Zinnat (cefuroxime) coated tablets 500 mg. №10

Description

Zinnat (cefuroxime) coated tablets 500 mg. №10

Composition

active ingredient: cefuroxime;

1 tablet contains cefuroxime (in the form of cefuroxime axetil) 125 mg or 250 mg or 500 mg;

excipients: microcrystalline cellulose, croscarmellose sodium (type A), sodium lauryl sulfate, hydrogenated vegetable oil, anhydrous colloidal silicon dioxide, hypromelose, propylene glycol, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), Opaspray White M-1-7120J (contains sodium benzoate (E 211)).

Dosage form

Coated tablets.

Basic physical and chemical properties:

• coated tablets, biconvex capsule-shaped, white or almost white; labeled GX ES5 on one side for 125 mg tablets;
• film-coated tablets, biconvex capsule-shaped, white or almost white; labeled GX ES7 on one side for 250 mg tablets;
• film-coated tablets, biconvex capsule-shaped, white or almost white; labeled GX EG2 on one side for 500mg tablets.

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 is active against a wide range of Gram-positive and Gram-negative microorganisms.

The bactericidal action of cefuroxime is the result of inhibition of the synthesis of the cell wall of microorganisms.

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

Cefuroxime usually has activity against such microorganisms in vitro:

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

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.

Contraindications

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).

Method of application and dose

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.

Adults

• 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;
• (Bronchitis)
• 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).

Sequential therapy

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.

Overdose

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.

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.