pharmacopeia
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Mechanism of action

Sourced from openFDA

Mechanism-of-action class: beta Lactamase Inhibitors.

beta Lactamase

Indications

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  • 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.

Contraindications

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  • The use of ampicillin and sulbactam for injection is contraindicated in individuals with a history of serious hypersensitivity reactions (e.g., anaphylaxis or Stevens-Johnson syndrome) to ampicillin, sulbactam or to other beta-lactam antibacterial drugs (e.g., penicillins and cephalosporins). Ampicillin and sulbactam for injection is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with ampicillin and sulbactam for injection.contraindicated

Dosage & administration

Sourced from openFDA

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 DIRECTIONS FOR USE-Preparation for Intramuscular Injection section). 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.

Warnings & precautions

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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, ampicillin and sulbactam for injection should be discontinued and the appropriate therapy instituted. Hepatotoxicity Hepatic dysfunction, including hepatitis and cholestatic jaundice has been associated with the use of ampicillin and sulbactam for injection. 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 Ampicillin and sulbactam for injection may cause severe skin reactions, such as toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), dermatitis exfoliative, erythema multiforme, and Acute generalized exanthematous pustulosis (AGEP). If patients develop a skin rash they should be monitored closely and ampicillin and sulbactam for injection discontinued if lesions progress (see CONTRAINDICATIONS and ADVERSE REACTIONS sections).

Adverse reactions

Sourced from openFDA

Adult Patients Ampicillin and sulbactam for injection 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 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.

Use in specific populations

Sourced from openFDA

Pregnancy Reproduction studies have been performed in mice, rats, and rabbits at doses up to ten (10) times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to ampicillin and sulbactam for injection. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed (see PRECAUTIONS Drug/Laboratory Test Interactions section).

Overdosage

Sourced from openFDA

Neurological adverse reactions, including convulsions, may occur with the attainment of high CSF levels of beta-lactams. Ampicillin may be removed from circulation by hemodialysis. The molecular weight, degree of protein binding and pharmacokinetics profile of sulbactam suggest that this compound may also be removed by hemodialysis.

Approval history

Sourced from openFDA
  • Dec 31, 1986NDANDA050608Pfizer
  • Nov 25, 2005ANDAANDA065188Hq Speclt Pharma
  • Nov 29, 2005ANDAANDA065222Istituto Bio Ita Spa
  • Nov 30, 2005ANDAANDA065176Hq Speclt Pharma
  • Jul 25, 2006ANDAANDA065310Sandoz
  • Nov 27, 2006ANDAANDA065314Istituto Bio Ita Spa
  • Dec 22, 2009ANDAANDA065406Acs Dobfar
  • May 23, 2023NDANDA216974Entasis Therap

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
2,560 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Pyrexia2017.9%
  2. 2Pneumonia1917.5%
  3. 3Drug Ineffective1445.6%
  4. 4Dyspnoea1174.6%
  5. 5Diarrhoea1094.3%
  6. 6Rash1034.0%
  7. 7Sepsis933.6%
  8. 8Pain833.2%
  9. 9Nausea813.2%
  10. 10Off Label Use793.1%
  11. 11Vomiting793.1%
  12. 12Anaemia742.9%
  13. 13Hypotension732.9%
  14. 14Condition Aggravated682.7%
  15. 15Respiratory Failure682.7%

Literature

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Recent PubMed references pinned to Sulbactam as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 69 ClinicalTrials.gov registrations naming Sulbactam as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Sulbactam work?
Mechanism-of-action class: beta Lactamase Inhibitors.
What is Sulbactam used for?
According to FDA labeling, Sulbactam carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Sulbactam?
Sulbactam is classified as Beta-lactamase inhibitors, beta Lactamase Inhibitor, beta Lactamase Inhibitors.
What are the brand names for Sulbactam?
Sulbactam is marketed under brand names including Unasyn, Xacduro.
What are the contraindications for Sulbactam?
Sulbactam labeling lists contraindications including: The use of ampicillin and sulbactam for injection is contraindicated in individuals with a history of serious hypersensitivity reactions (e.g., anaphylaxis or Stevens-Johnson syndrome) to ampicillin, sulbactam or to other beta-lactam antibacterial drugs (e.g., penicillins and cephalosporins). Ampicillin and sulbactam for injection is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with ampicillin and sulbactam for injection.. Always consult the full prescribing information and a clinician.
Note. Data for sulbactam is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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