Sitagliptin Tablet 100 mg (Sitagliptin Hydrochloride Monohydrate)

Adult dose

This medicine is administered at a dosage of 100 mg once daily as monotherapy or in combination therapy, with a maximum daily dosage of 100 mg. For renal impairment patients, dose adjustment is required based on kidney function. - Mild renal impairment (eGFR 60 to less than 90): No dose adjustment needed. - Moderate renal impairment (eGFR 45 to less than 60): No dose adjustment needed. - Moderate renal impairment (eGFR 30 to less than 45): 50 mg once daily.

This medicine may cause severe allergic reactions after administration, so if symptoms such as rash or difficulty breathing occur, use should be stopped immediately, and consultation with a physician is required. If symptoms of acute pancreatitis, such as abdominal pain, nausea, or vomiting occur during treatment with this medicine, immediate notification to healthcare professionals is necessary, and use should be discontinued if pancreatitis is suspected. This medicine should not be used in patients with type 1 diabetes or diabetic ketoacidosis, and should also not be administered in cases of hypersensitivity to this medicine or its components. Patients with reduced kidney function may have delayed excretion of this medicine, so dose adjustment is necessary, and regular kidney function tests should be performed. In clinical trials, common side effects reported were upper respiratory tract infections, nasopharyngitis, and headaches, and the risk of hypoglycemia may increase when taken together with insulin or sulfonylureas. If severe arthralgia or bullous eruptions occur during treatment with this medicine, inform a physician immediately and discontinue use. Women who are pregnant or nursing are advised not to take this medicine, and safety has not been established for children or adolescents under 18 years of age. Elderly patients should be cautious of dose adjustment and kidney function monitoring as they may have reduced kidney function. In the event of overdose, general treatment can be administered, and blood dialysis may be performed if necessary to remove the medicine. Interactions with other drugs are relatively few; however, caution is needed when taken with cyclosporine or digoxin, and consultation with healthcare professionals is required.

Serious side effects

Rash, severe swelling (angioedema), anaphylaxis, severe skin reactions (Stevens-Johnson syndrome, exfoliative dermatitis, rash), acute pancreatitis (including hemorrhagic or necrotizing), difficulty breathing, severe and disabling arthralgia, bullous pemphigoid, liver disorders (elevated liver enzyme levels, jaundice-related liver diseases, etc.), acute renal failure, cardiac arrest, severe headache, seizures, altered consciousness, visual disturbances, paralysis, severe

Mild side effects

• Upper respiratory tract infection
• nasopharyngitis
• constipation
• vomiting
• headache
• myalgia
• limb pain
• back pain
• pruritus
• thrombocytopenia

This medicine must be stored in a tightly sealed container to prevent air ingress, and it is advisable to keep it at room temperature between 1 degree and 30 degrees Celsius. This helps to maintain the medicine's effectiveness.

Appearance

Bright brown, round, bilaterally convex film-coated tablet

Package unit

28 tablets/PTP [(14 tablets/PTP x 2)]