Movizar - instructions for use, dose, side effects, contraindications

Antibacterial agent from the group of cephalosporins of the IV generation. It acts bactericidal, disrupting the synthesis of the cell wall of microorganisms. Has a wide spectrum of action against Gram-positive and Gram-negative bacteria, strains resistant to aminoglycosides and / or cephalosporin antibiotics of the third generation. Highly resistant to beta-lactamases.

It is active against gram-positive aerobes: Staphylococcus aureus and Staphylococcus epidermidis (only, methicillin-sensitive strains), Staphylococcus hominis, Staphylococcus saprophytics, other strains of Staphylococcus spp .; Streptococcus pyogenes (group A); Streptococcus agalactiae (group B); Streptococcus pneumoniae; other beta-hemolytic Streptococcus spp. (groups C, G, F), Streptococcus bovis (group D), Streptococcus viridans;

Gram-negative aerobes: Pseudomonas spp. (including Pseudomonas aeruginosa, Pseudomonas putida and Pseudomonas stutzeri); Escherichia coli, Klebsiella spp. (including Klebsiella pneumoniae, Klebsiella oxytoca, Klebsiella oxaenae); Enterobacter spp. (including Enterobacter cloacae, Enterobacter aerogenes, Enterobacter agglomerans, and Enterobacter sakazakii); Proteus spp. (including Proteus vulgaris); Acinetobacter calcoaceticus (Acinetobacter anitratum, Acinetobacter calcoaceticus subsp. Iwoff); Aeromonas hydrophila; Capnocytophaga spp .; Citrobacter spp. (including Citrobacter diversus, Citrobacter freundii); Campylobacter jejuni, Gardnerella vaginalis, Haemophilus ducreyi, Haemophilus influenzae (including strains that produce beta-lactamase; Haemophilus parainfluenzae, Hafiiia alvei, Legionella spp .; Morganella morganii; Moraxella cataiThalis (including strains that produce beta-lactamase); Neisseria gonorrhoeae (including strains , producing beta-lacgamases), Neisseria meningitidis, Providencia spp. (including Providencia rettgeri, Providencia stuartii), Salmonella spp, Serratia spp. (including Serratia marcescens, Serratia liquifaciens), Shigella spp .; Yersinia enterocolitica, anaerobes: Prevotella spp. (Including Prevotella melaninogenicus), Clostridium perfringens, Fusobacterium spp, Mobiluncus spp, Peptostreptococcus spp., Veillonella spp.

Inferior to ceftazidime by activity against Pseudomonas strains.

Inactive against Xanthomonas maltophilia; Bacteroides fragilis and Clostridium difficile, methicillin-resistant staphylococci, penicillin-resistant pneumococci.

Pharmacokinetics:

Bioavailability of 100%. Time to reach the maximum concentration after intravenous (intravenous) and intramuscular injection (IM) administration at a dose of 500 mg - by the end of infusion and 1-2 hours, respectively. The maximum concentration at the IM injection in doses of 500 mg, 1 g and 2 g - 14, 30 and 57 μg / ml, respectively; with intravenous administration in doses of 250 mg and 500 mg, 1 g and 2 g - 18, 39,82 and 164 μg / ml, respectively; time to reach the average therapeutic concentration in plasma - 12 h; the average therapeutic concentration for the / m administration is 0.2 μg / ml, with the w / in - 0.7 μg / ml. High concentrations are determined in urine, bile, peritoneal fluid, blister exudate, bronchial mucus secretion, sputum, prostate gland, appendix and gallbladder. Penetrates into breast milk. The volume of distribution is 0.25 l / kg, in children from 2 months to 16 years - 0.33 l / kg. Connection with plasma proteins - 20%.

Metabolized in the liver and kidneys by 15%. The half-life (T_1/2) -2 hours, total clearance - 120 ml / min, renal clearance - 110 ml / min. It is excreted by the kidneys (by glomerular filtration in the unmodified form -85%). T_1/2 at a hemodialysis - 13 ch, at a continuous peritoneal dialysis-19 ch.

Indications:

Movizar® is used for bacterial infections caused by sensitive microorganisms: infections of the respiratory system (including pneumonia, bronchitis, abscess of the lungs, empyema of the pleura), gastrointestinal tract (including cholangitis, cholecystitis, empyema of the gallbladder), urinary tract (including pyelonephritis, pyelitis, urethritis, cystitis, gonorrhea), bones and joints, skin and soft tissues, peritonitis, sepsis, meningitis, infected wounds and burns, febrile neutropenia, infections with immunodeficiency.Prevention of postoperative infection.

Contraindications:Hypersensitivity to cefepime (including other cephalosporins, penicillins, other beta-lactam antibiotics), arginine, children under 2 months.

Carefully:Pregnancy, lactation; children's age (up to 12 years-efficiency and safety not established); diseases of the gastrointestinal tract including. in the history: ulcerative colitis, regional enteritis or antibiotic-associated colitis, renal failure.

Dosing and Administration:

Movizar® is used intravenously (IV), intramuscularly (IM). Adults and children over 12 years of age - 2 g / day in 2 divided doses; course of treatment - 7-10 days.

For infections of the urinary tract - 0.5-1 g 2 times a day; with infections of other localization - 1 g every 12 hours.

In severe infection, 4 g / day in 2 divided doses, with an interval of 12 hours, with life-threatening infections, febrile neutropenia - 2 g IV every 8 hours for 7 days.

