Acute streptococcal tonsillitis and pharyngitis; acute bacterial sinusitis; acute otitis media; exacerbation of chronic bronchitis caused by pathogens sensitive to cefuroxime; cystitis; pyelonephritis; uncomplicated infections of the skin and soft tissues; early manifestations of Lyme disease.
active substance Zinnat: cefuroxime;
1 tablet of Zinnat contains cefuroxime (in the form of cefuroxime axetil) 250 mg
Excipients Zinat: microcrystalline cellulose, croscarmellose sodium (type A), sodium lauryl sulfate, hydrogenated vegetable oil, colloidal silicon dioxide, hypromellose, propylene glycol, methylparaben (E 218), propylbenzoparohydro-hydro (contains sodium benzoate (E 211)).
Zinnat – coated tablets.
MAIN PHYSICO-CHEMICAL PROPERTIES:
Zinnat film-coated tablets, biconvex, capsule-shaped, white or almost white; marked “GX EG2” on one side for tablets of 250 mg.
Antimicrobials for systemic use. Beta-lactam antibiotics. ATX code J01D C02.
Cefuroxime axetil is an oral form of the bactericidal cephalosporin antibiotic cefuroxime, which is resistant to most beta-lactamases and is active against a wide range of gram-positive and gram-negative microorganisms.
The bactericidal action of Zinnat is due to the 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, if available, to consult local data on antibiotic susceptibility, especially in the treatment of severe infections.
Zinnat is usually active against such microorganisms in vitro
After oral administration of Zinnat, axetil is absorbed in the intestine, hydrolyzed on the mucous membrane and enters the bloodstream in the form of cefuroxime.
The optimal level of absorption of Zinnat is observed immediately after a meal. The maximum level of Zinnat in the blood serum is observed approximately 2-3 hours after taking the drug Zinnat. The half-life of Zinnat 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%.
Zinnat serum levels decrease due to dialysis.
Treatment of infections caused by Zinnat-sensitive microorganisms:
- ENT organs: otitis media, sinusitis, tonsillitis, pharyngitis;
- respiratory infections: pneumonia, acute bronchitis and exacerbation of chronic bronchitis;
- urinary tract infections: pyelonephritis, cystitis and urethritis;
- skin and soft tissue infections: boils, pyoderma and impetigo;
- gonorrhea, acute uncomplicated gonococcal urethritis and cervicitis.
Treatment of early manifestations of Lyme disease and further prevention of late manifestations of Lyme disease in adults and children over 12 years.
Hypersensitivity to cephalosporin antibiotics, cefuroxime and to any of the components of the drug Zinat. Severe history of hypersensitivity reactions (eg, anaphylactic reactions) to any beta-lactam antibiotics of another type (penicillins, monobactams, and carbapenems).
INTERACTION OF ZINNAT WITH OTHER MEDICINES AND OTHER TYPES OF INTERACTION
Drugs that reduce the acidity of gastric juice may reduce the bioavailability of Zinnat and have the ability to eliminate the effect of improved absorption after a meal.
Like other antibiotics, Zinnat can affect the intestinal flora, reducing estrogen reabsorption and reducing the effectiveness of combined oral contraceptives.
Because the ferrocyanide test may show a false negative result, it is recommended that glucose oxidase or hexokinase methods 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 of Zinnat with probenicide 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 probenicide is not recommended.
Concomitant use of Zinnat with oral anticoagulants may lead to an increase in IOP (international normalized ratio).
Zinnat serum levels are reduced by dialysis.
Coombs tested positive for cephalosporins. This phenomenon can affect the cross-test on blood compatibility.
FEATURES OF APPLICATION
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 isolated fatalities 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 Zinnat therapy, it is necessary to determine whether the patient has a history of 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.
The use of cefuroxime axetil (as well as other antibiotics) can lead to excessive growth of Candida. Prolonged treatment can 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, which can range from mild to life-threatening. Therefore, it is important to keep this in mind if patients develop severe diarrhea during or after antibacterial therapy. If prolonged or severe diarrhea occurs or the patient experiences severe cramp-like abdominal pain, treatment should be stopped immediately and the patient should be carefully examined.
During Zinnat treatment of Lyme disease, a Jarisch-Herksheimer reaction was observed, which occurs directly through the bactericidal action of Zinnat on the microorganism that causes Lyme disease, the spirochete Borrelia burgdorferi. Patients need to be explained that this is a common consequence of Lyme disease antibiotic therapy, which goes untreated.
In sequential therapy, the time of transition from parenteral to oral therapy is determined by the severity of the infection, the clinical condition of the patient and the susceptibility of the pathogen. 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.
Zinnat tablets contain parabens, which can cause allergic reactions (possibly delayed).
