Trade name of the drug: BITEXIM Active ingredients (INN): Cefixime, Lactobacilli (Bacillus coagulans) Dosage form: powder for preparation of suspension for oral administration Composition: 5 ml of suspensions contain: active substances: cefixime trihydrate 100 mg, lactobacilli 60 x 106 excipients: D.K. Description: Powder: free-flowing crystalline powder of light orange color with orange flavor. Reduced suspension: orange viscous liquid. Pharmacotherapeutic group: Antibiotic (group of cephalosporins). ATX Code: J01DD08
Pharmacological properties Cefixime inhibits the formation of peptidoglycan, which is the main structural component of the cell wall of microorganisms. Cefixime is resistant to the action of beta-lactamases. Cefixime is active against many gram-negative and gram-positive microorganisms. Like other cephalosporins, the bactericidal effects of cefixime result from inhibition of the cell wall synthesis. As a result, many organisms resistant to penicillin and some cephalosporins due to the presence of beta-lactams may be susceptible to cefixime. Cefixime can be active against most strains of the following microorganisms both in vitro and in clinical infections. Gram-positive microorganisms: Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae. Gram–negative microorganisms Haemophilus influenzae (beta-lactamase positive and negative strains), Moraxella (Branhamella) catarrhalis (most of which - beta-lactamase positive), Escherichia coli, Proteus mirabilis, Neisseria gonorrhoeae (including penicillinase and non-penicillinase strains), Haemophilus parainfluenzae (beta-lactamase positive and negative strains), Proteus vulgaris, Klebsiella pneumoniae, Klebsiella oxytoca, Pasteurella multicida, Providencia varieties, Salmonella varieties, Shigella varieties, Citrobacter amalonaticus, Citrobacter diversus, Serratia marscescens. Like other beta-lactam antibiotics, cefixime binds specific penicillin binding proteins located inside the bacterial wall wall, causing its inhibition and the last stage of bacterial wall synthesis. Cell lysis consequently occurs as autolysis of a bacterial cell by enzymes such as autolysin, it is possible that cefixime interacts with an autolysin inhibitor. Pharmacokinetics When taken orally, the drug is absorbed by 40-50% (regardless of food intake), but the time to reach the maximum concentration when taking cefixime with food increases by 0.8 hours. A single application of 200 mg of cefixime reaches a maximum peak plasma concentration of 2 mcg / ml (from 1 to 4 mcg / ml) and a single dose of 400 mg of cefixime reaches a maximum peak plasma concentration of 3.7 mcg / ml (from 1.3 to 7.7 mcg / ml). The peak plasma concentration is observed between 2 and 8 hours after taking a single dose of 200 mg or a single dose of 400 mg. Plasma level of cefixime after taking tablets (mcg / ml) Dose (mg) 1 hour2 hour4 hour6 hour8 hour12 hour24 hour 2000,71,421,510,40,03 4001,22,53,52,71,70,60,04 About 50% of the dose is excreted unchanged in urine for 24 hours. When studied on animals, it should be noted that cefixime is also excreted with bile more than 10% of the dose taken. Cefixime also binds exclusively to the albumin fraction of about 30%. Plasma protein binding is 65%. The half-life of cefixime plasma in healthy volunteers averages 3-4 hours, and can reach up to 9 hours in some volunteers. The average AUCs of steady state in elderly patients is 40% higher than in healthy adult volunteers. In patients with impaired renal function of moderate degree (20-40 ml /min creatinine clearance), the average half-life of cefixime in serum was increased to 6.4 hours. In severe impairment (carrying out creatinine calculations for 5-20 ml / min), the half-life increased to 11.5 hours. The drug is not completely removed from the blood by hemodialysis or peritoneal dialysis. However, the study proved that at a dose of 400 mg, patients receiving hemodialysis have similar blood profiles as subjects with creatinine data of 21-60 ml/min. There is no evidence of cefixime metabolism in vivo. Adequate data on cefixime levels in cerebrospinal fluid are not available.
