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Candida and parasitic infection: Helminths, trichomoniasis, lice, scabies, and malaria
Published in Hung N. Winn, Frank A. Chervenak, Roberto Romero, Clinical Maternal-Fetal Medicine Online, 2021
Pediculosis capitis during pregnancy follows a similar course to nonpregnant adults so treatment prior to delivery is not required, but there is typically a desire to treat due to the itching and psychologic distress of carrying a parasite in a visible location. Permethrin is the drug of choice for treatment in pregnancy and breastfeeding due to the low systemic absorption (<2% of the applied dose) and rapid clearance (53). There was no teratogenicity noted in animal studies of permethrin and there are no controlled human trials so it is a pregnancy category B drug. Observational reviews of use in humans have not identified any increased risk of adverse pregnancy outcomes (53). Permethrin use is considered to be compatible with use during breastfeeding due to the very low levels found in breastmilk. Malathion is also a pregnancy category B drug, but is typically not used in pregnancy or breastfeeding. Lindane and benzyl alcohol have been associated with abnormal neurodevelopment in animal teratogenicity studies (pregnancy category C) so should not be used in pregnancy unless absolutely necessary.
Monographs of fragrance chemicals and extracts that have caused contact allergy / allergic contact dermatitis
Published in Anton C. de Groot, Monographs in Contact Allergy, 2021
Benzyl alcohol is a colorless clear oily liquid; its odor type is floral and its odor at 100% is described as ‘floral rose phenolic balsamic’ (www.thegoodscentscompany.com). Benzyl alcohol is used in cosmetics as a fragrance component, preservative, solvent and diluting agent for perfumes and flavors, and viscosity-decreasing agent. It is used as a solvent for surface-coating materials, cellulose esters and ethers, alkyd resins, acrylic resins, fats, dyestuffs, casein (when hot), gelatin, shellac and waxes. It is added in small amounts to surface-coating materials to improve their flow and gloss. In the textile industry, benzyl alcohol is used as an auxiliary in the dyeing of wool, polyamides, and polyesters. In pharmacy it is used as a local anesthetic ingredient in over-the-counter anorectal, oral healthcare and topical analgesic drug products and, because of its antimicrobial effect, as an ingredient of ointments and other preparations (U.S. National Library of Medicine).
The administration of medicines to children
Published in Evelyne Jacqz-Aigrain, Imti Choonara, Paediatric Clinical Pharmacology, 2021
Evelyne Jacqz-Aigrain, Imti Choonara
Benzyl alcohol and benzoate salts may be used as co-solvents or preservatives and may not be tolerated by neonates when metabolism is immature. ‘Gasping syndrome’ and death have been described in neonates treated with intravenous saline preserved with benzyl alcohol [5,6]. Preparations such as lorazepam injection and amiodarone injection contain benzyl alcohol and have been contraindicated for children up to 3 years of age. Use of such excipients is potentially denying useful drugs to this age group.
Spinosad topical suspension (0.9%): a new topical treatment for scabies
Published in Expert Review of Anti-infective Therapy, 2022
Deepani D Fernando, Katja Fischer
The pharmacodynamics of the formulated 0.9% spinosad suspension in humans have not been studied [39]. However, at the concentration used for human head lice treatment, the drug is not found to be toxic to mammals, as the median lethal dose (LD50) of oral spinosad in rats was 3783–5000 mg/kg [44]. No embryo-fetal developmental toxicity effects were seen in pregnant rats at 200 mg/kg/day and in pregnant rabbits at 50 mg/kg/day [45]. No reproductive developmental toxicity was detected when up to 10 mg/kg/day were fed in two generation dietary reproduction studies in rats. Following topical application, spinosad was not systemically absorbed, therefore, it is considered safe to use during breastfeeding [45]. In addition, the levels of benzyl alcohol present in the formulated 0.9% spinosad topical suspension, although not enumerated, are not expected to result in clinically relevant skin absorption in breastfeeding women [45]. However, the safety and efficacy of the formulated 0.9% spinosad suspension is not established for children younger than 4 years old.
Pirfenidone as a potential antifibrotic injectable for Dupuytren’s disease
Published in Pharmaceutical Development and Technology, 2022
Suchitra Panigrahi, Amanda Barry, Scott Multner, Gerald B. Kasting, Julio A. Landero Figueroa, Latha Satish, Harshita Kumari
SC injection doses usually have small volumes; hence, we aimed to use an injection volume of 0.4 mL for safety studies in animals, which is within the generally accepted range (≤1.5 mL). The clear homogenous solution could lead to pain at the injection site if factors, such as the tonicity, pH, buffer type, and viscosity are not controlled during formulation. As the PFD solution was prepared in an aqueous medium, the viscosity was not investigated. Benzyl alcohol was added as a preservative to prevent the growth of microorganisms (typically in multidose injections). Benzyl alcohol is considered safe up to 2% w/v for small-molecule injectable formulations (Usach et al. 2019) and has been used in many approved injectable preparations (U.S. Food and Drug Administration). Buffers are added to maintain the pH of the overall formulation close to physiological pH. Most buffering agents in injectable products are used at concentrations of 10–100 mM (Usach et al. 2019) depending on the amount of active ingredient in the final product. Citric acid, which is commonly used as a buffer in approved parenteral products (Nash et al. 2016), induced more pain than other buffers. Therefore, phosphate, which is the second most common buffering agent, was used at the recommended concentration to maintain the pH of the prepared formulation close to physiological pH during storage (pH of the formulation without buffer observed to be ∼5).
Association between in-line filtration and Type I hypersensitivity reactions in pediatric oncology patients receiving intravenous etoposide
Published in Pediatric Hematology and Oncology, 2021
Rebecca Ronsley, Lisa Jacques, James E. Potts, Kerri Clement, David B. Dix, Paula Mahon
The mechanism of hypersensitivity reactions with most chemotherapy medications is not well understood and there is little data describing hypersensitivity related to inline filters. Although hypersensitivity is reported in other chemotherapy medications where inline filters are used,20 the pathophysiology of these reactions is not described. Previously, it was hypothesized that higher concentrations of etoposide resulted in an increased risk for hypersensitivity reactions.21 Despite these data, other studies have demonstrated hypersensitivity reactions with a wide range of etoposide concentrations.19, 22,23 The diluent used during the etoposide infusion may play a role in hypersensitivity reactions. Weiss et al published data suggesting that polysorbate conferred risk for a hypersensitivity reaction when compared to etoposide dissolved in benzyl alcohol.18 Our data did not demonstrate an association between diluent used (dextrose versus normal saline) and risk of hypersensitivity reaction. Furthermore, in our model, diluent was not associated with the presence or absence of a hypersensitivity reaction.