Roxipime powder for solution for injection is indicated for infections whose pathogens are sensitive to cefepime.
adults: septicemia; intra-abdominal infections, including peritonitis and biliary tract infections; skin and subcutaneous tissue infections; gynecological infections; respiratory tract infections, including pneumonia, bronchitis; Prevention of postoperative complications in intra-abdominal surgery; Empirical therapy of patients with neutropenic fever. children: pneumonia; urinary tract infections, including pyelonephritis; skin and subcutaneous tissue infections; septicemia; empirical therapy of patients with neutropenic fever; bacterial meningitis.
Composition
Active ingredient: cefepime;
1 vial of the drug contains cefepime (in the form of cefepime dihydrochloride
monohydrate) 1.0 g;
Excipients: arginine.
1 ampoule of solvent contains 10 ml of water for injection.
Contraindication
Hypersensitivity to cephalosporin antibiotics or L-arginine, penicillins or other β-lactam antibiotics.
Method of application
Before using the drug, a skin test should be performed for tolerance.
The usual adult dosage is 1 g, administered intravenously or intramuscularly at 12-hour intervals. The usual duration of treatment is 7-10 days; longer treatment is possible in severe infections.
Application features
Pregnant women
It can only be prescribed when the expected benefit to the mother outweighs the potential risk to the fetus.
Children
The drug is used in children from 1 month of age.
Drivers
You should refrain from driving or operating machinery.
Overdose
Symptoms. In cases of significant excess of recommended doses, especially in patients with impaired renal function, the manifestations of side effects are enhanced. Symptoms of overdose include encephalopathy, accompanied by hallucinations, impaired consciousness, stupor, coma, myoclonus, epileptiform seizures, neuromuscular excitability.
Treatment. It is necessary to stop the administration of the drug, conduct symptomatic therapy. The use of hemodialysis accelerates the removal of cefepime from the body; peritoneal dialysis is ineffective. Severe allergic reactions of the immediate type require the use of adrenaline and other forms of intensive therapy.
Side effects
Roxipime is usually well tolerated.
Allergic reactions: rash, itching, urticaria, erythema, anaphylactic shock, fever. Gastrointestinal: diarrhea, nausea, vomiting, constipation, abdominal pain, dyspepsia, stomatitis, colitis (including pseudomembranous). Cardiovascular: chest pain, tachycardia. Hematopoietic: agranulocytosis, hypereosinophilia, neutropenia, thrombocytopenia, prolongation of prothrombin time and activated partial thromboplastin time, hypotension, vasodilation, decreased serum phosphate concentration. Respiratory: cough, sore throat, shortness of breath. Central nervous system: headache, dizziness, insomnia, paresthesia, anxiety, confusion, convulsions; encephalopathy, which may manifest as loss of consciousness, hallucinations, stupor, coma; myoclonus. Infections: candidiasis. Reactions at the injection site: with intravenous infusion - phlebitis and inflammation, with intramuscular injection - pain, inflammation. Other: asthenia, increased sweating, vaginitis, peripheral edema, back pain.
Interaction
There are possible cases of increased activity of oral anticoagulants in patients receiving cephalosporins.
When using high doses of aminoglycosides simultaneously with Roxipim, renal function should be closely monitored due to the potential nephrotoxicity and ototoxicity of aminoglycoside antibiotics. Nephrotoxicity has been observed after concomitant use of other cephalosporins with diuretics such as furosemide.
Roxipim is compatible with the following solvents: water for injection, 0.9% sodium chloride solution for injection (with or without 5% glucose solution), 5 and 10% glucose solutions for injection, 1/6M sodium lactate solution for injection, lactated Ringer's solution (with or without 5% glucose solution), lidocaine hydrochloride solution.
Storage conditions
Store at a temperature not exceeding 25 °C, protected from light and out of the reach of children.
Shelf life - 3 years.
