ampicillin sodium / cloxacillin sodium

Action and Spectrum

Actions and Spectrum: 

• Inhibition of Cell Wall Synthesis: Both ampicillin and cloxacillin interfere with bacterial cell wall synthesis. They inhibit the activity of enzymes called transpeptidases (penicillin-binding proteins or PBPs) that are involved in the cross-linking of peptidoglycan chains, an essential component of bacterial cell walls. 
• Bactericidal Activity: Ampicillin-cloxacillin has bactericidal (killing) activity against susceptible bacteria. These antibiotics cause bacterial cells to weaken and eventually lyse by interfering with the formation of their cell walls. 

By combining ampicillin and cloxacillin, the antibiotic formulation can provide a broader spectrum of activity compared to using either drug alone. This combination is often used in situations where both Gram-positive and Gram-negative bacteria are suspected or identified, and resistance to beta-lactamase-producing strains is a concern. 

Drug Interaction

Adverse Reaction

Frequency not defined 

Common 

nausea 

skin rash 

diarrhoea 

Uncommon 

Vomiting 

Very Rare 

Convulsions 

Hyperactivity 

Kidney problems 

Headache 

Black Box Warning

Black box warning: 

None 

Contraindication / Caution

Contraindications/caution: 

• Allergy to Penicillins: Individuals with a known hypersensitivity or allergy to penicillins should not use ampicillin sodium/cloxacillin sodium. From minor rashes to severe, potentially fatal reactions like anaphylaxis, allergic reactions can take many different forms. 
• History of Allergic Reactions: It may have an increased risk of cross-reactivity and should avoid ampicillin/cloxacillin. 
• Mononucleosis (Infectious Mononucleosis): Ampicillin/cloxacillin is contraindicated in patients with infectious mononucleosis . There is a higher chance of getting a rash when using ampicillin for this ailment. 
• Hepatic Dysfunction: Individuals with severe hepatic dysfunction (liver impairment) may require dosage adjustments or avoidance of ampicillin/cloxacillin. Cloxacillin is primarily excreted by the liver, and it may lead to elevated drug levels. 
• Renal Impairment: Caution should be exercised in individuals with severe renal impairment, as both ampicillin and cloxacillin are excreted through the kidneys. Adjustments to the dosage or frequency may be necessary. 

Pregnancy / Lactation

Pregnancy consideration: Insufficient data available 

Lactation: Excretion of the drug in human breast milk is unknown 

Pregnancy category: 

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 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: 

Both ampicillin and cloxacillin are beta-lactam antibiotics that belong to the penicillin class. The combination of these two antibiotics provides a broader spectrum of activity against various bacterial infections.  

• Ampicillin: It works by inhibiting the bacterial cell wall synthesis. It interferes with the formation of peptidoglycan cross-links, weakening the bacterial cell wall and leading to cell lysis. 
• Cloxacillin: Functions similarly to ampicillin, inhibiting bacterial cell wall synthesis. It is particularly effective against beta-lactamase-producing bacteria, including certain strains of Staphylococcus aureus. 

Pharmacokinetics: 

Absorption 

Ampicillin and cloxacillin are absorbed in the gastrointestinal tract after oral administration. Food may affect the rate of absorption. 

Distribution 

Both antibiotics distribute into various tissues and body fluids. They can cross the blood-brain barrier, but their concentrations in cerebrospinal fluid may be lower than in plasma. 

Metabolism 

The metabolism of ampicillin and cloxacillin is minimal. These antibiotics are primarily excreted unchanged in the urine. 

Elimination and Excretion 

Both antibiotics are excreted through the kidneys. Adjustments may be necessary in individuals with renal impairment. 

Adminstartion

Administration: 

It will be administered  

intravenously—by injection or  

infusion—into a vein or  

intramuscularly—into a muscle. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: ampicillin sodium / cloxacillin sodium   

Why do we use ampicillin sodium / cloxacillin sodium? 

Ampicillin sodium and cloxacillin sodium are antibiotics commonly used in combination to treat a variety of bacterial infections. The combination of these two antibiotics broadens the spectrum of activity, making it effective against a range of bacteria, particularly those that may produce beta-lactamase enzymes. 

• Respiratory Tract Infections: Ampicillin-cloxacillin combination is often used to treat respiratory tract infections, including bronchitis, lung abscesses and pneumonia.  
• Urinary Tract Infections (UTIs): Ampicillin-cloxacillin may be used to treat urinary tract infections. It is effective against some strains of Escherichia coli and other uropathogens. 
• Gynecological Infections: Infections of the female reproductive system, such as endometritis, pelvic inflammatory disease (PID), and cervicitis, may be treated with ampicillin-cloxacillin. 
• Intra-Abdominal Infections: The combination is sometimes used to treat intra-abdominal infections, including peritonitis and infections of the abdominal organs.