Regulatory and Manufacturing Guidance
Sarfaraz K. Niazi in Handbook of Pharmaceutical Manufacturing Formulations, 2019
The active pharmacologic ingredient in AndroGel is testosterone. Testosterone United States Pharmacopeia is a white to practically white crystalline powder. Inactive ingredients in AndroGel are ethanol, 67.0%, purified water, sodium hydroxide, carbomer 980, and isopropyl myristate; these ingredients are not pharmacologically active. The cream formulation contains the following other inactive ingredients: Carbomer 940, dimethicone, glycerin, methyl gluceth-20, methyl methacry-late/glycol dimethacrylate crosspolymer, methyl paraben, octyl hydroxy stearate, polyethylene glycol 400, polysorbate 80, propylene glycol, propyl paraben, purified water, sorbitan monooleate, stearic acid, and trolamine. Cutivate ointment, 0.005%, contains fluticasone propionate, a synthetic fluorinated corticosteroid for topical dermatologic use. Each gram of Cutivate ointment contains fluticasone propionate 0.05 mg in a base of liquid paraffin, microcrystalline wax, propylene glycol, and sorbitan sesquioleate.
Respiratory Agents
Joyce Generali in Clin-Alert 2001, 2001
A total of 159 trials of inhaled steroid therapy were identified for inclusion in a meta-analysis to determine the effects of inhaled therapy on linear growth in children. Of these, only five trials met the criteria for the meta-analysis, including a randomized controlled trial which included children with asthma in the study and providing greater than 12 weeks of inhaled steroid therapy. Four of the five trials used inhaled beclomethasone (328 to 400 mcg daily) and one study used inhaled fluticasone (200 mcg daily). Analysis of the four beclomethasone trials demonstrated a significant reduction in linear growth in children with mild to moderate asthma who received inhaled beclomethasone when compared to children with a nonsteroid medication (-1.51 cmlyear). In the fluticasone study, there was a mean difference of -0.43 crn/year between 96 children treated with inhaled fluticasone and 87 treated with placebo.
AMPRENAVIR AMYL NITRITE
Neil Shear in Litt's Drug Eruptions and Reactions Manual, 2013
AMPRENAVIR Trade name: Agenerase (GSK) Indications: HIV infection Class: Antiretroviral, Protease inhibitor, HIV Half-life: 7-11 hours Clinically important, potentially hazardous interactions with: alprazolam, amiodarone, amitriptyline, amlodipine, amoxapine, antacids, atorvastatin, avanafil, benzodiazepines, bepridil, bosentan, carbamazepine, cisapride, clomipramine, clonazepam, clorazepate, cyclosporine, delavirdine, desipramine, dexamethasone, diazepam, didanosine, dihydroergotamine, diltiazem, doxepin, efavirenz, ergotamine, estradiol, felodipine, fentanyl, flurazepam, fluticasone, imipramine, indinavir, isradipine, itraconazole, ixabepilone, ketoconazole, lidocaine, lopinavir, lorazepam, lovastatin, methadone, methylergonovine, methysergide, midazolam, mifepristone, nelfinavir, nevirapine, nicardipine, nifedipine, nimodipine, nisoldipine, nortriptyline, oral contraceptives, oxazepam, phenobarbital, phenytoin, pimozide, protriptyline, quazepam, quinidine, rapamycin, rifabutin, rifampin, ritonavir, saquinavir, sildenafil, sildenafil, simvastatin, St John’s wort, tacrolimus, temazepam, trazodone, triazolam, tricyclic antidepressants, trimipramine, verapamil, vitamin E, warfarin Pregnancy category: C Note: Safety and effectiveness in pediatric patients
Fluticasone furoate for the treatment of childhood asthma
Published in Expert Review of Respiratory Medicine, 2015
Inhaled corticosteroids offer substantial benefit in controlling symptoms for the vast majority of children with asthma. However, poor adherence to therapy is very common, especially among older children and adolescents as they transition to self-management of their disease. The introduction of once-daily inhaled fluticasone furoate, either alone or in combination with the long-acting β-agonist, vilanterol, simplifies chronic asthma therapy and may improve adherence and as a result, outcomes in this vulnerable population. Opportunities exist for additional study of this agent in younger children, particularly with regard to safety and growth suppression. This review provides an overview of the pharmacology, safety and efficacy data regarding use of fluticasone furoate in the treatment of childhood asthma.
Similar Efficacy of Ciclesonide Once Daily Versus Fluticasone Propionate Twice Daily in Patients with Persistent Asthma
Published in Journal of Asthma, 2007
Helgo Magnussen, Jerzy Hofman, Pawel Staneta, John-Philip Lawo, Michael Hellwig, Renate Engelstätter
This 12-week, double-blind, parallel-group study compared the efficacy and safety of once daily ciclesonide and twice daily fluticasone propionate in patients aged 12–75 years with persistent asthma. Patients were randomized to once-daily ciclesonide 80 μg (n = 278) or 160 μ g (n = 271), or twice daily fluticasone propionate 88 μ g (n = 259) (all ex-actuator). Significant improvements from baseline were seen in all three treatment groups for forced expiratory volume in 1 second, asthma symptom scores and rescue medication use (all p < 0.0001). Asthma exacerbation rates were low (each ciclesonide group, n = 2; fluticasone group, n = 1). Adverse event reporting indicated good tolerability. Once daily ciclesonide 80 μg or 160 μg showed comparable efficacy and tolerability to twice daily fluticasone propionate 88 μg in persistent asthma.
Effects of FESS and additional fluticasone propionate nasal drops on psychological well-being in nasal polyposis with asthma
Published in Acta Oto-Laryngologica, 2013
Steven Nordin, Petter Olsson, Ebba Hedén Blomqvist, Pär Stjärne, Anders Ehnhage
Conclusion: A combined therapy of fluticasone propionate nasal drops (FPND) and functional endoscopic sinus surgery (FESS) can improve quality of life (QoL). When compared with prior data, the results imply that a generic measure of psychological aspects of QoL may be better than measures of respiratory symptoms and clinical parameters to capture a patient's perception of the disease and its treatment. Objective: To better understand effects of FPND and FESS on generic QoL. Methods: Sixty nasal polyposis patients with concomitant asthma completed participation in a randomized, double-blind, placebo-controlled, 14-week study in which they responded to the General Well-Being Schedule (GWBS). Results: GWBS scores (i) increased significantly after administration of FPND, independent of FESS (from lower than normal to normal), (ii) increased after FESS independent of FPND (from lower than normal to normal), and (iii) increased additively after FPND and FESS.
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