Ampicillin (injection)

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# Overview
Ampicillin (injection) is an antibiotic that is FDA approved for the treatment of respiratory tract infections, bacterial infections, septicemia, endocarditis, urinary tract infections, and gastrointestinal infections.   Common adverse reactions include anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, agranulocytosis,  hypersensitivity reactions, glossitis, and stomatitis.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)
- To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ampicillin for Injection and other antibacterial drugs, Ampicillin for Injection 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.
- Ampicillin for Injection is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below:
- Respiratory Tract Infections caused by S. 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 streptococcal endocarditis.
- Urinary Tract Infections caused by sensitive 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.
- Indicated surgical procedures should be performed.

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
- Gonorrhea: single ORAL dose of 3.5 g in conjunction with 1 g probenecid
Infection of digestive system: 500 mg ORALLY every 6 hours.
- Infectious disease of genitourinary system: 500 mg ORALLY every 6 hours.
- Premature rupture of membranes: 2 g IV every 6 hours, with erythromycin 250 mg every 6 hours for 48 hours followed by amoxicillin 250 mg ORALLY every 8 hours and erythromycin base 333 mg every 8 hours for 5 days (study dose)  OR 1 g IV every 6 hours for 24 hours followed by 500 mg ORALLY every 6 hours until the patient returns for delivery, then ampicillin 1 g IV every 6 hours until delivery (study dose) 
- Respiratory tract infection: 250 mg ORALLY every 6 hours.

### NonGuideline-Supported Use
- Postoperative wound infection, topical use.
- Premature rupture of membranes.

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)
- Adults and children: 150 to 200 mg/kg/day in equally divided doses every 3 to 4 hours. (Treatment may be initiated with intravenous infusion therapy and continued with intramuscular injections.) The doses for other infections may be given by either the intravenous or intramuscular route.
- Adults and children: 150 to 200 mg/kg/day. Start with intravenous administration for at least 3 days and continue with the intramuscular route every 3 to 4 hours.

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
- Gonorrhea: (20 kg or less) 100 mg/kg/day ORALLY divided every 6 hours.
- Gonorrhea: (greater than 20 kg) single ORAL dose of 3.5 g in conjunction with 1 g probenecid.
- Infection of digestive system: (20 kg or less) 100 mg/kg/day ORALLY in divided doses every 6 hours.
- Infection of digestive system: (greater than 20 kg) 500 mg ORALLY every 6 hours
- Infectious disease of genitourinary system: (20 kg or less) 100 mg/kg/day ORALLY in divided doses every 6 hours.
- Infectious disease of genitourinary system: (greater than 20 kg) 500 mg ORALLY every 6 hours.
- Respiratory tract infection: 50 mg/kg/day ORALLY divided every 6 to 8 hours; MAX 1000 mg/day.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Ampicillin (injection) in pediatric patients.

# Contraindications
There is limited information regarding Ampicillin (injection) Contraindications in the drug label.

# Warnings
- Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy.
- Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. These reactions are more apt to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens.
- There have been well-documented reports of individuals with a history of penicillin hypersensitivity reactions who have experienced severe hypersensitivity reactions when treated with a cephalosporin.
- Before initiating therapy with a penicillin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, and other allergens. If an allergic reaction occurs, the drug should be discontinued and appropriate therapy instituted.
- SERIOUS ANAPHYLACTOID REACTIONS REQUIRE IMMEDIATE EMERGENCY TREATMENT WITH EPINEPHRINE.
- OXYGEN, INTRAVENOUS STEROIDS, AND AIRWAY MANAGEMENT, INCLUDING INTUBATION, SHOULD ALSO BE ADMINISTERED AS INDICATED.
- Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Ampicillin for Injection, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
- C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy.
- CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
- If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

