CEFIXIM 100mg Vidipha oral powder for infection treatment (10 packs x 2g)
Dosage form 10 package box
Specifications Cefixime
Ingredient Acute bronchitis, typhoid, chronic bronchitis, dysentery by shigella dysenteriae
Ingredient
| Composition information | Content |
| Cefixime | 100mg |
Uses
Indications
Treatment of infections caused by sensitive bacteria strains, including:
It is necessary to conduct sensitive tests before starting treatment with Cefixim. If necessary, the treatment may be started before knowing the sensitive results. However, once the test results are sensitive, it may be necessary to adjust the treatment.
Pharmacokology
cefixim is a 3rd generation cephalosporin antibiotic, used by oral. The drug has a bactericidal effect. Cefixim's bactericidal mechanism is similar to that of other cephalosporins attached to target proteins (penicillin -mounted proteins that inhibit mucopeptide synthesis in bacterial cell walls
Cefixim has high sustainability with the hydrolysis of beta - lactamase encoded by gene more than Cefaclor, Cefoxitin, Cefuroxim, Cephalexin, Cephradin.
antibacterial spectrum:
Gram -positive bacteria: Gram -positive bacteria streptococcus pyogenes (Beta bacterial soluble bacteria). S.Agalactiae (Bacterial League Group B) and streptococcal group C, F and G; Some S.Pneumoniae strains are worse than some other oral cephalosporins (such as Cefdinir, Cefpodoxim, Cefprozil, Cefuroxim); S.pneumoniae strains of penicillin resistant are considered cefixim resistance. The majority of streptococcal group D and S.Vidirans are often considered Cefixim resistance. Cefixim does not have the effect of in vitro for staphylococcus aureus or no penicillinase secretion including Staphylococcus aureus, S. Epidermidis and S. Saprophyticus, Staphylococcus resistant to methicilin.
Gram -positive bacillus corynebacterium, listeria monocytogenes is usually resistant to cefixim.
Gram -negative bacteria: Cefixim works for Neisseria Meningitidis, N.Gonorrhoeae, secreted or non -secreted penicillinase. The drug also has in vitro effects on N.Gonorrhoeae resistant peniclin through plasmid intermediaries.
Cefixim has an in vitro effect on the majority of H.influenzae secretion or no beta-lactamase secretion and H.Parainfluenzae. Cefixim works better than Cefaclor, Cephalexin, Cefuroxim or Amoxicilin combined with potassium clavulanate for H.influenzae producing beta-lactamase, but less or less than Ciprofloxacin, Ceftriaxon or Co-Trimoxazol. Cefixim in vitro also works for high-quality anti-drug H.influenzae strains (ampicilin, chloramphenicol, tetracyclin, co-trimoxazol, cefaclor and/or erythromycin). However, some H.influenzae strains are not bata-lactamse but ampicillin and cephalosoprin are also reduced to cefixim.
In vitro, Cefixim works for Moraxella Catnrhalis, even when ampicillin resistance, cefaclor, cephalexin.
In vitro, Cefixim works for most important animaliaceae. In vitro, Cefixim work for many strains E.coli, Citrobacter Fruendii, K.pneumoniae and P.Mirabilis resistant to other antibiotics (aminoglycosides, tetracyclin, ampicilin, chloramphenicol and/or co-trimoxazol).
Many strains of Cefixim resistant pseudomonas.
Anaerobic bacteria: Most of the bacteroides fragilis strains, bacteroides spp. Other, most Clostridium strains (including C. Difficile) resistance Cefixim.
Chlamydia and Mycoplasma: Chlamydia Trachomatis and Ureaplasma Urealyticum resistant Cefixim.
Spirochetes: Cefixim has a few effects on Borelia Burgdorferi which is the cause of Lyme disease (concentration of 0.8 micrograms/ml).
Drug resistance:
Cefixim high sustainable, not hydrolyzed by many beta-lactamase through plasmid and chromosomes, but the drug is hydrolyzed by some beta-lactamase of Enterobacter, Klebsiella Oxytoca, Proteus Vulgaris and Pseudomonas Cepacia, Citrobacter Freundii, Enterobacter Cloahera, Flavobacterium and bacteroides fragilis.
Cefixim staphylococcus aureus is caused by a weak drug with PBP, of bacteria. Enterococcus and Listeria monocytogenes are resistant to drugs with poor affinity for bacterial PBPs. Citrobacter Freundii and Enterobacter resistant Cefixim are caused by factors that prevent the drug from penetrating bacteria and produce beta-lactamase. Pseudomonas and acinetobacter resistant drugs are caused by bacterial cell membranes.
Cefixim stimulates the production of beta-lactamase in some Morganella Morganii strains, but the drug still works in vitro for those strains after releasing those beta-lactamase.
Some 3rd generation cephalosporin still work with Staphylococci, Cefixim usually does not work on these bacteria. Cefixim has no in vitro active activity on staphylococci (secretive or no beta-lactamase secretion) such as Staphylococcus aureus, s.epidermidis, and S.Saprophyticus.
