Permapen (Penicillin G Benzathine) - Summary

PERMAPEN SUMMARY

PERMAPEN® ISOJECT®
(Penicillin G Benzathine)
Injectable Suspension
1,200,000 units
For lntramuscular Use Only

Permapen® (Penicillin G Benzathine) Injectable Suspension, a sterile antibacterial agent, is a repository penicillin compound which provides blood levels for long periods following its intramuscular injection. This property is the result of its extremely low solubility in water. Each milliliter contains 600,000 units of penicillin G benzathine; 0.006 grams sodium citrate; 0.003 grams polyvinylpyrrolidone; 0.010 grams lecithin, and 0.003 grams sodium carboxymethylcellulose in an aqueous suspension. Permapen also contains methylparaben 0.09% and propylparaben 0.01% as preservatives.

Intramuscular penicillin G benzathine is indicated in the treatment of infections in both children and adults due to penicillin G-susceptible microorganisms that are susceptible to the low and very prolonged serum levels common to this particular dosage form in the indications listed below. Therapy should be guided by clinical response.

Note: When high sustained serum levels are required, injectable penicillin G either IM or IV should be used.

The following infections will usually respond to adequate dosages of intramuscular penicillin G benzathine:

Upper Respiratory Tract (pharyngitis): streptococci (group A – without bacteremia).

Venereal Infections: Syphilis

Yaws, bejel, and pinta.

Medical Conditions in Which Penicillin G Benzathine Therapy is Indicated As Prophylaxis

Rheumatic fever and/or chorea: Prophylaxis with penicillin G benzathine has proven effective in preventing recurrence of these conditions. It has also been used as follow-up prophylactic therapy for rheumatic heart disease and acute glomerulonephritis.

See all indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Permapen (Penicillin)

penicillin V, Pen-Vee-K, Veetids
Source: MedicineNet Clostridium Difficile Colitis Specialty [2009.03.27]
Title: penicillin V, Pen-Vee-K, Veetids
Category: Medications
Created: 12/31/1997
Last Editorial Review: 3/27/2009

Drug Resistance Weakening Revenue Lines Of Antibiotic Products
Source: MRSA / Drug Resistance News From Medical News Today [2009.10.02]
Drug resistance is a key public health problem and also a problem for makers of branded antibacterial products, according to the findings of a new report. Traditional antibiotics: quinolones, cephalosporins, and penicillins, have seen their market share erode due to loss of effectiveness, while at the same time they are facing heavy generic competition.

more news >>

Published Studies Related to Permapen (Penicillin)

Randomized, comparative efficacy trial of oral penicillin versus cefuroxime for perianal streptococcal dermatitis in children. [2008.12]
OBJECTIVE: To investigate the efficacy of penicillin compared with cefuroxime for group A beta-hemolytic Streptococcus pyogenes (GABHS) perianal dermatitis... CONCLUSIONS: Cefuroxime was more effective than penicillin and therefore should be considered as the treatment of choice for perianal dermatitis due to GABHS.

Antibiotic prophylaxis for orthognathic surgery: a prospective, comparative, randomized study between amoxicillin-clavulanic acid and penicillin. [2008.11]
CONCLUSION: There were no differences in infection between the two groups of antibiotics. Based on the present study, short-term penicillin is still the most appropriate choice for prophylactic antibiotic in orthognathic surgery.

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.

Continuous versus intermittent infusion of temocillin, a directed spectrum penicillin for intensive care patients with nosocomial pneumonia: stability, compatibility, population pharmacokinetic studies and breakpoint selection. [2008.02]
BACKGROUND AND AIMS: Temocillin, a 6alpha-methoxy-penicillin stable towards most beta-lactamases (including extended-spectrum beta-lactamase), is presented as an alternative to carbapenems for susceptible Enterobacteriaceae in microbiological surveys. We aimed at documenting its potential clinical usefulness in intensive care (IC) patients using pharmacokinetic/pharmacodynamic approaches applied to conventional (twice daily) and continuous infusion (CI) modes of administration... CONCLUSIONS: Temocillin (4 g/day) by CI yields stable free serum concentrations above the current breakpoint (16 mg/L), although individual variations may suggest lowering the breakpoint to 8 mg/L (as for twice daily) unless the daily dose or the frequency of administration is increased.

Comparison of oral amoxicillin and intravenous benzyl penicillin for community acquired pneumonia in children (PIVOT trial): a multicentre pragmatic randomised controlled equivalence trial. [2007.12]
OBJECTIVE: To ascertain whether therapeutic equivalence exists for the treatment of paediatric community acquired pneumonia by the oral and intravenous (IV) routes... CONCLUSION: Oral amoxicillin is effective for most children admitted to hospital with pneumonia (all but those with the most severe disease who were excluded from this study). Prior to this study, the British Thoracic Society guidelines on childhood pneumonia could not draw on evidence to address this issue. This will spare children and their families the trauma and pain of cannulation, and children will spend less time in hospital.

more studies >>

Clinical Trials Related to Permapen (Penicillin)

Bicillin L-A vs Placebo for the Treatment of Chronic, Plaque-Type Psoriasis Unresponsive to Topical Medications [Recruiting]
The purpose of this study is to determine the efficacy for Bicillin L-A, administered intramuscularly in a dose of 2. 4 million units every three (3) weeks, for the treatment of chronic, plaque-type psoriasis unresponsive to topical medications or when other systemic therapies are contraindicated.

