Zinnat granules for suspension preparation 125mg 5ml 50ml
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Active ingredients
Cefuroxime
Release form
Granules
Composition
Active ingredient: Cefuroxime (Cefuroximum) Active ingredient concentration (mg): 125
Pharmacological effect
Cefuroxime axetil is a precursor to cefuroxime, which is a second-generation cephalosporin antibiotic. Cefuroxime is active against a wide range of pathogens, including β-lactamase producing strains. Cefuroxime is resistant to bacterial β-lactamase, therefore, effective against ampicillin-resistant or amoxicillin-resistant strains. Cefuroxime bactericidal effect is associated with the suppression of the synthesis of the cell wall of bacteria as a result of binding to the main target proteins. : Gram-negative aerobes — Haemophilus influenzae (including ampicillin-resistant strains), Haemophilus parainfluenzae, Moraxella catarrhalis, Neisseria gonorrhoeae (including both producing and non-producing penicillinase digesters), Escherichia coli, Klebsiella spp., Proteus mirabilis, Providencia spp., Providencia rettgeri; Grammy Acers - Staphylococcus Acerus (Staphylococcus epidermidis); group B (Streptococcus agalactiae); anaerobes - gram-positive and gram-negative cocci (including Peptococcus spp. and Peptostreptococcus spp.), gram-positive bacilli (including Clostridium spp., except Clostridium difficile, Propionibacterium spp.), gram-negative bacilli (including Bacteroides spp., Ifets, I aus, I auspus spp.), Gram-negative bacilli (including Bacteroides spp. Ifets, I asectus I, spp.), Gram-negative bacilli (including Bacteroides spp. Ifets, I asectus I, spp.), Gram-negative bacilli (including Bacteroides spp. Ifets, I aus, I auspus, I would like to say that I use Bacterium spp. Borrelia burgdorferi). The following microorganisms are not sensitive to cefuroxim: Clostridium difficile, Pseudomonas spp. , Enterobacter spp., Citrobacter spp., Serratia spp., Bacteroides fragilis.
Pharmacokinetics
Absorption After ingestion, cefuroxime axetil is slowly absorbed from the gastrointestinal tract and is rapidly hydrolyzed in the intestinal mucosa and blood, releasing cefuroxime. Cefuroxime axetil is optimally absorbed under the condition of taking the drug immediately after a meal. After taking Cmax suspension of cefuroxime (2-3 mg / l for a dose of 125 mg and 4-6 mg / l for a dose of 250 mg) are observed approximately 2-3 hours after taking the drug after a meal. Distribution Cefuroxime binding to plasma proteins is 33-50%. Cefuroxime penetrates through the BBB, crosses the placenta and is excreted in breast milk. Metabolism Cefuroxime is not metabolized in the body. Cefuroxime serum levels are reduced by dialysis. T1 / 2 is 1-1.5 hours.
Indications
- sea and air sickness; - prevention and treatment of symptoms of vestibular and labyrinth disorders (dizziness, nausea, vomiting), with the exception of symptoms caused by antitumor therapy; - Meniere's disease.
Contraindications
- Phenylketonuria (for oral administration); - Children up to 3 months (for oral administration); - For pills - Children up to 3 years old (for children from 3 months to 3 years, Zinnat should be used in the form of a suspension); - hypersensitivity to antibiotics of the cephalosporins group.
Use during pregnancy and lactation
Caution should be exercised when prescribing a drug to patients with an allergic reaction to beta-lactam antibiotics in history. In the treatment process, kidney function must be monitored, especially in patients receiving the drug at a high dose. A false-positive reaction of urine to glucose is possible in the period of taking Zinnat. As and when using other antibiotics, long-term use of the drug Zinnat can lead to excessive growth of fungi of the genus Candida. Long-term use may cause the growth of other resistant microorganisms (Enterococcus and Clostridium difficile), which may require cessation of treatment. Pseudomembranous colitis was observed with the use of broad-spectrum antibiotics, therefore it is necessary to carry out a differential diagnosis of pseudomembranous colitis in patients with severe diarrhea that occurred during or after the course treatment with antibiotics. The reaction of Yarish-Herxheimer was observed with borreliosis (Lyme disease) while taking the drug Zinnat and is due to a bactericidal act The effectiveness of the drug against the causative agent of the disease Spirochetes Borrelia burgdorferi. Patients should be informed that these symptoms are a typical consequence of the use of antibiotics for this disease. If the clinical effect is not achieved within 72 hours from the start of treatment, the parenteral course of therapy should be continued. Before starting the step therapy, refer to the available references. cefuroxime sodium salt (Zinacef preparation). Tablets of Zinnat cannot be crushed and crushed. Therefore, this dosage form is not used to treat patients with difficulties in swallowing, incl.young children who cannot swallow a whole pill. The sucrose content of Zinnat suspension should be considered when treating patients with diabetes.5 ml of prepared Zinnat suspension contains 0.25 bread units (HE) .The effect on the ability to drive vehicles and control mechanisms. Since cefuroxime axetil can cause dizziness, it is necessary to warn patients about precautions when driving or working with moving machinery.
