Roxipime (Injections) 

(Cefepime)

 

CONTENT:

Vials. Vial contains cefepime (as dihydrochloride monohydrate) 0.5 g/1.0 g /2.0 g 

 

PHARMACOLOGICAL PROPERTIES:

PHARMACODYNAMIC. Roxipime is a semisynthetic broad-spectrum antibiotic of the fourth generation cephalosporins, intended for parenteral dosing. Active substance of drug has a bactericidal action, which is due to inhibition of synthesis of cellular bacterial membrane. This antibiotic is highly stable to hydrolysis by betalactamases of majority of microbes and it quickly penetrates in cells of gramnegative microorganisms. Cefepime is active against most of strains in vitro and in clinical infections: gram- negative aerobes, gram-positive aerobes, anaerobes. Cefepime does not show activity against Bacteroides fragilis and Clostridium difficile and some strains of Xantomonas maltpphilia. PHARMACOKINETICS. Cefepime is approximately 20% bound to serum proteins; binding is independent of drug concentrations. The half-period is 2 h, total clearance - 120 ml/min. after single injection the therapeutical concentrations are determined in urine, bile, peritoneal fluid, bronchial secret, tissues of gall-bladder, appendix, prostate gland; during inflammation of meninges it goes through blood-brain barrier. It is mainly excreted through kidneys by glomerular filtration, 85% of dose is found unchanged in urine. Partially it is excreted with breast milk. 

 

THERAPEUTIC INDICATIONS:

Roxipime is prescribed as drug for treatment of infections caused by microorganism sensitive strains:

infection of lower respiratory tracts (mild and severe pneumonia, bronchitis), including cases with concomitant bacteriemia;

uncomplicated and complicated infections of urinary system (pyelonephritis), including cases with concomitant bacteriemia; uncomplicated infections of skin and soft tissues;

complicated infections of abdominal organs (used in combination with metronidasole); gynaecological infections; neutropenic fever (empirical therapy); bacterial meningitis in children.

 

CONTRAINDICATIONS:

increased sensitivity to cefepime and other cephalosporin, penicillin and other beta- lactam antibiotics; age below 2 months.

 

SIDE EFFECTS:

Drug is usually well-tolerated.

The following reactions may occur very seldom:

From the side of gastrointestinal tract: nausea, vomiting, diarrhea, constipation, pain in abdomen.

From CNS side: dizziness, headache, insomnia, paresthesia.

From cardiovascular system: tachycardia, pain in chest.

Topical reactions: painful feelings and/or inflammation in the site of injection. Allergic reactions: rash, itch, increased body temperature, very seldom - anaphylactic

reactions

 

DOSAGEAND ADMINISTRATION:

Injection of Roxipime is fulfilled:

- intravenously slowly for 3-5 minutes; 

-intravenously with infusion solutions for 30 minutes; - intramuscularly deeply in muscle.

Intravenous way of injection is preferable for patients with severe and life threatening infections, particularly in case of risk of septic shock.

In adults and children with body weight more than 40 kg with normal kidney function usual dose is 0.5-2.0 g twice a day. For prophylaxis of infection in surgical operations Roxipime is injected 60 minutes before operation in dose 2.0 g intravenously during 30 minutes.

For the treatment of uncomplicated and complicated urinary tract infections (including pyelonephritis), uncomplicated skin and skin structure infections, or pneumonia the pediatric dose for patients weighing less than 40 kg receive is 50 mg/kg given IV every 12 hours. Maximal dose in pediatrics mustn't exceed recommended dose for adults. The treatment duration is 7-10 days. For patients with kidney function disorder Roxipime dose must be corrected.

 

PACKAGING:

10 vials in carton box with enclosed leaflet.

1 vial with powder for solution for injection and 1 ampoule with solvent in carton box with enclosed leaflet.