rokitamycin and Urticaria

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.

Topics: Administration, Oral; Adolescent; Adult; Aged; Aged, 80 and over; Angioedema; Anti-Bacterial Agents; Capsules; Drug Hypersensitivity; Erythema Multiforme; Female; Humans; Immune Tolerance; Male; Middle Aged; Miocamycin; Surveys and Questionnaires; Urticaria; Young Adult

Clinical efficacies of a new macrolide antibiotic, rokitamycin (RKM, TMS-19-Q), were studied in acute pediatric infections. Responses to the RKM administration were evaluable in 62 out of 68 patients consisted of 7 patients with pharyngitis (efficacy rate of 85.7%, 6/7 patients), 4 with bronchitis (25.0%, 1/4), 9 with tonsillitis (100%, 9/9), 13 with mycoplasmal pneumonia (100%, 13/13), 13 with hemolytic streptococcal infections (92.3%, 12/13), 14 with pneumonia (57.1%, 8/14), one with pertussis (100%, 1/1) and another with Chlamydia pneumonia (100%, 1/1) thus an overall efficacy rate of 82.3% was achieved. Urticaria was observed in one of the patients as an adverse reaction to the drug, while abnormal laboratory test results were noted in 3 patients, but none of such changes were severe. The drug, even when administered in combination with a theophylline preparation, exerted no effects on the serum concentration of the latter.

Topics: Acute Disease; Administration, Oral; Bacterial Infections; Child; Child, Preschool; Drug Evaluation; Female; Humans; Infant; Infant, Newborn; Leucomycins; Male; Miocamycin; Theophylline; Urticaria