Universal reference book for medicines
Product name: CEFURUS ® (CEFURUS)

Active substance: cefuroxime

Type: Cephalosporin II generation

Manufacturer: SYNTHESIS (Russia)
Composition, form of production and packaging
Powder for preparation of a solution for iv and in / m introduction
white or white with a yellowish shade of color.

1 f.

cefuroxime (in the form of a sodium salt) 750 mg

Vials with a capacity of 10 ml (1) - packs of cardboard.

Vials with a capacity of 10 ml (50) - cardboard boxes.

Powder for preparation of a solution for iv and in / m introduction white or white with a yellowish shade of color.

1 f.

cefuroxime (in the form of a sodium salt) 1.5 g

Vials with a capacity of 20 ml (1) - packs of cardboard.

Vials with a capacity of 20 ml (50) - carton boxes.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2013.

PHARMACHOLOGIC EFFECT

Cefuroxime belongs to the second generation cephalosporin antibiotics for parenteral administration.
Cefuroxime is active against a wide range of pathogens, including strains producing β-lactamases. The bactericidal action of cefuroxime is associated with the suppression of bacterial cell wall synthesis.
Cefuroxime is active in vitro for aerobic Gram-positive microorganisms: Staphylococcus aureus, Staphylococcus epidermidis (including strains resistant to penicillins and with the exception of methicillin-resistant strains), Streptococcus pneumoniae, Streptococcus pyogenes (and other? -hemolytic streptococci), Streptococcus group B Streptococcus agalactiae), Streptococcus mitis (viridans group);
aerobic gram-negative microorganisms: Haemophilus influenzae (including ampicillin-resistant strains), Haemophilus parainfluenzae (including ampicillin-resistant strains), Moraxella catarrhalis, Escherichia coli, Klebsiella spp., Proteus mirabilis, Providencia spp. (including Rovidencia rettgeri), Neisseria gonorrhoeae (including penicillinase producing and non-penicillinase producing strains), Neisseria meningitidis, Salmonella spp., Bordetella pertussis; anaerobic microorganisms: Gram-positive and Gram-negative cocci (including Peptococcus and Peptostreptococcus sp.), Clostridium spp., Bacteroides spp. (except Bacteroides fragilis), Fusobacterium spp., Propionibacterium spp .; other microorganisms: Borrelia burgdorferi.
The following microorganisms are resistant to cefuroxime: Clostridium difficile, Pseudomonas spp., Campylobacter spp., Acinetobacter calcoaceticus, Listeria monocytogenes, methicillin-resistant strains of Staphylococcus aureus and Staphylococcus epidermidis, Enterococcus faecalis;
Legionella spp., Morganella morganii, Proteus vulgaris, Enterobacter spp., Citrobacter spp., Serratia spp., Bacteroides fragilis.
PHARMACOKINETICS

Suction

After the / m administration of the drug at a dose of 750 mg C max is reached after 15-60 minutes and is 27 μg / ml.
With iv administration of the drug in doses of 750 mg and 1.5 g of C max is achieved after 15 minutes and is 50 μg / ml and 100 μg / ml, respectively. The therapeutic concentration in the blood remains 5.3 and 8 hours, respectively.
Distribution and Metabolism

It is not metabolized in the liver.

Binding to plasma proteins - 33-50%.
Therapeutic concentrations are achieved in the pleural fluid, bile, sputum, myocardium, skin and soft tissues. Concentrations of cefuroxime exceeding the minimum inhibitory concentration for most common microorganisms can be achieved in bone tissue, synovial fluid and intraocular fluid.When meningitis penetrates the BBB. Passes through the placental barrier and is excreted in breast milk.
Excretion

T 1/2 for iv and in / m introduction - 1.3-1.5 h, for newborns - 2-2.5 h.

85-90% is excreted by glomerular filtration and tubular secretion unchanged for 8 hours (most of the drug is excreted within the first 6 hours, while creating high concentrations in the urine);
after 24 hours it is completely removed (50% by tubular secretion, 50% by glomerular filtration).
INDICATIONS

Bacterial infections caused by susceptible microorganisms:

- respiratory tract infections (bronchitis, pneumonia, lung abscess, pleural empyema);

- infection of the ENT organs (sinusitis, tonsillitis, pharyngitis);

- urinary tract infections (pyelonephritis, cystitis, symptomatic bacteriuria);

- Gonorrhea;

- skin and soft tissue infections (erysipelas, pyoderma, impetigo, furunculosis, cellulitis, wound infection, erysipelitis);

- infections of bones and joints (osteomyelitis, septic arthritis);

- infections of the pelvic organs (endometritis, adnexitis, cervicitis);

- sepsis;

- meningitis;

- Lyme disease (borreliosis).

