Zinnat coated pills 125mg N10
Condition: New product
1000 Items
Rating:
Be the first to write a review!
More info
Active ingredients
Cefuroxime
Release form
Pills
Composition
1 tablet contains: cefuroxime axetil 150.36 mg, which corresponds to the content of cefuroxime 125 mg. Excipients: microcrystalline cellulose - 47.51 mg, croscarmellose sodium - 20 mg, sodium lauryl sulfate - 2.25 mg, vegetable oil, hydrogenated - 4.25 mg, colloidal silicon dioxide - 0.66 . The composition of the film coating: hypromellose - 5.55 mg, propylene glycol - 0.33 mg, methyl parahydroxybenzoate - 0.06 mg, propyl parahydroxybenzoate - 0.04 mg, white daspray dye - 1.52 mg (hypromellose - 3%, titanium dioxide - 36%, sodium benzoate - 0.1%).
Pharmacological effect
Cefuroxime axetil is a prodrug of cefuroxime, an antibiotic of the group II cephalosporins with bactericidal action. Cefuroxime is active against a wide range of pathogens, including strains that produce beta-lactamase. Cefuroxime is resistant to bacterial β-lactamase, therefore, effective against ampicillin-resistant or amoxicillin-resistant strains. The bactericidal effect of cefuroxime is associated with the suppression of the synthesis of the bacterial cell wall as a result of binding to the main target proteins. The prevalence of acquired resistance to cefuroxime bacteria varies depending on the region and over time, resistance can be very high in certain types of microorganisms. It is preferable to have local data on sensitivity, especially when treating severe infections. In vitro cefuroxime is usually active against the following microorganisms. Bacteria usually susceptible to cefuroxime: Gram-positive aerobes - Staphylococcus aureus (strains sensitive to methicillin) 1, coagulase-negative staphylococci (strains sensitive to methicillin), Streptococcus pyogenes1 (beta-hemolytic streptococci) Gram-negative aerobes - Haemophilus influenzae1 (including ampicillin-resistant strains), Haemophilus parainfluenzae1, Moraxella catarrhalis1, Neisseria gonorrhoeae1 (including strains that produce and do not produce penicillinase); Gram-positive anaerobes - Peptostreptococcus spp, Propionibacterium spp, Gram-negative spirochete - Borrelia burgdorferi.1 bacteria, for which the probability acquired resistance to cefuroxime:.. Gram-positive aerobes - Streptococcus pneumoniae1, aerobic gram - Citrobacter spp. (except C.freundii), Enterobacter spp. (except for E. aerogenes and E.cloacae), Escherichia coli1, Klebsiella spp. (including Klebsiella pneumonia1), Proteus mirabilis, Proteus spp. (except P. penneri and P. vulgaris), Providencia spp .; gram-positive anaerobes - Clostridium spp. (with the exception of C. difficile), gram-negative aerobes - Bacteroides spp. (except B. fragilis), Fusobacterium spp. Bacteria with natural resistance to cefuroxime: Gram-positive aerobes - Enterococcus spp. (including E. faecalis and E. faecium), Listeria monocytogenes; gram-negative aerobes - Acinetobacter spp., Burkholderia cepacia, Campylobacter spp., Citrobacter freundii, Enterobacter aerogenes, Enterobacter cloacae, Morganella morganii, Proteus penneri, Proteus vulgaris, Pseudomonas spp. (including Pseudomonas aeruginosa), Serratia spp., Stenotrophomonas maltophilia; Gram-positive anaerobes - Clostridium difficile, Gram-negative aerobes - Bacteroides fragilis); others - Chlamydia spp., Mycoplasma spp., Legionella spp. 1 - for these bacteria, the clinical efficacy of cefuroxime was demonstrated in clinical studies.
Pharmacokinetics
Absorption: After oral administration, cefuroxime axetil is absorbed from the gastrointestinal tract and is rapidly hydrolyzed in the small intestine bolus mucosa and in the blood to release cefuroxime. Optimal absorption of cefuroxime axetil in the form of film-coated pills is achieved with the intake of the drug immediately after a meal. Cmax cefuroxime in serum (2.1 mg / l for a dosage of 125 mg, 4.1 mg / l for a dosage of 250 mg, 7.0 mg / l for a dosage of 500 mg) is observed after approximately 2-3 hours while taking the drug during a meal. Distribution: Binding to plasma proteins is approximately 33-50% and depends on the method of determination. Metabolism: Cefuroxime is not metabolized. Excretion: T1 / 2 is 1-1.5 hours. Cefuroxime is excreted by glomerular filtration and tubular secretion. With the simultaneous administration of probenecid, the AUC is increased by 50%. Pharmacokinetics in special clinical situations: Patients with impaired renal function: The pharmacokinetics of cefuroxime were studied in patients with impaired renal function of varying severity. Cefuroxime T1 / 2 increases with decreasing renal function, which underlies the recommendations for the correction of the dosing regimen for this group of patients (see section Dosing regimen). In patients on hemodialysis, at least 60% of the total amount of cefuroxime present in the body at the time of onset of dialysis will be removed during the 4-hour period of dialysis. Thus, an additional single dose of cefuroxime should be administered after completion of the hemodialysis procedure.
Indications
Treatment of infectious and inflammatory diseases caused by microorganisms sensitive to the drug: Infections of the upper respiratory tract, ENT organs (otitis media, sinusitis, tonsillitis, pharyngitis).Lower respiratory infections (including Pneumonia, acute bacterial bronchitis and exacerbation of chronic bronchitis). Urinary tract infections (including pyelonephritis, cystitis, urethritis). Infections of the skin and soft tissues (including furunculosis, pyoderma, impetigo). Gonorrhea: acute uncomplicated gonorrheal urethritis and cervicitis. Treatment of borreliosis (lime disease) at an early stage and prevention of the late stages of this disease in adults and children over 12 years old. Cefuroxime is also available in the form of sodium salt (zinacef preparation) for parenteral administration. This allows for step therapy using the transition from the parenteral form to the oral form of cefuroxime, if there are clinical indications for use. If necessary, step therapy is indicated in the treatment of pneumonia and in the exacerbation of chronic bronchitis. The sensitivity of bacteria to cefuroxime varies depending on the region and over time. Where possible, local sensitivity data should be taken into account (see Pharmacological Action Section).
