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Antiinfectives for Systemic Use

Rotacef (Injections)
(Ceftriaxone)



CONTENT:
Vials. Vial contains ceftriaxone (as sodium salt) 0.5 g /1.0 g /2.0 g.
 
PHARMACOLOGICAL PROPERTIES:
PHARMACODYNAMICS. Rotacef is antibiotic of third generation of cephalosporins with wide spectrum of action. It shows bactericidal action due to inhibition of bacterial cellular wall synthesis. It is active against majority of gram-negative, many gram-positive pathogens and some anaerobes. It is resistant to action of beta-lactamases, produced by bacteria. Many strains of above mentioned organisms, which persistently prolifirate in presence of other antibiotics, for example, penicillins, second generations of cephalosporins, and aminoglycosides, are susceptible to Rotacef. Ceftriaxone is drug of choice for many infections caused by gram-negative bacteria. Good effectiveness against primary and secondary syphilis of the preparation is noted on the basis of clinical data. PHARMACOKINETICS. The bioavailability after intramuscular administration is 100%. Maximum concentration in blood plasma is achieved within 2-3 hours after intramuscular administration. It reversibly binds to plasma albumins by 85-95%, and the binding is inverse as its blood concentration. Half-life period is long and makes 8 hours in adults, it becomes 2 times longer in elderly people at the age more than 75 years, it is 6.5 - 8 days in infants. 50-60% of Rotacef is excreted in unchanged form with urine, 40-50% with bile. In newborn about 70% of administered Rotacef dose is excreted by kidneys. Ceftriaxone is widely distributed into body tissues and fluids including the gallbladder, lungs, bone, heart, bile, prostate adenoma tissue, uterine tissue, appendix, sputum, tears, middle ear fluid, and pleural, peritoneal, synovial, ascitic, and blister fluids. Rotacef pharmacokinetics doesn't change at renal or hepatic function impairments (not significant half-life period prolongation is possible) due to redistribution of functions: if the renal function is impaired, bile excretion increases, at liver pathology-renal excretion increases.
 
THERAPEUTIC INDICATIONS:
- respiratory tract infections (pneumonia, lung abscess, pleural empyema);
- infections of abdominal organs (including cholangitis,
gallbladder empyema, inflammatory diseases of gastrointestinal tract, peritonitis);
- bones and joints infections;
- skin and soft-tissues infections;
- urinary tracts infections (including pyelonephritis);
- sexually-transmitted infections (including gonorrhea);
- infected wounds and burns;
- meningitis, sepsis;
- prophylaxis of post-operational infections;
- ceftriaxone is used for the treatment of native valve or prosthetic valve endocarditis caused by viridans streptococci.
 
CONTRAINDICATIONS:
hypersensitivity to cephalosporins and penicilins;
first trimester of pregnancy;
the drug should be prescribed with care to newborn babies especially to premature children due to high risk of hyperbilirubinemia development.
 
SIDE EFFECTS:
Rotacef is well tolerated in most cases. Adverse effects, as a rule, are reversible and
disappear after the preparation cancellation.
 
DOSAGE AND ADMINISTRATION:
Rotacef is administered intramuscularly and intravenously.
For newborn (before two weeks) Rotacef is prescribed at a dose 20-50 mg/kg of body weight one time per day. For infants and children at the age before 12 years Rotacef daily dose is 20-80 mg/kg of body weight 1 time per day. Usual adult doses are used for children with body mass of 50 kg and more. Usual doses for adults and children at the age of 12 years and older are 1-2 g of Rotacef one time per day. In severe cases daily dose may be increased to 4 g. During treatment of gonorrhea the recommended single dose is 250 mg of Rotacef intramuscularly. In patients with renal function impairments hepatic function impairments it is not necessary to reduce preparation dose. In case of expressed renal insufficiency (creatinine clearance <10 ml/min) Rotacef dose should not exceed 2 g per day. For the prophylaxis of post-operational infections single administration of 1-2 g of Rotacef 30-90 minutes before operation is recommended.
 
PACKAGING:
1 vial with powder for the preparation of injection solution and 1 ampoule with solvent in carton box with leaflet.
Rotacef 0.5 g, or 1.0 g. 10 vials in contour cellular package. 1 contour cellular package in carton box with leaflet.
 
 
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