Ampicillin for Injection, USP
Ampicillin for Injection, USP the monosodium salt of [2S-[2α,5α,6β(S*)]]-6-[(aminophenylacetyl)amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2. 0]heptane-2-carboxylic acid, is a synthetic penicillin. It is an antibacterial agent with a broad spectrum of bactericidal activity against both penicillin-susceptible Gram-positive organisms and many common Gram-negative pathogens.
Ampicillin for Injection, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions:
Respiratory tract Infections caused by S. pneumoniae (formerly D. pneumoniae). Staphylococcus aureus (penicillinase and nonpenicillinase-producing), H. influenzae, and Group A beta-hemolytic Streptococci.
Bacterial Meningitis caused by E. coli, Group B Streptococci, and other Gram-negative bacteria (Listeria monocytogenes, N. meningitidis). The addition of an aminoglycoside with ampicillin may increase its effectiveness against Gram-negative bacteria.
Septicemia and Endocarditis caused by susceptible Gram-positive organisms including Streptococcus sp., penicillin G-susceptible staphylococci, and enterococci. Gram-negative sepsis caused by E. coli, Proteus mirabilis and Salmonella sp. respond to ampicillin. Endocarditis due to enterococcal strains usually respond to intravenous therapy. The addition of an aminoglycoside may enhance the effectiveness of ampicillin when treating streptoccoccal endocarditis.
Urinary Tract Infections caused by sensitve strains of E. coli and Proteus mirabilis.
Gastrointestinal Infections caused by Salmonella typhosa (typhoid fever), other Salmonella sp., and Shigella sp. (dysentery) usually respond to oral or intravenous therapy.
Bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed. Therapy may be instituted prior to obtaining results of susceptibility testing.
It is advisable to reserve the parenteral form of this drug for moderately severe and severe infections and for patients who are unable to take the oral forms. A change to oral ampicillin may be made as soon as appropriate.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of AMPICILLIN and other antibacterial drugs, AMPICILLIN 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.
Indicated surgical procedures should be performed.
Published Studies Related to Ampicillin
A prospective, multi centre, randomized clinical study to compare the efficacy and safety of Ertapenem 3 days versus Ampicillin-Sulbactam 3 days in the treatment of localized community acquired intra-abdominal infection. (T.E.A. Study: Three days Ertapenem vs three days Ampicillin-sulbactam). [2011.04.18]
BACKGROUND: The recommendations outlined in the latest guidelines published by the Surgical Infection Society (SIS) and the Infectious Disease Society of America (IDSA) regarding the proper duration of antibiotic therapy in patients with intra-abdominal infections are limited and non-specific.
Ampicillin/sulbactam versus cefuroxime as antimicrobial prophylaxis for cesarean delivery: a randomized study. [2010.11.30]
BACKGROUND: The efficacy and safety of a single dose of ampicillin/sulbactam compared to a single dose of cefuroxime at cord clamp for prevention of post-cesarean infectious morbidity has not been assessed... CONCLUSIONS: Ampicillin/sulbactam was as safe and effective as cefuroxime when administered for the prevention of infections following cesarean delivery. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT01138852.
Comparison of ampicillin plus gentamicin vs. penicillin plus gentamicin in empiric treatment of neonates at risk of early onset sepsis. [2010.05]
AIM: We aimed to compare the clinical efficacy of ampicillin (AMP) vs. penicillin (PEN) both combined with gentamicin in the empirical treatment of neonates at risk of early onset neonatal sepsis (EOS)... CONCLUSIONS: AMP and PEN combined with gentamicin have similar effectiveness in the empiric treatment of suspected neonatal EOS.
Pharmacokinetic properties and bioequivalence of two compound formulations of 1500 mg ampicillin (1167 mg)/probenecid (333 mg): a randomized-sequence, single-dose, open-label, two-period crossover study in healthy Chinese male volunteers. [2010.03]
BACKGROUND: Ampicillin/probenecid is an antimicrobial formulation indicated for the treatment of respiratory, urinary tract, and gastrointestinal infections. Ampicillin sodium is the active antimicrobial ingredient that can act on the phase of bacterial breeding and inhibit the biosynthesis of bacterial mucopeptide in the cell wall. Probenecid acts synergistically by competitively inhibiting an organic anion transporter in renal tubules, increasing the plasma concentrations, and thus extending the plasma elimination t(1/2). OBJECTIVE: The aim of this study was to assess and compare the pharmacokinetic (PK) properties, bioavailability, and bioequivalence of a newly developed dispersible tablet formulation (test) of ampicillin/ probenecid with those of an established branded capsule formulation (reference) in healthy Chinese male volunteers... CONCLUSIONS: In this small study in healthy Chinese male volunteers, a single 1500-mg dose of the dispersible tablet formulation (test) of ampicillin/probenecid met the SFDA's regulatory criteria for bioequivalence to the reference capsule formulation based on the rate and extent of absorption. Both formulations were well tolerated. Copyright 2010 Excerpta Medica Inc. All rights reserved.
