ampicillin/sulbactam

Action and Spectrum

Actions and Spectrum: 

Ampicillin/sulbactam is a combination antibiotic used to treat a variety of bacterial infections. It is a combination of two antibiotics, ampicillin (a penicillin-type antibiotic) and sulbactam (a beta-lactamase inhibitor). 

Actions: 

• Ampicillin: Inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins. 
• Sulbactam: Inhibits bacterial beta-lactamases, which can inactivate ampicillin and other beta-lactam antibiotics. 

Spectrum: 

• Ampicillin/sulbactam has a broad spectrum of activity and is effective against a wide range of gram-positive and gram-negative bacteria, including Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Proteus mirabilis, and Streptococcus pneumoniae. 

Drug Interaction

Adverse Reaction

Frequency defined 

1-10% 

Rash ( < 2%) 

Diarrhea (3%) 

IV injection site pain (3%) 

Thrombophlebitis (3%) 

>10% 

IM injection site pain (16%) 

<1% 

Candidiasis 

Chills 

Chest pain 

Dysuria 

Abdominal distention 

Epistaxis 

Edema 

Erythema 

Flatulence 

Fatigue 

Glossitis 

Itching 

Headache 

Black Box Warning

Black Box Warning: 

The black box warning for ampicillin/sulbactam states that patients with a history of severe hypersensitivity reactions (e.g. anaphylaxis, angioedema) to beta-lactam antibiotics, including penicillins and cephalosporins, may be at increased risk for such reactions with ampicillin/sulbactam. 

Contraindication / Caution

Contraindications: 

• Hypersensitivity to penicillin antibiotics or other beta-lactam antibiotics. 
• Severe liver or kidney disease. 

Cautions: 

• Patients with a history of gastrointestinal problems such as colitis or diarrhea may experience worsening of symptoms. 
• This medication may increase the risk of bleeding for patients taking anticoagulants. 
• Antibiotic-associated colitis is a potential side effect of ampicillin/sulbactam. 
• It is not recommended for use during pregnancy and breastfeeding. 
• Patients with a history of allergies or asthma may be at higher risk of allergic reactions. 

Pregnancy / Lactation

Pregnancy warnings:     

US FDA pregnancy category: B 

Lactation:   

Excreted into human milk is known  

Pregnancy Categories:         

Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester.    

Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.   

Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.     

Category D: adequate data available with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.     

Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.     

Category N: There is no data available for the drug under this category 

Pharmacology

Pharmacology: 

Ampicillin/sulbactam is a combination antibiotic medication that contains both ampicillin and sulbactam. Ampicillin is a broad-spectrum penicillin antibiotic and sulbactam is a beta-lactamase inhibitor. 

Pharmacodynamics: 

Ampicillin works by inhibiting the bacterial cell wall synthesis and causing the bacteria to break down and eventually die. It is active against a wide range of gram-positive and gram-negative bacteria, including Escherichia coli, Haemophilus influenzae, and Streptococcus pneumoniae. 

Sulbactam, on the other hand, works by inhibiting the production of beta-lactamases, enzymes that break down the penicillin antibiotic and make it ineffective. This allows the ampicillin to remain active against bacteria that would normally be resistant to it. 

The combination of ampicillin and sulbactam provides a broader spectrum of coverage and is used to treat infections caused by resistant bacteria. This includes urinary tract infections, skin and soft tissue infections, and lower respiratory tract infections. 

Pharmacokinetics: 

Absorption 

ampicillin is well absorbed from the gastrointestinal tract and reaches peak blood levels within 1 to 2 hours of oral administration. sulbactam is less well absorbed and reaches peak blood levels within 1 to 2 hours. 

Distribution 

ampicillin is distributed widely in the body, including the cerebrospinal fluid, bile, and renal tubules. Sulbactam is distributed throughout the body and is particularly concentrated in the liver and kidneys. 

Metabolism 

ampicillin is not metabolized in the body and is eliminated as the unchanged drug. Sulbactam is hydrolyzed to its active form and then eliminated from the body as the inactive metabolite. 

Elimination and Excretion 

ampicillin is excreted primarily in the urine, with smaller amounts excreted in the bile and feces. Sulbactam is excreted in the urine, with a half-life of approximately 1 hour. 

Adminstartion

 Administration: 

Ampicillin/sulbactam is typically administered intravenously (IV) in a hospital setting. The dose and frequency of administration will depend on the individual patient’s needs, such as their age, weight, and medical history, as well as the type of infection being treated. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: ampicillin/sulbactam 

Why do we use ampicillin/sulbactam? 

ampicillin/sulbactam is used as an antibiotic to treat bacterial infections. ampicillin is a beta-lactam antibiotic that is commonly used to treat infections caused by gram-positive bacteria. However, it is not effective against bacteria that produce beta-lactamase enzymes, which can inactivate ampicillin. 

sulbactam is a beta-lactamase inhibitor that prevents the inactivation of ampicillin. By combining ampicillin with sulbactam, the efficacy of ampicillin is increased, and it can effectively treat infections caused by both gram-positive and gram-negative bacteria, including those that produce beta-lactamase enzymes. 

ampicillin/sulbactam is used to treat a variety of infections, including respiratory tract infections, skin and soft tissue infections, intra-abdominal infections, and gynecological infections.