Teicoplanin Injection 400 mg (Teicoplanin)

Adult administration

This medication should be administered at adjusted doses according to the type and severity of infection, the patient's clinical response, sex, and renal function, as follows. 1. Adults and elderly patients with normal renal function Skin and soft tissue infections Pneumonia Complicated urinary tract infections Initial dose: 6 mg/kg by intravenous or intramuscular injection 3 times at 12-hour intervals Maintenance dose: 6 mg/kg by intravenous or intramuscular injection once daily Bone and joint infections Initial dose: 12 mg/kg by intravenous injection 3 ∼ 5 times at 12-hour intervals Maintenance dose: 12 mg/kg by intravenous or intramuscular injection once daily Infective endocarditis Initial dose: 12 mg/kg by intravenous injection 3 ∼ 5 times at 12-hour intervals Maintenance dose: 12 mg/kg by intravenous or intramuscular injection once daily Calculate and administer the dose according to the patient's body weight (kg). The duration of administration 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. 4. Elderly patients No dose adjustment is necessary unless renal impairment is present. 5. Adults and elderly patients with renal impairment For patients with renal impairment, dose reduction is not necessary through Day 4; however, dosage adjustment is needed to maintain a minimum serum trough concentration of 10 mg/L. After Day 4 of administration 1) Mild to moderate renal impairment (creatinine clearance of 30 ∼ 80 mL/min): Halve the dose by administering the initial unit dose every 2 days or administering 1/2 of the initial dose daily. 2) Severe renal impairment (patients with creatinine clearance below 30 mL/min) and patients on hemodialysis: Administer the initial unit dose every 3 days or administer 1/3 of the initial dose once daily. This medication is not removed by dialysis. Patients on continuous ambulatory peritoneal dialysis If the patient has a fever, administer a loading dose of 400 mg (6 mg/kg) by intravenous injection once, followed by 20 mg per liter of dialysate: administer with every dialysis bag during the first week, with alternate bags during the second week, and only with the overnight bag during the third week. Administration is generally once daily; however, in severe infections, administer twice on the first day of treatment to rapidly achieve the target blood concentration.

Child administration

Children (2 months ∼ 12 years of age): Administer an initial dose of 10 mg/kg intravenously 3 times at 12-hour intervals, 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 by intravenous infusion over 30 minutes once daily.

Caution must be exercised when removing the injection solution from the glass ampoule as glass fragments may mix in, especially when used in children or the elderly. Although rare, this drug may cause serious allergic reactions, including anaphylactic shock; if allergy symptoms occur, use should be halted immediately, and emergency measures should be taken. When injecting, do not administer rapidly; it should be given as a slow intravenous infusion over more than 30 minutes as rapid infusion may cause shock or skin reactions. This drug may induce severe skin reactions, so if a skin rash or mucosal damage occurs, administration should stop immediately. Patients with impaired kidney function or those on long-term use should undergo regular monitoring of auditory, blood, liver, and kidney functions. When determining the initial dosing, blood creatinine levels must be checked, and adverse reactions should be carefully monitored. This drug should not be administered intraventricularly due to the risk of seizures. Patients with an allergy to this drug should not use it, and caution should be taken for those allergic to similar classes of drugs. Elderly patients or those with diminished kidney or liver function should use this drug cautiously, as well as patients at risk of auditory impairment. This drug may cause gastrointestinal symptoms like nausea, vomiting, diarrhea, blood pressure changes, dizziness, headaches, and hearing loss; thus, symptoms should be closely monitored. Various adverse reactions including skin rash, itching, anaphylaxis, and injection site pain have been reported, so if any unusual symptoms appear, inform the healthcare provider immediately. When using this drug, it is important to administer it for an appropriate duration after susceptibility tests to prevent the emergence of resistant bacteria. Caution is required when used in combination with other nephrotoxic or ototoxic agents as side effects may be intensified. Pregnant or breastfeeding women should carefully consider the potential risks and benefits of using this drug. This drug may cause dizziness or headaches, requiring caution while driving or operating machinery. Overdose may lead to thrombocytopenia or anxiety symptoms and there is no specific antidote, thus symptomatic treatment should be provided. This drug is contraindicated for intraventricular administration and should be used as soon as possible after reconstitution, with any remaining solution discarded within 24 hours at a temperature below 4 degrees Celsius.

• Hypersensitivity
• anaphylactic shock
• shock
• red man syndrome
• mucocutaneous syndrome
• toxic epidermal necrolysis
• nausea
• vomiting
• diarrhea
• increased blood pressure

This drug should be stored in a sealed container to avoid contact with air and kept in a cool place below 25 degrees Celsius, away from direct sunlight or heat. Proper storage will maintain the drug's efficacy and prevent degradation.

Appearance

A colorless and transparent vial containing a white to slightly yellow freeze-dried powder.

Package unit

10 vials/box