MustFix-B.E 75mg Merap oral epidemic nuggets for urinary tract infections (20 packs)

Like other cephalosporins, the bactericidal effect of cetixime is due to inhibition of cell wall synthesis. Cefixime stability is high in the presence of many beta - lactamase enzymes. Therefore, many penicillin -resistant bacteria and some cephalosporin thanks to the presence of beta - lactamase may be sensitive to cefixime.

Drug resistance

Cefixime resistance of Haemophilus Influenzae and Neisseria Gonorrhoeae is often associated with changes in proteins associated with penicillin (PBPS). Cefixime may have a limited activity for the Beta -Beta - Lactamase bacteria. Pseudomonas, Enterococcus, strains of group D, Listeria monocytogenes, most staphical strains (including methicillin strains), bacteroides fragilis strains, and most strains of Enentobacter, Clostridium are resistant to cefixime.

antibacterial spectrum

Cetixime has been indicated that there is activity for most strains of the following bacteria on both in vitro and clinical infections.

Gram -positive bacteria: Streptococcus pneumonia, Streptococcus pyogenes.

Gram -negative bacteria: Escherichia Coli, Haemophilus Influenza, Moraxella Catarrhalis, Neisseria Gonorrhoeae, Proteus Mirabilis.

At least 90% of the bacteria below have a minimum inhibitory concentration (mic) in vitro smaller than or by sensitive fracture (susceptible breakpoint) of Cefixime for strains of the same limb or group of organisms. However, the effectiveness of Cefixime in the treatment of clinical infections caused by these bacteria has not been set up by adequate and well -controlled clinical trials.

Gram -positive bacteria: Streptococcus agalactiae.

Gram -negative bacteria: Citrobacter Amalonaticus, Citrobacter Diversus, Haemophilus Parainfluenzae, Klebsiella Oxytoca, Klebsiella Pneumoniae, Pasteurella Multocida, Proteus vulgaris, Serratia Marcescens, Providencia, Salmonella, Salmonella, Salmonella, Salmondla Shigella.

pharmacokinetic

absorption

Cefixime oral fluid is absorbed about 40 - 50% regardless of food presence; However, the maximum absorption time increased by about 0.8 hours when used with food. Peak concentration in plasma reaches 3µg/ml (1 - 4.5µg/ml) after taking a single dose of 200mg about 2 - 5 hours and reaches 4.6µg/ml (1.9 - 7.7pg/ml) after taking a single dose of 400mg about 2 - 6 hours.

Distribution

About 65% Cefixime in the blood is attached to plasma proteins and this cohesion does not depend on concentration.

Metabolism and elimination

There is no evidence of cefixime metabolism in the body.

About 50% of the absorption dose of the drug is eliminated in urine in the form of constant for 24 hours. In animal studies, over 10% of Cefixime dose is also eliminated through the bile. Cefixime's exhaust time in healthy people does not depend on the form of preparation and the average is from 3 to 4 hours, but can be up to 9 hours in some ordinary volunteers.

*** Special subjects

Elderly: The area under the average curve at a stable state in elderly patients is about 40% higher than adults. The pharmacokinetic parameters between 12 young subjects and 12 elderly subjects have the same dose of Cefixime 400mg/day for 5 days of difference. However, these differences have no clinical significance.

Renal failure: In patients with medium impaired renal function (creatinine clearance 20 - 40ml/minute), the average selling time of cefixime is up to 6.4 hours. When the renal failure is severe (clearinine clearance 5 - 20ml/minute), the average selling time increases to 11.5 hours. Hematomopiaiasis and peritoneal fertilizer are not eliminated a significant amount of drugs from the blood. However, a study showed that at a dose of 400mg, the pharmacokinetic parameters in patients were ruling as much as they were in people with creatinine clearance from 21 to 60ml/min.

Precautions when using

Children

Safety and effectiveness of Cefixime over 6 months of age has not been set up.

The rate of unwanted effects on digestive, including diarrhea and loose stools, in children using the same mixture as the ratio in adults using tablets.