USE OF ZINNAT DURING PREGNANCY OR BREAST-FEEDING
There are limited data on the use of Zinnat 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 in cases where the benefits of the drug outweigh the possible risks.
Zinnat passes into breast milk in small quantities. Adverse reactions are not expected with therapeutic doses of Zinnat, 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. Zinnat is prescribed during breastfeeding only after the doctor evaluates the benefit and risk of its use.
There are no data on the effect of Zinnat 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
Because Zinnat can cause dizziness, patients should be warned to drive and operate machinery with caution.Method of application and dose
Sensitivity to the antibiotic Zinnat varies by region and may change over time. If necessary, refer to local antibiotic susceptibility data.
Usually the duration of treatment is 7 days (can be from 5 to 10 days).
For better absorption, Zinnat is recommended to be taken after a meal.
- most infections – 250 mg 2 times a day;
- urinary tract infections – 125 mg 2 times a day;
- respiratory infections
- mild and moderate severity – 250 mg 2 times a day;
- more severe respiratory infections – 500 mg 2 times a day;
- ways (pneumonia)
- pyelonephritis – 250 mg 2 times a day;
- uncomplicated gonorrhea – once 1 g of the drug Zinnat
Lyme disease in adults and children – 500 mg 2 times a day for 20 days. over 12 years
Cefuroxime is also available as a sodium salt for parenteral use. This makes it possible to carry out sequential therapy with one antibiotic in the transition from parenteral to oral administration, if there are clinical indications.
Zinnat is effective for the consistent treatment of pneumonia and exacerbations of chronic bronchitis after previous parenteral administration of Zinacef (cefuroxime sodium).
Pneumonia: 1.5 g of cefuroxime 2-3 times a day (intravenously or intramuscularly) for 48-72 hours, followed by the use of Zinnat 500 mg 2 times a day for 7-10 days.
Exacerbation of chronic bronchitis: 750 mg of cefuroxime 2-3 times a day (intravenously or intramuscularly) for 48-72 hours, followed by the use of Zinnat 500 mg 2 times a day for 5-10 days.
The duration of both parenteral and oral treatment should be determined taking into account the severity of the infection and the patient’s condition.
The usual dose of Zinnat for the treatment of most infections is 125 mg twice a day (the maximum daily dose of Zinnat is 250 mg). Children aged 2 years with otitis media or serious infections – 250 mg 2 times a day (maximum dose of Zinnat 500 mg). There is no experience with the use of cefuroxime axetil in children under 3 months of age.
Zinnat tablets should not be broken, so children under 2 years of age are recommended to prescribe Zinnat in the form of a suspension.
Patients with renal insufficiency
Cefuroxime is excreted by the kidneys. It is recommended to reduce the dose of cefuroxime in patients with severe renal impairment.
Patients with hepatic insufficiency
There are no data on the use of this drug in patients with impaired liver function. Cefuroxime is excreted by the kidneys, so existing hepatic impairment is not expected to affect the pharmacokinetics of cefuroxime.
There is no experience with the use of cefuroxime axetil for the treatment of children under 3 months of age. Children under 2 years of age are recommended to prescribe Zinnat in the form of a suspension.
Cephalosporin overdose may cause brain irritation and neurological complications, including encephalopathy, convulsions, and coma. Symptoms of overdose may occur if the dose of Zinnat has not been adjusted appropriately for patients with renal impairment (see sections “Method and Dosage” and “Special Precautions”).
Serum cefuroxime levels can be reduced by hemodialysis and peritoneal dialysis.
Side effects when using cefuroxime axetil are moderate and are mostly reversible
The adverse reactions reported below are classified according to system organ class and frequency and frequency. By frequency of occurrence are divided into the following categories:
very often ≥ 1 in 10, often ≥ 1 in 100 and <1 in 10, infrequently ≥ 1 in 1000 and <1 in 100, rarely ≥ 1 in 10,000 and <1 in 1000, very rarely <1 in 10,000.
Infections and invasions
Often excessive growth of Candida.
Unknown: excessive growth of Clostridium difficile.
From the blood and lymphatic system
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 digestive tract
Often gastrointestinal disorders, including diarrhea, nausea, abdominal pain.
Rarely pseudomembranous colitis (see section “Features of application”).
From the digestive system
Often transient increase in liver enzymes (ALT, AST, LDH).
Very rarely jaundice (mainly cholestatic), hepatitis.
From the skin and subcutaneous tissue
Very rarely polymorphic erythema, Stevens-Johnson syndrome, toxic epidermal necrolysis (exanthematous necrolysis).
Not known: angioneurotic edema.
The safety profile of Zinnat in children is similar to that in adult patients.
Store Zinnat at a temperature not exceeding 30 ° C. Keep out of reach of children.
Blisters of 10 Zinnat tablets in a cardboard package.