ZINACEF

Active material: Cefuroxime
When ATH: J01DC02
CCF: Cephalosporin II generation
ICD-10 codes (testimony): A39, A40, A41, A46, A54, G00, H66, J00, J01, J02, J03, J04, J15, J20, J31, J32, J35.0, J37, J42, J47, J85, J86, K65.0, L01, L02, L03, L08.0, M00, M86, N10, N11, N30, N34, N41, N70, N71, N72, Z29.2
When CSF: 06.02.02
Manufacturer: GlaxoSmithKline s. p. a.. (Italy)

Pharmaceutical form, composition and packaging

Powder for solution for injection from white to light yellow in color.

Bottles (1) – packs cardboard.

Pharmacological action

Cephalosporin II generation. Cefuroxime is active against a broad spectrum of pathogens, including strains, продуцирующие b-лактамазы. Bactericidal activity associated with the repression of synthesis siruroksima cell walls of bacteria by linking with the main target proteins.

Cefuroxime in vitro active against gramotricationah aerobov: Haemophilus influenzae(incl. ampicillin-resistant strains), Haemophilus parainfluenzae, Moraxella catarrhalis, Esherichia coli, Klebsiella spp., Proteus is wonderful, Providencia spp., Proteus rettgeri and Neisseria gonorrhoeae (including strains, produciruûŝie and neproduciruûŝie penicillinazu), Neisseria meningitidis, Salmonella spp.; Gram-positive aerobes: Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes (and other β-hemolytic streptococci), Group B Streptococcus (Streptococcus agalactiae), Streptococcus (viridans group), Bordetella pertussis; anaerobes: Peptococcus spp., Peptostreptococcus spp., Clostridium spp., Bacteroides spp., Fusobacterium spp., Propionibacterium spp.; other microorganisms: Borrelia burgdorferi.

To cefuroxime not sensitive: Clostridium difficile, Pseudomonas spp., Campylobacter spp., Acinetobacter calcoaceticus, Listeria monocytogenes, Methicillin-resistant strains of Staphylococcus aureus and Staphylococcus epidermidis, Legionella spp.

Pharmacokinetics

Absorption

C_max siruroksima plasma after the/m introduction, noted in the period from 30 to 45 m, is 27 µg/ml and lasts for 5.3 no.

Distribution

Cefuroxime crosses the Geb, the placental barrier and is excreted in breast milk. Therapeutic concentrations siruroksima created in bones, skin, soft tissues, synovial, plevralynoy, intraocular liquid, bile, sputum and myocardium. Concentrations of cefuroxime, exceeding the minimum concentration for the overwhelming majority of organisms, It can be achieved in bone, synovial and intraocular fluids.

Plasma protein binding – 33%-50%.

Metabolism and excretion

Cefuroxime is not metabolized. T_1/2 siruroksima after injecting approximately 70 m. Newborn children T_1/2 cefuroxime may be 3-5 times longer, than in adults.

Excreted by the kidneys by glomerular filtration and tubular secretion. During 24 hours after parenteral cefuroxime is almost entirely (85-90%) excreted in the urine as unchanged, with most of the drug – for the first 6 no. Siruroksima serum levels are reduced when dialysis.

Testimony

Treatment of diseases, cefuroksimu caused by sensitive bacteria:

- Infections of the upper and lower respiratory tract (pneumonia, bronchitis, infected bronchiectasis, lung abscess, postoperative infectious diseases of the chest);

- Infections of upper respiratory tract (otitis media, sinusitis, sore throat, pharyngitis);

- Urinary tract infections (pyelonephritis, cystitis, asymptomatic bacteriuria, gonorrhea);

- Infections of the skin and soft tissues (furunculosis, Rózsa and wound infections);

- Bone and joint infections (osteomyelitis and septic arthritis);

- Pelvic infection;

- Septicemia;

- Meningitis;

- Peritonitis.

Prevention of infectious complications in abdominal operations, pelvic, orthopedic surgery, heart surgery, light, esophagus and blood vessels.

Dosage regimen

Adults appoint / m or / 750 mg 3 times / day. In more severe cases the drug is injected in/in the dose 1.5 g 3 times / day. Optionally Zinacef may be every 6 no, a daily dose can vary from 3 to 6 g.

At Some infections the appointment effectively Zinacefa the dose 750 mg or 1.5 g 2 times / day (w / o or w / w) followed by Zinnata inside.

Babies the drug is prescribed in a dose 30-100 mg / kg / day 3-4 admission. For most infections the optimal dose is 60 mg / kg / day.

Newborns appointed 30-100 mg / kg / day 2-3 admission.

To treatment of gonorrhea appointed 1.5 g once (two doses of 750 mg/m in different places, eg, both gluteal muscles).

