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Product
Anti-infective Products (Gatiquin)
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Ticocin
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Ticocin
COMPOSITION
Each vial contains
• Teicoplanin ............ 200 mg
• As sterile freeze-dried powder for reconstitution with 3 ml sterile water for injection IP.
• Each 3 ml of reconstituted injection contains
Teicoplanin ...................................... 200 mg
Powder for injection ( I.V / I.M )
PHARMACOLOGY
Pharmacodynamics
Teicoplanin is a bactericidal, glycopeptide antibiotic produced by fermentation of Actinoplanes teichomyceticus .
• Glycopeptide antibiotics are a class of antibiotic drugs.
Pharmacokinetics
Absorption
• In man the plasma level profile after I.V administration indicates a biphasic distribution |
» with a rapid distribution phase having a half-life of about 0.3 hours
» followed by a more prolonged distribution phase having a half-life of about 3 hours
» followed by slow elimination (with a terminal elimination half-life of about 150 hours).
• At 6mg/kg administered intravenously at 0, 12, 24 hours and every 24 hours thereafter as a 30 minute infusion .
Metabolism and Excretion
• No metabolites of teicoplanin have been identified.
• More than 97% of the administered teicoplanin is excreted unchanged.
• The elimination of teicoplanin from the plasma is prolonged with a terminal half-life of elimination in man of about 150 hours.
• Teicoplanin is excreted mainly in the urine.
INDICATIONS
• It is indicated in potentially serious Gram-positive infections including those which cannot be treated with other antimicrobial drugs, eg. penicillins and cephalosporins.
• It is useful in the therapy of serious staphylococcal infections in patients who cannot receive or who have failed to respond to the penicillins and cephalosporins, or who have infections with staphylococci resistant to other antibiotics.
The effectiveness of teicoplanin has been documented in the following infections:-
• Skin and soft tissue infections, urinary tract infections, lower respiratory tract infections, joint and bone infections, septicaemia, endocarditis and peritonitis related to continuous ambulatory peritoneal dialysis.
• It may be used for antimicrobial prophylaxis in orthopaedic surgery at risk of Gram-positive infection.
DOSAGE AND ADMINISTRATION
» » The reconstituted Teicoplanin injection can be administered either I.V or I.M .
» » I.V dosing may be by rapid injection over one minute or by a slow infusion over 30 minutes.
» » The total duration of therapy is determined by the type and severity of infection and the clinical response of the patient.
» » In endocarditis and osteomyelitis, treatment for 3 weeks or longer is recommended.
Neonates
» The recommended dosage regimen for neonates is a loading dose of 16mg/kg followed by a daily dose of 8mg/kg.
In continuous ambulatory periotoneal dialysis
After a single loading IV dose of 400mg if the patient is febrile, the recommended dosage is ……
• 20mg/1 per bag in the first week,
• 20mg/1 in alternate bags in the second week and
• 20mg/1 in the overnight dwell bag only during the
third week.
CONTRAINDICATIONS
Teicoplanin is contraindicated in patients who have exhibited previous hypersensitivity to the drug.
Pregnancy
» » TICOCIN should not be used during confirmed or presumed pregnancy unless a physician considers that the potential benefits outweigh the possible risk.
Lactation
» » TICOCIN should not be used during lactation unless a physician considers that the potential benefits outweigh the possible risk.
UNDESIRABLE EFFECTS
Local reactions
erythema, local pain,thrombophlebitis, injection site abscess.
Hypersensitivity
rash, pruritis, fever, bronchospasm, anaphylactic shock, rigors, urticaria, angioedema
Gastric-intestinal
nausea, vomiting, diarrhoea.
Liver function
increases in serum transaminases and/or serum alkaline phosphatase.
Renal function
transient elevations of serum creatinine, renal failure.
Central nervous system
dizziness, headache.
Auditory/vestibular
mild hearing loss, tinnitus and vestibular disorder
Presentation
1 bot…200 mg +
1 vial …..3 ml
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