Ampicillin Information
Ampicillin ()
Ampicillin () Description
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.
It has the following chemical structure:
The molecular formula is CHNNaOS, and the molecular weight is 371.39. Ampicillin () for Injection, USP contains 2.9 milliequivalents of sodium per 1 gram of drug.
Ampicillin () Clinical Pharmacology
Ampicillin () for Injection, USP 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 () for Injection, USP is well tolerated by most patients and has been given in doses of 2 grams daily for many weeks without adverse reactions.
While studies have demonstrated the susceptibility of most strains of the following organisms, clinical efficacy for infections other than those included in the section has not been demonstrated.
The following bacteria have been shown in studies to be susceptible to Ampicillin () for Injection, USP:
GRAM-POSITIVE ORGANISMS: Hemolytic and nonhemolytic streptococci, nonpenicillinase-producing staphylococci, spp., and most strains of enterococci.
GRAM-NEGATIVE ORGANISMS: and many strains of Salmonella, Shigella, and
Ampicillin () does not resist destruction by penicillinase.
Ampicillin () Indications And Usage
Ampicillin () for Injection, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions:
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 () for Injection, USP and other antibacterial drugs, Ampicillin () for Injection, USP 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.
Ampicillin () Contraindications
A history of a previous hypersensitivity reaction to any of the penicillins is a contraindication.
Ampicillin () 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.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of , and surgical evaluation should be instituted as clinically indicated.
Ampicillin () Precautions
The possibility of superinfections with mycotic organisms or bacterial pathogens should be kept in mind during therapy. In such cases, discontinue the drug and substitute appropriate treatment.
A high percentage (43 to 100 percent) of patients with infectious mononucleosis who receive Ampicillin () develop a skin rash. Typically, the rash appears 7 to 10 days after the start of oral Ampicillin () therapy and remains for a few days to a week after the drug is discontinued. In most cases, the rash is maculopapular, pruritic, and generalized. Therefore, the administration of Ampicillin () is not recommended in patients with mononucleosis. It is not known whether these patients are truly allergic to Ampicillin () .
Prescribing Ampicillin () for Injection, USP in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
Patients should be counseled that antibacterial drugs including Ampicillin () for Injection, USP should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Ampicillin () for Injection, USP is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may: (1) decrease the effectiveness of the immediate treatment, and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Ampicillin () for Injection, USP or other antibacterial drugs in the future.
Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.
As with any potent drug, periodic assessment of organ system function, including renal, hepatic, and hematopoietic, should be made during prolonged therapy.
Transient elevation of serum transaminase has been observed following administration of Ampicillin () . The significance of this finding is not known.
Ampicillin () Adverse Reactions
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 () :
Ampicillin () 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.
Ampicillin () Dosage And Administration
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 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
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.
Ampicillin () Directions For Use
Use only freshly prepared solutions. Intramuscular and intravenous injections should be administered within one hour after preparation since the potency may decrease significantly after this period.
While Ampicillin () for Injection, USP, 1 g and 2 g, are primarily for intravenous use, they may be administered intramusculary when the 250 mg or 500 mg vials are unavailable. In such instances, dissolve in 3.5 or 6.8 mL Sterile Water for Injection, USP, or Bacteriostatic Water for Injection, USP, respectively. The resulting solution will provide a concentration of 250 mg per mL.
Ampicillin () for Injection, USP, 125 mg, is intended primarily for pediatric use. It also serves as a convenient dosage form when small parenteral doses of the antibiotic are required.
Only those solutions listed above should be used for the intravenous infusion of Ampicillin () for injection, USP. The concentrations should fall within the range specified. The drug concentration and the rate and volume of the infusion should be adjusted so that the total dose of Ampicillin () is administered before the drug loses its stability in the solution in use.
Ampicillin () How Supplied
Ampicillin () for Injection, USP for IM or IV Injection. Ampicillin () sodium equivalent to 250, 500 mg, 1 gram Ampicillin () per vial.
NDC 26637-323-25 – 250 mg vial packaged in 10s
NDC 26637-322-50 – 500 mg vial packaged in 10s
NDC 26637-321-01 – 1 gram vial packaged in 10s
Ampicillin ()
Ampicillin () Mg Label
PUTNEY
NDC 26637-323-25
Ampicillin ()
For Injection, USP
250 mg
Rx only
FOR IM OR IV USE
Ampicillin () Mg Label
PUTNEY
NDC 26637-322-50
Ampicillin ()
For Injection, USP
500 mg
Rx only
FOR IM OR IV USE
Ampicillin () Gram Label
PUTNEY
NDC 26637-321-01
Ampicillin ()
For Injection, USP
1 gram
Rx only
FOR IM OR IV USE
