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Clinical evaluation of rectally administered ampicillin in acute otitis media
B K Bergström1, S O Bertilson, G Movin
1ENT Department, Central Hospital, Karlstad, Sweden.
Abstract:
An ampicillin suppository was compared with amoxycillin suspension in the treatment of acute otitis media in children. Both antibiotics were given three times daily for 5 days in a daily dose of 25-50 mg/kg body weight. Safety was evaluated in 454 patients in the group given suppository and in 229 given the suspension, and 421 and 229 patients, respectively, were evaluable for efficacy. Ampicillin was rapidly absorbed and produced plasma concentrations well above the minimum inhibitory concentration for common respiratory pathogens. The overall clinical outcome was satisfactory (cured plus improved) in 89% of the patients given the suppository and in 86% given the suspension. Gastro-intestinal disturbances occurred in 28.4% of the patients given the suppository compared with 14.4% of those given the suspension. Perianal irritation was recorded in 12.1% of the patients given the suppository and in 5.2% of those given the suspension. Treatment was interrupted in 9.8% of patients given the suppository and in 0.9% of those given the suspension. In spite of these discomforts rectally administered ampicillin is considered to be a good alternative in children when oral medication is not feasible.
Insights
Ampicillin suppositories and amoxycillin suspension showed similar efficacy for acute otitis media in children. Ampicillin suppositories had higher rates of gastrointestinal issues and perianal irritation, leading to more treatment interruptions.
Area of Science:
- Pediatrics
- Infectious Diseases
- Pharmacology
Background:
- Acute otitis media is a common childhood infection.
- Oral antibiotic administration can be challenging in pediatric patients.
- Alternative drug delivery methods are essential for effective treatment.
Purpose of the Study:
- To compare the efficacy and safety of ampicillin suppositories versus amoxycillin suspension for treating acute otitis media in children.
- To evaluate ampicillin absorption and plasma concentrations following rectal administration.
Main Methods:
- A comparative study involving children diagnosed with acute otitis media.
- Treatment with ampicillin suppositories or amoxycillin suspension, 3 times daily for 5 days (25-50 mg/kg/day).
- Evaluation of safety and clinical efficacy in a large patient cohort.
Main Results:
- Both treatments demonstrated high overall clinical success rates (89% for ampicillin, 86% for amoxycillin).
- Ampicillin showed rapid absorption and effective plasma concentrations.
- Ampicillin suppositories were associated with increased gastrointestinal disturbances (28.4% vs 14.4%), perianal irritation (12.1% vs 5.2%), and treatment interruptions (9.8% vs 0.9%).
Conclusions:
- Rectally administered ampicillin is a viable alternative for pediatric acute otitis media when oral intake is not possible.
- Despite higher local side effects, ampicillin suppositories offer a comparable clinical outcome to amoxycillin suspension.
- Careful monitoring for adverse effects is recommended with ampicillin suppository use.