Tagocid Injection 200 mg (Teicoplanin)

Adult administration

1. Adults and elderly patients with normal renal function · Skin and soft tissue infections · Pneumonia · Complicated urinary tract infections 6mg/kg intravenously or intramuscularly every 12 hours for 3 doses 6mg/kg intravenously or intramuscularly once daily · Bone and joint infections 12mg/kg intravenously every 12 hours for 3~5 doses 12mg/kg intravenously or intramuscularly once daily · Infective endocarditis 12mg/kg intravenously every 12 hours for 3~5 doses 12mg/kg intravenously or intramuscularly once daily The dose should be calculated and administered according to the patient's body weight (kg). The duration of administration should be determined based on the clinical response. For infective endocarditis, a minimum of 21 days of treatment is appropriate. The treatment period should not exceed 4 months. To achieve the minimum serum trough concentration, the following serum trough concentrations of this medicine should be monitored at steady state after completion of the loading-dose regimen. · Most Gram-positive infections: minimum 10 mg/L when measured by HPLC (High Performance Liquid Chromatography), minimum 15 mg/L when measured by FPIA (Fluorescence Polarization Immunoassay) · Endocarditis and other severe infections: minimum 15‑30 mg/L when measured by HPLC, minimum 30-40 mg/L when measured by FPIA During maintenance treatment, serum trough concentrations of this medicine may be monitored at least once weekly to ensure stable concentrations. 4. Elderly patients No dose adjustment is needed unless renal impairment is present. 5. Adults and elderly patients with renal impairment Dose reduction is not required through day 4 in patients with renal impairment; however, dose adjustment is needed to maintain a minimum serum trough concentration of 10 mg/L when measured by HPLC (minimum 15 mg/L when measured by FPIA). After day 4 of administration 1) Mild to moderate renal impairment (creatinine clearance 30~80mL/min): Halve the dose by administering the initial unit dose every 2 days or by administering half the initial dose daily. 2) Severe renal impairment (patients with creatinine clearance below 30mL/min) and hemodialysis patients: Administer the initial unit dose every 3 days or administer 1/3 of the initial dose once daily. This medicine is not removed by dialysis. Patients receiving continuous ambulatory peritoneal dialysis If the patient has a fever, administer a single intravenous loading dose of 400mg (6mg/kg), followed by 20mg per L of dialysate in every dialysis bag during the first week, every other bag during the second week, and only the overnight bag during the third week. The frequency of administration is generally once daily; however, in severe infections, administer twice on the first day of treatment to rapidly achieve the target blood concentration. In severe infections, the minimum serum concentration should not be below 10 mg/L when measured by HPLC (minimum 15 mg/L when measured by FPIA). The peak concentration measured 1 hour after intravenous administration of 400mg is usually in the range of 20~50mg/L, and concentrations of up to 250mg/L have been reported after intravenous administration of 25mg per kg of body weight (microbiological potency assay).

Child administration

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

This drug may contain glass particles when using glass ampoules for injections; hence, care should be taken to avoid glass fragments, especially when administering to children or the elderly. This drug may cause severe and life-threatening allergic reactions; if any allergic symptoms appear, administration must be stopped immediately and emergency measures should be taken. When injecting, do not administer rapidly; it should be administered slowly via intravenous drip for more than 30 minutes, and if any reactions such as rash or itching on the face, neck, or body occur during administration, stop immediately. It can cause serious skin adverse reactions; hence, if symptoms such as red spots, blisters, rashes, or mucosal damage appear, usage must be stopped immediately and medical consultation should be sought. It may affect kidney function, so patients with kidney disorders or those requiring high doses should be monitored closely for renal function. Hearing loss or nephrotoxicity has been reported, so particularly for patients with impaired renal function or those on prolonged therapy, regular tests for hearing and blood, liver, and kidney functions are required. Intraventricular administration is absolutely prohibited due to the risk of seizures. Patients with known allergies to this drug or its components should not receive it. Patients with previous hypersensitivity reactions or allergies to similar classes of drugs should be very cautious when administering; immediate discontinuation is warranted if allergy symptoms occur. Particular caution is required in patients with impaired renal or liver function and in the elderly. Digestive symptoms such as nausea, vomiting, diarrhea, blood pressure changes, blood cell reductions, dizziness, tinnitus, and hearing loss may occur, so healthcare providers should be notified if such symptoms appear. Allergic reactions such as skin rash, itching, hives, and anaphylactic shock may occur, so caution is advised. During the administration of this drug, it is important to check the sensitivity of the infectious organisms and administer only for the necessary duration to prevent the development of resistance. Using other drugs that can cause nephrotoxicity or ototoxicity may increase the risk of side effects; therefore, consultation with medical professionals is necessary. Pregnant or nursing women should take this drug only after careful consideration of its risks and benefits; it is unclear whether it is excreted in breast milk. This drug may cause dizziness and headaches, so it is safest to avoid driving or operating machinery until symptoms are resolved. Overdosage may manifest as thrombocytopenia or anxiety symptoms, and this drug is poorly removed by hemodialysis, so symptomatic treatment is necessary in case of overdose. When dissolving and administering this drug, appropriate solvent must be used, and once dissolved, it should be used as soon as possible, discarding any remaining solution within 24 hours under 4 degrees Celsius.

Hypersensitivity, anaphylactic shock, shock, red man syndrome, mucocutaneous syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, Lyell's syndrome, drug-induced hypersensitivity with eosinophilia and systemic symptoms, DRESS syndrome, acute generalized exanthematous pustulosis, nephrotoxicity, renal failure, nausea, vomiting, diarrhea, hypertension, palpitations, hypotension, reversible agranulocytosis, leukopenia, neutropenia, thrombocytopenia, thrombocytosis, eosinophilia, pancytopenia, dizziness, tinnitus, hearing loss, deafness, vestibular disturbance, headache, ALT elevation, AST elevation, ALP elevation, LDH elevation, γ-GTP elevation, total bilirubin elevation, jaundice, elevated serum creatinine level, exfoliative dermatitis, erythema multiforme, rash, pruritus, fever, rigidity, bronchospasm, anaphylactic reaction, urticaria, angioedema, phenomenon, erythema, local pain, venous thrombosis, injection site abscess with intramuscular injection, superinfection, anxiety

This drug should be stored in a sealed container to prevent exposure to air, in a cool place, away from direct sunlight and heat, ideally at temperatures below 25 degrees. This helps maintain the effectiveness of the medication for a longer period.

Appearance

Colorless and transparent vial containing freeze-dried powder of Teicoplanin for injection and solvent ampoule containing distilled water for injection.

Package unit

1 vial/box [(200 mg/vial)]