Medication info

Taposin Injection 400 mg (Teicoplanin)

Prescription medicationIntramuscular injection · Intravenous injection
Ingredient · strength
Teicoplanin›400mg / 1 vial
Manufacturer / importer
HK inno.N Co., Ltd.
Appearance
A colorless, transparent vial containing a white or light yellow freeze-dried powder.
Packaging
1 vial (400 mg potency) x 10 / carton
Approval status
Active

MFDS item code 200709021 · Notified 2007.08.03 · Insurance code 640003581

Summary

Main use
Treatment of infections caused by gram-positive bacteria (e.g., skin and soft tissue infections, pneumonia)
Who receives it
Adults · Children
Adult administration
Adults and elderly patients with normal renal function Skin and soft tissue infections, pneumonia, complicated urinary tract infections: Initial dose of 6 mg/kg intravenously or intramuscularly every 12 hours for 3 doses, followed by a maintenance dose of 6 mg/kg intravenously or intramuscularly once daily. Bone and joint infections: Initial dose of 12 mg/kg intravenously every 12 hours for 3 ∼ 5 doses, followed by a maintenance dose of 12 mg/kg intravenously or intramuscularly once daily. Infective endocarditis: Initial dose of 12 mg/kg intravenously every 12 hours for 3 ∼ 5 doses, followed by a maintenance dose of 12 mg/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, administration for at least 21 days is appropriate. The duration of treatment should not exceed 4 months. Elderly patients: No dose adjustment is necessary unless renal impairment is present. Adults and elderly patients with renal impairment In patients with renal impairment, dose reduction is not necessary until day 4 of treatment; however, dosage adjustment is needed to maintain a minimum serum trough concentration of 10 mg/L. After day 4 of treatment Mild to moderate renal impairment (creatinine clearance 30 ∼ 80 mL/min): Halve the dose by administering the initial unit dose every 2 days or by administering half the initial dose daily. Severe renal impairment (patients with creatinine clearance below 30 mL/min) and patients receiving hemodialysis: Administer the initial unit dose every 3 days or administer one-third 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 loading dose of 400 mg (6 mg/kg) intravenously, followed by 20 mg per L of dialysis solution 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 achieve the target blood concentration promptly. In severe infections, the minimum serum concentration should not be less than 10 mg/L. The peak concentration measured 1 hour after intravenous administration of 400 mg is usually in the range of 20 ∼ 50 mg/L, and concentrations as high as 250 mg/L have been reported after intravenous administration of 25 mg per kg of body weight.
Child administration
Pediatric patients (2 months ∼ 12 years): 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.

Ingredients

Manufacturer
HK inno.N Co., Ltd.

Efficacy & effects

Treatment of infections caused by gram-positive bacteria (e.g., skin and soft tissue infections, pneumonia)

  • Skin infections
  • soft tissue infections
  • bone infections
  • joint infections
  • hospital-acquired pneumonia
  • community-acquired pneumonia
  • complicated urinary tract infections
  • infective endocarditis
  • peritonitis due to prolonged outpatient dialysis
  • bacteremia
View approved original text

This drug is an antibiotic in the glycopeptide class produced by Actinoplanes teichomyceticus, particularly effective against Gram-positive bacteria. It has a strong bactericidal action against various aerobic and anaerobic Gram-positive bacteria, including Staphylococcus aureus (including methicillin-resistant), Streptococcus, and Enterococcus. It is used in the treatment of various infections such as infected skin and soft tissues, bone and joint infections, pneumonia, complicated urinary tract infections, infective endocarditis, and peritonitis due to prolonged outpatient dialysis. This drug has no cross-resistance with various antibiotics and has relatively low resistance development, making it reliable. It effectively helps improve symptoms in patients with these infections.

