Sitagliptin Prolonged-Release Tablets 50/500 mg (Sitagliptin Hydrochloride Monohydrate, Metformin Hydrochloride)

Adult dose

In the context of antidiabetic therapy, the dosage of this medication is determined by considering each component's maximum recommended daily dosage, which should not exceed sitagliptin 100 mg and metformin 2000 mg, along with each patient's current treatment regimen, efficacy, and tolerability. This medication should be taken once daily in the evening with food to reduce gastrointestinal adverse effects caused by metformin, and the dosage should be gradually increased. To maintain prolonged-release properties, this medication should be swallowed whole and not split, crushed, or chewed. It has been reported that the medication can be improperly solubilized and excreted in feces. It is not known whether the active ingredient is included in the material excreted in feces. If a patient repeatedly reports finding this medication in feces, healthcare professionals should assess whether blood sugar is appropriately controlled (refer to usage precautions, 5. General precautions section). This medication 100/1000 mg prolonged-release is taken once daily, one tablet at a time. Patients taking this medication 50/500 mg prolonged-release or 50/1000 mg prolonged-release should take two tablets simultaneously once daily. 1. Patients who are not currently receiving treatment with metformin: This medication's initial dosage for patients with no prior experience of diabetes medication treatment, and who find it difficult to achieve sufficient blood sugar control with monotherapy or sitagliptin monotherapy, is a total daily dose of sitagliptin 100 mg and metformin 1000 mg. If sufficient blood sugar control cannot be achieved with the initial dosage, the dosage may be gradually increased up to the maximum recommended daily dose of metformin 2000 mg to reduce gastrointestinal adverse effects caused by metformin. Patients with kidney dysfunction who are reducing the dosage of sitagliptin should not switch to this medication (refer to usage precautions 2. Do not administer to the following patients section). 2. Patients being treated with metformin: - Recommended initial dosage of this medication for patients unable to achieve sufficient blood sugar control with metformin monotherapy is a total daily dose of sitagliptin 100 mg and the current metformin dosage. - Patients switching from combination therapy with sitagliptin and metformin can start at their current dosage of both medications. - Patients who were taking immediate-release metformin at a current dosage of 850 mg or 1000 mg twice daily can start this medication 50/1000 mg prolonged-release at a dose of 2 tablets once daily. 3. For patients unable to achieve sufficient blood sugar control with combination therapies such as metformin and sulfonylurea, metformin and insulin, or metformin and thiazolidinedione: The initial dosage of this medication is a total daily dose of sitagliptin 100 mg, and the initial dosage of metformin must consider the patient's blood sugar levels and current dosage. To reduce gastrointestinal adverse effects caused by metformin, the dosage should be gradually increased. When combined with sulfonylurea or insulin, consider reducing their dosages to decrease the risk of hypoglycemia induced by sulfonylurea or insulin (refer to usage precautions 5. General precautions section). There have been no studies examining the safety and efficacy of switching to this medication from other oral hypoglycemic agents for patients. Any changes in the treatment regimen for type 2 diabetes may lead to changes in blood sugar control, thus careful monitoring is warranted. Patients with kidney dysfunction This medication can be used for patients with moderate kidney dysfunction stage 3a (creatinine clearance [CrCl] ≥ 45 and <60 mL/min or estimated glomerular filtration rate [eGFR] ≥ 45 and <60 mL/min/1.73 m2) if there are no accompanying symptoms that could increase the risk of lactic acidosis, with appropriate dose adjustments. The starting dosage of metformin should be administered once daily at 500 mg or 850 mg, thus initiation with this medication is not recommended. The maximum recommended dose of metformin is 1000 mg. Renal function should be monitored carefully every 3 to 6 months. If CrCl <45 mL/min or eGFR <45 mL/min/1.73 m2, this medication should be immediately discontinued. Patients with liver dysfunction This medication should not be administered to patients with liver impairment due to the metformin component (refer to usage precautions 2. Do not administer to the following patients section).

This medication contains both sitagliptin and metformin. Due to potential precautions, it is crucial to follow the doctor's or pharmacist's instructions carefully. First, this medication can cause allergic reactions; therefore, if symptoms such as rash, difficulty breathing, or swelling of the face or neck occur after administration, immediately discontinue use and visit a hospital. Additionally, there is a risk of pancreatitis, a serious pancreatic condition; if symptoms such as abdominal pain, nausea, vomiting, or fever arise, notify healthcare professionals immediately. Patients with impaired kidney function, dehydration, severe infections, or heart diseases should avoid taking this medication. Especially in cases of moderate to severe renal impairment, administration is contraindicated. This medication should be temporarily discontinued before and after tests using iodine contrast agents, and can be resumed after confirming normal kidney function. Women who are pregnant or may become pregnant, and nursing mothers should not take this medication. This medication can cause hypoglycemia; therefore, caution is needed if irregular eating, insufficient food intake, or excessive exercise occurs. The risk of hypoglycemia may increase when taken with other blood sugar-lowering agents, so consult a doctor. Gastrointestinal side effects (diarrhea, nausea, vomiting, abdominal pain) may occur during treatment, and if these symptoms are severe, inform a healthcare professional. Patients with poor liver function or severe lung disease are also advised to avoid this medication. There is a rare but serious risk of lactic acidosis associated with this medication, so if symptoms such as weakness, muscle pain, difficulty breathing, or abdominal pain occur, immediately discontinue use and seek hospital care. Additionally, regular monitoring of kidney function and blood tests is advisable, and it is recommended to check vitamin B12 levels as well. Excessive alcohol intake increases the risk of side effects, so it is safer to avoid drinking while on this medication. Treatment should be interrupted for a certain period before and after surgery, and can be resumed after confirming normal kidney function and oral intake post-surgery. This medication has not been established for safety and efficacy in children or adolescents under 18, so it is advised not to use it in these groups. Older adults may have reduced kidney function, so dosage adjustments should be made under a doctor's supervision, and regular kidney function tests should be conducted. In case of overdose, contact a medical institution immediately for appropriate treatment, as some of this medication can be removed through hemodialysis. During the use of this medication, it is important to consult with the doctor and immediately report any symptoms or adverse reactions that occur.

Serious side effects

• Hives
• severe swelling (angioedema)
• chest tightness
• difficulty breathing
• anaphylaxis
• Stevens-Johnson syndrome
• severe rash with high fever
• blisters
• skin peeling
• oral/ocular mucosal pain

Mild side effects

• Diarrhea
• upper respiratory infection
• headache
• nausea
• vomiting
• abdominal pain
• nasopharyngitis
• constipation
• muscle pain
• limb pain

This medication must be stored in a tightly sealed container to protect it from exposure to air and moisture. It is recommended to maintain a storage temperature between 1 to 30 degrees Celsius.

Appearance

Bright blue, oval-shaped, biconvex prolonged-release film-coated tablet

Package unit

28 tablets/bottle, 56 tablets/bottle, 200 tablets/bottle