Medication info

Sitamono Tablet 50 mg (Sitagliptin Hydrochloride Monohydrate)

Prescription medicationTabletApproval withdrawn
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›56.7mg / 1 tablet
Manufacturer / importer
일동제약(주)
Appearance
A film-coated tablet that is round, biconvex, and light apricot in color
Packaging
28 tablets/box [14 tablets/pity *2]
Approval status
Approval withdrawn

MFDS item code 202101849 · Approved 2021.02.24

This product's status changed to Approval withdrawn on 2025.08.12. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of blood glucose control in type 2 diabetes
Who uses it
Adults
Adult dosage
This medication is administered as a once-daily dose of 100 mg, either as monotherapy or in combination therapy, with a maximum daily dose of 100 mg. It can be taken regardless of meals. In patients with renal impairment, dosage adjustments are necessary based on renal function. - For patients with mild renal impairment (eGFR 60 or more and less than 90): no dosage adjustment required - For patients with moderate renal impairment (eGFR 45 to less than 60): no dosage adjustment required - For patients with moderate renal impairment

Ingredients

Manufacturer
일동제약(주)

Efficacy & effects

Improvement of blood glucose control in type 2 diabetes

  • Type 2 diabetes
  • difficulty in blood glucose control
View approved original text

This medication is used in conjunction with dietary and exercise therapy to improve blood glucose control in patients with type 2 diabetes. It can be administered alone, and can be co-administered with metformin in cases where blood glucose control is inadequate with monotherapy and there has been no prior experience with diabetes medication. Additionally, it can be combined when blood glucose control is difficult using monotherapy with sulfonylureas, metformin, thiazolidinediones, or insulin. If the effect is insufficient even with combinations of various agents, this medication can be added to enhance blood glucose control.

Dosage and Administration

Adult dosage

This medication is administered as a once-daily dose of 100 mg, either as monotherapy or in combination therapy, with a maximum daily dose of 100 mg. It can be taken regardless of meals. In patients with renal impairment, dosage adjustments are necessary based on renal function. - For patients with mild renal impairment (eGFR 60 or more and less than 90): no dosage adjustment required - For patients with moderate renal impairment (eGFR 45 to less than 60): no dosage adjustment required - For patients with moderate renal impairment

Precautions

This medication may cause severe allergic reactions; therefore, if symptoms such as skin rash, difficulty breathing, or swelling of the face or neck occur, discontinue use immediately and seek medical attention. While taking this medication, symptoms of acute pancreatitis, which is inflammation of the pancreas, may occur; if there is severe abdominal pain or vomiting, notify the healthcare provider immediately. This medication should not be used in patients with type 1 diabetes or diabetic ketoacidosis, and also should not be administered to those with known allergies to this drug or its components. Patients with impaired renal function should have their dosage adjusted and regularly undergo renal function tests. Hypoglycemia may occur when this medication is used alone or in combination with other diabetes medications, so it is important to be well aware of hypoglycemia symptoms, especially when taken with insulin or sulfonylureas. During treatment with this medication, symptoms such as headache, upper respiratory tract infection, nasopharyngitis, diarrhea, nausea, etc. may occur; patients should consult a physician if the symptoms are severe or persistent. Women who are pregnant or breastfeeding are advised not to take this medication, and safety in children under 18 has not been established. Elderly patients should have dosage adjustments and renal function tests due to the potential for impaired renal function. In the case of overdose, seek medical attention immediately for appropriate treatment; this medication may be partially removed via hemodialysis. Furthermore, if patients experience severe joint pain or skin blisters during treatment with this medication, they must inform their doctor immediately; discontinuation and treatment may be necessary. Finally, this medication has relatively few drug interactions, but consultation with healthcare providers for appropriate monitoring is advised when taken concurrently with cyclosporine or digoxin.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (angioedema), anaphylaxis, severe hypersensitivity reactions, Stevens-Johnson syndrome, exfoliative skin conditions, acute pancreatitis (hemorrhagic or necrotizing, fatal/non-fatal), difficulty breathing, acute renal failure, severe and disabling arthralgia, bullous pemphigoid, jaundice (including increased liver enzymes), cardiac arrest, pneumonia, diabetes complications, metabolic acidosis, falls, rhabdomyolysis

Mild side effects

  • Nasopharyngitis
  • upper respiratory tract infection
  • headache
  • diarrhea
  • nausea
  • constipation
  • myalgia
  • limb pain
  • back pain
  • pruritus
Show 9 more
  • thrombocytopenia
  • dyspepsia
  • dizziness
  • increased blood triglycerides
  • increased low-density lipoprotein
  • hyperglycemia
  • hypertension
  • weight loss
  • 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 that does not allow air to penetrate, preferably between 1 degree to 30 degrees Celsius at room temperature. Proper storage will help maintain the drug's efficacy for a longer period.

Appearance and packaging

Appearance

A film-coated tablet that is round, biconvex, and light apricot in color

Package unit

28 tablets/box [14 tablets/pity *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.