Actions of Fixital in details
Pharmacotherapeutic Group: Antimicrobial (chemotherapeutic) agents, broad and medium spectrum antibiotics.
Pharmacology: Pharmacodynamics: Fixital is an orally-active cephalosporin antibiotic which has in vitro bactericidal activity against a wide variety of gram-positive and gram-negative organisms including Streptococcus pneumoniae, Streptococcus pyogenes, Escherichia coli, Proteus mirabilis, Klebsiella sp, Haemophilus influenzae (positive and negative β-lacatamases), Moxarella (Branhamella) catarrhalis (positive and negative β-lacatamases). Fixital is stable in the presence of β-lactamase enzymes.
Most strains of enterococci (Streptococcus faecalis, group D streptococci) and staphylococci (including coagulase positive and negative strains and methicillin-resistant strains) are resistant to Fixital. In addition, most strains of Enterobacter and Pseudomonas, Bacteroides fragilis, Listeria monocytogenes and Clostridia are resistant to Fixital.
Pharmacokinetics: Fixital, given orally, is about 40-50% absorbed whether administered with or without food; however, time to maximal absorption is increased approximately 0.8 hrs when administered with food. A single Fixital 200 mg tablet produces an average peak serum concentration (Cmax) of approximately 2 mcg/mL (range 1-4 mcg/mL); a single Fixital 100 mg dispersible tablet produces an average Cmax of approximately 1 mcg/mL (range 0.5-2 mcg/mL). Peak serum concentrations occur between 2 and 6 hrs following oral administration of a single 200 mg tablet or a single 100 mg tablet of Fixital.
Approximately 50% of the absorbed dose is excreted unchanged in the urine in 24 hrs. In animal studies, it was noted that Fixital is also excreted in the bile in excess of 10% of the administered dose. Serum protein-binding is concentration-independent with a bound fraction of approximately 65%.
The serum half-life (t½) of Fixital in healthy subjects is independent of dosage form and averages from 3-4 hrs but may range up to 9 hrs in some normal volunteers. Average area under time curve (AUC) at steady state in elderly patients are approximately 40% higher than average AUC in other healthy adults.
In subjects with moderate renal impairment [creatinine clearance (CrCl) 20-40 mL/min], the average serum t½ of Fixital is prolonged to 6.4 hrs. In severe renal impairment (CrCl 5-20 mL/min), the t½ increased to an average of 11.5 hrs. Fixital is not cleared significantly from the blood by hemodialysis or peritoneal dialysis. However, a study indicated that with doses of 400 mg, patients undergoing hemodialysis have similar profiles as subjects with CrCl 21-60 mL/min. There is no evidence of metabolism of Fixital in vivo.
How should I take Fixital?
Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.
Take this medicine with a full glass of water.
Fixital works best if you take it with a meal or within 30 minutes of a meal.
The Fixital chewable tablet must be chewed before you swallow it.
Do not crush, chew, or break an extended-release tablet. Swallow it whole.
Shake the oral suspension (liquid) well just before you measure a dose. Measure the liquid with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.
This medication can cause unusual results with certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using Fixital.
Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Fixital will not treat a viral infection such as the common cold or flu.
Store the tablets and capsules at room temperature away from moisture, heat, and light.
Store the oral liquid in the refrigerator. Throw away any unused medication after 14 days.
Fixital administration
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.
Take this medicine with a full glass of water.
Fixital works best if you take it with a meal or within 30 minutes of a meal.
The Fixital chewable tablet must be chewed before you swallow it.
Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. Breaking the pill may cause too much of the drug to be released at one time.
Shake the oral suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using Fixital.
Take Fixital for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Fixital will not treat a viral infection such as the common cold or flu.
Store the tablets and capsules at room temperature away from moisture, heat, and light.
Store the oral liquid in the refrigerator. Throw away any unused medication after 14 days.
Fixital pharmacology
Mechanism of Action
Fixital is a semisynthetic cephalosporin antibacterial drug.
Pharmacokinetics
Fixital tablets and suspension, given orally, are about 40% to 50% absorbed whether administered with or without food; however, time to maximal absorption is increased approximately 0.8 hours when administered with food. A single 200 mg tablet of Fixital produces an average peak serum concentration of approximately 2 mcg/mL (range 1 to 4 mcg/mL); a single 400 mg tablet produces an average peak concentration of approximately 3.7 mcg/mL (range 1.3 to 7.7 mcg/mL). The oral suspension produces average peak concentrations approximately 25% to 50% higher than the tablets, when tested in normal adult volunteers. Two hundred and 400 mg doses of oral suspension produce average peak concentrations of 3 mcg/mL (range 1 to 4.5 mcg/mL) and 4.6 mcg/mL (range 1.9 to 7.7 mcg/mL), respectively, when tested in normal adult volunteers. The area under the time versus concentration curve (AUC) is greater by approximately 10% to 25% with the oral suspension than with the tablet after doses of 100 to 400 mg, when tested in normal adult volunteers. This increased absorption should be taken into consideration if the oral suspension is to be substituted for the tablet. Crossover studies of tablet versus suspension have not been performed in children.
