Teicoplanin Injection 400mg

Adult administration

This medicine should be administered with dose adjustments according to the type and severity of infection, the patient's clinical response, sex, and renal function. Adults and older adults with normal renal function Skin and soft tissue infections, pneumonia, complicated urinary tract infections: 6 mg/kg intravenously or intramuscularly every 12 hours for 3 doses. The maintenance dose is 6 mg/kg intravenously or intramuscularly once daily. Bone and joint infections: 12 mg/kg intravenously every 12 hours for 3 ∼ 5 doses. The maintenance dose is 12 mg/kg intravenously or intramuscularly once daily. Infective endocarditis: 12 mg/kg intravenously every 12 hours for 3 ∼ 5 doses. The maintenance dose is 12 mg/kg intravenously or intramuscularly once daily. Calculate and administer the dose according to the patient's body weight (kg). The duration of treatment should be determined based on clinical response. A minimum of 21 days of treatment is appropriate for infective endocarditis. Treatment duration should not exceed 4 months. Older adults: No dose adjustment is necessary unless renal impairment is present. Adults and older adults with renal impairment In patients with renal impairment, dose reduction is not required through Day 4; however, dosage adjustment is necessary to maintain a minimum serum trough concentration of 10 mg/L. After Day 4 of administration Mild to moderate renal impairment (creatinine clearance 30 ∼ 80 mL/min): Reduce the dose by administering the initial unit dose every 2 days or one-half of the initial dose daily. Severe renal impairment (patients with creatinine clearance below 30 mL/min) and patients on hemodialysis: Administer the initial unit dose every 3 days or one-third of the initial dose once daily. This medicine is not removed by dialysis. Patients receiving continuous ambulatory peritoneal dialysis If the patient develops a fever, administer a single intravenous loading dose of 400 mg (6 mg/kg), followed by 20 mg per L of dialysis fluid in every dialysis bag during the first week, in alternate bags during the second week, and only in the overnight bag during the third week. The reconstituted injection may be administered directly by intravenous or intramuscular injection. Intravenous administration may be given as a rapid injection (bolus) or as an intravenous infusion over 30 minutes. The usual frequency of administration is once daily; however, in severe infections, two doses should be given on the first day of treatment to rapidly achieve the target blood concentration. Most infections caused by susceptible strains respond to treatment within 48 ∼ 72 hours. The total duration of treatment is determined by the type and severity of infection and the patient's clinical response. Measurement of the serum concentration of this medicine can help optimize treatment. In severe infections, the minimum serum concentration should not be below 10 mg/L. The peak concentration measured 1 hour after intravenous injection of 400 mg is usually in the range of 20 ∼ 50 mg/L, and a concentration of up to 250 mg/L has been reported after intravenous injection of 25 mg per kg of body weight. The relationship between serum concentration and toxicity has not been established.

Child administration

Children (2 months ∼ 12 years of age): Administer an initial dose of 10 mg/kg intravenously every 12 hours for 3 doses, followed by a maintenance dose of 6 ∼ 10 mg/kg intravenously once daily. Neonates (up to 2 months of age): Administer an initial dose of 16 mg/kg by intravenous infusion once on the first day, followed from the next day by a maintenance dose of 8 mg/kg once daily by intravenous infusion over 30 minutes.

This drug may have glass fragments when used from an ampoule, so special care should be taken when breaking the container, especially for children and the elderly. This drug may cause severe allergic reactions such as anaphylactic shock, so if allergy symptoms occur, use should be immediately stopped and emergency treatment sought. During infusion, injection-related reactions such as rash or itching may occur on the face, neck, or body, so the infusion rate should be slow, and rapid injection should be avoided. If severe reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis occur, use should be immediately stopped. This drug can be toxic to the ears and kidneys, so patients with impaired kidney function or those using it for long periods should have their hearing, blood, liver, and kidney functions regularly tested. If a high initial dose is used, adverse reactions may occur, so kidney function should be carefully monitored through blood tests. This drug poses a risk of seizures if administered via the cerebroventricular route, so it must never be injected into the cerebroventricular space. Patients allergic to this drug or its ingredients should not use it. Patients allergic to similar class antibiotics may experience cross-reactions, so caution is required in administering this drug, and those with a history of hearing impairment should also be cautious. Patients with decreased kidney or liver function and the elderly should be especially cautious when using this drug. Generally, this drug is well tolerated, but gastrointestinal symptoms such as nausea, vomiting, diarrhea, along with blood pressure changes, dizziness, and hearing impairment may occur. Allergic reactions such as rash, itching, and urticaria may occur, so close observation is required. To prevent the occurrence of resistant strains, it is recommended to perform sensitivity tests and administer the drug only for the necessary duration. Patients with impaired kidney function or those on long-term treatment should have their hearing, blood, liver, and kidney functions regularly monitored. This drug may have more severe side effects when used with other nephrotoxic or ototoxic drugs, so caution is required. Pregnant or nursing women should carefully consider the potential risks and benefits of using this drug. This drug may cause dizziness and headaches, making caution necessary when driving or operating machinery. In cases of overdose, symptoms of thrombocytopenia and anxiety may present, and removal by hemodialysis is not possible, requiring supportive care. This drug is contraindicated for intraventricular administration, and the reconstituted solution should be used immediately or discarded after storage at 4 degrees Celsius for a maximum of 24 hours.

• Hypersensitivity
• anaphylactic shock
• shock
• Red Man syndrome
• Stevens-Johnson syndrome
• toxic epidermal necrolysis
• ototoxicity
• hematotoxicity
• hepatotoxicity
• nephrotoxicity

This drug should be stored in a sealed container to avoid contact with air and kept in a cool place below 25 degrees Celsius, avoiding direct sunlight and heat. Proper storage will help maintain the effectiveness of the drug.

Appearance

A colorless, transparent vial containing freeze-dried powder of teicoplanin for injection.

Package unit

400mg/vial × 10