How it is given

Adult administration

Adults and elderly patients with normal renal function Skin and soft tissue infections, pneumonia, complicated urinary tract infections: Initial dose of 6 mg/kg intravenously or intramuscularly every 12 hours for 3 doses, followed by a maintenance dose of 6 mg/kg intravenously or intramuscularly once daily. Bone and joint infections: Initial dose of 12 mg/kg intravenously every 12 hours for 3 ∼ 5 doses, followed by a maintenance dose of 12 mg/kg intravenously or intramuscularly once daily. Infective endocarditis: Initial dose of 12 mg/kg intravenously every 12 hours for 3 ∼ 5 doses, followed by a maintenance dose of 12 mg/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, administration for at least 21 days is appropriate. The duration of treatment should not exceed 4 months. Elderly patients: No dose adjustment is necessary unless renal impairment is present. Adults and elderly patients with renal impairment In patients with renal impairment, dose reduction is not necessary until day 4 of treatment; however, dosage adjustment is needed to maintain a minimum serum trough concentration of 10 mg/L. After day 4 of treatment Mild to moderate renal impairment (creatinine clearance 30 ∼ 80 mL/min): Halve the dose by administering the initial unit dose every 2 days or by administering half the initial dose daily. Severe renal impairment (patients with creatinine clearance below 30 mL/min) and patients receiving hemodialysis: Administer the initial unit dose every 3 days or administer one-third 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 loading dose of 400 mg (6 mg/kg) intravenously, followed by 20 mg per L of dialysis solution 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 achieve the target blood concentration promptly. In severe infections, the minimum serum concentration should not be less than 10 mg/L. The peak concentration measured 1 hour after intravenous administration of 400 mg is usually in the range of 20 ∼ 50 mg/L, and concentrations as high as 250 mg/L have been reported after intravenous administration of 25 mg per kg of body weight.

Child administration

Pediatric patients (2 months ∼ 12 years): 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.

Precautions

This drug may have glass fragments when using glass ampule injections, so special caution should be exercised when cutting, especially for children and the elderly. This drug can cause serious allergic reactions, such as anaphylactic shock; therefore, treatment should be discontinued immediately and emergency measures should be taken if allergy symptoms appear. When administering intravenously, the infusion rate should be slowed to prevent side effects such as shock or red man syndrome, and rapid injection should be avoided. This drug can cause severe reactions on the skin, and if symptoms like Stevens-Johnson syndrome or toxic epidermal necrolysis occur, administration should be ceased immediately. Patients with impaired kidney function or those receiving long-term treatment should regularly monitor hearing, blood, liver, and kidney functions to check for side effects. This drug should never be administered intraventricularly as it has the risk of causing seizures. It should not be used in patients with hypersensitivity to this drug or any components thereof. Patients allergic to certain antibiotics or with hearing impairments, as well as those with compromised kidney or liver function, and the elderly should use this drug with extra caution. Side effects of this drug may include gastrointestinal symptoms such as nausea, vomiting, and diarrhea, as well as neurological symptoms like dizziness, tinnitus, and hearing loss; consultation with a physician is necessary if any unusual symptoms appear. This drug should be administered during pregnancy or lactation only after thoroughly considering the potential risks and benefits, and it is unclear whether it passes into breast milk. This drug can cause dizziness and headaches, so caution is needed when driving or operating machinery. In case of overdose, symptoms such as thrombocytopenia and anxiety may appear, and symptomatic treatment should be received with regular monitoring of liver and kidney functions. It is important to maintain the minimum period of administration only after confirming the sensitivity of pathogens to prevent the occurrence of resistant bacteria. Care should be taken when used with nephrotoxic or ototoxic drugs as adverse reactions may worsen. Dissolved drugs should be used immediately and any remaining solution must be discarded within 24 hours at 4 degrees Celsius. When administering this drug, an appropriate solvent should be used, and the concentration and infusion rate of the solution should be adjusted for safe use.

Side effects

  • hypersensitivity
  • anaphylactic shock
  • shock
  • red man syndrome
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • nausea
  • vomiting
  • diarrhea
  • increased blood pressure
Show 41 more
  • palpitations
  • decreased blood pressure
  • agranulocytosis
  • leukopenia
  • neutropenia
  • thrombocytopenia
  • thrombocytosis
  • eosinophilia
  • dizziness
  • tinnitus
  • hearing loss
  • deafness
  • vestibular disorders
  • headache
  • increased ALT
  • increased AST
  • increased ALP
  • increased LDH
  • increased γ-GTP
  • increased total bilirubin
  • jaundice
  • increased serum creatinine
  • renal failure
  • DRESS syndrome
  • exfoliative dermatitis
  • erythema multiforme
  • rash
  • pruritus
  • fever
  • rigidity
  • bronchospasm
  • anaphylactic reaction
  • urticaria
  • angioedema
  • erythema
  • localized pain
  • venous thrombosis
  • injection site abscess
  • opportunistic infection
  • anxiety
  • thrombocytopenia

Not everyone experiences these, and they can vary from person to person.

Storage

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

Appearance and packaging

Appearance

A colorless, transparent vial containing a white or light yellow freeze-dried powder.

Package unit

1 vial (400 mg potency) x 10 / carton

Same-ingredient medicines

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Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.