Rocephin, 1.0g, vial 1pc

Composition

of 1 fl. : ceftriaxone (in the form of ceftriaxone disodium salt-1,193 g) – 1 grastvoritel: lidocaine solution 1%

Pharmacological action

Rocefin is a long-acting cephalosporin broad-spectrum antibiotic of the third generation for parenteral use. The bactericidal activity of the drug is due to the suppression of cell membrane synthesis. 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., Branhamella catarrhalis (forming and non-forming beta-lactamases), Citrobacter spp., Enterobacter 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, 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 that are resistant to methicillin, Enterococcus strains, and many Bacteroides spp. strains that produce beta-lactamases are resistant to the drug.

Indications

Treatment of infectious diseases caused by drug-sensitive microorganisms: – sepsis– – meningitis; – infectious diseases of the abdominal cavity (peritonitis, biliary tract and gastrointestinal tract infections); – infectious diseases of 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 genitals (including gonorrhea). Prevention of postoperative infectious complications.

Recommendations for use

The safety of using the drug during pregnancy has not been established. If it is necessary to prescribe the drug during lactation, the question of stopping breastfeeding should be decided. In low concentrations, ceftriaxone is excreted in breast milk. Experimental studies did not reveal any embryotoxic, fetotoxic, teratogenic effects or other unfavorable factors on the fertility of males and females, the process of childbirth, and the perinatal and postnatal development of offspring. There were no signs of embryotoxicity or teratogenicity in primates.

Contraindications

Hypersensitivity to cephalosporins and penicillins.

Side effects

From the digestive system:  diarrhea, nausea, vomiting, stomatitis, glossitis; rarely-increased transaminase activity, darkening on the echogram of the gallbladder. From the hematopoietic system:  eosinophilia, leukopenia, granulocytopenia, hemolytic anemia, thrombocytopenia. From the central nervous system:  headache, dizziness. Allergic reactions:  rash, pruritus, dermatitis, urticaria, edema, exudative erythema polyforme; rarely-anaphylactoid or anaphylactic reactions. Local reactions:  in rare cases-phlebitis. Intravenous use without lidocaine is painful. Effects due to biological action:  it is possible to develop superinfection (mycoses of the genital tract). Other services:  oliguria, increased serum creatinine, fever, chills, blood clotting disorders. The frequency of all side effects does not exceed 2%.

Interaction

Rocefin and aminoglycosides have a synergistic effect against many gram-negative bacteria. Concomitant use of high doses of Rocefin and loop diuretics, such as furosemide, did not cause renal impairment. There is no evidence that Rocefin increases the nephrotoxicity of aminoglycosides. Probenecid does not affect the excretion of Rocefin. Pharmaceutical interaction. Rocefin solution is incompatible with solutions containing other antibiotics (both during preparation and use) 

How to take, course of use and dosage

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) assign a dose of 20-50 mg / kg of body weight 1 time/day. When calculating the dose, the degree of fullness of the child is not taken into account. children (from 3 weeks of life) 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 more than 50 kg are prescribed a dose for adults.

The duration of treatment is set individually. As a rule, the drug use should be continued for another 48-72 hours after the temperature normalizes.

In case of bacterial meningitis in children and young children, treatment begins with a dose of 100 mg/kg of body weight (but not more than 4 g) 1 time/day. When identifying the pathogen and the degree of its 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.

When gonorrhea is recommended to enter 250 mg / m once.

To prevent postoperative complications, it is recommended to inject 1-2 g of Rocefin once (depending on the degree of risk of infection) 30-90 minutes before the operation. For operations on the colon and rectum, additional use of a drug from the 5-nitroimidazole group is recommended.

Special instructions

With simultaneous severe renal and hepatic insufficiency, the concentration of the drug in the blood plasma should be regularly determined. In patients undergoing hemodialysis, it is necessary to monitor the concentration of the drug in the blood plasma, because they may decrease the rate of its excretion. With long-term treatment with the drug, it is necessary to regularly monitor the picture of peripheral blood. In rare cases, ultrasound of the gallbladder shows darkening, which disappears after discontinuation of the drug. Even if this phenomenon is accompanied by pain in the right hypochondrium, only symptomatic treatment is recommended. After alcohol consumption, no effects similar to those of disulfiram (teturam) were observed following Rocefin use. Pediatric use Rocefin should be administered with caution in children born with hyperbilirubinemia, especially preterm infants.

Form of production

Powder for preparation of an injectable solution for intramuscular use

Storage conditions

Keep out of the reach of children at temperatures up to 30C Fresh prepared Rocefin solutions are physically and chemically stable for 6 hours at room temperature.

Active ingredient

Ceftriaxone

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection

Indications

Skin Infections, Tonsillitis, Vaginal Infections, Urinary Tract Infections, Sepsis, Bronchitis, Pneumonia, Sinusitis