Cefuroxime | Zinacef bottle, 750 mg

Latin name

Zinacef

Packaging

In a bottle of 1.5 g of powder. In a cardboard box 1 bottle.

Pharmacological action

Pharmacodynamics

Phytopreparation used for functional disorders of urination associated with benign prostatic hyperplasia.

Inhibits the synthesis of dihydrotestosterone (due to blockade of 5-alpha reductase type I and II) and its fixation to cytosolic receptors, Peptostreptococcus spp., Clostridium spp., Bacteroides spp., Fusobacterium spp., Propionibacterium spp. other microorganisms: Borrelia burgdorferi.

Not sensitive to cefuroxime: Clostridium difficile, Pseudomonas spp., Campylobacter spp., Acinetobacter calcoaceticus, Listeria monocytogenes, methicillin-resistant strains of Staphylococcus aureus and Staphylococcus epidermidis.

Pharmacokinetics

Absorption of

Cmax of cefuroxime in plasma after i / m administration, is observed during 30 to 45 minutes, is 27 μg / ml and remains for 5.3 hours.

Distribution of

Cefuroxime crosses the BBB, and the placental barrier is released with breast milk. Therapeutic concentrations of cefuroxime are created in bones, skin, soft tissues, synovial, pleural, intraocular fluid, bile, sputum and myocardium. Cefuroxime concentrations in excess of the minimum inhibitory concentration for most microorganisms can be achieved in bone tissue, synovial and intraocular fluids.

Plasma Protein Binding - 33-50%.

Metabolism and excretion

Cefuroxime is not metabolized. T1 / 2 of cefuroxime after parenteral administration is approximately 70 minutes. In newborns, T1 / 2 of cefuroxime can be 3-5 times longer than in adults.

Excreted by the kidneys by glomerular filtration and tubular secretion. Within 24 hours after parenteral administration, cefuroxime is excreted almost completely (85-90%) in the urine unchanged, with most of the drug in the first 6 hours. Serum cefuroxime levels decrease during dialysis.

Indications

Treatment of diseases caused by cefuroxime-sensitive bacteria:

upper and lower respiratory tract infections (pneumonia, bronchitis, infected bronchiectasis, lung abscess, postoperative chest infections),

from ENT organs (medium sinusitis, sore throat, pharyngitis)

urinary tract infections (pyelonephritis, cystitis, asymptomatic bacteriuria, gonorrhea)

infections of the skin and soft tissues (furunculosis, erysipelas and wound infections)

infections of bones and joints (osteomyelitis sorbic arthritis and septic arthritis

septicemia

meningitis

peritonitis.

Prevention of infectious complications during operations on the organs of the abdominal cavity, pelvis, during orthopedic operations, operations on the heart, lungs, esophagus and blood vessels.

Contraindications

Hypersensitivity to cephalosporin antibiotics, penicillins and carbapenems.

Caution: the drug should be used in case of renal failure, gastrointestinal diseases (including a history of ulcerative colitis and ulcerative colitis), if necessary, combined with loop diuretics and aminoglycosides, during pregnancy and lactation, as well as in newborns (especially in premature infants).

Use during pregnancy and lactation

The drug belongs to category B. Caution is advised to prescribe the drug during pregnancy.

Cefuroxime is excreted in breast milk, so caution should also be exercised when prescribing the drug to nursing mothers.

There is no evidence of the development of embryotoxic or teratogenic effects of cefuroxime.

Composition

1 bottle contains:

Active substances:

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

Dosage and administration

Adults are prescribed iv or iv 750 mg 3 times / day. In more severe cases, the drug is administered iv in a dose of 1.5 g 3 times / day. If necessary, Zinacef can be administered every 6 hours, and the daily dose can be from 3 to 6 g.

For some infections, it is effective to prescribe Zinacef at a dose of 750 mg or 1.5 g 2 times / day (IM or IV) s subsequent intake of Zinnat inside.

For children, the drug is prescribed at a dose of 30-100 mg / kg / day in 3-4 doses. For most infections, the optimal dose is 60 mg / kg / day.

Newborns are prescribed 30-100 mg / kg / day in 2-3 doses.

For the treatment of gonorrhea, 1.5 g is prescribed once (two doses of 750 mg IM in different places, for example, in both gluteal muscles).

With meningitis, adults are prescribed 3 g IV every 8 hours for children - 150-250 mg / kg / day IV in 3-4 doses to newborns - 100 mg / kg / day IV.

For the prevention of infectious complications during operations on the organs of the abdominal cavity, pelvis and orthopedic interventions, Zinacef at a dose of 1.5 g is injected iv during the initial anesthesia. After 8 hours and 16 hours after surgery, 750 mg of Zinacef may be additionally administered IM.

To prevent infectious complications during operations on the heart, lungs, esophagus and blood vessels during introductory anesthesia, Zinacef is administered iv in a dose of 1.5 g, and then for 24-48 hours at 750 mg 3 times / day i / m.

With a complete joint replacement, 1.5 g of cefuroxime powder can be mixed with the polymer bag with methyl methacrylate cement before adding the liquid polymer.

Step therapy

With pneumonia, Zinacef is prescribed at a dose of 1.5 g 2-3 times / day (iv or iv) for 48-72 hours, followed by Zinnat (inside) at a dose of 500 mg 2 times / day within 7-10 days.

In case of exacerbation of chronic bronchitis, Zinacef is prescribed at a dose of 750 mg 2-3 times / day (IV or IM) for 48-72 hours, followed by Zinnat (inside) 500 mg 2 times / day for 5-10 days.

The duration of each period (parenteral therapy and oral administration) is determined by the severity of the infection and the general condition of the patient.

