plxi+neomicina - search results

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

sabakem metsulfuron 600wg herbicide

United States - English - NLM (National Library of Medicine)

zilxi- minocycline aerosol, foam

United States - English - NLM (National Library of Medicine)

zilxi- minocycline aerosol, foam

journey medical corporation - minocycline hydrochloride (unii: 0020414e5u) (minocycline - unii:fyy3r43wgo) - zilxi is indicated for the treatment of inflammatory lesions of rosacea in adults [see clinical studies (14)] . limitations of use this formulation of minocycline has not been evaluated in the treatment of infections. to reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, zilxi should be used only as indicated [see warnings and precautions (5.14)] . this drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines or any other ingredients in zilxi. risk summary available data with zilxi use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. systemic absorption of zilxi in humans is low following once daily topical administration of zilxi under maximal clinical use conditions [see clinical pharmacology (12.3)] . because of low systemic exposure, it is not expected that maternal use of zilxi will result in significant fetal exposure to the drug. tetracycline-class drugs may cause permanent discoloration of teeth and reversible inhibition of bone growth when administered orally during pregnancy [see warnings and precautions 5.2, 5.3, 5.4) . animal reproduction studies were not conducted with zilxi. in animal reproduction studies, oral administration of minocycline to pregnant rats and rabbits during organogenesis induced skeletal malformations in fetuses at systemic exposures of 2,000 and 1,300 times, respectively, the maximum recommended human dose (mrhd based on auc comparison) of zilxi (see data ). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data results of animal studies with oral administration indicate that tetracyclines cross the placenta, are found in fetal tissues, and can cause retardation of skeletal development of the developing fetus. minocycline induced skeletal malformations (bent limb bones) in fetuses when orally administered to pregnant rats and rabbits during the period of organogenesis at doses of 30 mg/kg/day and 100 mg/kg/day, respectively, (2,000 times and 1,300 times, respectively, the systemic exposure at the mrhd based on auc comparison). reduced mean fetal body weight was observed when minocycline was orally administered to pregnant rats during the period of organogenesis at a dose of 10 mg/kg/day (680 times the systemic exposure at the mrhd based on auc comparison). minocycline was assessed for effects on peri- and post-natal development of rats in a study that involved oral administration to pregnant rats during the period of organogenesis through lactation, at doses of 5, 10, or 50 mg/kg/day. in this study, body weight gain was significantly reduced in pregnant females that received 50 mg/kg/day (1,700 times the systemic exposure at the mrhd based on auc comparison). no effects of treatment on the duration of the gestation period or the number of live pups born per litter were observed. gross external anomalies observed in f1 pups (offspring of animals that received minocycline) included reduced body size, improperly rotated forelimbs, and reduced size of extremities. no effects were observed on the physical development, behavior, learning ability, or reproduction of f1 pups, and there was no effect on gross appearance of f2 pups (offspring of f1 animals). risk summary tetracycline-class drugs, including minocycline, are present in breast milk following oral administration. it is not known whether minocycline is present in human milk after topical administration to the nursing mother. there are no data on the effects of minocycline on milk production. because of the potential for serious adverse reactions, advise patients that breastfeeding is not recommended during treatment with zilxi [see warnings and precautions (5.2)]. the safety and effectiveness of zilxi for the treatment of inflammatory lesions of rosacea have not been evaluated in pediatric patients. there were 278 subjects aged 65 or older in the clinical trials of zilxi (16.6% of 1,678 subjects). no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Australia - English - Department of Health (Therapeutic Goods Administration)