Elderly

Clinical studies do not include enough subjects from over 65 to determine whether or not the difference between the elderly and the younger subjects. Clinical experience is not determined to have a difference between elderly patients and young patients. A pharmacological study study in the elderly has found a difference in pharmacological parameters between these two groups of objects, however, these differences are small and do not show the need to adjust the dose in the elderly.

kidney failure

Cefixime dose must be adjusted in patients with renal failure, as well as continuous peritoneals and hemorrhage. Patients in the process of hemolysis should be carefully monitored when using Cefixime

Hypersensitivity reaction

Anaphylactic reactions (including shock and death) have been reported when using Cefixime.

Before starting treatment with cefixime, it is necessary to determine if the patient has a history of hypersensitivity to cephalosporin, penicillin or other drugs. If this drug is used for patients sensitive to penicillin, be cautious because of the diagonal hypersensitivity between beta - lactam antibiotics has been recorded and may occur over 10% of patients with a history of penicillin allergies. If the allergic reaction occurs with Cefixime, stop the drug.

diarrhea caused by Clostridium difficile

diarrhea caused by Clostridium Difficile (CDAD) has been reported to most antibiotics, including Cefixime, with severity from mild diarrhea to death colitis. The treatment with antibiotics changes the normal bacterial system in the colon, leading to the overgrowth of C. Difficile.

C. Difficilie toxin A and B, contributing to CDAD development. C. Difficile's high toxin strains increase disease and death because these strains may be resistant to antibiotics and may need surgery to remove the colon. CDAD must be considered in all patients with diarrhea after using antibiotics. Careful evaluation is necessary because CDAD has been reported after more than two months of using antibiotics if suspected or confirmed that CDAD, stop using antibiotics does not work directly with C. Difficile. Water and electrolyte compensation, protein supplementation, antibiotic treatment work with C. Difficile, and surgical evaluation should be conducted in accordance with clinical indications.

affect blood clotting

Cephalosporin, including cefixime, can reduce prothrombin activity. The risk group includes patients with liver or renal failure, poor nutritional condition, patients using prolonged antibiotics and patients who have previously used stable anti -coagulation therapy. Prothrombin time must be monitored in patients at risk and use vitamin K as directed.

Development of anti -drug bacteria

Cefixime prescription when there is no clear suspicion or bacterial infection that has been shown to bring benefits to patients and increase the risk of developing anti -drug bacteria.

The ability to drive and operate machinery

There is no report showing that Cefixime affects the ability to drive and operate machinery. However, unwanted effects have been reported by Cefixime such as headaches, dizziness can affect the ability to drive and operate machinery.

Pregnancy and lactation

Pregnancy

Reproductive studies have been conducted on mice at a dose of 40 times higher than the dose in humans, the results show that there is no evidence of Cefixime harmful to the mouse fetus. However, there are no well -controlled and complete studies in pregnant women. Because animal reproductive studies do not always predict to be met in humans, using this drug only during pregnancy when really necessary.

Breastfeeding period

Do not know if the cefixime is excreted through breast milk or not, it is necessary to temporarily stop breastfeeding when treating with this drug.

Always consult a doctor or pharmacist before taking any drug during pregnancy or breastfeeding.

Drug interaction

carbamazepine

Increased carbamazepine concentration when used simultaneously with Cefixime has been reported. Quantifying drugs can support detection of carbamazepine changes in plasma.

warfarin and anticoagulants

Increase prothrombin time, with or without bleeding, which has been reported when used simultaneously with cefixime.

Testing

A false positive reaction to the ureter may occur during a nitroprussid test, but does not occur when using nitroferricyanid.

The use of cefixime can lead to a false positive reaction with glucose in urine when using clinitest® **, benedict or fehling solution. Glucose tests are based on the glucose oxidase enzyme reaction (such as Clinistix® ** or Testape® **) recommended to be used. False positive coombs test has been reported when treated with other cephalosporins. Therefore, it is necessary to recognize the positive Coombs test may be due to the drug.

(**) Clinitest® and Clinistix® are brands registered by Ames Division, Miles Laboratories Inc.; TestAme® is a brand registered by Eli Lilly and Company.