Zinnat (cefuroxime) granules for suspension 125 mg/5 ml. 100 ml. vial №1

Description

Zinnat (cefuroxime) granules for suspension 125 mg/5 ml. 100 ml. vial №1

Composition

active ingredient: cefuroxime;

5 ml of the finished suspension in a vial contains cefuroxime (in the form of cefuroxime axetil) 125 mg or 250 mg;

excipients: povidone KZ0, stearic acid, sucrose, fruit flavor, aspartame (E 951), xanthan gum, acesulfame potassium.

Dosage form

Granules for suspension preparation.

Basic physical and chemical properties: white or almost white crumbly granules.

Pharmacological group

Antimicrobial agents for systemic use. Beta-lactam antibiotics. Code ATX J01D С02.

Pharmacological properties

Cefuroxime axetil is an oral form of the bactericidal cephalosporin antibiotic cefuroxime, which is resistant to most beta-lactamases and active against a wide range of gram-positive and gram-negative microorganisms.

The bactericidal action of cefuroxime is due to inhibition of the synthesis of the cell membrane of microorganisms.

Acquired antibiotic resistance varies from region to region and may change over time, and may differ significantly for individual strains. It is advisable to consult local data on antibiotic susceptibility, especially in the treatment of severe infections.

Sensitive microorganisms:

• Gram-positive aerobes: (Staphylococcus aureus (methicillin-sensitive), Coagulase-negative staphylococcus (methicillin-sensitive), Streptococcus pyogenes, Streptococcus agalactiae);
• Gram-negative aerobes: (Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis);
• Spirochetes: (Borrelia burgdorferi).
• Microorganisms, the acquired resistance of which may be a problem:
• Gram-positive aerobes: (Streptococcus pneumoniae);
• Gram-negative aerobes: (Citrobacter freundii, Enterobacter aerogenes, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Proteus strains (other than P. vulgaris), Providencia strains);
• Gram-positive anaerobes: (Peptostreptococcus strains, Propionibacterium strains);
• Gram-negative anaerobes: (Fusobacterium strains, Bacteroides strains).

Resistant microorganisms:

• Gram-positive aerobes: (Enterococcus faecalis, Enterococcus faecium);
• Gram-negative aerobes: (strains of Acinetobacter, strains of Campylobacter, Morganella morganii, Proteus vulgaris, Pseudomonas aeruginosa, Serratia marcescens);
• Gram-negative anaerobes: (Bacteroides fragilis);
• Others: (Chlamydia strains, Mycoplasma strains, Legionella strains).

Indications

Zinnat suspension  is intended for the treatment of the infections listed below in adults and children older than 3 months.

• Acute streptococcal tonsillitis and pharyngitis.
• Acute bacterial sinusitis.
• Acute otitis media.
• Exacerbation of chronic bronchitis caused by pathogens sensitive to cefuroxime axetil.
• Cystitis.
• Pyelonephritis.
• Uncomplicated skin and soft tissue infections.
• Early manifestations of Lyme disease.

Contraindications

Hypersensitivity to cephalosporin antibiotics, cefuroxime and any of the components of the drug. Severe history of hypersensitivity reactions (eg anaphylactic reactions) to any beta-lactam antibiotics of another type (penicillins, monobactams and carbapenems).

Method of application and dose

Antibiotic sensitivity varies by region and may change over time. If necessary, refer to local data with antibiotic susceptibility.
The usual duration of treatment is 7 days (can be from 5 to 10 days).
For better absorption of the drug in suspension form is recommended to take with food.
In the treatment of respiratory infections of moderate and mild severity, adults receive 250 mg twice a day. Children from 3 to 6 months take 40 or 60 mg, from 6 months and up to 2 years – 60 or 120 mg, from 2 to 12 years – 125 mg twice a day.
In the treatment of severe respiratory infections and otitis media, the drug is prescribed to adults at 500 mg twice a day, children from 3 to 6 months – from 60 to 90 mg, from 6 months and up to 2 years – from 90 to 180 mg, from 2 to 12 years – from 180 to 250 mg twice a day.
In the treatment of urogenital infections, adults receive Zinnat 125 mg twice a day, and in the treatment of pyelonephritis – 250 mg twice a day.
There is no experience of using Zinnat suspension for the treatment of children under 3 months of age.

Overdose

Cephalosporin overdose may cause brain irritation and neurological complications, including encephalopathy, convulsions, and coma. Symptoms of overdose may occur if the dose of the drug has not been appropriately adjusted for patients with renal impairment.
Serum cefuroxime levels can be reduced by hemodialysis and peritoneal dialysis.

Side effects:

• Infections and infestations: Candida overgrowth.
• From the blood and lymphatic system: eosinophilia.
• From the nervous system: headache, dizziness.
• From the gastrointestinal tract: gastroenterological disorders, including diarrhea, nausea, abdominal pain.
• From the hepatobiliary system: a transient increase in the level of liver enzymes (ALT, AST, LDH), usually reversible.