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Fludrocortisone Acetate/Fluocinolone Acetonide 1531

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Fludrocortisone Acetate/Fluocinolone Acetonide 1531 Fludrocortisone Acetate/Fluocinolone Acetonide 1531 Flumetasone Pivalate (BANM, rINNM) ⊗ Careflu; Charlyn; Citiflux; Desaflu; Doricoflu; Eliosid; Euroflu; Fluminex; Flu- nigar†; Flunitop; Gibiflu; Givair; Inalcort; Kaimil; Levonis; Lunibron; Lunis; Flumetason pivalát; Flumétasone, pivalate de; Flumetasoni pivalas; Nebulcort; Nereflun; Nisolid; Nisoran; Pantasol†; Plaudit; Pulmist; Syntaris; OH Turm; Ventoflu; Neth.: Syntaris; Norw.: Lokilan; Switz.: Broncort†; Syn- Flumetasonipivalaatti; Flumetasonpivalat; Flumetasonum Pivalas; taris†; UK: Syntaris; USA: AeroBid; AeroSpan; Nasalide†; Nasarel. O CH Flumetazon Pivalat; Flumetazono pivalatas; Flumetazon-pivalát; 3 Multi-ingredient: Ital.: Plenaer. Flumetazonu piwalan; Flumethasone Pivalate (USAN); Flumetha- O H H3C CH3 sone Trimethylacetate; NSC-107680; Pivalato de flumetasona. HO Flumethasone 21-pivalate. O H3C H Fluocinolone Acetonide (BANM, USAN, rINN) ⊗ Флуметазона Пивалат H Acetónido de fluocinolona; 6α,9α-Difluoro-16α-hydroxypred- C27H36F2O6 = 494.6. H H nisolone Acetonide; Fluocinolon acetonid; Fluocinolonacetonid; CAS — 2002-29-1. Fluocinolon-acetonid; Fluocinolone, acétonide de; Fluocinoloni O ATC — D07AB03. acetonidum; Fluocinolono acetonidas; Fluocynolonu acetonid; HF Fluosinoloniasetonidi; NSC-92339. 6α,9α-Difluoro-11β,21-dihy- ATC Vet — QD07AB03. droxy-16α,17α-isopropylidenedioxypregna-1,4-diene-3,20-di- Pharmacopoeias. In US which specifies the hemihydrate. one. USP 31 (Flunisolide). A white to creamy-white crystalline pow- Флуоцинолона Ацетонид O der. Practically insoluble in water; soluble in acetone; sparingly OH C24H30F2O6 = 452.5. soluble in chloroform; slightly soluble in methyl alcohol. CAS — 67-73-2. H3C OH HO CH3 ATC — C05AA10; D07AC04; S01BA15. Adverse Effects, Treatment, Withdrawal, ATC Vet — QC05AA10; QD07AC04; QS01BA15. H3CH and Precautions As for corticosteroids in general (see p.1490). CH HF O 3 Interactions HO O H3C O CH The interactions of corticosteroids in general are de- HO O 3 F scribed on p.1494. H3CH (flumetasone) Pharmacokinetics For a brief outline of the pharmacokinetics of corticos- HF Pharmacopoeias. In Eur. (see p.vii) and US. Ph. Eur. 6.2 (Flumetasone Pivalate). A white or almost white, teroids, see p.1495. Flunisolide is reported to undergo O crystalline powder. It shows polymorphism. Practically insoluble extensive first-pass metabolism, with only 20% of the F in water; slightly soluble in alcohol and in dichloromethane; dose available systemically if it is given by mouth. The sparingly soluble in acetone. Protect from light. major metabolite, 6β-hydroxyflunisolide has some Pharmacopoeias. In Eur. (see p.vii), Jpn, and Viet. Br. and Vi- USP 31 (Flumethasone Pivalate). A white to off-white crystal- glucocorticoid activity; it has a half-life of about 4 et. have a separate monograph for the dihydrate; US allows either line powder. Insoluble in water; soluble 1 in 89 of alcohol, 1 in the anhydrous form or the dihydrate. 350 of chloroform, and 1 in 2800 of ether; slightly soluble in me- hours. Only small amounts of flunisolide are absorbed after intranasal doses. Ph. Eur. 6.2 (Fluocinolone Acetonide). A white or almost white, thyl alcohol; very slightly soluble in dichloromethane. Store in crystalline powder. It exhibits polymorphism. Practically insolu- airtight containers. Protect from light. ◊ References. ble in water; soluble in dehydrated alcohol and in acetone. Pro- Profile 1. Chaplin MD, et al. Flunisolide metabolism and dynamics of a tect from light. Flumetasone pivalate is a corticosteroid used topically for its glu- metabolite. Clin Pharmacol Ther 1980; 27: 402–13. BP 2008 (Fluocinolone Acetonide Dihydrate). A white or almost 2. Möllmann H, et al. Pharmacokinetic/pharmacodynamic evalua- white, crystalline powder. Practically insoluble in water and in cocorticoid activity (p.1490) in the treatment of various skin dis- tion of systemic effects of flunisolide after inhalation. J Clin orders. It is usually used as a 0.02% cream, ointment, or lotion. Pharmacol 1997; 37: 893–903. hexane; soluble in dehydrated alcohol; freely soluble in acetone; When applied topically, particularly to large areas, when the skin sparingly soluble in dichloromethane and in methyl alcohol. Pro- is broken, or under occlusive dressings, corticosteroids may be tect from light. Uses and Administration USP 31 (Fluocinolone Acetonide). It is anhydrous or contains absorbed in sufficient amounts to cause systemic effects Flunisolide is a corticosteroid with glucocorticoid ac- (p.1490). The effects of topical corticosteroids on the skin are two molecules of water of hydration. A white or practically described on p.1492. For recommendations concerning the cor- tivity (p.1490) used