Like other cephalosporins, cefixim has no activity on Staphylococci, Enterococci and Listeria spp. No longer sensitive to Cefixim. Entobacter spp., Pseudomonas Aeruginosa and Bacteroides spp. has resisted cefixim. Cefixim has limited in vitro activity on anaerobic bacteria; Most Clostridia strains (including C. Difficile) are resistant to drugs.
Gram-noodles such as Achromobacter Xylosoxidans and Flavobacterium meningosepticum are resistant to Cefixim.
With Chlamydia and Mycoplasma: Cefixim is not active with Chlamydia Trachomatis and Ureaplasma Urealyticum.
Dynamic pharmacokinetics
After taking a single dose of Cefixim, only 30-50% of the dose is absorbed through the gastrointestinal tract, regardless of drinking before or after meals, although the absorption rate may be reduced when taken with meals. The drug in the form of oral fluid is better absorbed in the form of tablets. The absorption of drugs is relatively slow. The peak concentration of plasma is 2 micrograms/ml (for 200mg dose), 3.7 micrograms/ml (for 400mg dose) and reaches after 2-6 hours. The sale time is usually about 3 to 4 hours and may last for kidney failure. About 65% Cefixim in the blood is attached to plasma proteins.
Information about Cefixim's distribution in tissues and fluid fluid is limited. Currently there is no adequate data on the concentration of cerebrospinal fluid. The drug can pass the placenta. The drug may reach relatively high concentrations in bile and urine. About 20% of oral doses are eliminated in the form of unchanged urine within 24 hours. Up to 60% of oral dose without kidney.
There is no evidence of metabolism but there may be a part of the drug eliminated from the bile into the feces. The drug is not equal to the hemolysis.
Renal failure: In people with medium-degree renal function (clearly 20-40ml creatinine/minute), the average selling time of cefixim lasts up to 6.4 hours. Severe renal failure (clearing creatinine 5-20 ml/minute), the average selling time increased to 11.5 hours. The drug is not significantly eliminated from blood by hemons or peritoneal fertilizer. However, a study showed that at a dose of 400mg, dialysis patients have a blood formula similar to those with creatinin clearance 21-60ml/ min.
Before taking CEFIXIM 100mg Vidipha oral powder for infection treatment (10 packs x 2g)
How to use
Used by oral.
Put the powder in a glass containing about 20ml of cool boiled water (about 4 tablespoons of coffee), stir and drink immediately.
Dosage
Children 6 months - 12 years: The suggested dose is 8mg/kg/day, once a day. When necessary, the dose of 4mg/kg for twice a day can be considered to eliminate urinary tract infections, which must be used once a day.
Children> 12 years old or weighing over 50kg: Treatment with adult doses (using other appropriate forms).
Safe and effective in children under six months of age has not been established.
Treatment time: Clinical treatment time is 10-14 days. The treatment time should be guided by the clinical response and bacteria of the patient.In the treatment of infections caused by Streptococcus Pyogenes, it is recommended to treat at least 10 days.
People with kidney failure:
What to do when overdose? Because there is no specific treatment, it is mainly symptomatic treatment.
When there is an overdose symptom, stop immediately and handle as follows: Gastroentric lavage, anti -convulsions may be used if clinical indications. Because the drug is not eliminated by hemolysis, no dialysis or peritoneal filter.
What to do when you forget 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double doses to compensate for missed dose.
Side Effects
Common: ADR> 1/100
Digestive: diarrhea and stool (27%), abdominal pain, vomiting, nausea, flatulence, not delicious, dry mouth. Gastrointestinal disorders usually occur in the first two days of treatment and respond to symptomatic medications, rarely stop the drug.
Nervous system: headache (3 - 16%), dizziness, restlessness, insomnia, fatigue.
Hypersensitivity (7%): Red rash, urticaria, drug fever.
Other effects: increased blood amylase levels (1.5 - 5%), but there is no correlation between increased blood amylase levels and unwanted effects in the patient's digestive tract.
Uncommon: 1/1,000
Digestive: heavy diarrhea caused by Clostridium difficile and fake colitis.
Systemic: Anaphylaxis, angioedema, Stevens - Johnson syndrome, diverse roses, poisoned epidermal necrosis.
Hematology: A decrease in platelets, leukocytes, white blood cells, hemoglobin and hematocrit levels.
liver: hepatitis and jaundice; Temporarily increased AST, ALT, alkaline phosphatase, bilirubin and LDH.
Kidney: Acute renal failure, hypercogen nitrogen nitrogen and temporary plasma creatinine levels.
Other cases: Vaginal infection and infection.
Rare: ADR
Hematology: Prothrombin time.
Systemic: convulsions.
Note: Notify the doctor the unwanted effects encountered when using the drug.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
contraindicated
Be cautious when using
Before starting cefixim treatment, you need to carefully investigate the patient's allergic history of penicillin and other cephalosporins due to the hypersensitivity between beta-lactam antibiotics, including: penicillin, cephalosporin and cephamycin.