Contraindications
Phenylketonuria (for oral administration). Children's age up to 3 months (for suspension for oral administration). For pills, children up to 3 years of age (for children from 3 months to 3 years, Zinnat should be used in the form of a suspension). Hypersensitivity to the antibiotics of the cephalosporins group. C Caution: Caution should be exercised when used in patients with impaired renal function. Diseases of the gastrointestinal tract (including a history of, as well as ulcerative colitis). Pregnant women during breastfeeding.
Precautionary measures
Use caution when using in patients with impaired renal function; gastrointestinal diseases (including in history, as well as ulcerative colitis); pregnant women during breastfeeding.
Use during pregnancy and lactation
Zinnat should be used if the intended benefit to the mother outweighs the potential risk to the fetus and child. Pregnancy There is no experimental evidence for the embryopathic or teratogenic effects of cefuroxime axetil, but as with other drugs, caution should be exercised when prescribing it in early pregnancy.Breastfeeding Period Care should be taken when prescribing it to nursing mothers, because the drug is determined in breast milk.
Dosage and administration
A single dose for adults and children over 12 years old is usually 250 mg 2 times a day. For severe infections of the lower respiratory tract - 500 mg 2 times a day. For urinary tract infections, 125 mg is prescribed 2 times a day, and for pyelonephritis, 250 mg twice a day. In the treatment of uncomplicated gonorrhea, 1 g is administered once. With Lyme disease - 500 mg 2 times a day for 20 days.
Side effects
On the part of the digestive system, nausea, vomiting, diarrhea. perhaps a temporary increase in the activity of liver enzymes (ALT, AST, LDH), jaundice. Cases of pseudomembranous colitis are described. On the part of the hemopoietic system, hemolytic anemia, eosinophilia, neutropenia, thrombocytopenia, leukopenia (sometimes pronounced). Allergic reactions: skin rash, pruritus, urticaria, fever, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, serum sickness. in isolated cases - anaphylaxis. CNS headache.
Overdose
Symptoms: an overdose of cephalosporins can cause an increase in the excitability of the brain with the development of seizures. Treatment: conduct symptomatic therapy. Cefuroxime serum concentrations decrease with hemodialysis and peritoneal dialysis.
Interaction with other drugs
Drugs that reduce the acidity of gastric juice, can reduce the bioavailability of cefuroxime when compared with the observed after taking the drug on an empty stomach, as well as level the effect of increased absorption of the drug after a meal. Like other antibiotics, Zinnat can affect the intestinal microflora, which leads to a decrease in estrogen reabsorption and, consequently, to a decrease in the effectiveness of oral hormonal combined contraceptives. When conducting a ferrocyanide test, a false-negative result may be observed, therefore, it is recommended to use glucose oxidase or hexokinase methods to determine the level of glucose in the blood and / or plasma. The drug Zinnat does not affect the quantitative determination of creatinine by the alkaline-picrate method.Simultaneous intake with loop diuretics slows down tubular secretion, reduces renal clearance, increases plasma concentration and increases T1 / 2 cefuroxime. Simultaneous administration of cefuroxime and probenecid leads to an increase in AUC by 50%. When taken simultaneously with aminoglycosides and diuretics, the risk of nephrotoxic effects increases.
special instructions
Before use, you must carefully collect an allergic history. In the course of treatment, it is necessary to control renal function, especially in patients receiving the drug in a high dose. In the period of taking the drug Zinnat, false positive reaction of urine to glucose is possible. As with the use of other antibiotics, prolonged use of the drug Zinnat can lead to excessive growth of fungi of the genus Candida. Prolonged use may cause the growth of other resistant microorganisms (Enterococcus and Clostridium difficile), which may require cessation of treatment. Cases of pseudomembranous colitis occur when taking antibiotics, the severity of which can range from mild to life-threatening. Therefore, it is necessary to carry out a differential diagnosis of pseudomembranous colitis in patients with diarrhea that occurred during or after treatment with antibiotics. If the diarrhea is prolonged or severe, or the patient experiences abdominal cramps, treatment with Zinnat should be stopped immediately and the patient should be examined. The reaction of Yarish-Herksheimer was observed in borreliosis (Lyme disease) while taking the drug Zinnat and is due to the bactericidal activity of the drug against the causative agent of the spirochete Borrelia burgdorferi. Patients should be informed that these symptoms are a typical consequence of the use of antibiotics for this disease. With step therapy, the time to switch to oral therapy is determined by the severity of the infection, the clinical condition of the patients and the sensitivity of the pathogen. If the clinical effect is not achieved within 72 hours from the start of treatment, the parenteral course of therapy should be continued. Before the start of step therapy, one should carefully read the instructions for using cefuroxime sodium for parenteral administration (Zinacef preparation).The pills of the drug Zinnat can not be crushed and crushed. Therefore, this dosage form is not used to treat patients with difficulties in swallowing, incl. small children who can not swallow the whole pill. The sucrose content in the Zinnat suspension should be considered when treating patients with diabetes mellitus. 5 ml of prepared Zinnat suspension contains 0.25 bread units (XE). Effects on the ability to drive and control machinery: Since cefuroxime axetil can cause dizziness, it is necessary to warn patients about precautions when driving or working with moving machinery.