Janusitin 50 mg (Sitagliptin Hydrochloride Hydrate)

Adult dose

This medicine 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. In patients with renal impairment, dosage adjustment may be necessary based on kidney function. - Mild renal impairment: No dosage adjustment needed - Moderate renal impairment (glomerular filtration rate 30-60 mL/min/1.73m2): Administer 50 mg once daily - Severe renal impairment and dialysis patients: once daily

This medicine may cause severe allergic reactions; therefore, if symptoms such as skin rash or difficulty breathing occur within 3 months of administration, immediately discontinue use and consult a doctor. This medicine may induce acute pancreatitis, so if symptoms such as abdominal pain, vomiting, or nausea appear, discontinue use immediately and inform healthcare professionals. This medicine should not be used in patients with type 1 diabetes or diabetic ketoacidosis, and should also be avoided in those with allergies to the drug or its components. Patients with impaired kidney function may have difficulty excreting this medicine, thus dosage adjustment is necessary, and periodic kidney function tests are recommended. During treatment with this medicine, symptoms of hypoglycemia may occur; therefore, blood sugar levels should be monitored closely, especially when taken with insulin or sulfonylureas. If severe joint pain or skin blistering occurs, inform a doctor immediately and discontinue use. Pregnant or breastfeeding women are advised not to use this medicine, and its safety and efficacy have not been established in children or adolescents under 18 years of age. Elderly patients may experience decreased kidney function, so dosage adjustment and monitoring of kidney function is necessary. In the case of overdose, seek medical attention immediately for appropriate treatment, and consider that some may be removed by hemodialysis, thus it might be necessary to take this into account for dialysis patients. This medicine generally has low interaction with other diabetes medications, but when used in conjunction with specific drugs, blood concentrations may change, therefore, consultation with a doctor prior to use is necessary.

Serious side effects

Urticaria, angioedema, anaphylaxis, Stevens-Johnson syndrome, exfoliative skin disease, hemorrhagic or necrotizing pancreatitis including acute pancreatitis, acute renal failure, pneumonia, cardiac arrest, rash, severe allergic reactions, severe joint pain accompanying disability, bullous pemphigoid, elevation of liver enzymes, liver abnormalities (possible jaundice), severe hypoglycemia, thrombocytopenia

Mild side effects

• Upper respiratory tract infection
• nasopharyngitis
• headache
• diarrhea
• nausea
• indigestion
• dizziness
• abdominal pain
• constipation
• vomiting

This medicine should be stored in a tightly sealed container to prevent air exposure, at room temperature between 1 degree and 30 degrees Celsius. Storing it this way will help maintain its effectiveness for a longer period.

Appearance

A light orange, round, biconvex, film-coated tablet

Package unit

28 tablets/box [14 tablets/PTP*2], 30 tablets/box [10 tablets/PTP*3]