monotherapy is insufficient for initial treatment, it can be used in combination with metformin. Additionally, when blood glucose control is difficult with sulfonylureas, metformin, thiazolidinedione, or insulin monotherapy, the medication can be co-administered to enhance therapeutic effects. For patients requiring complex medication regimens, it is added to combination therapies of sulfonylureas and metformin, or thiazolidinedione and metformin, or insulin and metformin. Its flexible usability in diverse situations effectively improves blood glucose control.

How to take

Adult dose

The medication is administered once daily at a dosage of 100 mg for monotherapy or combination therapy, with a maximum daily dosage of 100 mg. It can be taken regardless of meals. For renal impairment patients, dose adjustments are necessary according to kidney function. No dose adjustment is needed for mild and moderate renal impairment (eGFR 45 mL/min/1.73 m² or greater).

Precautions

This medication may cause severe allergic reactions in some patients; if symptoms such as skin rash, breathing difficulties, or swelling of the face or neck occur, discontinue use immediately and consult a healthcare professional. While taking this medication, symptoms of pancreatitis, which is inflammation of the pancreas, may occur, so if you experience abdominal pain, vomiting, or decreased appetite, you should visit a hospital immediately. Patients with type 1 diabetes or diabetic ketoacidosis should not take this medication, and it should be avoided if there is an allergy to this medication or its ingredients. Patients with impaired kidney function should adjust the dose of this medication, so if there are kidney diseases, consult a doctor to determine the appropriate dose. This medication can be used alone or in combination with other diabetes medications; however, when used with insulin or sulfonylureas, the risk of hypoglycemia may increase, so blood glucose levels should be monitored regularly and dose adjustments made as necessary. Pregnant or breastfeeding women are advised against using this medication, and safety in children and adolescents under 18 has not been established. Elderly patients may have reduced kidney function, so it is important to regularly check kidney function before and after taking this medication. In case of overdose, symptomatic treatment is necessary, and this medication may be partially removed through hemodialysis, so dialysis treatment may be considered in cases of severe overdose. If joint pain or skin blisters occur while taking this medication, inform a healthcare professional immediately for appropriate diagnosis and treatment. Additionally, side effects such as upper respiratory infections, headaches, indigestion, and diarrhea have been reported in some patients, so if abnormal symptoms persist, consult a healthcare professional. Lastly, this medication generally has few drug interactions but consulting a doctor or pharmacist when taking certain medications is advisable.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), anaphylaxis, chest tightness, difficulty breathing, severe allergic reactions, severe rash with high fever, blisters, skin peeling, oral/ocular mucosal pain, Stevens-Johnson syndrome, acute pancreatitis (including hemorrhagic or necrotizing), liver abnormalities (jaundice), sudden and severe headaches, seizures, altered consciousness, visual disturbances, paralysis, serious neurological symptoms, decreased urine output, systemic reactions

Mild side effects

  • Pharyngitis
  • upper respiratory infection
  • headache
  • constipation
  • vomiting
  • myalgia
  • limb pain
  • back pain
  • pruritus
  • thrombocytopenia
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  • diarrhea
  • nausea
  • indigestion
  • dizziness
  • increased blood triglycerides
  • elevated 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 prevent the ingress of air or moisture, and it is best kept at temperatures between 1°C and 30°C at room temperature. Storing it this way helps maintain the drug's effectiveness for a longer period.

Appearance and packaging

Appearance

Beige round film-coated tablets

Package unit

PTP - 30 tablets/box [10 tablets/PTP x 3]

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.