Indications for use Bitexim suspension is prescribed for the treatment of the following infectious diseases caused by sensitive microorganisms uncomplicated urinary tract infections caused by Escherichia coli, Proteus mirabilis; middle ear infections caused by Haemophilus influenzae beta-lactam positive and negative strains), Moraxella (Branhamella) catarrhalis (most of which beta-lactam positive), S.pyogenes, Pharyngitis & Tonsillitis caused by S.pyogenes. Pharyngitis and tonsillitis caused by Streptococcus pyogenes. Note Penicillin is the drug of choice in the treatment of S.pyogenes infections, including the prevention of rheumatic attack. Cefixime is mainly effective in the spread of Streptococcus pyogenes from the nasopharynx, however, there are no presented data on the effectiveness of Icsim for the prevention of rheumatoid attack. -Acute bronchitis and exacerbation of chronic bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (positive and negative beta-lactamase strains). -Uncomplicated multi-resistant and quinolone resistant typhoid fever caused by Salmonella typhy. -uncomplicated gonorrhea (cervical-urethral) caused by Neisseria gonorrhoeae (penicillase and non-penicillase producing strains).
Method of administration and dosage Inside. For children over 12 years of age with a body weight of more than 50 kg and adults, the average daily dose is 400 mg once a day (or 200 mg 2 times a day). With uncomplicated gonorrhea of the urethra and cervix - 400 mg once. Children under the age of 12 are prescribed at a dose of 8 mg / kg 1 time a day or 4 mg / kg 2 times a day (every 12 hours). For children aged 5-11 years, the daily dose of suspension is 6-10 ml, at the age of 2-4 years - 5 ml, aged from b months to 1 year - 2.5-4 ml. The average duration of the course of treatment is 7-10 days. For diseases caused by Streptococcus pyogenes, the course of treatment should be at least 10 days. In case of impaired renal function, the dose is set depending on the creatinine clearance (CC) in serum: with CC 21-60 ml / min or in patients on hemodialysis, the daily dose should be reduced by 25%; with CC 20 ml/ min or less or in patients on peritoneal dialysis, the daily dose it should be reduced by 2 times. The method of preparation of the suspension. Turn the bottle over and shake the powder. Approximately half (17 ml) of the required volume (34 ml) of boiled water cooled to room temperature is added to the vial with the preparation, closed with a lid, thoroughly shaken until a homogeneous suspension is formed. Then add the cooled boiled water to the mark (arrow) indicated on the label, close the lid, shake thoroughly until a homogeneous suspension is formed. Allow to settle for 5 minutes . Before use, the finished suspension is well shaken. Use no later than 14 days after cooking.
Side effects Cefixime is generally well tolerated. Most of the adverse reactions observed in clinical trials were mild or limited in nature. Gastrointestinal disorders: diarrheayou can be sure of admission to the Ferdinando dos cefixima. In the occurrence of symptomstheleventsextemporal diarei reception Ixima doljen B aposematic. Disorders co storon. central nervous system. Non-quantifiable cephalosporin evaluative fits, partially in a patient with a greater deficiency, when the dose was not ambiguously reduced. In the long run, trebuet's wonderful treatments. Rarely tick off multiform canberritema, Stevena-Johnson syndrome and toxic canberranspidermaln urgrolis. Disorders co-storon laboratory transgendered assay: leucopenia, thrombocytopenia, neutropenia, gemmolytic anaemia. Intermediate grade transient impairment of analytic function before and after roasting. Transaminase, phosphatase, and zheltuha transaminase transaminase transient disorders Other disorders: Sud sexually urgent organ and vaginitis.
