Zinnat (cefuroxime) granules for suspension 125 mg/5 ml. 100 ml. vial

$36.00

Zinnat is intended for the treatment of the infections listed below in adults and children from 3 months of age: Acute streptococcal tonsillitis and pharyngitis. Acute bacterial sinusitis. Acute otitis media. Exacerbation of chronic bronchitis caused by agents sensitive to cefuroxime axetil. Cystitis. Pyelonephritis. Complicated skin and soft tissue infections. Early manifestations of Lyme disease.

COMPOSITION

active substance: cefuroxime;

5 ml of the finished suspension in the vial contain 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, potassium acesulfame.

PHARMACEUTICAL FORM

Granules for preparation of suspension.

MAIN PHYSICO-CHEMICAL PROPERTIES:

white or almost white crumbly granules.

PHARMACOLOGICAL GROUP

Antimicrobials for systemic use. Beta-lactam antibiotics. ATX code J01D C02.

PHARMACOLOGICAL PROPERTIES

Pharmacological.

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.

Cefuroxime is usually active against the following microorganisms in vitro:

Sensitive microorganisms:
Gram-positive aerobes:
Staphylococcus aureus (methicillin-sensitive) *
Coagulase-negative staphylococci (methicillin-sensitive)
Streptococcus pyogenes
Streptococcus agalactiae
Gram-negative aerobes
Haemophilus influenzae
Haemophilus parainfluenzae
Moraxella catarrhalis
spirochetes:
Borrelia burgdorferi
Microorganisms whose acquired resistance 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)
strains of Providencia
Gram-positive anaerobes:
Peptostreptococcus strains
strains of Propionibacterium
Gram-negative anaerobes:
strains of Fusobacterium
strains of Bacteroides
Resistant microorganisms:
Gram-positive aerobes:
Enterococcus faecalis
Enterococcus faecium
Gram-negative aerobes:
Acinetobacter strains.
Campylobacter strains
Morganella morganii
Proteus vulgaris
Pseudomonas aeruginosa
Serratia marcescens
Gram-negative anaerobes:
Bacteroides fragilis
others:
strains of Chlamydia
strains of Mycoplasma
strains of Legionella

Category:

Description

COMPOSITION

active substance: cefuroxime;

5 ml of the finished suspension in the vial contain cefuroxime (in the form of cefuroxime axetil) 125 mg

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

PHARMACEUTICAL FORM

Granules for preparation of suspension.

MAIN PHYSICO-CHEMICAL PROPERTIES:

white or almost white crumbly granules.

PHARMACOLOGICAL GROUP

Antimicrobials for systemic use. Beta-lactam antibiotics. ATX code J01D C02.

PHARMACOLOGICAL PROPERTIES

Pharmacological

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.

Cefuroxime is usually active against the following microorganisms in vitro:

  • Sensitive microorganisms:
  • Gram-positive aerobes: Staphylococcus aureus (methicillin-sensitive) *,Coagulase-negative staphylococci (methicillin-sensitive), Streptococcus pyogenes, Streptococcus agalactiae, Gram-negative aerobes, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis.
  • spirochetes: Borrelia burgdorferi.
  • Microorganisms whose acquired resistance 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),strains of Providencia
  • Gram-positive anaerobes: Peptostreptococcus strains,strains of Propionibacterium,Gram-negative
  • anaerobes: strains of Fusobacterium,strains of Bacteroides
  • Resistant microorganisms:
  • Gram-positive aerobes: Enterococcus faecalis,Enterococcus faecium
  • Gram-negative aerobes: Acinetobacter strains.,Campylobacter strains,Morganella morganii,Proteus vulgaris,Pseudomonas aeruginosa,Serratia marcescens
  • Gram-negative anaerobes: Bacteroides fragilis
  • others:,strains of Chlamydia,strains of Mycoplasma,strains of Legionella.

Pharmacokinetics

After oral administration of cefuroxime axetil is absorbed in the intestine, hydrolyzed on the mucous membrane and in the form of cefuroxime enters the bloodstream.

