Aznam J (Aznam J)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceAzrethonAzrethon
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  • Aznam J
    powder w / m in / in 
    Jodas Expo Pvt.Ltd     India
  • Azrerebol®
    powder w / m in / in 
    PREBAND PFC, LLC     Russia
    • Dosage form: & nbsppowder for solution for intravenous and intramuscular administration
    Composition:

    One bottle contains

    Active substance:

    Azrethene in terms of anhydrous aztreonam 0.5 g or 1.0 g,

    Excipient: L-arginine.

    Description:White or white with a yellowish tint powder.
    Pharmacotherapeutic group:Antibiotic monobactam
    ATX: & nbsp

    J.01.D.F   Monobactams

    J.01.D.F.01   Azrethon

    Pharmacodynamics:

    Monocyclic beta-lactam antibiotic, structurally differs from other beta-lactam antibiotics (such as penicillins, cephalosporins). The nucleus of the molecule is alpha-methyl-3-amino mono-bactamic acid. Suppresses the synthesis of the cell wall, acts bactericidal, disrupting the synthesis of the cell wall of microorganisms. Because of the high affinity of aztreonam to penicillin-binding protein 3 is resistant to beta-lactamases (including penicillinases and cephalosporinases) of gram-negative bacteria. Has a strong and specific activity in vitro for gram-negative aerobic pathogens, including Pseudomonas aeruginosa.

    Is active against most strains of microorganisms as in vitro, and in vivo:

    Aerobic Gram-negative microorganisms

    Citrobacter spp., including C.Jreundii

    Enterobacter spp., including E. cloacae
    Escherichia     coli
    Haemophilus     injluenzae (including ampicillin-resistant and dp. penicillinase-producing strains)
    Klebsiella oxytoca
    Klebsiella pneumoniae
    Proteus mirabilis
    Pseudomonas aeruginosa
    Serratia species,     including S. marcescens

    The following strains were sensitive in vitro, but, the clinical significance of this data is unknown

    Aeromonas hydrophila

    Morganella morganii
    Neisseria     gonorrhoeae (including penicillinase-producing strains)
    Pasteurella multocida
    Proteus vulgaris
    Providencia
    Stuartii
    Providencia rettgeri
    Yersinia enterocolitica

    AT combinations from aminoglycosides in vitro active at respect majority strains R. aeruginosa, some strains Enterobacteriaceae, and dr. gram-negative aerobic bacteria.

    Possible use of aztreonama for allergies to penicillins, cephalosporins and carbapenems. Between the aztreonam and aminoglycosides, there is cross-resistance. Rarely causes dysbacteriosis.

    Pharmacokinetics:

    The time to reach the maximum concentration after IM administration (TCmah) - 1h. After a single IV or IM injection equal doses, serum concentrations after 1 hour are similar (1.5 hours after the onset of IV infusion), the dynamics of serum concentrations being subsequently similar. Passes through the histohematic barriers and penetrates well into the tissues. The half-life period (T1 / 2) is about 1.7 hours (in the interval of 1.5-2 hours) with normal renal function irrespective of the dose and mode of administration,if there is a violation of the excretory function of the kidneys and in the elderly - lengthens. Whey clearance - about 90 ml / min, renal clearance - about 56 ml / min. The apparent volume of distribution in the equilibrium state is about 12 liters, which is approximately equivalent to the volume of the extracellular fluid. Penetrates through the blood-brain barrier (BBB) ​​with inflammation of the meninges, penetrates the placenta, excreted in breast milk. It is slightly metabolized in the liver. 60-70% is excreted by the kidneys in unchanged form and as an inactive product of the hydrolysis of the beta-lactam ring, 12% through the intestine. Pharmacokinetic parameters in adults and children (older than 9 months) are comparable.

    Indications:

    Infectious-inflammatory diseases caused by sensitive to the preparation by microorganisms:

    - Urinary tract (complicated and uncomplicated), including pyelonephritis and cystitis (including recurrent);

    - Lower respiratory tract, including pneumonia and bronchitis;

    -septicemia;

    -skin and soft tissues;

    -intraabdominal infections, including peritonitis;

    - gynecological infections, including endometritis and parametritis.

    Aztreon is also indicated as an adjunctive therapy for surgical interventions to prevent infections, including abscess, infectious complications in perforation of hollow organs, infection of the skin and serous surfaces.

    Contraindications:

    Hypersensitivity, chronic renal failure (CRF) (creatinine clearance less than 10 ml / min), hepatic insufficiency, pregnancy, lactation, children's age (up to 9 months).

    Carefully:

    Allergic reactions to other beta-lactam antibiotics.

    Dosing and Administration:

    Intramuscularly or intravenously (drip or drip). The dose and method of administration is selected individually, depending on the sensitivity of the pathogen, the severity and location of the infection, as well as the general condition of the patient. The course of treatment depends on the severity of the infection and treatment should continue for at least 48 hours after the disappearance of the clinical symptoms of the infection.

    Intravenous route of administration is recommended in patients who require single doses of more than 1 g or for septicemia, limited parenchymal abscess (including intra-abdominal abscess), peritonitis or other severe systemic or life-threatening infections.

