Medication info

Tycon Injection 400 mg (Teicoplanin)

Prescription medicationInjectionsIntramuscular injection · Intravenous injection
Ingredient · strength
Teicoplanin›400mg / 1 vial
Manufacturer / importer
Dongkuk Pharmaceutical Co., Ltd.
Appearance
A vial injection containing a white to light yellow freeze-dried powder and a solvent ampoule with a colorless and transparent liquid.
Packaging
1 vial/box (main drug), 1 ampoule/box (solvent)
Approval status
Active

MFDS item code 201601696 · Notified 2016.03.30 · Insurance code 653403591

Summary

Main use
Treatment of infections (e.g., bacteremia, pneumonia, and skin infections)
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 treatment should be determined based on clinical response. For infective endocarditis, treatment for at least 21 days is appropriate. 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 required 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 less than 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 drug 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), then add 20 mg per L of dialysate to every dialysis bag during the first week, alternate bags 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 the drug twice on the first day of treatment to rapidly achieve the target blood concentration. 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 a peak concentration of 250 mg/L has been reported after intravenous administration of 25 mg per kg of body weight.
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.

Ingredients

Manufacturer
Dongkuk Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of infections (e.g., bacteremia, pneumonia, and skin infections)

  • Skin infections
  • soft tissue infections
  • bone infections
  • joint infections
  • pneumonia
  • urinary tract infections
  • infective endocarditis
  • peritonitis
  • bacteremia
View approved original text

This drug is a glycopeptide antibiotic produced by Actinoplanes teichomyceticus, effective against aerobic and anaerobic strains of gram-positive bacteria. It acts particularly against methicillin-resistant Staphylococcus aureus (MRSA), streptococci, enterococci, and other various gram-positive bacteria. It is also effective against anaerobes such as Clostridium and Peptococcus. However, its effectiveness is limited against gram-negative bacteria and some resistant strains. This drug is used to treat skin and soft tissue infections, bone and joint infections, hospital-acquired and community-acquired pneumonia, complicated urinary tract infections, infective endocarditis, and bacteremia related to prolonged outpatient dialysis-related peritonitis.

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 treatment should be determined based on clinical response. For infective endocarditis, treatment for at least 21 days is appropriate. 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 required 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 less than 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 drug 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), then add 20 mg per L of dialysate to every dialysis bag during the first week, alternate bags 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 the drug twice on the first day of treatment to rapidly achieve the target blood concentration. 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 a peak concentration of 250 mg/L has been reported after intravenous administration of 25 mg per kg of body weight.

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.

Precautions

There is a risk of glass fragments contaminating the solution when using glass ampoules, so extreme caution is needed when cutting the container, especially for children and the elderly. Serious allergic reactions such as anaphylactic shock may occur upon administration, so if any allergy symptoms arise, administration must be stopped immediately, and emergency measures should be taken. Reactions such as shock, skin rash, or itching may occur during administration, so it should be administered slowly via intravenous infusion over more than 30 minutes, and rapid intravenous injection should be avoided. Severe skin reactions may occur; if symptoms of Stevens-Johnson syndrome or toxic epidermal necrolysis appear, administration should stop immediately. Patients with weak kidney or liver function, patients on long-term therapy, and those with hearing issues have a risk of toxicity from this drug, so regular hearing tests and blood tests, as well as liver and kidney function tests, should be performed. This drug should never be administered intraventricularly due to the risk of seizures. Patients with hypersensitivity to this drug should not be administered, and caution should be exercised for patients allergic to similar class drugs. The elderly and those with decreased kidney or liver function should also be monitored carefully, and thorough evaluation and monitoring are necessary before administration. This drug generally has good tolerance, but side effects such as nausea, vomiting, diarrhea, dizziness, headache, and changes in blood pressure may occur, and any adverse effects should be reported to healthcare providers. To prevent the emergence of antibiotic-resistant bacteria, it is important to only administer this drug for the necessary duration after appropriate susceptibility testing. During administration of this drug, regular inspections of hearing, blood, liver, and kidney functions are necessary, and caution should be taken as the risk of side effects may increase when used in conjunction with other nephrotoxic or ototoxic drugs. In pregnant or breastfeeding women, this drug should only be used if necessary, and sufficient precautions should be considered regarding its impact on the fetus or newborn. This drug may cause dizziness and headache, so caution is advised while driving or operating dangerous machinery. In case of overdose, symptoms such as thrombocytopenia or anxiety may occur, and appropriate treatment must be sought immediately. The solution of this drug should be used as soon as possible, and any remaining solution after use should be stored at temperatures below 4 degrees Celsius and discarded within 24 hours. Finally, this drug is effective only against certain infections, so it should be used only after confirming the sensitivity of the appropriate bacterial strain, as it is often not suitable for monotherapy and should be used according to healthcare providers' instructions.

Side effects

  • Hypersensitivity
  • anaphylactic shock
  • shock
  • red man syndrome
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • ototoxicity
  • blood toxicity
  • hepatic toxicity
  • renal toxicity
Show 45 more
  • nausea
  • vomiting
  • diarrhea
  • hypertension
  • palpitations
  • hypotension
  • agranulocytosis
  • leukopenia
  • neutropenia
  • thrombocytopenia
  • thrombocytosis
  • eosinophilia
  • dizziness
  • tinnitus
  • hearing loss
  • deafness
  • vestibular disturbance
  • headache
  • ALT elevation
  • AST elevation
  • ALP elevation
  • LDH elevation
  • γ-GTP elevation
  • total bilirubin elevation
  • jaundice
  • serum creatinine elevation
  • kidney failure
  • DRESS syndrome
  • exfoliative dermatitis
  • erythema multiforme
  • rash
  • pruritus
  • fever
  • rigidity
  • bronchospasm
  • anaphylactic reaction
  • urticaria
  • angioedema
  • erythema
  • localized pain
  • venous thrombosis
  • injection site abscess
  • superinfection
  • 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 prevent contact with air, preferably in a cool place away from heat at temperatures below 25 degrees Celsius. Storing it this way will help maintain the drug's effectiveness and prevent deterioration.

Appearance and packaging

Appearance

A vial injection containing a white to light yellow freeze-dried powder and a solvent ampoule with a colorless and transparent liquid.

Package unit

1 vial/box (main drug), 1 ampoule/box (solvent)

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.