The 400 mg capsule is bioequivalent to the 400 mg tablet under fasting conditions. However, food reduces the absorption following administration of the capsule by approximately 15% based on AUC and 25% based on Cmax.
Peak serum concentrations occur between 2 and 6 hours following oral administration of a single 200 mg tablet, a single 400 mg tablet or 400 mg of Fixital suspension. Peak serum concentrations occur between 2 and 5 hours following a single administration of 200 mg of suspension. Peak serum concentrations occur between 3 and 8 hours following oral administration of a single 400 mg capsule.
Distribution
Serum protein binding is concentration independent with a bound fraction of approximately 65%. In a multiple dose study conducted with a research formulation which is less bioavailable than the tablet or suspension, there was little accumulation of drug in serum or urine after dosing for 14 days. Adequate data on CSF levels of Fixital are not available.
Metabolism and Excretion
There is no evidence of metabolism of Fixital in vivo. Approximately 50% of the absorbed dose is excreted unchanged in the urine in 24 hours. In animal studies, it was noted that Fixital is also excreted in the bile in excess of 10% of the administered dose. The serum half-life of Fixital in healthy subjects is independent of dosage form and averages 3 to 4 hours but may range up to 9 hours in some normal volunteers.
Special Populations
Geriatrics: Average AUCs at steady state in elderly patients are approximately 40% higher than average AUCs in other healthy adults. Differences in the pharmacokinetic parameters between 12 young and 12 elderly subjects who received 400 mg of Fixital once daily for 5 days are summarized as follows:
| Pharmacokinetic Parameters (mean ± SD) for Fixital in Both Young & Elderly Subjects | ||
| Pharmacokinetic parameter | Young | Elderly |
| Cmax (mg/L) | 4.74 ± 1.43 | 5.68 ± 1.83 |
| Tmax (h)* | 3.9 ± 0.3 | 4.3 ± 0.6 |
| AUC (mg.h/L)* | 34.9 ± 12.2 | 49.5 ± 19.1 |
| T½ (h)* | 3.5 ± 0.6 | 4.2 ± 0.4 |
| Cave (mg/L)* | 1.42 ±0.50 | 1.99 ± 0.75 |
| *Difference between age groups was significant. (p<0.05) | ||
However, these increases were not clinically significant.
Renal Impairment: In subjects with moderate impairment of renal function (20 to 40 mL/min creatinine clearance), the average serum half-life of Fixital is prolonged to 6.4 hours. In severe renal impairment (5 to 20 mL/min creatinine clearance), the half-life increased to an average of 11.5 hours. The drug is not cleared significantly from the blood by hemodialysis or peritoneal dialysis. However, a study indicated that with doses of 400 mg, patients undergoing hemodialysis have similar blood profiles as subjects with creatinine clearances of 21 to 60 mL/min.
Microbiology
Mechanism of Action
As with other cephalosporins, the bactericidal action of Fixital results from inhibition of cell wall synthesis. Fixital is stable in the presence of certain beta-lactamase enzymes. As a result, certain organisms resistant to penicillins and some cephalosporins due to the presence of beta-lactamases may be susceptible to Fixital.
Resistance
Resistance to Fixital in isolates of Haemophilus influenzae and Neisseria gonorrhoeae is most often associated with alterations in penicillin-binding proteins (PBPs). Fixital may have limited activity against Enterobacteriaceae producing extended spectrum beta-lactamases (ESBLs). Pseudomonas species, Enterococcus species, strains of Group D streptococci, Listeria monocytogenes, most strains of staphylococci (including methicillin-resistant strains), most strains of Enterobacter species, most strains of Bacteroides fragilis, and most strains of Clostridium species are resistant to Fixital.
Antimicrobial Activity
Fixital has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections [see Indications And Usage (1).
Gram-positive Bacteria
Streptococcus pneumoniae
Streptococcus pyogenes
Gram-negative Bacteria
Escherichia coli
Haemophilus influenzae
Moraxella catarrhalis
Neisseria gonorrhoeae
Proteus mirabilis
The following in vitro data are available, but their clinical significance is unknown. At least 90 percent of the following bacteria exhibit an in vitro minimum inhibitory concentration (MIC) less than or equal to the susceptible breakpoint for Fixital against isolates of similar genus or organism group. However, the efficacy of Fixital in treating clinical infections caused by to these bacteria has not been established in 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
Providencia species
Salmonella species
Serratia marcescens
Shigella species
Susceptibility Testing
For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC.
References
- DailyMed. "CEFIXIME: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- NCIt. "Cefixime: NCI Thesaurus (NCIt) provides reference terminology for many systems. It covers vocabulary for clinical care, translational and basic research, and public information and administrative activities.". https://ncit.nci.nih.gov/ncitbrowser... (accessed September 17, 2018).
Reviews
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Information checked by Dr. Sachin Kumar, MD Pharmacology
