Description
Latin name
Rocephin
Release form
Powder for preparation of injectable solution for intramuscular injection
Packaging
1 bottle.
Pharmacological action
Rocefinum is a long-acting cephalosporin antibiotic of the III generation of a wide spectrum of action for parenteral administration. The bactericidal activity of the drug is due to the suppression of the synthesis of cell membranes. Rocefin is highly resistant to the action of most beta-lactamases of gram-negative and gram-positive microorganisms.
Active against gram-positive aerobes: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus viridans, Streptococcus bovis Gram-negative aerobes: Aeromonas spp., Alcaligenes spp., Spp. (some strains are resistant), Escherichia coli, Haemophilus ducreyi, Haemophilus influenzae (including penicillinase forming strains), Haemophilus parainfluenzae, Klebsiella spp. (including Klebsiella pneumoniae), Moraxella spp., Morganella morganii, Neisseria gonorrhoeae (including penicillinase forming strains), Neisseria meningitidis, Plesiomonas shigelloides, Proteus mirabilis, Proteus vulgaris, Providenciaella spp. (including Salmonella typhi), Serratia spp. (including Serratia marcescens), Shigella spp., Vibrio spp. (including Vibrio cholerae), Yersinia spp. (including Yersinia enterocolitica), individual strains of Pseudomonas aeruginosa are also sensitive to the preparation of anaerobes: Bacteroides spp. (including some strains of Bacteroides fragilis), Clostridium spp. (except Cl.difficile), Fusobacterium spp. (except Fusobacterium mortiferum and Fusobacterium varium), Peptococcus spp., Peptostreptococcus spp.
Staphylococcus spp. strains resistant to methicillin, Enterococcus strains, many Bacteroides spp. strains producing beta-lactamases are resistant to the drug.
Indications
Treatment of infectious diseases caused by drug-sensitive microorganisms: – sepsis
– meningitis
– infectious diseases of the abdominal organs (peritonitis, biliary tract and gastrointestinal tract infections)
– infectious diseases of the bones, joints, soft tissues, skin, and wound infections
– infectious diseases in people with weakened immune systems
– infectious diseases of the upper and lower respiratory tract (including pneumonia)
– infectious diseases of the kidneys and urinary tract
– infectious diseases of the genital organs (including gonorrhea).
Prevention of postoperative infectious complications.
Contraindications
Hypersensitivity to cephalosporins and penicillins.
Use during pregnancy and lactation
The safety of the drug during pregnancy has not been established.
If necessary, the appointment of the drug during lactation should decide on the termination of breastfeeding. In low concentrations, ceftriaxone is excreted in breast milk.
In experimental studies, no embryotoxic, fetotoxic, teratogenic effects or other adverse factors on the fertility of males and females, the process of childbirth, perinatal and postnatal development of offspring were revealed. In primates, no embryotoxicity or teratogenicity was observed.
Composition
1 vial: ceftriaxone (as ceftriaxone disodium salt – 1.193 g) – 1 g
solvent: lidocaine solution 1%
Dosage and administration
Adults and children over 12 years of age are prescribed 1-2 g of Rocefin 1 time / day. Depending on the clinical situation, the daily dose can be increased to 4 g.
Newborns (up to 2 weeks) are prescribed at a dose of 20-50 mg / kg body weight 1 time / day.
When calculating the dose, the degree of full-term baby is not taken into account.
Infants (from 3 weeks of age) and children under 12 years of age are prescribed 20-80 mg / kg of body weight 1 time / day.
Children with a body weight of over 50 kg are prescribed a dose for adults.
Duration of treatment is set individually. As a rule, the introduction of the drug must be continued for another 48-72 hours after the normalization of temperature.
With bacterial meningitis in infants and young children, treatment begins with a dose of 100 mg / kg body weight (but not more than 4 g) 1 time / day. When identifying the pathogen and its degree of sensitivity to the drug, the dose can be adjusted. The duration of treatment depends on the pathogen and can range from 4 days for Neisseria meningitidis, up to 7 days for sensitive strains of St. pneumoniae.
With gonorrhea, it is recommended to administer 250 mg IM once.
For the prevention of postoperative complications, it is recommended to administer 1-2 g of Rocefin once (depending on the degree of danger of infection) 30-90 minutes before the operation. For operations on the colon and rectum, additional administration of the drug from the group of 5-nitroimidazoles is recommended.
Side effects
From the digestive system: diarrhea, nausea, vomiting, stomatitis, glossitis rarely – an increase in transaminase activity, darkening on the echogram of the gallbladder.
From the hemopoietic system: eosinophilia, leukopenia, granulocytopenia, hemolytic anemia, thrombocytopenia.
From the side of the central nervous system: headache, dizziness.
Allergic reactions: rash, itching, dermatitis, urticaria, edema, exudative erythema multiforme rarely – anaphylactoid or anaphylactic reactions.
Local reactions: in rare cases, phlebitis. Intramuscular administration without lidocaine is painful.
Effects due to biological effects: superinfection (genital tract mycosis) is possible.
Other: oliguria, increased serum creatinine, fever, chills, bleeding disorder.
The frequency of all side effects does not exceed 2%.
Drug Interactions
Rocefin and aminoglycosides have synergistic effects against many Gram-negative bacteria.
Concomitant use of high doses of rocefin and loop diuretics, such as furosemide, did not show renal impairment. There is no indication that rocefin increases the nephrotoxicity of aminoglycosides.
Probenecid has no effect on the excretion of rocefin.
Pharmaceutical interaction.
The rocefin solution is incompatible with solutions containing other antibiotics (both during preparation and administration)
Storage conditions
Keep out of the reach and sight of children at temperatures up to 30 C
Freshly prepared rocefin solutions are physically and chemically stable for 6 hours at room temperature.
active substance
Ceftriaxone
Terms leave through pharmacies
In retseptu
dosage form
solution for injection
Indications
Urinary tract infections, Tonsillitis, Skin infections, Vaginal infections, Pneumonia, Sinusitis, Bronchitis, Sepsis
Possible product names
ROCEFIN 1.0 FLAC POR D / R-RA B / M + 3.5ML R-L
ROCEFIN 1.0 + 3.5ML RAS – W / M
Rocefin for i / m injection 1.0 g, vial 1 pc.
Rocefin por p / r v / m 1g x 1
Rocefin p. d / in. v / m 1g vial + lidocaine 3.5ml N1 Switzerland