Be cautious when using Cefixim in people with a history of gastrointestinal diseases and colitis, especially when used for prolonged use, because there may be risk of excessive growth of anti -drug bacteria. Especially Clostridium dificile in the intestine causes severe diarrhea, need to stop the drug and treat with other antibiotics (Metronidazol, Vancomycin, ...). In addition, diarrhea for 1-2 days is mainly due to the drug, if mild does not need to stop the drug. Cefixim also changes the bacteria in the intestine.
Like other antibiotics, using long -term cefixim can cause excessive breeding bacteria to reproduce, leading to superinfection or infection seriously. Gram -positive bacteria have occurred in patients using Cefixim to treat otitis media or urinary tract infections. Therefore, careful monitoring of patients using Cefixim to promptly treat appropriate if superinfection occurs.
Acute renal failure: As with other cephalosporins, cefixim can cause acute kidney failure including interstitial nephritis as a hidden condition. When acute renal failure occurs, CEFIXIM should be discontinued and should take appropriate treatment and/or necessary measures.
Dosage and number of drug use need to be reduced in people with renal impairment, including patients dialysis due to plasma cefixim concentrations in people with higher renal impairment and longer than patients with normal renal function.
For children under 6 months old, so far there is no data on the safety and effectiveness of Cefixim.
For the elderly: In general, there is no need to adjust the dose, unless there is impaired renal function (creatinine clearance
Serious harmful reactions on the skin: serious skin reactions such as poisoned epidermal necrosis, Stevens-Johnson syndrome and rash with eosin leukemia and systemic symptoms have been reported in some patients using Cefixim. When the reaction is seriously harmful on the skin occurs, Cefixim should be discontinued and needed treatment and / or appropriate measures.
Hemorrhagic anemia: Hematopsius anemia includes serious results that are deaths, which have been described with cephalosporins. The recurrence of hemolytic anemia after re -drinking cephalosporins in some patients with a history of cephalosporin (including cefixim) that is related to hemolytic anemia has also been reported.
Aspartam excipients have a phenylalanin root. May be harmful to patients with phenylceton.
Lactose excipients: Do not use for patients with galactose intolerance, Lapp Lactase deficiency, Glucose-Galactose absorption disorders.
The effect of the drug on the ability to drive and operate machinery
should be cautious when driving or operating machinery because the drug can cause unwanted effects of headache, dizziness, fatigue.
Use drugs for women during pregnancy and lactation
Studies have been conducted in mice and rats with a dose of 400 times the dose of humans and have shown no evidence of fertility ability or harm to the fetus caused by Cefixim. On rabbits with 4 times the dose of people, there is no evidence of teratogenic effect; There is a high percentage of miscarriage and death is a consequence known as rabbit sensitivity for antibiotics changing the microbiological system of the intestine. There is no adequate and controlled research in pregnant women. Therefore, CEFIXIM should not be used during pregnancy or breastfeeding unless the doctor is considered necessary.
Drug interaction
Probenecid increases the peak and AUC concentration of Cefixim, reducing the clearance of the kidneys and the distribution of the drug.
Used with anticoagulants such as warfarin increases prothrombin time, with or without bleeding.
cefixim increases carbamazepine levels in plasma when taken together.
nifedipine increases the bioavailability of cefixim when taken together, manifested by increasing peak concentration and AUC.
A four -way cross study on 12 healthy men to evaluate Cefixim's pharmacokinetics when used with, before, and after aluminum/magnesium antacids. The use of antacids does not significantly change the pharmacokinetic parameters of Cefixim.
Research on drug interactions related to cohesion to protein in human serum, the non -cohesive change of Cefixim when adding acetaminophen, heparin, phenytoin, ibuprofen, furosemid or diazepam is not significant in terms of statistics that have been reported in maximum therapeutic concentration. With salicylic acid, significantly increased by about twice, from 35% to 66%
No cohesion. When studying dog interaction, it has confirmed that ASA preparations (for example, salicylic acid) increases the Cefixim part without cohesion, resulting in an increase in the distribution and clearance of the drug. However, due to the increasing distribution and clearance integral, there is no effect on the sale time of Cefixim.
Cefixim's activity may increase when used with ureteric acidic agents. Cefixim can reduce the activity of typhoid vaccine.
The effect of drugs on tests:
Palf -positive reaction Ketone in urine can occur with tests using nitroprussid but does not occur with tests using nitroferricyanid.
The use of the beta-lactam group can lead to a false positive reaction of glucose in the urine when testing using clinitest, benedict solution, or fehling solution. Therefore, glucose tests should be used based on glucose oxidase enzyme reactions (like clinistix
or testape).
The coombs direct test results have been reported during treatment with cephalosporin antibiotics. Therefore, it should be said that the positive Coombs test may be due to the drug.
Storage
Leave a cool place, avoid light, temperature below 30⁰C.
To be out of reach of children, read the user manual carefully before use.
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