    Doses of aztreonam in the treatment of adults and children older than 9 months

    Type of infection

    Doses

    Interval between administrations (h)

    Adults *

    Infections

    urinary tract

    0.5-1 g

    8 or 12 hours

    Moderately severe systemic infections

    1-2 g

    8 or 12 hours

    Heavy or

    life-threatening

    infection

    2 grams

    6 or 8 hours

    * The maximum recommended daily dose

    8 grams

    Children*

    Mild and moderately severe infections

    30 mg / kg

    8h

    Moderately severe and severe infections

    30 mg / kg

    6 or 8 hours

    * The maximum recommended daily dose

    120 mg / kg

    With CRF (QC more than 10 ml / min), dosage adjustment is required taking into account the QC index. With QC 10-30 ml / min, the dose is 1/2 of the recommended dose, depending on the severity of the infection.

    Creatinine clearance can be calculated by the following formula: For men: QC = body weight (kg) х (140 - age (years)) / 72 x serum creatinine concentration (mg / dL)

    For women, the result is multiplied by 0.85.

    Children with normal renal function need IV injection. There are limited data on the I / m administration of the drug in children, as well as on the correction of the dosing regimen in cases of kidney failure in children.

    Rules for the preparation of solution for intravenous and / m administration

    For IV injection: the contents of the vial must be dissolved with 6-10 ml of sterile water for injection, shake until completely dissolved. The diluted drug is injected i / v slowly slowly for 3-5 minutes.

    For IV injection: the contents of the vial (1 g) are pre-dissolved with at least 3 ml of sterile water for injection, then the solution dissolved in this way is diluted with the following solvents (not less than 50 ml per 1 preparation):

    0.9% solution of sodium chloride

    Ringer's injection solution

    Ringer's solution with lactate for injection

    5% or 10% dextrose (glucose) solution for injection

    In / in the drip introduction is carried out for 20-60 minutes.

    For the / m introduction: the contents of the vial with 0.5 g of aztreonam are dissolved with 1.5 ml, 1 g aztreonam - 3 ml solvent, respectively.

    The following solutions can be used as the solvent:

    -styrene water for injections;

    -0.9% solution of sodium chloride for injection.

    Enter by deep injection into the upper outer quadrant of the gluteus muscle or lateral part of the thigh.

    The solution is prepared immediately before administration, the unused solution must be destroyed.

    Side effects:

    Allergic reactions: anaphylaxis, angioedema, bronchospasm; toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, urticaria.

    Co hematopoietic side: pancytopenia, neutropenia, thrombocytopenia, anemia, eosinophilia, leukocytosis, thrombocytosis.

    From the digestive system: spastic abdominal pain, hepatitis, jaundice, rare cases of diarrhea caused by C. difficile, including pseudomembranous colitis or bleeding from the gastrointestinal tract. The appearance of symptoms of pseudomembranous colitis is possible both during and after treatment with the drug.

    From the skin: purpura, petechia, itching, profuse sweating.

    From the cardiovascular system: decrease arterial pressure, transient changes in ECG (ventricular bigemia and premature contraction of the ventricles), "hot flashes" of blood.

    On the part of the respiratory system: wheezing, shortness of breath, chest pain.

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

    From the side of skeletal musculature: pain in the muscles.

    From the senses: tinnitus, diplopia, ulceration of the oral mucosa, taste distortion, numbness of the tongue, sneezing, nasal congestion, unpleasant odor from the mouth.

    Other: vaginal candidiasis, vaginitis, tenderness of the mammary glands, weakness, headache, fever, malaise.

    Laboratory indicators: increased activity aspartate aminotransferase (ACT), alanine aminotransferase (ALT), alkaline phosphatase (AFP), an increase in prothrombin time and partial thromboplastin time, positive Coombs test, hypercreatininaemia.

    Local reactions: with iv administration - phlebitis, thrombophlebitis, unpleasant sensations at the site of the / m administration.

    Overdose:

    Symptoms: polymorphic nonspecific manifestations.

    Treatment: symptomatic, hemo- or peritoneal dialysis.

    Interaction:

    Pharmaceutically incompatible in one vial with heparin, cefradine and metronidazole.

    Synergism - with vancomycin, clindamycin, aminoglycosides, penicillins, cephalosporins, carbapenems, metronidazole.

    Special instructions:
    Effect on the ability to drive transp. cf. and fur:
    Form release / dosage:Powder for solution for intramuscular and intravenous administration 0.5 g, 1.0 g.
    Packaging:

    By 0.5 and 1.0 g of the active substance into a vial of clear glass, sealed with a plug of chlorobutyl rubber, crimped with an aluminum ring, and a plastic cap. 1 bottle with instructions for use in a cardboard box.

    For hospitals:

    10, 25, 48 or 100 vials together with an equal number of instructions for use in a cardboard pack.
    Storage conditions:

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

    Shelf life:

    3 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-002492/10
    Date of registration:26.03.2010
    The owner of the registration certificate:Jodas Expo Pvt.LtdJodas Expo Pvt.Ltd India
    Manufacturer: & nbsp
    Representation: & nbspJodas Expoim, Open CompanyJodas Expoim, Open Company
    Information update date: & nbsp17.08.2015
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