SBIA Tablets 100 mg (Sitagliptin Hydrochloride Monhydrate)

Adult dose

This medication is administered as 100 mg once daily for monotherapy or combination therapy, and the maximum daily dose is 100 mg. In cases of renal impairment, dosage adjustments may be necessary based on kidney function. No dosage adjustment is required in mild to moderate renal impairment (glomerular filtration rate above 45 and below 60). For moderate renal impairment (glomerular filtration rate between 30 and 45), the dose of 50 mg is administered once daily.

This medication may cause allergic reactions; therefore, if symptoms such as skin swelling or difficulty breathing occur, the medication should be discontinued immediately and a healthcare professional should be consulted. This medication may cause a serious pancreatic disease known as pancreatitis, so if symptoms such as abdominal pain, vomiting, or nausea occur during use, it is important to inform medical personnel promptly. 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 severe allergy to this medication or its components. Patients with impaired kidney function may require dosage adjustments for this medication, so kidney function tests should be conducted before use, and the physician's instructions should be followed. While taking this medication, side effects similar to cold symptoms, headaches, diarrhea, and nausea may occur, particularly attention should be paid to hypoglycemia symptoms. When taken with other antidiabetic medications or insulin, the risk of hypoglycemia may increase, and the physician may adjust the medication dosage as necessary. If severe joint pain or skin blisters occur, notify a doctor immediately and discontinue medication use. Pregnant or breastfeeding women should preferably avoid this medication, and safety and effectiveness have not been established in children under 18 years of age. Elderly patients may have a possibility of decreased kidney function, so regular monitoring of kidney function should be conducted, and dosage adjustments may be needed as necessary. In cases of overdose, measures such as gastrointestinal decontamination or clinical monitoring including electrocardiogram tests will be implemented, and some may be removed by hemodialysis if necessary.

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, pallor (severe allergic reaction), rash accompanied by high fever, blisters, desquamation of the skin, pain in mucous membranes of the mouth/eyes (severe skin adverse reactions), acute pancreatitis (including fatal/non-fatal hemorrhagic or necrotizing pancreatitis), shortness of breath or difficulty breathing, asthma attacks, respiratory difficulties accompanied by cough + fever, yellowing of the skin or eyes

Mild side effects

• Upper respiratory infections
• nasopharyngitis
• headache
• abdominal pain
• nausea
• diarrhea
• constipation
• vomiting
• myalgia
• limb pain

This medication should be stored in a tightly sealed container to prevent air and moisture from entering. It is advisable to maintain storage temperature between 1°C and 30°C at room temperature. By storing it this way, the efficacy of the medication can be safely maintained.

Appearance

Pale orange, round, biconvex film-coated tablet

Package unit

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