Assimilation of Zinnat suspension is increased when taken with food. The level of absorption of cefuroxime suspension is lower than that of tablets, which leads to lower blood plasma levels and reduced systemic bioavailability. The maximum level of cefuroxime in blood serum is observed in 2 – 3:00 after drug use. The half-life is approximately 1-1.5 hours. The level of binding to proteins is 33-55% depending on the method of determination. Cefuroxime is excreted unchanged by the kidneys by tubular secretion and glomerular filtration.

Concomitant use of probenecid increases the area under the curve of the average concentration in the serum by 50%.

Serum cefuroxime levels decrease due to dialysis.

INDICATIONS

Zinnat 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).

INTERACTION WITH OTHER MEDICINES AND OTHER TYPES OF INTERACTIONS

Drugs that reduce the acidity of gastric juice may reduce the bioavailability of Zinnat and have the ability to minimize the effect of accelerating absorption after a meal.

Like other antibiotics, Zinnat can affect the intestinal flora, which may reduce estrogen reabsorption and reduce the effectiveness of combined oral contraceptives.

Because the ferrocyanide test may show a false-negative result, it is recommended that glucose oxidase or hexokinase be used to determine blood and plasma glucose levels in patients treated with cefuroxime axetil. Cefuroxime does not affect the alkaline-picrate analysis for creatinine.

Concomitant use with probenecid leads to a significant reduction in the maximum concentration, the area under the curve “serum concentration – time” and the half-life of cefuroxime. Therefore, concomitant use with probenecid is not recommended.

Concomitant use with oral anticoagulants may lead to an increase in MNO (international normalized ratio).

Serum cefuroxime levels are reduced by dialysis.

A positive Coombs’ test has been reported during treatment with cephalosporins. This phenomenon can affect the cross-test on blood compatibility.

FEATURES OF APPLICATION

hypersensitivity reactions

Particular caution should be exercised if patients have a history of allergic reactions to penicillins or other beta-lactam antibiotics, as there is a risk of cross-sensitivity. As with all beta-lactam antimicrobial drugs, serious and sometimes fatal cases of hypersensitivity reactions have been reported. In the event of severe hypersensitivity reactions, cefuroxime treatment should be stopped immediately and the patient given appropriate emergency medical care.

Before starting therapy, it is necessary to determine whether the patient has experienced severe hypersensitivity reactions to cefuroxime, other cephalosporins or beta-lactam drugs of other types. Cefuroxime should be used with caution in patients with a history of mild hypersensitivity reactions to other beta-lactam drugs.

Special care should be taken if patients have a history of allergic reactions to penicillins or other beta-lactam antibiotics.

The use of cefuroxime axetil (as well as other antibiotics) can lead to excessive growth of Candida. Prolonged use may also lead to overgrowth of other insensitive microorganisms (eg Enterococci, Clostridium difficile), which may, in turn, require discontinuation of treatment.

With the use of antibiotics, pseudomembranous colitis can develop from mild to life-threatening. Therefore, it is important to keep this in mind if patients develop diarrhea during or after antibacterial therapy. If prolonged or severe diarrhea occurs or the patient experiences severe cramping abdominal pain, treatment should be stopped immediately and the patient carefully examined.

The composition of the granules for the preparation of the suspension includes sucrose, which should be taken into account when prescribing the drug to patients with diabetes. Granules for the preparation of a suspension for oral administration of 125 mg / 5 ml contain 3 g of sucrose per dose of 5 ml. Granules for the preparation of a suspension for oral administration of 250 mg / 5 ml contain 2.3 g of sucrose per dose of 5 ml.

During Zinnat’s treatment of Lyme disease, a Jarisch-Herksheimer reaction was observed, which was directly due to Zinnat’s bactericidal action on the microorganism that causes Lyme disease, the spirochete Borrelia burgdorferi. The patient should be aware that this is a common occurrence in Lyme disease antibiotic therapy that does not require treatment.

The suspension contains aspartame, which is a source of phenylalanine, and therefore it should not be used to treat patients with phenylketonuria.

At carrying out consecutive therapy time of change of parenteral therapy to oral is defined by severity of an infection, a clinical condition of the patient and sensitivity of a pathogenic microorganism. If there is no clinical improvement within 72 hours, parenteral therapy should be continued. Before starting sequential therapy, read the relevant instructions for use of cefuroxime sodium.

