Actions of Geniclor in details
Pharmacology: In vitro tests demonstrate that the bactericidal action of the cephalosporins results from inhibition of cell wall synthesis.
Pharmacokinetics: Geniclor is well absorbed after oral administration to fasting subjects. Total absorption is the same whether the drug is given with or without food; however, the presence of food may delay the absorption. About 25% is bound to plasma proteins. Geniclor appears to be widely distributed in the body; it crosses the placenta and is excreted in low concentration in breast milk.
Approximately 60-85% of the drug is excreted unchanged in the urine within 8 hrs, the greater portion being excreted in the first 2 hrs. The serum half-life in normal subjects is 0.6-0.9 hr. In patients with reduced renal function, the serum half-life of Geniclor is slightly prolonged. In those with complete absence of renal function, the plasma half-life of the intact molecule is 2.3-2.8 hrs. Excretion pathways in patients with markedly impaired renal function have not been determined. Hemodialysis shortens the half-life by 25-30%.
Microbiology: Geniclor is active in vitro against most strains of clinical isolates of the following organisms:
Aerobes, Gram-Positive: Staphylococci, including coagulase-positive, coagulase-negative and penicillinase-producing strains (when tested by in vitro methods), exhibit cross-resistance between Geniclor and methicillin; Streptococcus pyogenes (group A β-hemolytic streptococci); Streptococcus pneumoniae.
Aerobes, Gram-Negative: Moraxella (Branhamella) catarrhalis; Haemophilus influenzae including β-lactamase-producing ampicillin-resistant strains; Escherichia coli; Proteus mirabilis; Klebsiella spp; Citrobacter diversus; Neisseria gonorrhoeae.
Anaerobes: Propionibacterium acnes and Bacteroides spp (excluding Bacteroides fragilis), Peptococci, Peptostreptococci.
Note: Pseudomonas spp, Acinetobacter calcoaceticus (formerly Mirna spp and Herellea spp) and most strains of enterococci [Enterococcus faecalis (formerly Streptococcus faecalis), group D streptococci], Enterobacter spp, indole-positive Proteus and Serratia spp are resistant to Geniclor. When tested by in vitro methods, staphylococci exhibit cross-resistance between Geniclor and methicillin-type antibiotics. Geniclor is not active against Morganella morganii, Proteus vulgaris and Providencia rettgeri.
Susceptibility Testing: Disk Susceptibility Tests: Quantitative methods that require measurement of zone diameters give the most precise estimates of antibiotic susceptibility. One such procedure has been recommended for use with disks for testing susceptibility to cephalothin. The currently accepted zone diameter interpretative criteria for the cephalothin disk are appropriate for determining bacterial susceptibility to Geniclor. With this procedure, a report from the laboratory of "resistant" indicates that the infecting organism is not likely to respond to therapy. A report of "intermediate susceptibility" suggests that the organism would be susceptible if the infection is confined to tissues and fluids (eg, urine) in which high antibiotic levels can be obtained or if high dosage is used.
How should I take Geniclor?
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.
Geniclor works best if you take it with a meal or within 30 minutes of a meal.
The Geniclor 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 false results with certain medical tests, including urine glucose (sugar) tests. Tell any doctor who treats you that you are using Geniclor.
Take Geniclor for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Geniclor will not treat a viral infection such as the common cold or flu.
Store the tablets and capsules at room temperature away from moisture and heat.
Store Geniclor oral liquid in the refrigerator. Do not allow it to freeze. Throw away any unused medication that is older than 14 days.
Geniclor administration
Oral: Administer around-the-clock to promote less variation in peak and trough serum levels.
Capsules and oral suspension: Administer without regard to meals; shake oral suspension well before using
ER tablets: Do not chew, crush, or split; administer with or within 1 hour of food.
Bariatric surgery: Some institutions may have specific protocols that conflict with these recommendations; refer to institutional protocols as appropriate. Switch to IR formulation. Capsule may be opened and contents sprinkled onto soft food of choice. Patient should be instructed to swallow the mixture without biting down or chewing.
Geniclor pharmacology
Pharmacokinetics
The Geniclor extended-release tablet formulation of Geniclor is pharmacokinetically different from the Geniclor immediate-release capsule formulation of Geniclor. No direct comparisons with the suspension formulation of Geniclor have been conducted; therefore, there are no data with which to compare the pharmacokinetic properties of the extended-release tablet formulation and the suspension formulation. Until further data are available, the pharmacokinetic equivalence of the extended-release tablet and the suspension formulations should NOT be assumed.
Absorption and Metabolism
The extent of absorption (AUC) and the maximum plasma concentration (Cmax) of Geniclor from Geniclor extended-release tablets are greater when the extended-release tablet is taken with food.
[NOTE: The extent of absorption (AUC) of Geniclor from Geniclor immediate-release capsules is unaffected by food intake; however, when Geniclor immediate-release capsules are taken with food, the Cmax is decreased.]
There is no evidence of metabolism of Geniclor in humans.
Comparative Serum Pharmacokinetics
Serum pharmacokinetic parameters for Geniclor extended-release tablets and Geniclor immediate-release capsules are shown in the table below.
No drug accumulation was noted when Geniclor extended-release tablets were given twice daily.