Prevention of infectious complications during operations on the chest (including operations on the lungs, heart, esophagus), abdominal cavity, pelvis, joints, vascular surgery with a high risk of infection complications, with orthopedic operations.

DOSING MODE

The drug is given in / m and / in (jet or drip).

In / in and / m adults are prescribed 750 mg 3 times / day;
for infections of severe course, the dose is increased to 1.5 g 3-4 times / day (if necessary, the interval between administrations can be reduced to 6 hours). The average daily dose is 3-6 g.
Children older than 3 months are prescribed 30-100 mg / kg / day in 3-4 injections.
For most infections, the optimal dose is 60 mg / kg / day.
Newborns and children up to 3 months are prescribed 30 mg / kg / day in 2-3 injections.

With gonorrhea - in / m 1.5 g once (or in the form of 2 injections of 750 mg with the introduction in different areas, for example, in both gluteal muscles).

With bacterial meningitis - iv 3 g every 8 hours;
children younger and older - 150-250 mg / kg / day in 3-4 injections, the newborn - 100 mg / kg / day.
With pneumonia , I / m or IV 1.5 g 2-3 times / day for 48-72 hours, then go to the inside (use medicinal forms for oral administration) 500 mg 2 times / day for 7- 10 days.

With an exacerbation of chronic bronchitis , I / m or IV is prescribed 750 mg 2-3 times / day for 48-72 hours, then go to the inside (use medicinal forms for oral administration) 500 mg 2 times / day for 5-10 days.

For the prevention of postoperative complications:

- for operations on the heart, lungs, esophagus and vessels - iv 1.5 g for 0.5-1 h before surgery and 750 mg IV or IM every 8 h for prolonged operations for the next 24-48 h operations on the open heart a total dose of up to 6 g);

- for operations on the abdominal cavity, pelvic organs and orthopedic operations - iv 1.5 g with induction of anesthesia, then additionally / in 750 mg at 8 and 16 h after the operation;

- when the joint is completely replaced, 1.5 g of the powder is mixed dry with each polymer methyl methacrylate cement packet before adding the liquid monomer.

In chronic renal failure in adults , correction of the dosing regimen is necessary.
With CC 10-20 ml / min , I / in or in / m 750 mg 2 times / day, with a CC less than 10 ml / min - 750 mg once a day.
In chronic renal failure in children, the dosing regimen should be changed in accordance with the recommendations for adults.

Patients on continuous hemodialysis using an arteriovenous shunt or high-speed haemofiltration in intensive care units are prescribed 750 mg twice daily.
Forpatients on low-velocity haemofiltration, doses recommended for renal impairment are prescribed.
Preparation of suspension and solution for parenteral administration

To prepare a suspension for the / m introduction to 750 mg (10 ml bottle), add 3 ml of water for injection, to 1.5 g (20 ml bottle) - 6 ml of water for injection.
Gently shake until a slurry forms.
To prepare a solution for IV infusion to 750 mg (10 ml bottle), add 9 ml of water for injection;
to 1.5 g (20 ml vial) - 14 ml of water for injection.
To prepare a solution for intravenous infusions - short-term IV infusions (eg, up to 30 min) - 1.5 g is dissolved in 50 ml of water for injection.
This solution can be injected directly into the vein or into the infusion system if the patient is parenterally injected with liquids.
SIDE EFFECT

Allergic reactions: chills, rash, itching, urticaria;
rarely erythema multiforme, bronchospasm, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), bronchospasm, drug fever, serum sickness, anaphylactic shock, cutaneous vasculitis.
On the part of the digestive system: diarrhea, nausea, vomiting or constipation, flatulence, cramps and abdominal pain, ulceration of the oral mucosa, oral candidiasis, glossitis, pseudomembranous enterocolitis, impaired liver function (increased activity of AST, ALT, APF, LDG) , hyperbilirubinemia, cholestasis.

On the part of the reproductive system: itching in the perineum, vaginitis.

On the part of the urinary system: a violation of kidney function (decreased creatinine clearance, increased creatinine and / or urea nitrogen in the blood), dysuria, interstitial nephritis.

On the part of the organs of hematopoiesis: eosinophilia, leukopenia, neutropenia, thrombocytopenia, agranulocytosis, hemolytic anemia, reduction of hemoglobin and hematocrit.

From the nervous system: convulsions.

From the senses: a decrease in hearing.

Local reactions: with the / m introduction - pain, irritation and infiltration at the injection site;
with iv administration - phlebitis, thrombophlebitis.
Laboratory indicators: false-positive Coombs test, hypoprothrombinemia, lengthening prothrombin time.

