Penicillin V (Penicillin V Potassium) - Summary

PENICILLIN V SUMMARY

Penicillin V Potassium for Oral Solution, USP

Penicillin V Potassium for Oral Solution, the potassium salt of penicillin V, monopotassium [2S-(2α,5α,6β)]-3,3-dimethyl-7-oxo-6-[(phenoxyacetyl)amino]-4-thia-1-azabicyclo [3.2.

Penicillin V potassium is indicated in the treatment of mild to moderately severe infections due to penicillin G-sensitive microorganisms. Therapy should be guided by bacteriologic studies (including sensitivity tests) and by clinical response.

NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage.

Indicated surgical procedures should be performed.

The following infections will usually respond to adequate dosage of penicillin V.

Streptococcal infections (without bacteremia). Mild-to-moderate infections of the upper respiratory tract, scarlet fever, and mild erysipelas.

NOTE: Streptococci in groups A, C, G, H, L, and M are very sensitive to penicillin. Other groups, including group D (enterococcus), are resistant.

Pneumococcal infections. Mild to moderately severe infections of the respiratory tract.

Staphylococcal infections –penicillin G-sensitive. Mild infections of the skin and soft tissues.

NOTE: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections.

Fusospirochetosis (Vincent’s gingivitis and pharyngitis)–Mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin.

NOTE: Necessary dental care should be accomplished in infections involving the gum tissue.

Medical conditions in which oral penicillin therapy is indicated as prophylaxis:

For the prevention of recurrence following rheumatic fever and/or chorea: Prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Penicillin V Potassium for Oral Solution and other antibacterial drugs, Penicillin V Potassium for Oral Solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

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NEWS HIGHLIGHTS

Published Studies Related to Penicillin V

Once-daily amoxicillin versus twice-daily penicillin V in group A beta-haemolytic streptococcal pharyngitis. [2008.06]
BACKGROUND: Rheumatic fever is a preventable chronic disease preceded by group A beta-haemolytic streptococcal (GABHS) pharyngitis. OBJECTIVE: To test the non-inferiority of once-daily (QD) oral amoxicillin to the recommended twice-daily (BID) oral penicillin V in GABHS pharyngitis... CONCLUSION: In this adequately powered study, once-daily oral amoxicillin is not inferior to twice-daily penicillin V for the treatment and eradication of GABHS in children with pharyngitis.

Comparative bioavailability study of two phenoxymethylpenicillin potassium tablet formulations in healthy volunteers. [2007.12]
CONCLUSION: Since the 90% CI for AUC0-t, AUC0-infinity and Cmax ratios were all within the 80 - 125% interval proposed by the US FDA and accepted by ANVISA, it was concluded that the Meracilina formulation (manufactured by AchA(c) S.A.) is bioequivalent to Pen-Ve-Oral (manufactured by Eurofarma) for both the rate and the extent of bioavailability.

Evaluation of phenoxymethylpenicillin treatment of acute otitis media in children aged 2-16. [2007.09]
OBJECTIVE: To study the clinical recovery from acute otitis media (AOM) in children, 2-16 years of age, managed with or without treatment with phenoxymethylpenicillin (PcV)... CONCLUSIONS: Our investigation supports that PcV treatment of AOM does not affect the recovery time or complication rates. PcV provided some symptomatic benefit in the treatment of AOM in otherwise healthy children, aged 2-16 years.

A randomized prospective controlled trial of antibiotic prophylaxis in intraoral bone-grafting procedures: preoperative single-dose penicillin versus preoperative single-dose clindamycin. [2006.05]
In this comparative study, 150 consecutive patients undergoing local intraoral bone grafting randomly received either an oral single dose of 600 mg clindamycin or 2 g of the penicillin phenethicillin 1 h before incision. Primary endpoint was wound infection at the receptor site within 8 weeks of surgery...

Comparison of a two- or three-week regimen and a review of treatment of erythema migrans with phenoxymethylpenicillin. [2006]
BACKGROUND: A longer duration treatment is preferred in erythema migrans (EM) to prevent late complaints. OBJECTIVES: To determine whether 20 (20d-pt) or 14 days (14d-pt) of phenoxymethylpenicillin (PenV) have similar efficacy in treating EM and preventing further sequelae... CONCLUSION: A 2-week treatment regimen of PenV seems to be as effective as a 3-week course with no statistical differences for clinical and serological findings after treatment. Copyright (c) 2006 S. Karger AG, Basel.

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Clinical Trials Related to Penicillin V

Treating Patients With a History of Non-Life Threatening Allergic Reaction to Penicillin With Penicillin [Terminated]
The purpose of this study is to examine whether oral challenge with penicillin for patients with a known history of non-life threatening allergic reaction to penicillin is well-tolerated irrespective of skin-testing results

TELI TON - Telithromycin in Tonsillitis [Terminated]
This is a multinational, randomized (1: 1), double blind, double dummy, comparator-controlled, 2 parallel treatment group study in subjects from 6 months to < 13 years of age, with Streptococcus pyogenes tonsillitis/pharyngitis (T/P).Each subject will receive either telithromycin 25 mg/kg once daily for 5 days or penicillin V, 13. 3 mg/kg three times daily for 10 days. Matching placebo for telithromycin and penicillin V will also be dispensed for 5 and 10 days respectively, to provide blinding to the different treatment regimens. A positive rapid identification test for streptococcal Group A antigen will be required for all subjects at Visit 1 (Day 1) for entry into the study. Throat swab specimens for bacterial culture, identification, and antibiotic-susceptibility testing will be taken at Visits 1, 3 and 4.

TELI TAD - Telithromycin in Tonsillitis in Adolescents and Adults [Terminated]
This is a multinational, randomized (1: 1), double blind, comparator-controlled, 2 parallel treatment group study in subjects equal to or over 13 years of age, with Streptococcus pyogenes tonsillitis/pharyngitis (T/P). Each subject will receive either telithromycin, 400 mg over-encapsulated tablets, 800 mg once daily for 5 days or penicillin V 250 mg over-encapsulated tablets, 500 mg three times daily for 10days. Matching placebo capsules will be dispensed to maintain the blind between the treatment groups. A positive rapid identification test for streptococcal Group A antigen will be required for all subjects at Visit 1 (Day 1) for entry into the study. Throat swab specimens for bacterial culture, identification, and antibiotic-susceptibility testing will be taken at Visits 1, 3 and 4.

Penicillin Skin Testing in Patients With History of Allergic Reactions to Betalactams [Recruiting]
This study aims to compare the readings of skin testing results in patients with suspected penicillin allergy between in-house penicillin test preparation and commercial available penicillin testing kit.

Oral Penicillin and Penicillin Levels in Venous Umbilical Cord Blood [Not yet recruiting]
Pregnant,laboring women will receive 2 grams of oral penicillin V before delivery. At the time of delivery of the infant, umbilical vein cord blood will be obtained from the umbilical cord. These cord blood samples will be sent for bioassay of penicillin levels.

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PATIENT REVIEWS / RATINGS / COMMENTS

Penicillin V review by 30 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		strep throat
Dosage & duration:		200 milligrams (dosage frequency: twice a day) for the period of 10 days
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		The treatment effectively got rid of my infection and also alleviated my pain after taking twice(on day).
Side effects:		The only side effects were I felt a little sick if I took the pill on an empty stomach and I got diarrhea a couple of times
Comments:		After seeing my doctor I was prescribed Penicillin V and took it for ten days twice a day.