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Overview
Ampicillin sodium and sulbactam sodium is a antibiotic that is FDA approved for the treatment of beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli*, Klebsiella spp.* (including K. pneumoniae*), Proteus mirabilis*, Bacteroides fragilis*, Enterobacter spp.*, and Acinetobacter calcoaceticus. Common adverse reactions include diarrhea.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Ampicillin and sulbactam for injection is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below.
Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli*, Klebsiella spp.* (including K. pneumoniae*), Proteus mirabilis*, Bacteroides fragilis*, Enterobacter spp.*, and Acinetobacter calcoaceticus*.
NOTE: For information on use in pediatric patients see PRECAUTIONS-PEDIATRIC USE and CLINICAL STUDIES sections.
Intra-Abdominal Infections caused by beta-lactamase producing strains of Escherichia coli, Klebsiella spp. (including K. pneumoniae*), Bacteroides spp. (including B. fragilis), and Enterobacter spp.*.
Gynecological Infections caused by beta-lactamase producing strains of Escherichia coli*, and Bacteroides spp.* (including B. fragilis*).
Efficacy for this organism in this organ system was studied in fewer than 10 infections.
While ampicillin and sulbactam for injection is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with ampicillin and sulbactam for injection due to its ampicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to ampicillin and sulbactam for injection should not require the addition of another antibiotic.
Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to ampicillin and sulbactam for injection.
Therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies, when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above in the indicated organ systems. Once the results are known, therapy should be adjusted if appropriate.
To reduce the development of drug-resistant bacteria and maintain effectiveness of ampicillin and sulbactam for injection and other antibacterial drugs, ampicillin and sulbactam 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 and sulbactam for injection may be administered by either the IV or the IM routes.
For IV administration, the dose can be given by slow intravenous injection over at least 10-15 minutes or can also be delivered, in greater dilutions with 50-100 mL of a compatible diluent as an intravenous infusion over 15-30 minutes.
Ampicillin and sulbactam for injection may be administered by deep intramuscular injection. (See PREPARATION FOR INTRAMUSCULAR INJECTION.)
The recommended adult dosage of ampicillin and sulbactam for injection is 1.5 g (1 g ampicillin as the sodium salt plus 0.5 g sulbactam as the sodium salt) to 3 g (2 g ampicillin as the sodium salt plus 1 g sulbactam as the sodium salt) every six hours. This 1.5 to 3 g range represents the total of ampicillin content plus the sulbactam content of ampicillin and sulbactam for injection, and corresponds to a range of 1 g ampicillin/0.5 g sulbactam to 2 g ampicillin/1 g sulbactam. The total dose of sulbactam should not exceed 4 grams per day.
Pediatric Patients 1 Year of Age or Older:
The recommended daily dose of ampicillin and sulbactam for injection in pediatric patients is 300 mg per kg of body weight administered via intravenous infusion in equally divided doses every 6 hours. This 300 mg/kg/day dosage represents the total ampicillin content plus the sulbactam content of ampicillin and sulbactam for injection, and corresponds to 200 mg ampicillin/100 mg sulbactam per kg per day. The safety and efficacy of ampicillin and sulbactam for injection administered via intramuscular injection in pediatric patients have not been established. Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations, and the total dose of sulbactam should not exceed 4 grams per day. The course of intravenous therapy should not routinely exceed 14 days. In clinical trials, most children received a course of oral antimicrobials following initial treatment with intravenous ampicillin and sulbactam for injection. (See CLINICAL STUDIES section.)
Impaired Renal Function
In patients with impairment of renal function the elimination kinetics of ampicillin and sulbactam are similarly affected, hence the ratio of one to the other will remain constant whatever the renal function. The dose of ampicillin and sulbactam for injection in such patients should be administered less frequently in accordance with the usual practice for ampicillin and according to the following recommendations:
There is limited information regarding Ampicillin sodium and sulbactam sodium FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Ampicillin sodium and sulbactam sodium in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Ampicillin sodium and sulbactam sodium in pediatric patients.
Contraindications
The use of ampicillin and sulbactam for injection is contraindicated in individuals with a history of hypersensitivity reactions to any of the penicillins.
Warnings
SERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVITY (ANAPHYLACTIC) REACTIONS HAVE BEEN REPORTED IN PATIENTS ON PENICILLIN THERAPY. THESE REACTIONS ARE MORE APT TO OCCUR IN INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY AND/OR HYPERSENSITIVITY REACTIONS TO MULTIPLE ALLERGENS. THERE HAVE BEEN REPORTS OF INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY WHO HAVE EXPERIENCED SEVERE REACTIONS WHEN TREATED WITH CEPHALOSPORINS. BEFORE THERAPY WITH A PENICILLIN, CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO PENICILLINS, CEPHALOSPORINS, AND OTHER ALLERGENS. IF AN ALLERGIC REACTION OCCURS, AMPICILLIN AND SULBACTAM FOR INJECTION SHOULD BE DISCONTINUED AND THE 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 and sulbactam 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 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 C. difficile, and surgical evaluation should be instituted as clinically indicated.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Ampicillin sodium and sulbactam sodium Clinical Trials Experience in the drug label.