Renal failure

A reduction in the dose of Zinacef is recommended in renal failure. However, there is no need to reduce the standard dose of the drug (0.75-1.5 g 3 times / day) in patients with CC more than 20 ml / min.

Zinacef dose adjustment for renal failure in adults

Creatinine clearance

Zinacef dose

> 20 ml / min

0.75-1.5 g 3 times / day

10-20 ml / min

750 mg 2 times / day

750 mg / day

Patients undergoing hemodialysis, at the end of each hemodialysis session, an additional dose of Zinacef equal to 750 mg should be administered.

A dose of 750 mg 2 times / day is recommended for patients in the intensive care unit on continuous hemodialysis using an arteriovenous shunt or on high-speed hemofiltration. If hemofiltration is used at a low rate, then doses are used, as in renal failure.

Rules for the preparation of an injection solution

To prepare a solution for i / m administration, add 1 ml of water for injection to 250 mg of Zinacef or 3 ml of water for injection to 750 mg of Zinacef. Shake gently until a suspension forms.

To prepare a solution for iv administration, 250 mg of Zinacef in 2 ml or more of water for injection should be dissolved, 750 mg of Zinacef in 6 ml or more of water for injection, 1.5 g of Zinacef in 15 ml or more of water for injection.

To prepare a solution for short intravenous infusions (up to 30 min), 1.5 g of the drug is dissolved in 50 ml of water for injection. These solutions can be injected directly into a vein or into the tube of the infusion system.

Side effects of the digestive system: nausea, vomiting, diarrhea, cramping and abdominal pain, pseudomembranous colitis, candidiasis of the oral cavity, increased activity of liver enzymes (ALT, AST, LDH, alkaline phosphatase), hyperbilirubinemia.

From the hemopoietic system: eosinophilia, leukopenia, neutropenia, thrombocytopenia, agranulocytosis, hemolytic anemia.

From the central nervous system and sensory organs: cramps, hearing loss.

From the genitourinary system: impaired renal function with an increase in creatinine and / or urea nitrogen and a decrease in KK, itching in the perineum, vaginitis (with the development of candidiasis).

Allergic reactions: exudative erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), skin rash (including urticaria), skin itching, drug fever, bronchospasm, serum sickness - anaphylactic shock.

Laboratory findings: false positive Coombs test.

Local reactions: with i / m administration - pain, irritation and infiltrate at the injection site, with i / v administration - phlebitis, thrombophlebitis.

Long-term use of Zinacef may be accompanied by excessive growth of insensitive microorganisms, including Candida fungi with the development of candidiasis of the oral cavity and vagina (itching, discharge).

Drug Interaction

Concurrent administration with loop diuretics (furosemide) and aminoglycosides slows tubular secretion, decreases renal clearance, increases plasma concentration, and increases T1 / 2 cefuroxime, which increases the risk of cefuroxime. Zinacef in combination with aminoglycosides act additively, but sometimes synergism of action can be observed.

Pharmaceutical Interaction

When mixed with a solution of cefuroxime (1.5 g in 15 ml water for injection) and metronidazole (500 mg / 100 ml), both components retain their activity for up to 24 hours at a temperature not exceeding 25 РC. Zinacef at a dose of 1.5 g is compatible with a solution of azlococillin (1 g in 15 ml or 5 g in 50 ml) both components retain their activity for up to 24 h at 4 РC or up to 6 h at a temperature not exceeding 25 РC. Zinaceph solution (5 mg / ml) in 5% or 10% xylitol solution can be stored for up to 24 h at a temperature not exceeding 25 РC.

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, the drug is stable for up to 24 h at room temperature: 0.9% sodium chloride solution 5% dextrose solution for injection 0.18% sodium chloride solution and 4% dextrose solution for injection 5% dextrose solution and 0.9 % sodium chloride solution 5% dextrose solution and 0.45% sodium chloride solution 5% dextrose solution and 0.225% sodium chloride solution 10% dextrose injection solution Ringer's solution Ringer's lactate solution Hartmann's solution.

Stability of cefuroxime at 0, 9% sodium chloride solution and 5% dextrose solution are not disturbed in the presence of sodium phosphate hydrocortisone.

With the following solutions, Zinacef is compatible and stable for 24 hours at room temperature: heparin (10 U / ml and 50 U / ml) in 0.9% sodium potassium chloride solution (10 mEq / l and 40 mEq / l) 0.9% sodium chloride solution.

Zinacef should not be mixed in one syringe with antibiotics from the aminoglycoside group.

Sodium bicarbonate solution of 2.74% has a pH that significantly influences the color of the cefuroxime solution, so it is not recommended to use for dilution of Zinacef. However, if the patient is injected with sodium bicarbonate solution by infusion, then Zinacef can be injected directly into the infusion tube if necessary.

Overdose

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

Treatment: carry out symptomatic therapy, hemodialysis, peritoneal dialysis.

Storage conditions

Store in a dark place, out of the reach of children, at a temperature not exceeding 25 РC.

After dilution, the solution is stored for 5 hours at a temperature not exceeding 25 РC and 48 hours at a temperature of 4 РC (in the refrigerator).

Expiration

2 years.

Deystvuyuschee substances

Cefuroxime

Terms of delivery from

pharmacies Prescription

Possible product names

ZINACEF 0.75 FLAC POR D / R-RA D / IN

Zinacef 750 mg No. 1 v / v, v / m

Zinacef 750mg por. d / prg. solution for in / in and / m introduction. Fl. X1 B M (R)

Zinacef 750mg No. 1

ZINATSEF POR I / O and I / O 750MG No. 1

GlaksoSmitKlyan, United Kingdom