Ampicillin (injection): Difference between revisions

Ampicillin (injection)
	Adult Indications & Dosage
	Pediatric Indications & Dosage
	Contraindications
	Warnings & Precautions
	Adverse Reactions
	Drug Interactions
	Use in Specific Populations
	Administration & Monitoring
	Overdosage
	Pharmacology
	Clinical Studies
	How Supplied
	Images
	Patient Counseling Information
	Precautions with Alcohol
	Brand Names
	Look-Alike Names

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Revision as of 22:42, 8 December 2014

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ammu Susheela, M.D. [2]

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Overview

Ampicillin (injection) is a 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, 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

There is limited information regarding Off-Label Guideline-Supported Use of Ampicillin (injection) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Ampicillin (injection) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1

Dosing Information

Dosage

Condition2

There is limited information regarding FDA-Labeled Use of Ampicillin (injection) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

Developed by:

Class of Recommendation:

Strength of Evidence:

Dosing Information

Dosage

Condition2

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

Non–Guideline-Supported Use

Condition1

Dosing Information

Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-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

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

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

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

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

Drug

Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

Pregnancy Category

Pregnancy Category (AUS):

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

Oral

Intravenous

Monitoring

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

Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

Description

Management

Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Ampicillin (injection) in the drug label.

Pharmacology

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

Mechanism of Action

Structure

File:Ampicillin (injection)01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

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

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

Storage

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

Images

Drug Images

{{#ask: Page Name::Ampicillin (injection) |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Ampicillin (injection) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

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

®^[1]

Look-Alike Drug Names

A® — B®^[2]

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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[1] Empty citation (help)

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[1]

[2]

@@ Line 27: / Line 27: @@
 * 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.
-|offLabelAdultGuideSupport=
+|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
+|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
-There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
-|offLabelAdultNoGuideSupport=
-There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
 |fdaLIADPed======Condition1=====
@@ Line 79: / Line 70: @@
 <!--Contraindications-->
-|contraindications=* Condition1
+|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.
-<!--Warnings-->
+* 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]].
-|warnings=* Description
+* 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.
-====Precautions====
+* 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.
-* Description
+* 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.
-<!--Adverse Reactions-->
+* 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.
-<!--Clinical Trials Experience-->
 |clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.