Postmarketing Experience
Adult Patients:
Ampicillin and sulbactam for injection is generally well tolerated. The following adverse reactions have been reported.
Local Adverse Reactions
Pain at IM injection site - 16%
Pain at IV injection site - 3%
Thrombophlebitis - 3%
Systemic Adverse Reactions
The most frequently reported adverse reactions were diarrhea in 3% of the patients and rash in less than 2% of the patients.
Additional systemic reactions reported in less than 1% of the patients were: itching, nausea, vomiting, candidiasis, fatigue, malaise, headache, chest pain, flatulence, abdominal distension, glossitis, urine retention, dysuria, edema, facial swelling, erythema, chills, tightness in throat, substernal pain, epistaxis and mucosal bleeding.
Pediatric Patients:
Available safety data for pediatric patients treated with ampicillin and sulbactam for injection demonstrate a similar adverse events profile to those observed in adult patients. Additionally, atypical lymphocytosis has been observed in one pediatric patient receiving ampicillin and sulbactam for injection.
Adverse Laboratory Changes
Adverse laboratory changes without regard to drug relationship that were reported during clinical trials were:
Hepatic: Increased AST (SGOT), ALT (SGPT), alkaline phosphatase, and LDH.
Hematologic: Decreased hemoglobin, hematocrit, RBC, WBC, neutrophils, lymphocytes, platelets and increased lymphocytes, monocytes, basophils, eosinophils, and platelets.
Blood Chemistry: Decreased serum albumin and total proteins.
Renal: Increased BUN and creatinine.
Urinalysis: Presence of RBC's and hyaline casts in urine.
The following adverse reactions have been reported with ampicillin-class antibiotics and can also occur with ampicillin and sulbactam for injection.
Gastrointestinal:
Gastritis, stomatitis, black "hairy" tongue and enterocolitis. Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment. (See WARNINGS.)
Hypersensitivity Reactions:
Urticaria, erythema multiforme, and an occasional case of exfoliative dermatitis have been reported. These reactions may be controlled with antihistamines and, if necessary, systemic corticosteroids. Whenever such reactions occur, the drug should be discontinued, unless the opinion of the physician dictates otherwise. Serious and occasional fatal hypersensitivity (anaphylactic) reactions can occur with a penicillin. (See WARNINGS.)
Hematologic:
In addition to the adverse laboratory changes listed above for ampicillin and sulbactam for injection, agranulocytosis has been reported during therapy with penicillins. All of these reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena. Some individuals have developed positive direct Coombs Tests during treatment with ampicillin and sulbactam for injection, as with other beta-lactam antibiotics.
Drug Interactions
There is limited information regarding Ampicillin sodium and sulbactam sodium Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Ampicillin sodium and sulbactam sodium in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Ampicillin sodium and sulbactam sodium in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Ampicillin sodium and sulbactam sodium during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Ampicillin sodium and sulbactam sodium in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Ampicillin sodium and sulbactam sodium in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Ampicillin sodium and sulbactam sodium in geriatric settings.
Gender
There is no FDA guidance on the use of Ampicillin sodium and sulbactam sodium with respect to specific gender populations.
Race
There is no FDA guidance on the use of Ampicillin sodium and sulbactam sodium with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Ampicillin sodium and sulbactam sodium in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Ampicillin sodium and sulbactam sodium in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Ampicillin sodium and sulbactam sodium in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Ampicillin sodium and sulbactam sodium in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Ampicillin sodium and sulbactam sodium Administration in the drug label.
Monitoring
There is limited information regarding Ampicillin sodium and sulbactam sodium Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Ampicillin sodium and sulbactam sodium and IV administrations.
Overdosage
There is limited information regarding Ampicillin sodium and sulbactam sodium overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Ampicillin sodium and sulbactam sodium Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Ampicillin sodium and sulbactam sodium Mechanism of Action in the drug label.
Structure
There is limited information regarding Ampicillin sodium and sulbactam sodium Structure in the drug label.
Pharmacodynamics
There is limited information regarding Ampicillin sodium and sulbactam sodium Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Ampicillin sodium and sulbactam sodium Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Ampicillin sodium and sulbactam sodium Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Ampicillin sodium and sulbactam sodium Clinical Studies in the drug label.
How Supplied
There is limited information regarding Ampicillin sodium and sulbactam sodium How Supplied in the drug label.
Storage
There is limited information regarding Ampicillin sodium and sulbactam sodium Storage in the drug label.
Images
Drug Images
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There is limited information regarding Ampicillin sodium and sulbactam sodium Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Ampicillin sodium and sulbactam sodium interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Ampicillin sodium and sulbactam sodium Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Ampicillin sodium and sulbactam sodium Look-Alike Drug Names in the drug label.