Dosage and administration
The drug Zinnat in the form of a suspension for oral administration is recommended for use in children from 3 months. There is no experience with Zinnat in children under the age of 3 months. If a fixed dose is preferred, then for most infections it is recommended to take 125 mg 2 times / day. Children aged 2 years and older, with otitis media or with more severe infections, are prescribed 250 mg 2 times / day; The maximum daily dose is 500 mg. When treating infants and children, it may be necessary to calculate the dose depending on body weight and age. In most infections, the dose for infants and children aged 3 months to 12 years is 10 mg / kg 2 times / day, but not more than 250 mg / day. With otitis media and more severe infections, the recommended dose is 15 mg / kg 2 times / day, but not more than 500 mg / day. The following tables show the doses depending on the age and body weight of the child for dosing Zinnat 125 mg / 5 ml. 5 ml measuring spoons attached to the package. Dose at the rate of 10 mg / kg body weight prescribed for most infections Age of Body weight (kg) (approximately) Single dose (mg) when taken 2 times / day Number of measuring spoons (5 ml) in one dose of 3-6 months 4-6 40-60 1/26 months-2 years 6-12 60-120 1 / 2-12-12 years from 12 and more 20 125 1 Dose at the rate of 15 mg / kg of body weight prescribed for otitis media and more severe infections Age Body weight (kg) (approximately) Single dose (mg) when taking body weight Number of measuring spoons (5 ml) in one dose 3-6 months 4-6 60-90 1 / 26 months-2 years 6-12 90-180 1-1.52-12 years old from 12 and more 20 180-250 1.5-2
Side effects
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 neutralize the effect of increased absorption of the drug after a meal. estrogen and as a resultto reduce 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. Alkaline-rhythmic method does not affect the quantitative determination of creatinine. with loop diuretics, slows tubular secretion, reduces renal clearance, increases plasma concentration and increases Vaeth T1 / 2 tsefuroksima.Odnovremennoe cefuroxime and probenecid leads to an increase AUC by 50% .If concomitantly with aminoglycosides and diuretics increases the risk of nephrotoxic effects.
Overdose
The adverse events presented below are listed depending on the anatomical and physiological classification and frequency of occurrence. The frequency of occurrence is determined as follows: very often (≥1 / 10), often (≥1 / 100 and <1/10), infrequently (≥1 / 1 000 and <1/100), rarely (≥1 / 10 000 and <1/1 000), very rarely (<1/10 000, including individual cases). Frequency categories were formed on the basis of clinical studies of the drug and post-registration observation. Infections: often - superinfection with Candida fungi. On the side of the hematopoietic and lymphatic systems: often - eosinophilia; infrequently - false-positive Coombs reaction (cephalosporins are absorbed on the cell surface of red blood cells, binding to antibodies to cephalosporins, which leads to a false-positive result of Coombs and in very rare cases - to hemolytic anemia), thrombocytopenia, leukopenia (sometimes severe); very rarely - hemolytic anemia. From the immune system: hypersensitivity reactions: infrequently - skin rash; rarely - urticaria, itching; very rarely - drug fever, serum sickness and anaphylaxis. On the nervous system: often - headache, dizziness. On the part of the digestive system: often - diarrhea, nausea, abdominal pain; infrequently - vomiting; rarely - pseudomembranous colitis. From the side of the liver and biliary tract: often - a transient increase in the level of liver enzymes ALT, ACT, LDH; very rarely - jaundice (mainly cholestatic), hepatitis. On the side of the skin and subcutaneous fat: very rarely - erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.
Interaction with other drugs
Precautionary measures
special instructions
Symptoms: an overdose of cephalosporins can cause an increase in the excitability of the brain with the development of convulsions. Treatment: symptomatic therapy is carried out. Cefuroxime serum concentrations decrease with hemodialysis and peritoneal dialysis.