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Tricexone

Tricexone

ceftriaxone

Manufacturer:

Swiss Parenterals

Distributor:

ECE Pharma

Marketer:

Sanimed
Concise Prescribing Info
Contents
Ceftriaxone
Indications/Uses
Treatment of pneumonia (community or hospital acquired); bacterial meningitis; complicated skin & soft tissue infections; infections in neutropenic patients; gonorrhoea. Peri-operative prophylaxis of infections associated w/ surgery.
Dosage/Direction for Use
Adult (including elderly w/ no significant renal & hepatic impairment), & adolescent >12 yr & childn weighing ≥50 kg 1-2 g once daily, can be increased up to 4 g once daily in serious infections or infections caused by moderately sensitive micro-organisms. Childn 15 days to 2 yr weighing <50 kg 20-80 mg/kg IV once daily. Must not exceed 80 mg/kg daily in severe infections except meningitis. Newborn infant (age 0-14 days) 20-50 mg/kg IV once daily. Must not exceed 50 mg/kg daily in severe infections. Patient w/ severe renal impairment (CrCl <10 mL/min) Max: 2 g daily. Meningitis Childn Initially 100 mg/kg (not exceeding 4 g) once daily, may be reduced after determining sensitivity of pathogen. Newborn infant <2 wk Max: 50 mg/kg/24 hr.
Contraindications
Hypersensitivity to ceftriaxone or other cephalosporins. Previous immediate &/or severe hypersensitivity reaction to penicillin or any other β-lactam medicinal products.
Special Precautions
Increased risk of hypersensitivity reactions in patients w/ any other type of hypersensitivity reaction or asthma bronchiale; more severe & faster emergence in patients w/ allergic diathesis. Cross-allergy w/ penicillin or β-lactam medicinal products. Combine w/ aminoglycosides in infections caused by Pseudomonas aeruginosa w/ proven sensitivity to ceftriaxone; & in interventional treatment of infections caused by other bacteria in patients w/ neutropenic fever. Monitor renal & hepatic function & haematological parameters at regular intervals during long-term treatment. Observe for signs of consecutive secondary infections w/ pathogens resistant to ceftriaxone (including candida & fungi) & treat accordingly. Reports of antibiotic-associated diarrhoea, colitis & pseudomembranous colitis. Discontinue if severe &/or bloody diarrhoea occurs during treatment & institute appropriate therapy. Do not give drugs that inhibit peristalsis. Caution in individuals w/ previous history of GI disease, particularly colitis. May precipitate in gallbladder & kidneys & be detectable as shadows on ultrasound. Rare reports of pancreatitis, possibly of biliary obstruction aetiology. May produce +ve Coombs' test & mild haemolytic anaemia. Can displace bilirubin from serum albumin. Consider incidental occurrences of vit K deficiency as w/ other antibiotics. High IV doses (>1 g or ≥50 mg/kg) should be administered slowly (over a min period of 30 min) to avoid high conc in the bile. If to be given w/ aminoglycosides, dose adjustment may be necessary & administer separately. Take into consideration Na content (3.6 mmol Na/vial) in patients on controlled Na diet. Dose reduction is required in severe renal impairment accompanied by hepatic insufficiency. Monitor serum ceftriaxone levels at regular intervals in case of simultaneous impairment of renal & liver function. Only use during pregnancy after benefit/risk assessment, especially during 1st trimester. Caution in breast-feeding women. Not to be used in jaundiced newborns or in those who are hypoalbuminaemic or acidotic, in whom bilirubin binding is likely to be impaired. Premature-born babies.
Adverse Reactions
Loose stools or diarrhoea, nausea, vomiting, stomatitis, glossitis & pancreatitis; haematological reactions including anaemia (all grades), haemolytic anaemia, granulocytopenia, leucopenia, neutropenia, agranulocytosis, thrombocytopenia & eosinophilia. Superinfection caused by microorganisms non-susceptible to ceftriaxone.
Drug Interactions
Increased risk of oto- & nephrotoxicity, & physicochemical incompatibility w/ aminoglycosides. Antagonized activity w/ bacteriostatic antibiotics eg, chloramphenicol & tetracycline. May adversely affect efficacy of hormonal contraceptives. False +ve results in Coombs' test; non-enzymatic methods for glucose determinations in urine; galactose determination in blood. Not to be mixed w/ or added to soln containing other agents. Not compatible w/ Ca-containing soln (eg, Hartmann's soln & Ringer's soln); amsacrine, vancomycin, fluconazole, aminoglycosides & labetalol.
MIMS Class
Cephalosporins
ATC Classification
J01DD04 - ceftriaxone ; Belongs to the class of third-generation cephalosporins. Used in the systemic treatment of infections.
Presentation/Packing
Form
Tricexone powd for inj 1 g
Packing/Price
(+ 10 mL amp diluent) 1's
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