At meninges adult appointed 3 g / in every 8 no; children – 150-250 mg/kg/day/in 3-4 admission; newborn – 100 mg/kg/day/.

To Prevention of infectious complications in abdominal operations, pelvis and orthopedic interventions Zinacef in dose 1.5 g is entered in/during induction of anesthesia. Through 8 and h 16 hours after the operation, optionally enter a/m 750 mg Zinacefa.

To Prevention of infectious complications in heart surgery, light, throat and blood vessels during induction of anesthesia Zinacef is entered in/in the dose 1.5 g, and then for 24-48 hr from 750 mg 3 times/day/m.

At total joint replacement 1.5 g powder can be mixed with siruroksima package polymer of methyl-metakrilatnym cement before adding liquid polymer.

Step therapy

At pneumonia Zinacef is prescribed in a dose 1.5 g 2-3 times / day (w / w or w / o) during 48-72 h and then assigning Zinnata (inside) dose 500 mg 2 times / day for 7-10 days.

At exacerbation of chronic bronchitis Zinacef is prescribed in a dose 750 mg 2-3 times / day (w / w or w / o) during 48-72 h and then assigning Zinnata (inside) 500 mg 2 times/sutv for 5-10 days.

The length of each period (Parenteral therapy and intake) determined by the seriousness of the infection and the patient's general condition.

Renal failure

At renal failure recommended lower doses Zinacefa. However, it is not necessary to reduce the standard dose (0.75-1.5 g 3 times / day) in patients with more CC 20 ml / min.

Dose adjustment in Zinacefa renal failure in adults

Patients, hemodialysis, at the end of each hemodialysis session, you must enter an extra dose of Zinacefa, equal 750 mg.

Patients, located in intensive care on a continuous hemodialysis using low-flow-arterio-venous shunt or high-speed Hemofiltration, recommended dose 750 mg 2 times / day. If you are using Hemofiltration with low speed, the applied doses, as in renal failure.

Terms of solution for injection

For preparation of a solution for the / m You should add 1 ml of water for injection to 250 mg Zinacefa or 3 ml of water for injection to 750 mg Zinacefa. Gently shake until a suspension.

For preparation of a solution for / in the should dissolve 250 mg Zinacefa in 2 ml or more of water for injections, 750 mg Zinacefa in 6 ml or more of water for injections, 1.5 g Zinacefa in 15 ml or more of water for injections.

For preparation of a solution for short-term infusions (to 30 m) 1.5 g of drug dissolved in 50 ml water for injection. These solutions can be injected directly into a vein or tube infusion system.

Side effect

From the digestive system: nausea, vomiting, diarrhea, cramps and abdominal pain, psevdomembranoznыy colitis, oral candidiasis, increase in liver enzymes (GOLD, IS, LDH, Alkaline phosphatase), giperʙiliruʙinemija.

From the hematopoietic system: eozinofilija, leukopenia, neutropenia, thrombocytopenia, agranulocytosis, gemoliticheskaya anemia.

On the part of the central nervous system and sensory organs: convulsions, hearing loss.

With the genitourinary system: violation of kidney function improved creatinine and/or urea nitrogen and reduced QC, itching in the perineum, vaginitis (with the development of candidiasis).

Allergic reactions: mnogoformnaya Erythema ekssoudatus, (incl. Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), skin rash, (incl. urticarnaya), itching, drug fever, bronchospasm, serum sickness; rarely – anaphylactic shock.

Laboratory findings: false positive Coombs test.

Local reactions: when i / m administration – pain, irritation and infiltration at the injection, at / in the introduction – phlebitis, tromboflebit.

Prolonged use of Zinacefa may be accompanied by excessive growth of insensitive microorganisms, incl. fungi kind Candida with the development of candidiasis of the oral cavity and vagina (itch, allocation).

Contraindications

-hypersensitivity to antibiotics zefalosporinovm, penicillin and carbapenems.

FROM caution use in patients with renal insufficiency, diseases of the digestive tract (incl. in history and when specific ulcerative colitis), If you need dual purpose with “loop” dioretikami and aminoglikozidami, Pregnancy and lactation, as well as in newborn infants (especially premature).

Pregnancy and lactation

The drug is classified in. Precautions should be prescribed the drug during pregnancy.

Cefuroxime is excreted in breast milk, Therefore it is necessary to be careful in appointing his nursing mothers.

No details about the development of embryotoxic or teratogenic effects of cefuroxime.

Cautions

The caution should appoint drug patients with anaphylactic reaction to penicillin and other beta-lactam antibiotics in history.

