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Antimicrobial Agents
Published in Karl H. Pang, Nadir I. Osman, James W.F. Catto, Christopher R. Chapple, Basic Urological Sciences, 2021
Thomas E. Webb, Karl H. Pang, Ased Ali
Key featuresBactericidal.Highly effective only against gram-negative bacilli, including Pseudomonas.Useful alternative for penicillin-allergic patients and an alternative to aminoglycosides for patients with renal insufficiency.Example: aztreonam.Considered a ‘last resort’ drug because of its significant adverse effects.Best avoided during pregnancy but animal studies have failed to reveal evidence of embryotoxicity, fetotoxicity, or teratogenicity.Urological uses: severe aerobic gram-negative bacilli infection in patients who have a serious beta-lactam allergy.Adverse effects: secondary fungal infections, can lower seizure threshold, GI upset, rash, thrombophlebitis.
Drugs in pregnancy and lactation
Published in Evelyne Jacqz-Aigrain, Imti Choonara, Paediatric Clinical Pharmacology, 2021
Evelyne Jacqz-Aigrain, Imti Choonara
The four types of embryo-fetal toxicity are intra-uterine death, dysmorpho-genesis, alterations to growth, and functional toxicities. Embryotoxicity and fetotoxicity were well defined in the ICH guidelines as “any adverse effect on the conceptus resulting from prenatal exposure, including structural or functional abnormalities or postnatal manifestations of such effects” [2]. These effects include death, malformation, variation, delayed ossification, body weight reduction, and also perinatal functional impairment.
Formulary
Published in Sarah Bekaert, Alison White, Integrated Contraceptive and Sexual Healthcare, 2018
Sarah Bekaert, Alison White, Kathy French, Kevin Miles
Doxycycline is contraindicated in pregnancy and in breastfeeding mothers. Results of animal studies indicate that tetracyclines cross the placenta, are found in foetal tissues and can have toxic effects on the developing foetus (often related to retardation of skeletal development). Evidence of embryotoxicity has also been noted in animals treated early in pregnancy.
Effect of orlistat intervention on in vitro fertilization/intracytoplasmic sperm injection outcome in overweight/obese infertile women
Published in Gynecological Endocrinology, 2022
Jing Tong, Lulu Xiang, Yichao Niu, Ting Zhang
In the USA and Europe, a 60 mg formulation of orlistat is available as a nonprescription drug. It is observed in a previous study that, orlistat administered at a dose of 60 mg thrice daily for 104 weeks is safe for severely obese patients with BMI 30–44 kg/m2 [17]. In addition, a double-blind, randomized, placebo-controlled studyv[18] proves the safety of 60 mg orlistat administered thrice daily for 24 weeks in the Asian (Japanese) participants with excessive visceral fat accumulation but without metabolic diseases. Neither embryotoxicity nor teratogenicity has been observed in animal models at a dose significantly higher (several times) than the calculated daily human dose. However, there are no controlled data on human pregnancy. Thus, this study limited the orlistat intervention until the day of embryo transfer.
A new active peptide from Neptunea arthritica cumingii exerts protective effects against gentamicin-induced sensory-hair cell injury in zebrafish
Published in Drug and Chemical Toxicology, 2022
Shanshan Zhang, Yan Gao, Qiuxia He, Yun Zhang, Liwen Han, Meng Jin, Tong Liu, Kechun Liu, Chen Sun
The assay to evaluate embryotoxicity was carried out according to the OECD-draft for the fish embryo acute toxicity (OECD 2013). Newly fertilized zebrafish eggs (80 embryos per concentration treatment) were exposed to 0, 60, 80, or 90 μg/mL of AP for 96 hours. All assessments of embryotoxicity were performed in duplicate and repeated twice. Hatching rate was calculated as the number of hatched embryos divided by the number of normal embryos at 96 hours post-fertilization (hpf). Mortality rate was calculated as the number of dead larvae divided by the number of total embryos. Systemic teratogenicity including bending of the spine and tail, malformed yolk sacs, edema in the body cavity and stunted growth were evaluated. The teratogenicity rate was calculated as the number of malformed embryos divided by the number of normal embryos at 96 hpf. Heart rate was recorded in real-time by direct microscopic inspection for one minute.
Safety of current therapies for onychomycosis
Published in Expert Opinion on Drug Safety, 2020
Jose W. Ricardo, Shari R. Lipner
Itraconazole is labeled as pregnancy category C by the FDA. In rodents, itraconazole is embryotoxic and teratogenic, causing craniofacial and rib abnormalities[56]. Embryotoxicity and teratogenicity data is less clear in humans. In a retrospective study of 229 pregnant women exposed to itraconazole (median dose 200 mg; range 50–800 mg), 198 of whom were exposed during first trimester for a median of 3 days (range 1–90), there was no increased risk of fetal malformation[76]. In addition, in an Italian prospective cohort study of 206 pregnant women exposed to itraconazole (mean daily dose 182 ± 63 mg for a mean of 6.9 ± 6.4 days) during the first trimester and 207 controls, there was no increased risk of embryotoxicity[77]. However, there was an increased risk of early fetal loss with first-trimester exposure[77]. In a recent systematic review and meta-analysis (9 studies; 971,450 pregnant women), the administration of itraconazole during pregnancy was not associated with an increased risk of spontaneous abortion, or stillbirths[78]. However, the frequency of ocular defects (0.56%; 95% CI: 0.18–1.32) was considerably higher than the rate reported in the general population (0.04%; 95% CI, 0.03–0.04)[78]. Therefore, itraconazole should be avoided during pregnancy[68]. Itraconazole is excreted into human milk[68]. In an unpublished report, in two healthy lactating volunteers who took two oral doses each of itraconazole 200 mg 12 hours apart, the average milk concentrations of itraconazole at 4, 24, and 48 hours following the second dose were 70, 28, and 16 ng/mL, respectively[79].