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Antiasthma Agents during Pregnancy
Published in “Bert” Bertis Britt Little, Drugs and Pregnancy, 2022
No birth defects were reported among 25 infants exposed to flunisolide in the first trimester (Namazy et al., 2004). Rat and rabbit offspring exposed to 10 and 20 times the usual; human dose had increased frequencies of congenital anomalies (Manufacturer Package Insert). Dose related increased frequencies of congenital anomalies (cleft palate) and maternal mortality was reported after flunisolide exposure at high doses during embryogenesis produced in mice and rats (Tamagawa et al., 1982; Itabashi et al., 1982).
Drug evaluation in children
Published in Evelyne Jacqz-Aigrain, Imti Choonara, Paediatric Clinical Pharmacology, 2021
Evelyne Jacqz-Aigrain, Imti Choonara
In an Italian study, over 60% of children received at least one drug prescription, and 22% received anti-asthmatic drugs [22]. The prevalence rate of anti-asthmatic drug prescriptions decreased significantly from 34% in children under 1 year to 11% in those over 12 years of age. In children receiving anti-asthmatic drugs, 59% received monotherapy, 30% two drugs, and 11% three or more drugs. 25% of children under 1 year received at least one prescription for beclomethasone. The prevalence of this drug decreased with increasing age, reaching 6% in children 12 to 13 years. The prevalence rates of salbutamol and flunisolide prescriptions also decreased with increasing age (from 12 to 3% and from 7 to 1%), while the prevalence rate of fluticasone prescriptions increased from 1 to 1.4%. 98% of prescriptions for beclomethasone and nearly all prescriptions for flunisolide were for nebulised suspensions, as opposed to inhalers.
Monographs of Topical Drugs that Have Caused Contact Allergy/Allergic Contact Dermatitis
Published in Anton C. de Groot, Monographs in Contact Allergy, 2021
From January 1990 to June 2008, in Leuven, Belgium, 315 patients were diagnosed with contact allergy to/allergic contact dermatitis from corticosteroids (CSs) from routine patch testing with a baseline series including tixocortol pivalate, budesonide, hydrocortisone butyrate and prednisone caproate, patch testing with patients’ own CS preparations, and testing those with proven contact allergy to a corticosteroid or strongly suspected of CS allergy later with a series of 66 CSs, including two sex hormones (progesterone and testosterone). 71% of the patients had relevant reactions, but these were not specified. In this group of 315 CS allergic patients, 35 had positive patch tests to flunisolide 0.1% alc. (2). It is unknown how many of these reactions were caused by the use of a pharmaceutical product containing flunisolide and how many were cross-reactions to other corticosteroids.
Chronic rhinosinusitis: pathogenesis, therapy options, and more
Published in Expert Opinion on Pharmacotherapy, 2018
Umut Can Kucuksezer, Cevdet Ozdemir, Mubeccel Akdis, Cezmi A. Akdis
Nasal irrigation and intranasal steroid administration are the mainstays in the pharmacological treatment of CRS, whereas systemic steroids and antibiotics serve as major relievers during exacerbations. Topical rather than oral steroids are preferred in corticosteroid therapy due to the possibility of sustained administration with no significant adverse effects. Beclomethasone dipropionate, flunisolide, budesonide, and triamcinolone acetonide are first-generation intranasal topical corticosteroids, whereas mometasone furoate, fluticasone propionate, fluticasone furoate, and ciclesonide represent newer preparations. The mechanisms of topical corticosteroid action involves the production of an anti-inflammatory effect through the suppression of pro-inflammatory mediators, adhesion molecules and chemotactic factors, all of which reduce inflammatory cellular infiltration, as well as increases in the transcription of anti-inflammatory genes [76]. There is clear evidence stating that intranasal corticosteroids are effective in reducing the symptoms of CRS and polyp formation in the nasal cavity [77].
Clinical implications of the tiotropium/olodaterol inhaler for patients with chronic obstructive pulmonary disease
Published in Postgraduate Medicine, 2018
Gary T. Ferguson, Richard N. Dalby
A number of phase I studies have been performed using gamma scintigraphy to quantify lung deposition of the aerosol cloud generated by the Respimat® SMI in comparison to other currently prescribed devices. A randomized three-way crossover study investigated the deposition of flunisolide delivered via the Respimat® SMI, a pMDI, and a pMDI plus spacer in 10 healthy, nonsmoking volunteers aged 19–28 years [25]. Mean whole-lung deposition (percentage of the metered dose) was significantly higher with the Respimat® SMI versus the pMDI (p < 0.01) and the pMDI plus spacer (p = 0.01): 39.7% versus 15.3% and 28.0%, respectively. Similar results were obtained in two further studies of 12 healthy, nonsmoking volunteers aged 18–65 years using flunisolide or fenoterol administered via the Respimat® SMI or conventional pMDIs with and without spacers [26].
Quality by design (QbD) approach for design and development of drug-device combination products: a case study on flunisolide nasal spray
Published in Pharmaceutical Development and Technology, 2018
Swapnil Sharadkumar Chudiwal, Mohamed Hassan G. Dehghan
Flunisolide was obtained from Healthcare Pharmaceuticals Limited (Mumbai, India). Polyethylene glycol (PEG) 3350 and propylene glycol (PG) were obtained from Dow Chemical Company (Midland, MI). Edetate disodium (EDTA), butylated hydroxyl anisole (BHA), benzalkonium chloride (BKC) 50% w/v solution, citric acid, sodium citrate, hydrochloric acid and sodium hydroxide were obtained from Merck Specialities (Mumbai, India). All the materials used were of pharmacopeial grade. Mechanical nasal spray pumps were received as kind gifts from Aptar Pharma (Mumbai, India).