# Adverse Reactions

## Clinical Trials Experience
- As with other penicillins, it may be expected that untoward reactions will be essentially limited to sensitivity phenomena. They are more likely to occur in individuals who have previously demonstrated hypersensitivity to penicillins and in those with a history of allergy, asthma, hay fever, or urticaria.
- The following adverse reactions have been reported as associated with the use of ampicillin.
- Glossitis, stomatitis, black "hairy" tongue, nausea, vomiting, enterocolitis, pseudomembranous colitis, and diarrhea. (These reactions are usually associated with oral dosage forms.)
- Skin rashes and urticaria have been reported frequently. A few cases of exfoliative dermatitis and erythema multiforme have been reported. Anaphylaxis is the most serious reaction experienced and has usually been associated with the parenteral dosage form. Note: Urticaria, other skin rashes, and serum sickness-like reactions may be controlled with antihistamines and, if necessary, systemic corticosteroids.
- Whenever such reactions occur, ampicillin should be discontinued, unless, in the opinion of the physician, the condition being treated is life-threatening and amenable only to ampicillin therapy. Serious anaphylactic reactions require the immediate use of epinephrine, oxygen, and intravenous steroids.
- A moderate rise in serum glutamic oxaloacetic transaminase (SGOT) has been noted, particularly in infants, but the significance of this finding is unknown. Mild transitory SGOT elevations have been observed in individuals receiving larger (two to four times) than usual and oft-repeated intramuscular injections. Evidence indicates that glutamic oxaloacetic transaminase (GOT) is released at the site of intramuscular injection of ampicillin and that the presence of increased amounts of this enzyme in the blood does not necessarily indicate liver involvement.
- Anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been reported during therapy with the penicillins. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena.

## Postmarketing Experience
There is limited information regarding Ampicillin (injection) Postmarketing Experience in the drug label.

# Drug Interactions
There is limited information regarding Ampicillin (injection) Drug Interactions in the drug label.

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA): B
- Pregnancy Category
Pregnancy Category (AUS): A
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Ampicillin (injection) in women who are pregnant.

### Labor and Delivery
There is no FDA guidance on use of Ampicillin (injection) during labor and delivery.

### Nursing Mothers
There is no FDA guidance on the use of Ampicillin (injection) with respect to nursing mothers.

### Pediatric Use
There is no FDA guidance on the use of Ampicillin (injection) with respect to pediatric patients.

### Geriatic Use
There is no FDA guidance on the use of Ampicillin (injection) with respect to geriatric patients.

### Gender
There is no FDA guidance on the use of Ampicillin (injection) with respect to specific gender populations.

### Race
There is no FDA guidance on the use of Ampicillin (injection) with respect to specific racial populations.

### Renal Impairment
There is no FDA guidance on the use of Ampicillin (injection) in patients with renal impairment.

### Hepatic Impairment
There is no FDA guidance on the use of Ampicillin (injection) in patients with hepatic impairment.

### Females of Reproductive Potential and Males
There is no FDA guidance on the use of Ampicillin (injection) in women of reproductive potentials and males.

### Immunocompromised Patients
There is no FDA guidance one the use of Ampicillin (injection) in patients who are immunocompromised.

# Administration and Monitoring

### Administration
- Intravenous

### Monitoring
- Infections of the respiratory tract and soft tissues.
- Patients weighing 40 kg (88 lbs) or more: 250 to 500 mg every 6 hours.
- Patients weighing less than 40 kg (88 lbs): 25 to 50 mg/kg/day in equally divided doses at 6 to 8 hour intervals.
- Infections of the gastrointestinal and genitourinary tracts (including those caused by Neisseria gonorrhoeae in females).
- Patients weighing 40 kg (88 lbs) or more: 500 mg every 6 hours.
- Patients weighing less than 40 kg (88 lbs): 50 mg/kg/day in equally divided doses at 6 to 8 hour intervals.
- In the treatment of chronic urinary tract and intestinal infections, frequent bacteriological and clinical appraisal is necessary. Smaller doses than those recommended above should not be used.
- Higher doses should be used for stubborn or severe infections. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.
- Urethritis in males due to N. gonorrhoeae.
- Adults: Two doses of 500 mg each at an interval of 8 to 12 hours. Treatment may be repeated if necessary or extended if required.
- In the treatment of complications of gonorrheal urethritis, such as prostatitis and epididymitis, prolonged and intensive therapy is recommended. Cases of gonorrhea with a suspected primary lesion of syphilis should have darkfield examinations before receiving treatment. In all other cases where concomitant syphilis is suspected, monthly serological tests should be made for a minimum of four months.
- The doses for the preceding infections may be given by either the intramuscular or intravenous route. A change to oral ampicillin may be made when appropriate.
- Adults and children: 150 to 200 mg/kg/day in equally divided doses every 3 to 4 hours. (Treatment may be initiated with intravenous infusion therapy and continued with intramuscular injections.) The doses for other infections may be given by either the intravenous or intramuscular route.
- Adults and children: 150 to 200 mg/kg/day. Start with intravenous administration for at least 3 days and continue with the intramuscular route every 3 to 4 hours.
- Treatment of all infections should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained.
- A minimum of 10-days treatment is recommended for any infection caused by Group A beta-hemolytic streptococci to help prevent the occurrence of acute rheumatic fever or acute glomerulonephritis.

