UNASYN
Generic: AMPICILLIN SODIUM AND SULBACTAM SODIUM
Basic Information
Manufacturer
Roerig
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAMUSCULAR
FDA Set ID
155c7ec0-5862-404f-b1d0-f278f8a8bbda
Indications & Usage
INDICATIONS AND USAGE UNASYN 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 , Efficacy for this organism in this organ system was studied in fewer than 10 infections.
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 ).
While UNASYN is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with UNASYN due to its ampicillin content.
Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to UNASYN should not require the addition of another antibacterial.
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 UNASYN.
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 UNASYN and other antibacterial drugs, UNASYN should be used only to treat 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.
Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus , Escherichia coli , Efficacy for this organism in this organ system was studied in fewer than 10 infections.
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 ).
While UNASYN is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with UNASYN due to its ampicillin content.
Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to UNASYN should not require the addition of another antibacterial.
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 UNASYN.
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 UNASYN and other antibacterial drugs, UNASYN should be used only to treat 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.
Warnings
WARNINGS Hypersensitivity 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, UNASYN should be discontinued and the appropriate therapy instituted.
Hepatotoxicity Hepatic dysfunction, including hepatitis and cholestatic jaundice has been associated with the use of UNASYN.
Hepatic toxicity is usually reversible; however, deaths have been reported.
Hepatic function should be monitored at regular intervals in patients with hepatic impairment.
Severe Cutaneous Adverse Reactions UNASYN may cause severe skin reactions, such as toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS), dermatitis exfoliative, erythema multiforme, and Acute generalized exanthematous pustulosis (AGEP).
If patients develop a skin rash they should be monitored closely and UNASYN discontinued if lesions progress (see CONTRAINDICATIONS and ADVERSE REACTIONS sections).
Clostridioides difficile -Associated Diarrhea Clostridioides difficile -associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including UNASYN, 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 antibacterial drug 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 antibacterial drug use not directed against C.
difficile may need to be discontinued.
Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C.
difficile , and surgical evaluation should be instituted as clinically indicated.
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, UNASYN should be discontinued and the appropriate therapy instituted.
Hepatotoxicity Hepatic dysfunction, including hepatitis and cholestatic jaundice has been associated with the use of UNASYN.
Hepatic toxicity is usually reversible; however, deaths have been reported.
Hepatic function should be monitored at regular intervals in patients with hepatic impairment.
Severe Cutaneous Adverse Reactions UNASYN may cause severe skin reactions, such as toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS), dermatitis exfoliative, erythema multiforme, and Acute generalized exanthematous pustulosis (AGEP).
If patients develop a skin rash they should be monitored closely and UNASYN discontinued if lesions progress (see CONTRAINDICATIONS and ADVERSE REACTIONS sections).
Clostridioides difficile -Associated Diarrhea Clostridioides difficile -associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including UNASYN, 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 antibacterial drug 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 antibacterial drug use not directed against C.
difficile may need to be discontinued.
Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C.
difficile , and surgical evaluation should be instituted as clinically indicated.
Adverse Reactions
ADVERSE REACTIONS Adult Patients UNASYN is generally well tolerated.
The following adverse reactions have been reported in clinical trials.
Local Adverse Reactions Pain at IM injection site – 16% Pain at IV injection site – 3% Thrombophlebitis – 3% Phlebitis – 1.2% 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 UNASYN demonstrate a similar adverse events profile to those observed in adult patients.
Additionally, atypical lymphocytosis has been observed in one pediatric patient receiving UNASYN.
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.
Post-marketing Experience In addition to adverse reactions reported from clinical trials, the following have been identified during post-marketing use of ampicillin sodium and sulbactam sodium or other products containing ampicillin.
Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made.
These events have been chosen for inclusion due to a combination of their seriousness, frequency, or potential causal connection to ampicillin sodium and sulbactam sodium.
Infections and Infestations: Clostridioides difficile -associated diarrhea (see WARNINGS section).
Blood and Lymphatic System Disorders: Hemolytic anemia, thrombocytopenic purpura, and agranulocytosis have been reported.
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 UNASYN, as with other beta-lactam antibacterials.
Gastrointestinal Disorders: Abdominal pain, cholestatic hepatitis, cholestasis, hyperbilirubinemia, jaundice, abnormal hepatic function, melena, gastritis, stomatitis, dyspepsia, and black "hairy" tongue (see CONTRAINDICATIONS and WARNINGS sections).
General Disorders and Administration Site Conditions: Injection site reaction Immune System Disorders: Serious and fatal hypersensitivity (anaphylactic) reactions (see WARNINGS section), Acute myocardial ischemia with or without myocardial infarction may occur as part of an allergic reaction.
Metabolism and Nutrition Disorders: Hypokalemia Nervous System Disorders: Convulsion and dizziness Renal and Urinary Disorders: Tubulointerstitial nephritis Musculoskeletal and Connective Tissue Disorders: Arthralgia Respiratory, Thoracic and Mediastinal Disorders: Dyspnea Skin and Subcutaneous Tissue Disorders: Toxic epidermal necrolysis, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), angioedema, Acute generalized exanthematous pustulosis (AGEP), erythema multiforme, exfoliative dermatitis, urticaria (see CONTRAINDICATIONS and WARNINGS sections), and linear IgA bullous dermatosis.
The following adverse reactions have been reported in clinical trials.
Local Adverse Reactions Pain at IM injection site – 16% Pain at IV injection site – 3% Thrombophlebitis – 3% Phlebitis – 1.2% 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 UNASYN demonstrate a similar adverse events profile to those observed in adult patients.
Additionally, atypical lymphocytosis has been observed in one pediatric patient receiving UNASYN.
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.
Post-marketing Experience In addition to adverse reactions reported from clinical trials, the following have been identified during post-marketing use of ampicillin sodium and sulbactam sodium or other products containing ampicillin.
Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made.
These events have been chosen for inclusion due to a combination of their seriousness, frequency, or potential causal connection to ampicillin sodium and sulbactam sodium.
Infections and Infestations: Clostridioides difficile -associated diarrhea (see WARNINGS section).
Blood and Lymphatic System Disorders: Hemolytic anemia, thrombocytopenic purpura, and agranulocytosis have been reported.
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 UNASYN, as with other beta-lactam antibacterials.
Gastrointestinal Disorders: Abdominal pain, cholestatic hepatitis, cholestasis, hyperbilirubinemia, jaundice, abnormal hepatic function, melena, gastritis, stomatitis, dyspepsia, and black "hairy" tongue (see CONTRAINDICATIONS and WARNINGS sections).
General Disorders and Administration Site Conditions: Injection site reaction Immune System Disorders: Serious and fatal hypersensitivity (anaphylactic) reactions (see WARNINGS section), Acute myocardial ischemia with or without myocardial infarction may occur as part of an allergic reaction.
Metabolism and Nutrition Disorders: Hypokalemia Nervous System Disorders: Convulsion and dizziness Renal and Urinary Disorders: Tubulointerstitial nephritis Musculoskeletal and Connective Tissue Disorders: Arthralgia Respiratory, Thoracic and Mediastinal Disorders: Dyspnea Skin and Subcutaneous Tissue Disorders: Toxic epidermal necrolysis, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), angioedema, Acute generalized exanthematous pustulosis (AGEP), erythema multiforme, exfoliative dermatitis, urticaria (see CONTRAINDICATIONS and WARNINGS sections), and linear IgA bullous dermatosis.