Penicillin V Potassium

PENICILLIN V POTASSIUM- penicillin v potassium tablet, film coated
Denton Pharma, Inc.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of penicillin V potassium and other antibacterial drugs, penicillin V potassium should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

DESCRIPTION

Penicillin V is the phenoxymethyl analog of penicillin G. Penicillin V potassium is the potassium salt of penicillin V.

Chemical Structure
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Penicillin V potassium tablets, for oral administration, contain 250 mg (400,000 units) or 500 mg (800,000 units). The 250 mg tablet is equivalent to 250 mg (400,000 units) penicillin V and the 500 mg tablet is equivalent to 500 mg (800,000 units) penicillin V. In addition, each tablet contains the following inactive ingredients: povidone, microcrystalline cellulose, talc, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide.

CLINICAL PHARMACOLOGY


Penicillin V exerts a bactericidal action against penicillin-sensitive microorganisms during the stage of active multiplication. It acts through the inhibition of biosynthesis of cell-wall mucopeptide. It is not active against the penicillinase-producing bacteria, which include many strains of staphylococci. The drug exerts high in vitro activity against staphylococci (except penicillinase-producing strains), streptococci (groups A, C, G, H, L and M), and pneumococci. Other organisms sensitive in vitro to penicillin V are Corynebacterium diphtheriae , Bacillus anthracis, Clostridia, Actinomyces bovis , Streptobacillus moniliformis , Listeria monocytogenes, Leptospira, and Neisseria gonorrhoeae. Treponema pallidum is extremely sensitive.
The potassium salt of penicillin V has the distinct advantage over penicillin G in resistance to inactivation by gastric acid. It may be given with meals; however, blood levels are slightly higher when the drug is given on an empty stomach. Average blood levels are two to five times higher than the levels following the same dose of oral penicillin G and also show much less individual variation.
Once absorbed, penicillin V is about 80% bound to serum protein. Tissue levels are highest in the kidneys, with lesser amounts in the liver, skin, and intestines. Small amounts are found in all other body tissues and the cerebrospinal fluid. The drug is excreted as rapidly as it is absorbed in individuals with normal kidney function; however, recovery of the drug from the urine indicates that only about 25% of the dose given is absorbed. In neonates, young infants, and individuals with impaired kidney function, excretion is considerably delayed.

Microbiology

Susceptibility Testing

Diffusion Techniques

Quantitative methods that require measurement of zone diameters provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. One such standardized procedure 2,4 which has been recommended for use with disks to test susceptibility of organisms to penicillin uses the 10 Unit (U) penicillin disk. Interpretation involves the correlation of the diameters obtained in the disk test with the minimum inhibitory concentration (MIC) for penicillin.

Reports from the laboratory providing results of the standard single-disk susceptibility test with a 10 U penicillin disk should be interpreted according to the criteria provided in Table 1.

Dilution Techniques

Quantitative methods that are used to determine minimum inhibitory concentrations (MICs) provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. One such standardized procedure 3,4 uses a standardized dilution method (broth or agar) or equivalent with penicillin powder. The MIC values obtained should be interpreted according to the criteria provided in Table 1.

Table 1: SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA
Pathogen Susceptibility Test Result Interpretive Criteria
Disk diffusion (Zone diameter in mm) Minimal Inhibitory Concentration (MIC in mcg/mL)
S I R S I R
Staphylococcus spp . ≥29 - ≤28 ≤0.12 - ≥0.25
Streptococcus spp. (beta-hemolytic group) ≥24 - - ≤0.12 - -
Streptococcus pneumoniae (non-meningitis isolates) ≤0.06 0.12 to 1 ≥2

A report of “susceptible” indicates that the pathogen is likely to be inhibited by usually achievable concentrations of the antimicrobial compound in the blood. A report of “Intermediate” (I) indicates that the result should be considered equivocal, 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 high dosage of the 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 pathogen is not likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable; other therapy should be selected .

Quality Control

Standardized susceptibility test procedures require the use of laboratory control microorganisms 2,3,4. The 10 U penicillin disk and the standard penicillin powder should provide respectively the following zone diameters and MIC values in these laboratory test quality control strains:

Table 2: ACCEPTABLE QUALITY CONTROL RANGES
Microorganism Acceptable Quality Control Ranges
Disk diffusion (Zone diameter ranges in mm) Minimal Inhibitory Concentration Range (MIC in mcg/mL)
Staphylococcus aureus ATCC ® 25923 26 to 37
Staphylococcus aureus ATCC ® 29213 0.25 to 2
Streptococcus pneumoniae ATCC ® 49619 24 to 30 0.25 to 1

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