A Pilot Study Evaluating Penicillin G and Ceftriaxone as Therapies for Presumed Neurosyphilis in HIV Seropositive Individuals [Completed]
To provide information on the response of HIV infected, neurosyphilis patients to the currently recommended treatment for neurosyphilis; to determine whether possible co-infection with both HIV and syphilis makes more difficult the diagnosis of syphilis; to explore the usefulness of an alternative treatment which, if effective, would permit outpatient treatment for neurosyphilis that until now required prolonged hospitalization.

Studies suggest that syphilis treatment failures may be more common in HIV infected patients than in patients without HIV infection and that treatment failures occur due to and/or are displayed as central nervous system (CNS) involvement. Very little is known about the best treatment course for neurosyphilis in patients who are also infected with HIV.

Azithromycin/Bicillin Syphilis [Active, not recruiting]
The purpose of this study is to determine if Azithromycin, a drug approved for treatment of other infections, is as affective for syphilis therapy is as the usual treatment. Approximately 600 healthy adults, who are HIV-negative, age 18 to 55 years of age with primary, secondary or early latent syphilis, will be participating in this research study. Volunteers will be enrolled in 4 cities of the United States and in Madagascar. Participants will be chosen randomly (by chance) to receive one of 2 study drugs: Benzathine Penicillin given as one dose (2 shots in the buttocks) or 4 tablets of Azithromycin. Over 2 years, 10 visits are required. Procedures will include blood samples, physical exam, and swabs of sores. For subjects who report history of Penicillin allergy will be given either 2. 0 g of oral Azithromycin or 100 mg Doxycycline taken orally, twice a day for 14 days.

Efficacy Study of Community-Based Treatment of Serious Bacterial Infections in Young Infants [Active, not recruiting]
Approximately one-third of neonatal deaths in developing countries are due to infections acquired through the birth canal and/or exposure to an unclean environment soon after birth. Current World Health Organization recommendations for the management of infants younger than 2 months of age who have serious bacterial infections involve hospitalization and parenteral therapy for at least 10 days with antibiotic regimens containing penicillin or ampicillin combined with an aminoglycoside. However, in many settings throughout the developing world, this is not currently possible, nor is this standard of care likely to be feasible in the near future. Several studies have reported that for a variety of sociocultural reasons many families are unable or unwilling to access hospital-based care and their sick young infants do not get hospitalized, and instead, receive a variety of home-based antibiotic therapies, or none at all. In our community field sites, approximately 70% of families refuse hospital referral for a sick newborn, despite provision of transport.

Thus, there is an urgent need to define the role of community/first-level facility-based care versus hospitalization for the management of young infants with serious bacterial infections, and the potential for community-based parenteral antibiotics as an alternative strategy in resource poor areas with high neonatal mortality rates. Bang and colleagues have demonstrated significant reductions in neonatal mortality from infections in an underdeveloped rural district in Maharashtra, India by a field-based case management approach which used oral cotrimoxazole and intramuscular gentamicin given for 7 days as treatment for neonates with sepsis.

This study is an equivalence randomized controlled trial (RCT) comparing once daily IM ceftriaxone injection to once daily IM procaine penicillin and gentamicin injection, to once daily intramuscular gentamicin injection and twice daily oral cotrimoxazole, given for 7 days in babies with clinically-diagnosed possible serious bacterial infection (pneumonia, or sepsis with or without local infections such as skin or umbilical infections) whose families refused referral to a hospital. After supplementary informed consent, patients meeting specific inclusion and exclusion criteria are randomly allocated to one of the three regimens being tested. The study hypothesis is that all 3 regimens will perform equally well in the treatment of sepsis in a first-level facility setting.

Management of Early Onset Neonatal Septicaemia: Selection of Optimal Antibacterial Regimen for Empiric Treatment [Completed]
A prospective two-center antibiotic regimen switch study will be conducted to compare the

clinical efficacy of two antibiotic regimens - penicillin/gentamicin versus

ampicillin/gentamicin - in the empirical treatment of early onset neonatal sepsis. The

influence of either regimen on bowel colonization pattern and on the development of antibiotic resistance of gut microflora will also be assessed. The primary endpoint is the need for a change in antibacterial treatment within 72 hours of therapy, based on pre-defined criteria. Secondary endpoints will be the incidence rate and etiology of early and late onset neonatal sepsis and susceptibility pattern of causative microorganisms; mortality rate within 60 days; duration of hospitalization in NICU; duration of artificial ventilation; colonization pattern and susceptibility of colonizing bacteria (including resistance to empiric antibiotic regimen).

more trials >>

PATIENT REVIEWS / RATINGS / COMMENTS

Permapen review by 56 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Extremely Severe Side Effects
		Treatment Info
Condition / reason:		tooth infection
Dosage & duration:		500mg taken twice a day for the period of 2 days
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		the pain in my tooth started to subside
Side effects:		I went into shock. My tongue swelled up, my face got very swollen. My heart was racing and I started to sweat something terrible. I was told that I was lucky not to die from taking this medication.
Comments:		I was rushed to the doctors office and given another drug to counter the effects of the penicillin. I was sick from the whole episode for a very long time. I am never suppose to take penicillin again or any drug that is a derivative of penicillin.