Pneumosolv

Pneumosolv

ceftriaxone

Manufacturer:

Swiss Parenterals Ltd

Distributor:

JustRight Healthcare
Concise Prescribing Info
Contents
Ceftriaxone
Indications/Uses
Infections in adults & childn including term neonates (from birth): Bacterial meningitis, community acquired pneumonia, hospital acquired pneumonia, acute otitis media, intra-abdominal infections, complicated UTI (including pyelonephritis), bone & joint infections, complicated skin & soft tissue infections, gonorrhoea, syphilis, bacterial endocarditis. Treatment of acute exacerbations of COPD in adults; disseminated Lyme borreliosis [early (stage II) & late (stage III)] in adults & childn including neonates from 15 days of age; patients w/ bacteraemia that occurs in association w/, or is suspected to be associated w/, any of the infections mentioned. Management of neutropenic patients w/ fever that is suspected to be due to bacterial infection. Pre-op prophylaxis of surgical site infections.
Dosage/Direction for Use
IM/IV Adult & childn >12 yr (≥50 kg) Community acquired pneumonia, acute exacerbation of COPD, intra-abdominal infection, complicated UTI (including pyelonephritis) 1-2 g once daily. Consider higher end of recommended dose range in documented bacteraemia. Hospital acquired pneumonia, complicated skin & soft tissue infection, bone & joint infection 2 g once daily. Management of neutropenic patient w/ fever that is suspected to be due to bacterial infection, bacterial endocarditis/meningitis 2-4 g once daily. Consider higher end of recommended dose range in documented bacteraemia. Consider bid (12 hrly) administration where doses >2 g daily are administered. Acute otitis media 1-2 g single IM dose. Pre-op prophylaxis of surgical site infection 2 g as single pre-op dose. Gonorrhoea 500 mg single IM dose. Syphilis 500 mg-1 g once daily increased to 2 g once daily for neurosyphilis for 10-14 days. Disseminated Lyme borreliosis [early (stage II) & late (stage III)] 2 g once daily for 14-21 days. Neonate, infant & childn 15 days to 12 yr (<50 kg) Intra-abdominal infection, complicated UTI (including pyelonephritis), community acquired pneumonia, hospital acquired pneumonia 50-80 mg/kg once daily. Consider higher end of recommended dose range in documented bacteraemia. Complicated skin & soft tissue infection, bone & joint infection, management of neutropenic patient w/ fever that is suspected to be due to bacterial infection 50-100 mg/kg once daily. Max: 4 g. Consider higher end of recommended dose range in documented bacteraemia. Consider bid (12 hrly) administration where doses >2 g daily are administered. Bacterial meningitis 80-100 mg/kg once daily. Max: 4 g. Consider higher end of recommended dose range in documented bacteraemia. Consider bid (12 hrly) administration where doses >2 g daily are administered. Bacterial endocarditis 100 mg/kg once daily. Max: 4 g. Consider bid (12 hrly) administration where doses >2 g daily are administered. Acute otitis media Initially 50 mg/kg single IM dose. Pre-op prophylaxis of surgical site infection 50-80 mg/kg as single pre-op dose. Syphilis 75-100 mg/kg (max 4 g) once daily for 10-14 days. Disseminated Lyme borreliosis [early (stage II) & late (stage III)] 50-80 mg/kg once daily for 14-21 days. Neonate 0-14 days Max: 50 mg/kg daily dose should not be exceeded. Intra-abdominal infection, complicated skin & soft tissue infection, complicated UTI (including pyelonephritis), community acquired pneumonia, hospital acquired pneumonia, bone & joint infection, management of neutropenic patient w/ fever that is suspected to be due to bacterial infection 20-50 mg/kg once daily. Consider higher end of recommended dose range in documented bacteraemia. Bacterial meningitis/endocarditis 50 mg/kg once daily. Patient w/ preterminal renal failure (CrCl <10 mL/min) Dose should not exceed 2 g daily.
Contraindications
Hypersensitivity to ceftriaxone or to any other cephalosporin. History of severe hypersensitivity (eg, anaphylactic reaction) to any other type of β-lactam antibacterial agent (penicillins, monobactams & carbapenems). Premature neonates up to postmenstrual age of 41 wk (gestational age + chronological age). Full-term neonates (up to 28 days of age) w/ hyperbilirubinaemia, jaundice, or who are hypoalbuminaemic or acidotic; if they require (or are expected to require) IV Ca treatment, or Ca-containing infusions. Exclude lidocaine contraindications before IM inj of ceftriaxone when lidocaine soln is used as solvent. Ceftriaxone soln containing lidocaine should never be administered IV.
Special Precautions
Reports of serious & occasionally fatal hypersensitivity reactions; severe cases of haemolytic anaemia; antibacterial agent-associated colitis & pseudo-membranous colitis; cases of pancreatitis, possibly of biliary obstruction aetiology; renal lithiasis. Discontinue treatment & initiate adequate emergency measures in case of severe hypersensitivity reactions. Caution to patients w/ history of non-severe hypersensitivity to other β-lactam agents. Must not be mixed or administered simultaneously w/ any Ca-containing IV soln. Perform CBC at regular intervals during prolonged treatment. Some patients w/ spirochete infections may experience Jarisch-Herxheimer reaction. Contains Na (85.4 mg/vial). Interference w/ Coombs tests; false +ve test results for galactosaemia & non-enzymatic methods for glucose determination in urine. Consider possibility of precipitates of Ca ceftriaxone when shadows are observed on sonograms. Close clinical monitoring for patients w/ severe renal & hepatic insufficiency. Should only be administered during pregnancy, particularly in 1st trimester, if benefit outweighs the risk. Discontinue breast-feeding during treatment or abstain from ceftriaxone therapy, taking into account the benefit of breast feeding for the child & the benefit of therapy for the woman. Reports of encephalopathy, particularly in elderly patients w/ severe renal impairment or CNS disorders; consider discontinuation of therapy if encephalopathy is suspected.
Adverse Reactions
Eosinophilia, leucopenia, thrombocytopenia; diarrhoea, loose stools; increased hepatic enzyme; rash.
Drug Interactions
Precipitate can form w/ Ringer's/Hartmann's soln (Ca-containing diluents); can also occur when ceftriaxone is mixed w/ Ca-containing soln in the same IV administration line. May increase anti-vit K effect & risk of bleeding w/ oral anticoagulants. Monitor aminoglycoside levels (& renal function) when used w/ aminoglycosides.
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
Pneumosolv powd for inj 1 g
Packing/Price
(+ 10 mL diluent) 10's