USE DURING PREGNANCY OR BREAST-FEEDING

Pregnancy

There are limited data on the use of cefuroxime in pregnant women. Animal studies do not indicate any adverse effects of cefuroxime axetil on pregnancy, embryonal / fetal development, parturition or postnatal development. Zinnat should be prescribed to pregnant women only if the benefits outweigh the potential risks.

Breastfeeding

Cefuroxime passes into breast milk in small amounts. Adverse reactions are not expected with therapeutic doses, but the risk of diarrhea or fungal infection of the mucous membranes cannot be ruled out. Therefore, these reactions may require discontinuation of breastfeeding. The possibility of a sensitizing effect of the drug should also be considered. Cefuroxime is prescribed during breastfeeding only after the doctor has evaluated the benefits and risks of its use.

Fertility

There are no data on the effect of cefuroxime axetil on human fertility. Reproductive function studies in animals have not shown an effect of this drug on fertility.
ABILITY TO INFLUENCE THE REACTION RATE WHEN DRIVING A MOTOR VEHICLE OR OTHER MECHANISMS
As the drug can cause dizziness, patients should be warned to drive and operate machinery with caution.
METHOD OF ADMINISTRATION AND DOSAGE
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 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.
ADVERSE REACTIONS
Adverse reactions when using cefuroxime axetil are moderate and are mostly reversible.
The frequency categories of the following adverse reactions are estimated because for most events (eg, placebo-controlled studies), adequate data are not available to calculate the exact frequency. In addition, the frequency of adverse reactions associated with the use of cefuroxime axetil may vary depending on the indications for use of the drug.
Clinical studies have been used to determine the frequency of adverse reactions from very common to rare. The frequency of all other adverse reactions (ie those that occurred with a frequency of <1 / 10,000) was predominantly determined based on post-marketing use data. The obtained frequency is an indicator of reporting rather than the real frequency of the phenomenon. There are no data from placebo-controlled studies. The frequency category calculated from clinical trials is based on drug-related data (which have been evaluated by the investigating physician).
The adverse reactions reported below are classified according to system organ class and frequency and frequency. Frequency categories: very common (≥ 1 in 10), common (≥ 1 in 100 and <1 in 10), uncommon (≥ 1 in 1000 and <1 in 100), rare (≥ 1 in 10,000 and <1 in 1000) very rare (<1 in 10,000) and unknown (cannot be estimated from the available data).

Infections and invasions

Often excessive growth of Candida.
Unknown: excessive growth of Clostridium difficile.
From the blood and lymphatic system
Often eosinophilia.
Uncommon: positive Coombs test, thrombocytopenia, leukopenia (sometimes profound).
Hemolytic anemia is very rare.
Cephalosporins as a class have the property of being absorbed on the surface of the erythrocyte membrane and interacting with antibodies, which can lead to a positive Coombs’ test (effect on blood compatibility determination) and (very rarely) to hemolytic anemia.
From the immune system
Hypersensitivity reactions, including:
Uncommon: skin rash.
Rare: urticaria, pruritus.
Very rarely drug fever, serum sickness, anaphylactic shock.
Unknown: Jarisch-Herksheimer reaction.
From the nervous system
Common: headache, dizziness.
From the gastrointestinal tract
Often gastrointestinal disorders, including diarrhea, nausea, abdominal pain.
Infrequent vomiting.
Rarely pseudomembranous colitis.
From the digestive system
Often a transient increase in liver enzymes (ALT, AST, LDH), which is usually reversible.
Very rarely jaundice (mainly cholestatic), hepatitis.
From the skin and subcutaneous tissues
Very rarely polymorphic erythema, Stevens-Johnson syndrome, toxic epidermal necrolysis (exanthematous necrolysis).
Not known: angioneurotic edema.
Where are you.
The safety profile of cefuroxime in children is similar to that in adult patients.
EXPIRY DATE
2 years.
After dissolution, the shelf life of the suspension in the vial is up to 10 days, provided that it is stored in a refrigerator at a temperature of 2-8 ° C.
STORAGE CONDITIONS
Store below 30 ° C. After reconstitution, store the suspension in a refrigerator at 2-8 ° C. Keep out of reach of children.
PACKAGING
Granules for preparation of 100 ml of suspension in a bottle from dark glass with a cover and a protective membrane, with a plastic measuring cap on a cover. Bottle together with a measuring cap and a measuring spoon in a cardboard box.