Together with aminoglikozidami and dioretikami increased risk of nefrotoksicskih effects, Therefore, it was necessary to monitor kidney function when applying this combination of drugs, especially in elderly patients, with kidney disease and receiving medication in high dose.

When treating meningitis Zinacefom some children mentioned hearing impairment mild, at the same time in cerebrospinal fluid were determined positive Haemophilus influenzae culture through 18-36 h therapy. Similar phenomena have been observed in the implementation of other antibiotics, their clinical relevance is not known.

Pseudomembranous colitis is observed when using a broad spectrum antibiotics, the possibility of its occurrence must be borne in mind in patients with severe diarrhea, occurred during or after treatment with antibiotics.

Cefuroxime is produced in the form of aksetila (Zinnat) tablets, that allows you to assign consistently the same antibiotic, When a transition from parenteral to oral therapy.

For the treatment of pneumonia and exacerbations of chronic bronchitis is the appointment effective treatment Zinacefom, antibiotic for parenteral, before using Zinnata inside (technique of step therapy).

If step therapy transition time of oral therapy was determined by the seriousness of the infection, patients ' clinical condition and the sensitivity of the pathogen. If no clinical effect within 72 h from the beginning of treatment, Parenteral therapy should be continued.

Before you begin step therapy contact information in handbooks about cefuroxime aksetila.

Zinacef does not affect the results of the determination of glucose in urine using enzymatic methods. But, When you apply other methods (Benedict, 'S, Clinical laboratory) Maybe interaction, not resulting in ložnopoložitel′nym results.

Patients, receiving Zinacef, It is recommended that you use to determine the level of glucose in the blood/plasma method with glûkozooksidazoj or geksokinazoj.

Zinacef does not affect the quantitative determination of creatinine alkaline pikratnym method.

Each vial of Zinacefa 750 mg contains 42 mg of sodium.

Effects on ability to drive vehicles and management mechanisms

There are no messages.

Overdose

Symptoms: increased excitability of the cerebral cortex with the development of seizures.

Treatment: symptomatic therapy, hemodialysis, pyeritonyealinyi dialysis.

Drug Interactions

Simultaneous reception “loop” Diuretics (furosemid) and aminoglikozidami slows kanalzevu secretion, reduces renal clearance, increases concentration in plasma and increases T_1/2 tsefuroksyma, that increases the risk of nefrotoksicskih effects. Zinacef in combination with aminoglikozidami Act additively, but sometimes there may be synergies action.

Pharmaceutical interaction

When mixing solution siruroksima (1.5 g 15 ml water for injection) and metronidazole (500 mg / 100ml) both components remain active until 24 h at a temperature of no higher than 25° c. Zinacef in dose 1.5 g is compatible with the solution azlocillina (1 g 15 ml or 5 g 50 ml); both components remain active until 24 h at a temperature of 4° c or up to 6 h at a temperature of no higher than 25° c.

Solution Zinacefa (5 mg / ml) in 5% or 10% solution of xylitol can store up to 24 h at a temperature of no higher than 25° c.

Zinacef is compatible with aqueous solutions, containing up to 1% Lidocaine hydrochloride.

Zinacef is compatible with the most widely used infusion solutions.

When mixed with the following solutions product is stable to 24 hours at room temperature: 0.9% sodium chloride solution; 5% dextrose solution for injection; 0.18%on a solution of sodium chloride and 4% dextrose solution for injection; 5% solution dekstrozy and 0.9% sodium chloride solution; 5% solution dekstrozy and 0.45% sodium chloride solution; 5% solution dekstrozy and 0.225% sodium chloride solution; 10% dextrose solution for injection; Ringer; solution ringer lactate; Hartmann's solution.

Stability of cefuroxime in the 0.9% solution of sodium chloride and 5% solution of dextrose is not disturbed in the presence of hydrocortisone sodium phosphate.

With the following solutions Zinacef is compatible and stable during 24 hours at room temperature: Heparin (10 IU / ml 50 U / ml) in 0.9% sodium chloride solution; potassium chloride (10 mEq / L 40 mEq / L) in 0.9% sodium chloride solution.

Zinacef is not to be confused with a sprite with antibiotics of aminoglycoside.

A solution of sodium bicarbonate 2.74% has a Ph, significantly affects the color solution siruroksima, Therefore, it is not recommended to use for breeding Zinacefa. But, If the patient is injected with sodium bicarbonate solution by infusion, What is Zinacef if necessary, you can enter directly into the tube infusion system.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

List B. The drug should be stored in the dark, inaccessible to children at temperature not exceeding 25 ° C . Shelf life – 2 year.

After breeding solution is stored 5 h at a temperature of no higher than 25° c 48 h at a temperature of 4° c (in a refrigerator).