Sitafio Tablets 100/15 mg (Sitagliptin Phosphate Hydrate, Pioglitazone Hydrochloride)

Adult dosage

This medicine may be administered as a single tablet once daily regardless of meals to patients with type 2 diabetes receiving both sitagliptin 100 mg and pioglitazone 15 mg or 30 mg. If the estimated glomerular filtration rate (eGFR) is above 45 mL/min/1.73 m2, no dose adjustment based on kidney function is necessary. If the estimated glomerular filtration rate (eGFR) is below 45 mL/min/1.73 m2, this medicine is

This medicine contains sitagliptin and pioglitazone and is used for the treatment of type 2 diabetes. The sitagliptin component can occasionally cause serious allergic reactions, so if symptoms such as skin rash, difficulty breathing, or swelling of the face or neck occur, you should immediately stop taking it and consult a doctor. Additionally, there is a risk of acute pancreatitis (inflammation of the pancreas), so if abdominal pain, nausea, or vomiting occurs during treatment, you should inform medical personnel immediately. The pioglitazone component can worsen heart failure in patients with weak cardiac function, so patients with heart failure or a history of heart failure should not take this medicine. During treatment, symptoms of heart failure such as weight gain, edema, and difficulty breathing should be carefully monitored, and if these symptoms occur, you should consult a doctor. This medicine requires dose adjustment in patients with reduced kidney function, and should not be taken by patients with severe renal impairment. Additionally, caution is needed in patients with liver dysfunction, and the decision to take the medicine should be based on liver function test results. This medicine should not be administered to patients with a history of bladder cancer or active bladder cancer, and should not be used if gross hematuria is observed. Women who are pregnant or may become pregnant should avoid taking this medicine, and premenopausal women should use appropriate contraception, as this medicine may promote ovulation. During treatment, symptoms of hypoglycemia (such as dizziness, tremors, cold sweat, etc.) may occur, so caution is necessary, especially when taking it in conjunction with insulin or sulfonylurea agents, which increases the risk of hypoglycemia. Common side effects that may occur with this medication include upper respiratory infections, headaches, edema, weight gain, dyspepsia, and diarrhea; if these symptoms are severe or persistent, you should inform medical personnel. Additionally, serious side effects such as liver dysfunction, joint pain, skin rash, and thrombocytopenia have been reported rarely, so if any unusual symptoms occur, seek medical attention immediately. There is a possibility of drug interactions with this medicine, so if you are taking other medications, you must inform your doctor or pharmacist, particularly when used in conjunction with cyclosporine, digoxin, gemfibrozil, etc. This medicine is inappropriate for use in patients before or after surgery, those with severe infections or trauma, patients with diabetic ketoacidosis, or those with type 1 diabetes, thus alternative treatments should be used. During the use of this medicine, regular blood glucose, kidney, and liver function tests should be conducted, and immediate consultation with medical personnel is crucial if any unusual symptoms arise.

Serious side effects

• Hives
• severe swelling (edema)
• anaphylaxis
• angioedema
• severe allergic reaction
• Stevens-Johnson syndrome
• exfoliative skin condition
• severe rash with high fever
• blisters
• skin peeling

Mild side effects

• Nasopharyngitis
• upper respiratory infection
• headache
• diarrhea
• nausea
• constipation
• muscle pain
• limb pain
• back pain
• pruritus

This medicine should be stored in a container that blocks light and air, maintained at a temperature between 15 to 30 degrees Celsius in a location with low humidity. This helps to preserve the efficacy of the medicine and prevent deterioration.

Appearance

Light orange oblong film-coated tablet

Package unit

28 tablets/box [14 tablets/PTP x 2]