SBIA Tablets 50 mg (Sitagliptin Hydrochloride Monohydrate)

Adult dose

This medication is administered once daily at a dose of 100 mg in monotherapy or combination therapy, with a maximum dose of 100 mg per day. In patients with renal impairment, dosage adjustments are necessary based on kidney function. - For mild to moderate renal impairment (eGFR 45 to less than 90), no dosage adjustment is required. - For moderate renal impairment (eGFR 30 to less than 45), 50 mg is administered once daily. - Severe

This medication may cause serious allergic reactions in some patients; therefore, if any symptoms such as skin rash, difficulty breathing, or swelling of the face or neck occur after taking the medicine, discontinue immediately and consult a physician. It may induce pancreatitis, a condition characterized by inflammation of the pancreas; if symptoms such as abdominal pain, vomiting, or loss of appetite appear, inform healthcare professionals immediately. This drug should not be used in patients with type 1 diabetes or diabetic ketoacidosis, and those with a history of allergic reactions to the drug or its components should avoid its use. Patients with impaired kidney function may have difficulty excreting the drug, increasing the risk of side effects, so dosage adjustments according to physician directions and regular kidney function tests are necessary. During treatment with this drug, symptoms such as upper respiratory infection, nasopharyngitis, headache, diarrhea, nausea may occur, particularly when taken with insulin or sulfonylurea, where the risk of hypoglycemic symptoms may be more frequent, requiring careful monitoring of blood glucose levels. Severe joint pain or skin diseases with blistering may occur; if such symptoms appear, notify a physician immediately, and medication may need to be discontinued if necessary. It is not recommended for use in pregnant or breastfeeding women, and safety for children and adolescents under 18 years old has not been established. Elderly patients may be at risk of impaired kidney function, thus require dosage adjustments and kidney function tests. In case of overdose, general symptomatic treatment is provided, and blood dialysis may be helpful if needed, following the healthcare provider's instructions. This medication may increase the risk of hypoglycemia when used with other hypoglycemic agents, requiring careful dosage adjustments of concomitant medications. Finally, abnormal liver function, deteriorating kidney function, skin rash, muscle pain, and various side effects have been reported, and any abnormal symptoms should be promptly discussed with healthcare professionals.

Serious side effects

• Hives
• severe swelling (angioedema)
• anaphylaxis
• skin rash
• Stevens-Johnson syndrome
• exfoliative dermatitis
• acute pancreatitis
• acute renal failure
• severe joint pain with disability
• blistering dermatitis

Mild side effects

• Nasopharyngitis
• upper respiratory infection
• headache
• diarrhea
• nausea
• abdominal pain
• constipation
• vomiting
• muscle pain
• limb pain

This medication should be stored in a sealed container to prevent air and moisture ingress, preferably at room temperature between 1 to 30 degrees Celsius. Proper storage maintains the effectiveness of the medication and prevents deterioration.

Appearance

Pale yellow-pink, round, biconvex, film-coated tablet

Package unit

(30 tablets) 10 tablets/PTP (x3)