Rocephin, 1 g

Rosefin is a long-acting, broad-spectrum III generation cephalosporin antibiotic for parenteral administration. Bactericidal activity of the drug is due to inhibition of cell membrane synthesis. Rocephin is highly resistant to the action of most beta-lactamases of gram-negative and gram-positive microorganisms.

It is 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., Branhamella catarrhalis (forming and non forming beta-lactamases), Citrobacter spp, Enterobacter spp. (some strains are resistant), Escherichia coli, Haemophilus ducreyi, Haemophilus influenzae (including penicillinase producing strains), Haemophilus parainfluenzae, Klebsiella spp. (including Klebsiella pneumoniae), Moraxella spp, Morganella morganii, Neisseria gonorrhoeae (including penicillinase-producing strains), Neisseria meningitidis, Plesiomonas shigelloides, Proteus mirabilis, Proteus vulgaris, Providencia spp., Salmonella spp. (including Salmonella typhi), Serratia spp. (including Serratia marcescens), Shigella spp, Vibrio spp. (including Vibrio cholerae), Yersinia spp. (including Yersinia enterocolitica), some strains of Pseudomonas aeruginosa are also sensitive to the drug; 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 showing resistance to methicillin, Enterococcus strains, many strains of Bacteroides spp. producing beta-lactamases are resistant to the action of the drug.

Indications

Treatment of infectious diseases caused by microorganisms sensitive to the drug:
– sepsis;
– meningitis;
– infectious diseases of the abdominal organs (peritonitis, biliary tract and gastrointestinal tract infections);
– Infectious diseases of bones, joints, soft tissues, skin, and wound infections;
– infectious diseases in immunocompromised people;
– infectious diseases of the upper and lower respiratory tracts (including pneumonia).Infectious diseases of the upper and lower respiratory tracts (including pneumonia);
– kidney and urinary tract infections;
– reproductive tract infections (including gonorrhea).
– Prevention of postoperative infectious complications.

Active ingredient

Composition

1 vial contains:

Active ingredients:

ceftriaxone dinatrium salt 596.5 mg, which corresponds to the content of ceftriaxone – 500 mg,

Solvent:

d/i water – 5 ml.

How to take, the dosage

Adults and children over 12 years of age are prescribed 1-2 g of Rocephin 1 time per day. Depending on the clinical situation the daily dose may be increased up to 4 g.
Newborn infants (less than 2 weeks) are prescribed in dose of 20-50 mg/kg of body weight once/day.

Interaction

Rotcephin and aminoglycosides have synergistic effects against many Gram-negative bacteria.

When using high doses of Rocephin and “loop” diuretics such as furosemide concomitantly, no renal dysfunction has been observed. There are no indications that Rocephin increases nephrotoxicity of aminoglycosides.

Probenecid has no effect on excretion of Rocephin.

Pharmaceutical interactions.

Rocephin solution is incompatible with solutions containing other antibiotics (both in preparation and administration)

Special Instructions

In patients on hemodialysis the plasma concentration of the drug should be monitored regularly, since they may have a reduced rate of excretion.

The peripheral blood count should be monitored regularly during long-term treatment with the drug.

In rare cases, darkening of gallbladder at ultrasound examination is noted, which disappears after discontinuation of the drug. Even if this phenomenon is accompanied by right-subcostal pain, only symptomatic treatment is recommended.

No effects similar to those of disulfiram (teturam) have been observed after alcohol consumption following the administration of Rocephin.

Pediatric use

Rosefin should be prescribed with caution in newborns with hyperbilirubinemia, especially premature infants.

Contraindications

Hypersensitivity to cephalosporins and penicillins.

Side effects

Digestive system disorders: diarrhea, nausea, vomiting, stomatitis, glossitis; rarely – increased transaminase activity, darkening on echogram of the gallbladder.

Hematopoietic system disorders: eosinophilia, leukopenia, granulocytopenia, hemolytic anemia, thrombocytopenia.

CNS disorders: headache, dizziness.

Allergic reactions: rash, itching, dermatitis, urticaria, edema, erythema exudative polyform; rarely – anaphylactoid or anaphylactic reactions.

Local reactions: in rare cases – phlebitis. I/m injection without lidocaine is painful.

The effects due to biological action: possible development of superinfection (mycosis of the genital tract).

Others: oliguria, increased serum creatinine, fever, chills, blood clotting disorders.

The frequency of all adverse effects does not exceed 2%.

Overdose

Hemodialysis and peritoneal dialysis will not reduce drug concentrations in case of overdose.

There is no specific antidote.

The treatment of overdose is symptomatic.

Pregnancy use

The safety of using the drug in pregnancy has not been established.

If it is necessary to prescribe the drug during lactation, the question of stopping breast-feeding should be solved. In low concentrations ceftriaxone is excreted with breast milk.

In experimental studies no embryotoxic, fetotoxic, teratogenic effects or other adverse factors on fecundity of males and females, the process of childbirth, perinatal and postnatal development of offspring have been found.

No embryotoxicity or teratogenicity phenomena were observed in primates.

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