as a nasal spray for the prophylaxis white, odourless, crystalline powder. Insoluble in water; soluble rect use of corticosteroids on the skin, and a rough guide to the and treatment of allergic rhinitis (p.565). In the UK a 1 in 45 of alcohol, 1 in 25 of chloroform, and 1 in 350 of ether; clinical potencies of topical corticosteroids, see p.1497. formulation containing 25 micrograms per metered soluble in methyl alcohol. Flumetasone pivalate is also used in ear drops in a concentration spray is available, whereas in the USA each metered Profile of 0.02% with clioquinol 1%. spray contains 29 micrograms flunisolide. In adults, Fluocinolone acetonide is a corticosteroid used topically for its glucocorticoid activity (p.1490) in the treatment of various skin Preparations the recommended starting dose is 2 sprays into each disorders. It is usually used as a cream, gel, lotion, ointment, or nostril twice daily, increased if necessary to three times scalp application; concentrations normally range from 0.0025 to USP 31: Flumethasone Pivalate Cream. daily, and then reduced for maintenance. In the USA a 0.025% although higher-strength preparations may be available. Proprietary Preparations (details are given in Part 3) maximum dose of 8 sprays into each nostril daily has When applied topically, particularly to large areas, when the skin Belg.: Locacortene; Ger.: Cerson; Locacorten; Ital.: Locorten†; Neth.: been established. For children aged from about 5 to 14 is broken, or under occlusive dressings, corticosteroids may be Locacorten; Pol.: Lorinden; Switz.: Locacorten; Venez.: Lexifal†; Loco- absorbed in sufficient amounts to cause systemic effects rten†. years, 1 spray into each nostril may be given up to 3 (p.1490). The effects of topical corticosteroids on the skin are Multi-ingredient: Arg.: Locorten Vioformo†; Salena†; Tresite F; Aus- times daily; the USA also allows for an initial 2 sprays described on p.1492. For recommendations concerning the cor- tral.: Locacorten Vioform; Austria: Locacorten mit Neomycin; Loca- into each nostril twice daily (this is the recommended rect use of corticosteroids on the skin, and a rough guide to the corten Tar; Locacorten Vioform; Locasalen; Belg.: Locacortene Tar†; Lo- clinical potencies of topical corticosteroids, see p.1497. cacortene Vioforme†; Locasalen; Braz.: Locorten Vioformio; Locorten†; maximum of 4 sprays into each nostril daily). Losalen; Canad.: Locacorten Vioform; Cz.: Locacorten Tar†; Lorinden A†; Flunisolide is also used by inhalation from metered- Fluocinolone acetonide is also used topically with an antibacte- Lorinden C†; Denm.: Locacorten Vioform; Fin.: Locacorten Vioform; Fr.: rial in the treatment of infective inflammatory eye, ear, and nose Locacortene Vioforme; Locacortene†; Locasalene; Psocortene; Ger.: Lo- dose aerosols in the management of asthma (p.1108). disorders. cacorten Vioform; Locasalen; Lorinden T†; Gr.: Locacorten Neomycin†; The usual adult dosage of flunisolide from an aerosol Locasalene; Hong Kong: Locacorten Tar†; Locasalen; Hung.: Lorinden A; A sterile implant of fluocinolone acetonide is used intravitreally Lorinden C; Indon.: Locasalen; Israel: Locacorten with Neomycin†; Topi- using chlorofluorocarbon (CFC) propellants is for the treatment of chronic non-infectious posterior uveitis. corten V; Topicorten-Tar; Topisalen; Ital.: Locorten; Locorten Vioformio; 500 micrograms inhaled twice daily. In severe asthma Formulation. The potency of fluocinolone acetonide varied Losalen; Vasosterone Oto; Neth.: Locacorten Vioform; Locasalen; NZ: Lo- 1 corten Vioform; Philipp.: Locasalen; Pol.: Lorinden A; Lorinden C; Lorind- the dosage may be increased but should not exceed a with the formulation in a study involving different Synalar top- en N; Port.: Locorten Vioformio†; Losalen†; Rus.: Lorinden A (Лоринден total of 2 mg daily. A dose for children of 6 to 15 years ical preparations, the gel, ointment, and cream. The cream was А); Lorinden C (Лоринден С); S.Afr.: Locacorten Vioform; Spain: Lo- the most potent followed by the gel, and then the ointment. A salen; Swed.: Locacorten Vioform; Switz.: Locasalen; Thai.: Flumasalen; of age is 500 micrograms inhaled twice daily, which comparison of topical vasoconstrictor activity (used as an index Locasalen; Turk.: Locacortene Vioform; Locasalene; UK: Locorten Vio- should not be exceeded. A hydrofluoroalkane (CFC- form; Venez.: Flutalon†; Locasalen; Locorten Vioformo. of potency) unexpectedly found that the commercial dilutions of free) aerosol, which is also available in some countries, the cream (containing 0.00625% and 0.0025%) were indistin- has a lower dose because of different delivery charac- guishable in their effects from the full-strength (0.025%) cream. teristics. The usual adult dose, expressed as flunisolide 1. Gao HY, Li Wan Po A. Topical formulations of fluocinolone
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