The plasma half-life in healthy subjects is independent of dosage form and averages approximately 1 hour.
Food Effect on Pharmacokinetics
When Geniclor extended-release tablets are taken with food, the AUC is 10% lower while the Cmax is 12% lower and occurs 1 hour later compared to Geniclor immediate-release capsules. In contrast, when Geniclor extended-release tablets are taken without food, the AUC is 23% lower while the Cmax is 67% lower and occurs 0.6 hours later, using an equivalent milligram dose of Geniclor immediate-release capsules as a reference. Therefore, Geniclor extended-release tablets should be taken with food.
Special Populations
Renal InsufficiencyIn patients with reduced renal function, the serum half-life of Geniclor is slightly prolonged. In those with complete absence of renal function, the plasma half-life of the intact molecule is 2.3 to 2.8 hours. Excretion pathways in patients with markedly impaired renal function have not been determined. Hemodialysis shortens the half-life by 25% to 30%.
Geriatric Patients
In elderly subjects (over age 65) with normal serum creatinine values, higher peak plasma concentrations and AUCs have been observed. This is considered to be primarily a result of an age-related decrement in renal function, and has no apparent clinical significance. Therefore, dosage adjustment is not necessary in elderly subjects with normal serum creatinine values.
Microbiology
Mechanism of Action
As with other cephalosporins, the bactericidal action of Geniclor results from inhibition of cell-wall synthesis.
Mechanism of Resistance
Resistance to Geniclor is primarily through hydrolysis of ß-lactamases alteration of penicillin-binding proteins (PBPs) and decreased permeability. Pseudomonas spp., Acinetobacter calcoaceticus and most strains of Enterococi (Enterococcus faecalis, group D streptococci), Enterobacter spp., indole-positive Proteus, Morganella morganii (formerly Proteus morganii), Providencia rettgeri (formerly Proteusrettgeri) and Serratia spp. are resistant to Geniclor. Geniclor is inactive against methicillin-resistant staphylococci, β-lactamase-negative, ampicillin-resistant strains of H. influenzae should be considered resistant to Geniclor despite apparent in vitro susceptibility to this agent.
List of Microorganisms
Geniclor extended-release tablets have been shown to be active against most strains of the following microorganisms both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section.
Gram-positive Bacteria
Staphylococcus aureus (methicillin susceptible only)
Streptococcus pneumoniae
Streptococcus pyogenes
Gram-negative Bacteria
Haemophilus influenzae (excluding β-lactamase-negative, ampicillin-resistant strains)
Moraxella catarrhalis
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 concentrations (MICs) less than or equal to the susceptible breakpoint for cefalor. However, the safety and effectiveness of Geniclor extended-release tablets in treating clinical infections due to these bacteria has not been established in adequate and well-controlled trials.
Gram-positive Bacteria
Staphylococcus epidermidis (methicillin susceptible only)
Gram-negative Bacteria
Haemophilus parainfluenzae
Klebsiella pneumoniae
Anaerobic Bacteria
Peptococcus niger
Peptostreptococci
Propionibacterium acnes
Susceptibility Testing
When available, the clinical microbiology laboratory should provide the result of in vitro susceptibility test results for antimicrobial drugs used in resident hospitals to the physician as periodic reports that describe the susceptibility profile of nosocomial and community-acquired pathogens. These reports should aid the physician in selecting an antibacterial drug for treatment.
Dilution Techniques
Quantitative methods are used to determine antimicrobial minimum inhibitory concentrations (MICs). These MICs provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MICs should be determined using a standardized method (broth, agar, or microdilution) 1,3. The MIC values should be interpreted according to criteria provided in Table 2.
Diffusion Techniques
Quantitative methods that require measurement of zone diameters also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. The zone size provides an estimate of the susceptibility of bacteria to antimicrobial compounds. The zone size should be determined using a standardized test method2,3. This procedure uses paper disks impregnated with 30 mcg Geniclor to test the susceptibility of microorganisms to Geniclor. The disc diffusion interpretive criteria are provided in Table 2.
A report of Susceptible indicates that antimicrobial is likely to inhibit growth of the pathogen if the antimicrobial compound reaches the concentrations at the site of infection necessary to inhibit growth of the pathogen. A report of Intermediate indicates that the result should be considered equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where a high dosage of drug can be used. This category also provides a buffer zone that prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of Resistant indicates that the antimicrobial is not likely to inhibit growth of the pathogen if the antimicrobial compound reaches the concentrations usually achievable at the infection site; other therapy should be selected.
Quality Control
Standardized susceptibility test procedures require the use of laboratory controls to monitor and ensure the accuracy and precision of supplies and reagents used in the assay, and the techniques of the individuals performing the test. 1, 2, 3, 4 Standard Geniclor powder should provide the following range of MIC values noted in Table 3. For the diffusion technique using the 30 mcg disk the criteria in Table 3 should be achieved.
References
- DailyMed. "CEFACLOR: 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. "Cefaclor Anhydrous: 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).
- EPA DSStox. "Cefaclor: DSSTox provides a high quality public chemistry resource for supporting improved predictive toxicology.". https://comptox.epa.gov/dashboard/ds... (accessed September 17, 2018).
Reviews
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Information checked by Dr. Sachin Kumar, MD Pharmacology