# IV Compatibility
There is limited information regarding IV Compatibility of Ampicillin (injection) in the drug label.

# Overdosage
- In cases of overdose, discontinue medication, treat symptomatically and institute supportive measures as required. In patients with renal function impairment, ampicillin-class antibiotics can be removed by hemodialysis but not peritoneal dialysis.

# Pharmacology

## Mechanism of Action
- Belonging to the penicillin group of beta-lactam antibiotics, ampicillin is able to penetrate Gram-positive and some Gram-negative bacteria. It differs from penicillin G, or benzylpenicillin, only by the presence of an amino group. That amino group helps the drug penetrate the outer membrane of Gram-negative bacteria.
- Ampicillin inhibit the cell wall synthesis by irreversible inhibition of transpeptidase. Ampicillin acts during the binary fission at the third and final stage of cell wall synthesis. It is bacteriocidal.

## Structure
- Ampicillin for Injection, USP, the monosodium salt of D(-)-6-(2-amino-2-phenylacetamido)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo  heptane-2-carboxylate is a sterile synthetic penicillin for intramuscular or intravenous use. 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.
- It has the following structural formula:

## Pharmacodynamics
There is limited information regarding Pharmacodynamics of Ampicillin (injection) in the drug label.

## Pharmacokinetics
- Ampicillin diffuses readily into most body tissues and fluids. However, penetration into the cerebrospinal fluid and brain occurs only when the meninges are inflamed. - Ampicillin is excreted largely unchanged in the urine and its excretion can be delayed by concurrent administration of probenecid. The active form appears in the bile in higher concentrations than those found in serum.
- Ampicillin is the least serum-bound of all the penicillins, averaging about 20% compared to approximately 60 to 90% for other penicillins. Ampicillin is well tolerated by most patients and has been given in doses of 2 grams daily for many weeks without adverse reactions.
- While in vitro studies have demonstrated the susceptibility of most strains of the following organisms, clinical efficacy for infections.
- The following bacteria have been shown in in vitro studies to be susceptible to ampicillin:
- Hemolytic and nonhemolytic streptococci, S. pneumoniae (formerly D. pneumoniae), nonpenicillinase-producing staphylococci, Clostridia spp., B. anthracis, Listeria monocytogenes, and most strains of enterococci.
- H. influenzae, N. gonorrhoeae, N. meningitidis, Proteus mirabilis, and many strains of Salmonella, Shigella, and E. coli.
- Ampicillin does not resist destruction by penicillinase.
- Ampicillin Susceptibility Test Discs, 10 mcg, should be used to estimate the in vitro susceptibility of bacteria to ampicillin.

## Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Ampicillin (injection) in the drug label.

# Clinical Studies
There is limited information regarding Clinical Studies of Ampicillin (injection) in the drug label.

# How Supplied
- Ampicillin for Injection, USP for IM or IV Injection. Ampicillin sodium equivalent to 250, 500 mg, 1 or 2 grams of ampicillin per vial.

## Storage
- Store at 20 to 25C (68 to 77F) .
Vial stoppers do not contain natural rubber latex.

# Images

## Drug Images

## Package and Label Display Panel

# Patient Counseling Information
There is limited information regarding Patient Counseling Information of Ampicillin (injection) in the drug label.

# Precautions with Alcohol
- Alcohol-Ampicillin (injection) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

# Brand Names
AMPICILLIN 

# Look-Alike Drug Names
There is limited information regarding Ampicillin (injection) Look-Alike Drug Names in the drug label.

# Drug Shortage Status

# Price