Roxipim (cefepime) powder for solution for injections 1g. №1 vial + solvent 10 ml.

Description

Roxipim (cefepime) powder for solution for injections 1g. №1 vial + solvent 10 ml. 

Composition

active substance: cefepime;

1 bottle of the drug contains cefepime (in the form of cefepime dihydrochloride monohydrate) 1.0 g;

excipient: arginine;

1 ampoule of solvent contains 10 ml of water for injection.

Medicinal form

Powder for solution for injection.

The main physical and chemical properties: the drug is a white to pale yellow powder, the solvent is a transparent, colorless solution.

Pharmacotherapeutic group

Antibacterial agents for systemic use. β-lactam antibiotics.
ATX code J01D E01.

Pharmacological properties

It is a 4th generation cephalosporin antibiotic that has a bactericidal effect (kills bacteria). Active against many gram-positive / negative bacteria.

Indications

Roxipim is prescribed for adults:

• with respiratory tract infections (sinusitis, pneumonia, bronchitis);
• with infections of the skin, subcutaneous tissue;
• with intra-abdominal (intra-abdominal) infection, incl. with peritonitis, infections of the biliary tract;
• with gynecological infection;
• with septicemia (blood poisoning);
• for empiric therapy (with an unknown diagnosis) of patients with neutropenic fever;
• to prevent postoperative complications in intra-abdominal surgery.

Roxipim is prescribed for children:

• with pneumonia;
• with infections of the skin, subcutaneous tissue;
• with urinary tract infection, incl. with pyelonephritis;
• with septicemia (blood poisoning);
• for empiric therapy (with an unknown diagnosis) of patients with neutropenic fever;
• with bacterial meningitis.

Contraindications

Roxipim is contraindicated:

• with intolerance to the components;
• with allergies to cephalosporins, penicillins, and other β-lactam antibiotics.

Roxipim is used with caution in diseases of the digestive tract (especially colitis).

Application during pregnancy and lactation

Only when prescribed by a doctor.
Small amounts of cefepime pass into breast milk, so feeding is stopped.

Method of administration and dosage

Roxipim is administered parenterally. For adults, it is usually administered intravenously or intramuscularly at a dose of 1000 mg at intervals of 12 hours. For life-threatening infections, 2000 mg is indicated every 8-12 hours.
The standard duration of treatment is 7-10 days.

Overdose

Symptoms: the development of encephalopathy (hallucinations, impaired consciousness, stupor, coma, myoclonus, epileptiform seizures, neuromuscular excitability).
Treatment: stop drug administration, carry out symptomatic therapy, apply hemodialysis.

Side effects:

• Immune disorders: allergies, including anaphylaxis, angioedema, anaphylactic shock, Stevens-Johnson syndrome, Lyell’s syndrome.
• Respiratory disorders: shortness of breath, cough, sore throat.
• Cardiovascular disorders: tachycardia, vasodilation.
• Digestive disorders: nausea, dyspepsia, oral candidiasis, perverted taste, diarrhea / constipation, pseudomembranous colitis, abdominal pain.
• Neurological disorders: dizziness, paresthesia, insomnia, headache, anxiety, convulsions, hallucinations, impaired consciousness, stupor, coma.
• Hepatobiliary disorders: cholestatic jaundice, hepatitis.
• Skin changes: rashes, itching, hives.
• Others: asthenia, sweating, fever, vaginitis, erythema, chest pain, back pain, peripheral edema, genital itching, candidiasis, renal failure, transient leukopenia, neutropenia, thrombocytopenia, agranulocytosis, increased AST / ALT, ALP, urea, creatinine , bilirubin, anemia, eosinophilia, increased partial thromboplastin time, prothrombin time, positive Coombs test result without hemolysis, bleeding.
• Respiratory disorders: dyspnea.
• Local changes: with intravenous administration – phlebitis, tissue inflammation; with intramuscular injection – pain, inflammation.