Children (over 2 months) with uncomplete urinary tract infections, skin and soft tissue infections, pneumonia are given a dose of 50 mg / kg every 12 hours. Patients with neutropenic fever and bacterial meningitis - every 8 hours.The maximum dose should not exceed the recommended dose for adults.

When creatinine clearance is 30-60 ml / min, depending on the severity of the infection, 0.5, 1 or 2 g 1-2 times a day, with KK 11-29 ml / min - 0.5, 1 g 1 time per day, less than 11 ml / min - once. During the hemodialysis, the initial dose is re-administered at the end of each session. With peritoneal dialysis - in the usual dose every 48 hours.

For IV introduction, Movizar® is dissolved in 5 ml (0.5 g) or 10 ml (1.0, 2.0 g) of sterile water for injection, 5% dextrose solution or 0.9% sodium chloride solution, administered for 3-5 minutes; for intravenous infusion, the prepared solution is combined with other solutions for intravenous infusions (0.9% sodium chloride solution, 5% or 10% dextrose solution, Ringer's solution with lactate and 5% dextrose solution, maximum concentration 40 mg / ml) and injected for at least 30 minutes; for IM IMMOVAZ® is dissolved in sterile water for injection, 0.9% solution of sodium chloride, bacteriostatic water for injection with paraben or benzyl alcohol, in 0.5% and 1% solution of lidocaine hydrochloride (0.5 g in 1.3 ml of solvent, 1.0 g - 2.4 ml).

Side effects:

Allergic reactions: skin rash (including erythematous rashes), urticaria, pruritus, fever, anaphylactoid reactions, Coombs positive reaction, eosinophilia, multiform exudative erythema (incl.Stevens-Johnson syndrome), rarely - toxic epidermal necrolysis (Lyell's syndrome).

From the nervous system: headache, dizziness, insomnia, paresthesia, anxiety, confusion, convulsions.

From the genitourinary system: Vaginitis.

From the urinary system: impaired renal function.

From the digestive system: diarrhea, nausea, vomiting, constipation, abdominal pain, pseudomembranous enterocolitis.

On the part of the organs of hematopoiesis: anemia, thrombocytopenia, leukopenia, neutropenia, pancytopenia, hemolytic anemia, bleeding.

From the respiratory system: cough.

From the side of the cardiovascular system: tachycardia, dyspnea, peripheral edema.

Local Reactions: with iv introduction - phlebitis, with / m - hyperemia and soreness at the site of administration.

Laboratory indicators: decreased hematocrit, increased prothrombin time, increased urea concentration, hypercreatininaemia, hypercalcemia, increased activity of "liver" transaminases and alkaline phosphatase, hyperbilirubinemia.

Other: sore throat, thoracology, increased sweating, back pain, asthenia, development of superinfection, oropharyngeal candidiasis.

Overdose: Symptoms (often occur in patients with chronic renal failure): convulsions, encephalopathy, agitation. Treatment: hemodialysis.

Interaction:

Pharmaceutically, Movizar® is incompatible with other antimicrobial drugs and heparin.

Diuretics, aminoglycosides, polymyxin B reduce the tubular secretion of Movizar® and increase its serum concentration, extend T1 / 2, increase nephrotoxicity (the risk of developing nephronecrosis increases).

Nonsteroidal anti-inflammatory drugs, slowing the excretion of cephalosporins, increase the risk of bleeding.

With the simultaneous administration of bactericidal antibiotics (aminoglycosides), synergism appears with bacteriostatic (macrolides, chloramphenicol, tetracyclines) - antagonism.

Special instructions:

With the development of pseudomembranous colitis with prolonged diarrhea, stop taking Movizar® and appoint vancomycin (inside) or metronidazole.

There is a possibility of cross-over hypersensitivity in patients with allergic reactions to penicillins.

With simultaneous severe renal and hepatic insufficiency, the concentration of Movizar® in the plasma should be regularly determined (dose adjustment is performed depending on the creatinine clearance).

With prolonged treatment, regular monitoring of peripheral blood, indicators of the functional state of the liver and kidneys is necessary.

With a mixed aerobic-anaerobic infection before identifying pathogens, a combination with drugs active against anaerobes is appropriate.

Patients who have a meningeal dissemination from a distant foci of infection, suspicions of meningitis or a diagnosis of meningitis are confirmed, an alternative antibiotic with confirmed clinical efficacy should be prescribed.

It is possible to detect a positive Coombs test, a false positive test for glucose in the urine.

The color change does not affect the activity of the drug.

Form release / dosage:

Powder for the preparation of solution for intravenous and intramuscular injection 0.5 g, 1.0 g or 2.0 g.

Packaging:

Powder for the preparation of solution for intravenous and intramuscular injection of 0.5 g, 1.0 g or 2.0 g of active substance in a bottle of clear, colorless glass type I with butyl rubber rubber stopper and a cap combined aluminum-plastic.

1 bottle together with the instruction for use is placed in a cardboard box.10 packets are placed in a cardboard box.

Storage conditions:

In a dry, the dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:

2 years. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-001565/08

Date of registration:14.03.2008 / 08.05.2009

Expiration Date:Unlimited

The owner of the registration certificate:Yucea Pharmaceutical Group Co., Ltd.Yucea Pharmaceutical Group Co., Ltd. China

Manufacturer: & nbsp

YOUCARE PHARMACEUTICAL GROUP, Co. Ltd. China

Representation: & nbspInstitute of Health CJSCInstitute of Health CJSC

Information update date: & nbsp10.06.2018

Illustrated instructions

Instructions

Movizar (Movizar)