Contraindications Cefixime contraindicated in patients with known hypersensitivity to cephalosporin. Attention! Home cefiximom treatments, convince, mistletoe you patient reactions hyperensities of cephalosporin, penicillin, or other preparation. This preparation is given to a patient with sensitivity to penicillin, sensitivity to penicillin, so how the name is marked in the literature of the hypercressible hyperactivity between beta-lactam and the antibiotics and can be stamped in 10% of the patient with sensitivity to penicillin. If symptomatic allergic reactions to cefixime occur, discontinue treatment. There is no need to perform any medical treatment, including oxygen, antihistamine injection, antihistamine injection, corticosteroid injection, Amine injection, Amine injection and air conditioning in clinical indications.
Pharmacovigilance interactions As well as other antibiotics grouppumper cephalosporin, cefixime increases prothrombin time, ferdinandto learn to extravasate in patients receiving anticoagulant treatment. Carbamazepine. Cefixim increases uvene carbamazepine. Necessary control of urea carbamazepine in plasma. Warfarin and anticoagulant. In one-time anticoagulants, prothrombin time without clinical symptomatic treatment is increased. Probenecid. In the case of time-lapse changes, the testenecid in plasma and the TESTENECID in plasma is reduced in the clearances and the cefixime is increased. Other detergent. Recent substitution of cefixima with nifedipinoma in the longer-term bioavailability of cefixima with B urgentsokim urovnim concentrations in plasma and squares below the curve plasma concentrations of the preparation.
Specificservice instructions Cefixima in the absence of any indication or in the presence of sensitive extravehicular bacteria with a prophylactic target undesirable for the patient, such as in the case of the extravehicular risk of development of resistant extravehicular bacteria in the preparation. It is possible to develop resistance in the body to be named in the form of treatment. In such cases, I had the necessary control for the patient at the time of treatment, and the need was necessary to prevent the development of superinfections. Dose of cefixime is regulated in a patient with a significant deficiency, on outpatient dialysis and gemodialysis. Patient repeater on dialysis, lower repeater on control. Cefixim doljen appoint with due diligence in patients with available in anamnez disease geludoctic-chisechnaya track, especially colitis. Symptom. pseudomembranous colitis mogut is removed in time, and then antibiotic treatments, and mogut is welcome to the complex. A locative glucose reaction may be detected in Benedicta grow or Fechling grow or Medi grow, but it is not detected in extravehicular glucose oxidase-based reactions. In the case of cephalosporin treatments, the direct analysis of Cumbsa is checked, the antibiotics are checked, the tests are checked, the cephalosporin tests are checked, the tests are checked, the tests are checked, the tests are checked, the tests are checked, the tests are checked, the tests are checked, the tests are checked, the tests are checked, the tests are checked, the tests are checked, the tests are checked, the tests are checked. Cefixime can give a positive reaction to the ketone, mochi, in the case of nitroprusside, but not in the case of nitroferricyanide. Change in bremenization and lactation period In the event of a change in circumstances so much in the case, it is assumed that there is a potential risk to the fetus. During the period of treatment preparation in lactation, tuberous incarmulation after discontinue.
Peredosis Symptomsimportant: (in many cases observed in a patient with chronic insufficiency): sudorogi, ambigncephalopathy, neuromuscular agitation. Treatment: gemodialysis and sub-living therapy.
Shape in aposematic Poroshok in the preparation of suspensions in the preparation of suspensions in the preparation of suspensions in the preparation of suspensions, 100 mg/ 5 ml. Instead of medical instruction.
Feeding conditions Eat in suhom Mesta at temperature not in Urgench 25 apostille C. Eat in an uncomplicated place.
Shelf life 36 months. 14 sutok (ready suspension). Do not follow the date of expiration.
Terms of leave from pharmacy Recipe.
Manufacturer HARASHA PHARMA PVT. LTD.
Owner registration certificates HARASHA PHARMA PVT. LTD., India
Name and address organizations making claims (proposals) for quality medicinal products of territories Republic of Uzbekistan «FUTURE-WORLD GROUP» Republic of Uzbekistan, Tashkent, Chilanzarsky r-n, str. Sanyat 13A. Tel.:+99891 134 94 14 E-mail: info.fwg@yandex.com
