Sitdium 50 mg (Sitagliptin Hydrochloride Hydrate)

Adult dose

This medication is administered orally as monotherapy or in combination therapy at a dose of 100 mg once daily, with a maximum daily dose of 100 mg. For patients with renal impairment, dosage adjustment is necessary based on the glomerular filtration rate. - In patients with mild to moderate renal impairment (glomerular filtration rate 45 or greater but less than 90), no dosage adjustment is necessary. - In patients with a glomerular filtration rate of 30 or greater but less than 45, the dose is 50 mg once daily.

This medication may rarely cause a severe allergic reaction, thus if symptoms such as skin rash, difficulty breathing, or swelling of the face or throat occur, you should stop taking it immediately and consult a doctor. This drug can cause a serious inflammation of the pancreas known as pancreatitis, so if symptoms such as abdominal pain, nausea, vomiting, or fever occur while taking this medication, you must stop taking it and seek medical advice. This medication should not be used in patients with type 1 diabetes or diabetic ketoacidosis, nor in patients allergic to this medication or its ingredients. Patients with impaired renal function may experience delayed excretion of this medication, and it is important to adjust the dosage under a physician's guidance and to regularly assess renal function. In clinical trials, side effects such as upper respiratory infections resembling colds, headaches, pharyngitis, and diarrhea were mostly reported, and the risk of hypoglycemia may increase when taken with insulin or sulfonylurea. Hypoglycemia symptoms may occur when this medication is used in combination with insulin or sulfonylurea, so it is important to monitor blood glucose levels frequently and adjust the dosage of these medications as necessary. If severe joint pain or blistering of the skin occurs during treatment, you should inform your physician immediately and stop taking the medication. The use of this drug is not recommended for pregnant or breastfeeding women, and its safety and efficacy have not been established in children and adolescents under 18 years of age. In cases of overdose, general emergency treatment should be conducted, and some of the drug can be removed through hemodialysis, so proper measures should be taken under the guidance of healthcare professionals. This medication generally has few drug interactions, but caution is needed when taking specific medications, so it is essential to inform healthcare providers of all medications being taken.

Serious side effects

Urticaria, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, pallor (anaphylaxis and severe allergic reactions), severe rashes along with high fever, blisters, skin peeling, pain in the mouth/eyes mucosa (Stevens-Johnson syndrome and severe skin adverse reactions), shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with cough and fever, jaundice (yellowing of the skin or eyes)

Mild side effects

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

Store this medication in a sealed container to prevent exposure to air or moisture. It is advisable to maintain the storage temperature between 1 degree and 30 degrees Celsius.

Appearance

A round, biconvex film-coated tablet in a light apricot color.

Package unit

28 tablets/box [14 tablets/PTP × 2]