Danumet XR Extended Release Tablet 100/1000 mg

Adult dose

This medication should be taken once daily with food in the evening to minimize gastrointestinal side effects related to metformin, with gradual dose increments. Extended-release tablets should not be split, crushed, ground, or chewed but swallowed whole. The 100/1000 mg extended release tablet is taken once daily with one tablet at a time. The 50/500 mg or 50/1000 mg extended release tablet should be taken once daily with two tablets at the same time. 1. For patients not currently being treated with metformin: For those with no previous experiences with diabetes medication and who cannot achieve sufficient blood sugar control with monotherapy, or for those who cannot achieve sufficient blood sugar control with sitagliptin monotherapy, the initial dosage is a total daily amount of 100 mg sitagliptin and 1000 mg metformin. If sufficient blood sugar control cannot be achieved with the initial dose, the dosage may be gradually increased up to the maximum recommended daily dose of 2000 mg metformin to reduce gastrointestinal side effects. Patients with renal impairment reducing the dose of sitagliptin should not be switched to this medication (refer to the precautions section on who should not be administered this medication). 2. For patients currently being treated with metformin: - The recommended initial dosage of this medication for patients unable to achieve sufficient blood sugar control with metformin monotherapy is a total daily amount of 100 mg sitagliptin and the current dose of metformin. - Patients transitioning from combination therapy with sitagliptin and metformin can start at the current dosages of sitagliptin and metformin. - For patients who were taking immediate-release metformin 850 mg or 1000 mg two times daily, this medication can be started at the 50/1000 mg extended release with two tablets once daily. 3. For cases where sufficient blood sugar control cannot be achieved with combination therapy of metformin and sulfonylurea or metformin and insulin, or metformin and thiazolidinediones: The initial dosage is a total daily amount of 100 mg sitagliptin, and the initial dose of metformin should consider the patient's blood sugar levels and the existing dosage. To minimize gastrointestinal side effects related to metformin, gradual dose increments should be followed. When administered in conjunction with sulfonylureas or insulin, consider reducing the doses of sulfonylureas or insulin to decrease the risk of hypoglycemia caused by sulfonylureas or insulin (refer to the precautions section for general considerations). No studies have been conducted to evaluate the safety and efficacy of switching patients from other oral hypoglycemic medications to this medication. Any changes in therapy for type 2 diabetes may result in changes in blood sugar control, and careful monitoring should occur. Renal Impairment This medication may be used with dose adjustments in patients with moderate renal impairment 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 other accompanying symptoms that would increase the risk of lactic acidosis. The starting dose of metformin should be 500 mg or 850 mg once daily, and this medication should not be initiated. The maximum recommended dose of metformin is 1000 mg. Kidney function should be carefully monitored every 3-6 months. If CrCl < 45 mL/min or eGFR < 45 mL/min/1.73 m², this medication should be discontinued immediately. Liver Impairment This medication should not be administered to patients with hepatic impairment due to the metformin component (refer to the precautions section on who should not be administered this medication).

This medication contains both sitagliptin and metformin, and is used for blood sugar control in patients with type 2 diabetes. Firstly, when taking this medicine, attention should be paid to allergic reactions. Rarely, hypersensitivity reactions such as anaphylaxis, angioedema, and severe skin diseases may occur, and if such symptoms are suspected, the use of this medicine should be stopped immediately and a doctor should be consulted. Additionally, inflammation of the pancreas (pancreatitis) may occur, so symptoms like abdominal pain, nausea, or vomiting should be reported immediately to a physician. The metformin component can rarely cause a serious metabolic condition known as lactic acidosis; therefore, patients with impaired kidney function, liver disease, dehydration, severe infections, or heart failure should not take this medicine. Regular checks for normal kidney function should be conducted while taking this medication, and if kidney function decreases, the medication should be discontinued. Moreover, the intake of this medication should be temporarily halted before and after tests using iodine-containing contrast agents, and it may be resumed only after normal kidney function has been confirmed. Women who are pregnant or may become pregnant, and those who are nursing, should avoid taking this medication for safety. While using this medicine, irregular meals and vigorous exercise should be avoided, and alcohol consumption should also be limited. Hypoglycemic symptoms may occur, so monitoring blood sugar levels closely is necessary, especially when taking it with insulin or sulfonylureas. This medication may rarely cause severe joint pain or blistering skin symptoms, so if these symptoms occur, notify a doctor immediately. Lastly, it is important to undergo regular blood tests and kidney function tests while taking this medication, and to consult healthcare providers immediately if any unusual symptoms arise.

Serious side effects

Urticaria, severe swelling (edema), anaphylaxis, angioedema, rash, exfoliative skin diseases (including Stevens-Johnson syndrome), severe rash with fever, blisters, skin peeling, oral/ocular mucosal pain, acute pancreatitis, acute kidney failure, difficulty breathing, asthma attacks, liver abnormalities (elevated liver enzyme levels, potential jaundice), severe lactic acidosis, acute or chronic metabolic acidosis, serious neurological symptoms (seizures, loss of consciousness)

Mild side effects

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

This medication is sensitive to air and moisture, so it must be stored in a tightly sealed container. Additionally, it is important to maintain a normal room temperature, between 1 degree and 30 degrees Celsius, while storing the medication.

Appearance

Bright blue, oval-shaped, bilaterally convex extended-release film-coated tablet

Package unit

Bottle - 100 tablets/bottle, Bottle - 30 tablets/bottle