CONTRAINDICATIONS

- Hypersensitivity (including to other cephalosporins, penicillins and carbapenems).

With caution should appoint the drug to the newborn (including premature), with chronic kidney failure, bleeding and gastrointestinal diseases (including in history, ulcerative colitis), weakened and emaciated patients, during pregnancy, during lactation, when used simultaneously with aminoglycosides, "loop" diuretics.

PREGNANCY AND LACTATION

The use of the drug during pregnancy and during breastfeeding is possible if the expected benefit for the mother exceeds the potential risk to the fetus and the baby.

APPLICATION FOR FUNCTIONS OF THE LIVER

In chronic renal failure , correction of the dosing regimen is necessary.
With CC 10-20 ml / min , I / in or in / m 750 mg 2 times / day, with a CC less than 10 ml / min - 750 mg once a day.
Patients on continuous hemodialysis using an arteriovenous shunt or on high-velocity haemofiltration in intensive care units are prescribed 750 mg 2 times / day;
for patients on low-velocity haemofiltration, doses recommended for renal impairment are prescribed.
APPLICATION FOR CHILDREN

With caution should prescribe the drug to the newborn (including premature).

Children older than 3 months are prescribed a drug IV and IM at 30-100 mg / kg / day in 3-4 injections.
For most infections, the optimal dose is 60 mg / kg / day.
Newborns and children up to 3 months are prescribed 30 mg / kg / day in 2-3 injections.

In bacterial meningitis - in / in children of younger and older age - 150-250 mg / kg / day in 3-4 injections, the newborn - 100 mg / kg / day.

APPLICATION IN ELDERLY PATIENTS

Older patients in the process of treatment need control of kidney function.

SPECIAL INSTRUCTIONS

Patients with a history of allergic reactions to penicillins may exhibit hypersensitivity to cephalosporin antibiotics.

In the process of treatment, control of kidney function is necessary, especially in patients receiving the drug in high doses, in elderly patients with a history of kidney disease, while using with aminoglycosides and loop diuretics.

Treatment continues for 48-72 hours after the disappearance of the symptoms.

In the case of infections caused by Streptococcus pyogenes, the course of treatment is at least 7-10 days.

During treatment, a false positive Coombs reaction and a false positive urine reaction to glucose are possible.
In patients receiving cefuroxime, glucose oxidase or hexokinase tests are recommended when determining blood glucose concentrations.
Pseudomembranous colitis is observed with a wide range of antibiotics, the possibility of its occurrence must be borne in mind in patients with severe diarrhea that occurred during or after a course of antibiotic treatment.

Do not use ethanol during treatment.

Against the background of treatment of meningitis in children, hearing loss is possible.

When switching from parenteral to ingestion, the severity of the infection, the sensitivity of the microorganisms and the general condition of the patient should be considered.
If there is no clinical effect after 72 hours from the start of treatment, the parenteral course of therapy should be continued.
Impact on the ability to drive vehicles and manage mechanisms

During the period of treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.

OVERDOSE

Symptoms: CNS excitement, convulsions.

Treatment: symptomatic therapy, hemodialysis and peritoneal dialysis.

DRUG INTERACTION

Simultaneous oral administration of "loop" diuretics slows tubular secretion, reduces renal clearance, increases plasma concentration and increases T 1/2 ofcefuroxime.

When used simultaneously with aminoglycosides and diuretics, the risk of nephrotoxic effects increases.

Pharmaceutical interaction

Pharmaceutically compatible with aqueous solutions containing up to 1% lidocaine hydrochloride, 0.9% solution of sodium chloride, 5% and 10% dextrose (glucose) solution, 0.18% sodium chloride solution and 4% dextrose (glucose) solution, 5% dextrose solution (glucose ) and 0.9% sodium chloride solution, Ringer's solution, sodium lactate solution, Hartman's solution, heparin (10 U / ml and 50 U / ml) in a 0.9% solution of sodium chloride.

Pharmaceutically incompatible with aminoglycosides, sodium bicarbonate solution 2.74%.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored in a dry, protected from light, out of reach of children, at a temperature of no higher than 25 ° C.
Shelf life - 2 years.
After dilution, it can be stored at room temperature for 7 hours, in the refrigerator for 48 hours. Yellow solution may be used during storage.

Alphabetical index of medicines:
A  B  V  G  D  E  J
Z  I  Y  K  L  M  N
O  P  R  S  T  U  F
H  C  CH  SH  E  U  Y
Rambler's Top100
Privacy policy:
Copyright 2009 - 2017. Universal reference book of medicines. All rights reserved.
When using site materials, an active hyperlink is required!