title: Immune tolerance to drugs. I. Long-term tolerability of rokitamycin in patients with antibiotics hypersensitivity.
abstract: Macrolides are considered one of the safest anti-infective groups in clinical use and are well-tolerated as alternative antibiotics in patients with a previous adverse reaction to other classes of antibiotics. However there is scarce information in the literature about their long-term tolerability. The present study was performed to determine whether the results of a challenge test with rokitamycin could predict the response to ingestion of rokitamycin during illness. The study was carried out on 335 patients, who experienced adverse reactions to one or more antibiotics. All patients received peroral challenges with rokitamycin (granules or capsules). On the first day patients received a number of placebo doses equivalent to the rokitamycin doses. One week later, the test was administered by increasing doses of rokitamycin at 60 min intervals until the common daily therapeutic dose of 406.25mg was reached (31.25-93.75-125-156.25mg). A questionnaire was distributed to all subjects. In particular, subjects were asked to clarify any reactive symptom they had developed after ingestion of the drug. It was found that only 3.1% (4/129) of subjects, who used this drug, reported adverse reactions: three experienced urticaria/angioedema and one patient experienced erythema multiforme during treatment. This study, points out a low percentage of adverse reactions to rokitamycin after a negative challenge test, thus, emphasizing both safety and good predictive value as a challenge test.
authors.affiliation: Department of Internal Medicine, Immunology and Infectious Diseases, Section of Allergy and Clinical Immunology, University of Bari, Bari, Italy. e.nettis@allergy.uniba.it
authors.forename: E
authors.initials: E
authors.lastname: Nettis
authors.forename: M C
authors.initials: MC
authors.lastname: Colanardi
authors.forename: R
authors.initials: R
authors.lastname: Di Paola
authors.forename: G
authors.initials: G
authors.lastname: Mangialardi
authors.forename: A
authors.initials: A
authors.lastname: Ferrannini
authors.forename: A
authors.initials: A
authors.lastname: Tursi
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000799:Angioedema / Q000276:immunology; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects*; D002214:Capsules; D004342:Drug Hypersensitivity / Q000175:diagnosis / Q000276:immunology*; D004892:Erythema Multiforme / Q000276:immunology; D005260:Female; D006801:Humans; D007108:Immune Tolerance; D008297:Male; D008875:Middle Aged; D015644:Miocamycin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D011795:Surveys and Questionnaires; D014581:Urticaria / Q000276:immunology; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D002214:Capsules; D015644:Miocamycin; C033383:rokitamycin