P1A recombinant beta-lactamase prevents emergence of antimicrobial resistance in gut microflora of healthy subjects during intravenous administration of ampicillin. [2009.06]
Ipsat P1A is a recombinant beta-lactamase which degrades antibiotic residue in the gastrointestinal tract. In an open-label, single-center controlled trial, 36 healthy subjects were randomized to receive (i) ampicillin (1 g intravenously [i.v.] every 6 h [q6h]), (ii) oral P1A recombinant beta-lactamase (8.2 mg q6h), or (iii) ampicillin (1 g i.v...
Clinical Trials Related to Ampicillin
Comparison of Ampicillin / Sulbactam vs. Ampicillin / Gentamicin for Treatment of Intrapartum Chorioamnionitis: a Randomized Controlled Trial [Recruiting]
Chorioamnionitis is an infection of the placenta and amniotic membranes (bag of waters)
surrounding the baby inside of a pregnant woman prior to delivery. This infection is
somewhat common and is routinely treated with antibiotics given to the mother both before
and after the baby is born. Currently it is not known what is the best choice of antibiotics
to treat this type of infection, but commonly used treatments include Unasyn
(ampicillin/sulbactam) or ampicillin/gentamicin. We plan to compare these two different
antibiotic regimens to see if one is better than the other at treating and preventing bad
outcomes from chorioamnionitis in women and babies.
Zithromax EV in Community-Acquired Pneumonia (CAP) [Completed]
The intravenous (IV) regimen containing azithromycin (Zithromax) plus ampicillin-sulbactam is
consistent with current guidelines for the treatment of CAP. In fact the International
guidelines for the treatment of CAP in hospitalised patients suggests the use of a
combination between a b-lactam and a macrolide.
This trial will allow investigators to evaluate the efficacy of azithromycin plus
ampicillin-sulbactam in the treatment of hospitalized subjects with community acquired
pneumonia. In addition, this trial will allow investigators to evaluate the safety and
toleration of combination therapy.
A Comparative Study of Ampicillin/Sulbactam Versus Moxifloxacin in the Treatment of Complicated Intra-abdominal Infections [Recruiting]
On the basis of monotherapy for intra-abdominal infection, the investigators are conducting
this study to identify the difference of drug efficacy between ampicillin/sulbactam and
T.E.A. Study Three Days Ertapenem Versus Three Days Ampicillin- Sulbactam [Recruiting]
The aim of the study was to compare the activity (efficacy and safety) of Ertapenem
administered according to a short treatment for three days versus a short treatment for
three days with AS in patients with an community acquired IAI of mild to moderate severity.
The Efficacy of Prophylactic Antibiotic Administration During Breast Cancer Surgery in Overweight Patients. [Recruiting]
This is a single center trial to compare the rate of surgical site infection in normal (BMI
equal to or less than 25) and overweight (BMI over 25) women who are undergoing breast
cancer surgery. The overweight patients are further randomized into two groups; in one group
patients receive prophylactic antibiotics (ampicillin/sulbactam), in the other they do not.
Reports of Suspected Ampicillin Side Effects
Drug Rash With Eosinophilia and Systemic Symptoms (21),
Jarisch-Herxheimer Reaction (10),
Drug Hypersensitivity (10),
Rash Maculo-Papular (7),
Maternal Exposure During Pregnancy (5),
Encephalopathy (5), more >>
PATIENT REVIEWS / RATINGS / COMMENTS
Based on a total of 2 ratings/reviews, Ampicillin has an overall score of 8.50. The effectiveness score is 9 and the side effect score is 10. The scores are on ten point scale: 10 - best, 1 - worst.
Ampicillin review by 42 year old male patient
|Overall rating:|| || |
|Effectiveness:|| || Highly Effective|
|Side effects:|| || No Side Effects|
|Condition / reason:|| || Eye infection|
|Dosage & duration:|| || two pills taken twice a day for the period of 15 days|
|Other conditions:|| || None|
|Other drugs taken:|| || None|
|Benefits:|| || The eye infection symptoms went away in about two days. My eye had been swollen shut. I had tried some over the counter with no results when I visited the doctor. He hesitated using it due to misuse from patients however my symptoms were so severe he made it happen for me.|
|Side effects:|| || I had no side effects with this treatment.|
|Comments:|| || Visit to the doctor. Diagnosis estimate made. Prescription made and finally cure happened.|
Ampicillin review by care giver of 16 year old male patient
|Overall rating:|| || |
|Effectiveness:|| || Considerably Effective|
|Side effects:|| || No Side Effects|
|Condition / reason:|| || Acne|
|Dosage & duration:|| || 500 mg taken twice daily for the period of more than a year|
|Other conditions:|| || none|
|Other drugs taken:|| || none|
|Benefits:|| || When he first started using the medication we saw remarkable results. As time has gone by the results don't get any better, but it does keep his flare ups to a minimum and he doesn't ever have the big painful sores.
|Side effects:|| || Have not experienced any side effects, except the plateau in visible results.|
|Comments:|| || He takes a capsule in the morning and one at night. Along with the medication he is faithful to wash his face twice a day with basis soap.|
Page last updated: 2011-12-09