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Hydrocortisone (Cortisol) manufacturers and suppliers on PharmaCompass

PharmaCompass
4p6x
Also known as: Cortisol, 50-23-7, Acticort, Cetacort, Cortef, Hydrasson
Molecular Formula
C21H30O5
Molecular Weight
362.5  g/mol
InChI Key
JYGXADMDTFJGBT-VWUMJDOOSA-N
FDA UNII
WI4X0X7BPJ

The main glucocorticoid secreted by the ADRENAL CORTEX. Its synthetic counterpart is used, either as an injection or topically, in the treatment of inflammation, allergy, collagen diseases, asthma, adrenocortical deficiency, shock, and some neoplastic conditions.
Hydrocortisone is a Corticosteroid. The mechanism of action of hydrocortisone is as a Corticosteroid Hormone Receptor Agonist.
1 2D Structure

4p6x

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(8S,9S,10R,11S,13S,14S,17R)-11,17-dihydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl-2,6,7,8,9,11,12,14,15,16-decahydro-1H-cyclopenta[a]phenanthren-3-one
2.1.2 InChI
InChI=1S/C21H30O5/c1-19-7-5-13(23)9-12(19)3-4-14-15-6-8-21(26,17(25)11-22)20(15,2)10-16(24)18(14)19/h9,14-16,18,22,24,26H,3-8,10-11H2,1-2H3/t14-,15-,16-,18+,19-,20-,21-/m0/s1
2.1.3 InChI Key
JYGXADMDTFJGBT-VWUMJDOOSA-N
2.1.4 Canonical SMILES
CC12CCC(=O)C=C1CCC3C2C(CC4(C3CCC4(C(=O)CO)O)C)O
2.1.5 Isomeric SMILES
C[C@]12CCC(=O)C=C1CC[C@@H]3[C@@H]2[C@H](C[C@]4([C@H]3CC[C@@]4(C(=O)CO)O)C)O
2.2 Other Identifiers
2.2.1 UNII
WI4X0X7BPJ
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 11 Epicortisol

2. 11-epicortisol

3. Cortef

4. Cortifair

5. Cortisol

6. Cortril

7. Epicortisol

8. Hydrocortisone, (11 Alpha)-isomer

9. Hydrocortisone, (9 Beta,10 Alpha,11 Alpha)-isomer

10. Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11beta)-

2.3.2 Depositor-Supplied Synonyms

1. Cortisol

2. 50-23-7

3. Acticort

4. Cetacort

5. Cortef

6. Hydrasson

7. Hydrocortisyl

8. Hydrocortone

9. Cobadex

10. Hytone

11. Cortenema

12. Cortril

13. Dermacort

14. Proctocort

15. Hycort

16. Signef

17. 17-hydroxycorticosterone

18. Optef

19. Kendall's Compound F

20. Cort-dome

21. Cortanal

22. Corticreme

23. Cortifan

24. Cortiment

25. Cortispray

26. Cortonema

27. Dermolate

28. Efcorbin

29. Efcortelan

30. Eldecort

31. Ficortril

32. Genacort

33. Hycortol

34. Hycortole

35. Penecort

36. Permicort

37. Tarcortin

38. Traumaide

39. Alacort

40. Cleiton

41. Epicort

42. Dihydrocostisone

43. Hytone Lotion

44. Hidro-colisona

45. Hydro-adreson

46. Scheroson F

47. Incortin-h

48. Reichstein's Substance M

49. Ala-scalp

50. Domolene-hc

51. Epiderm H

52. Esiderm H

53. Otosone-f

54. Polcort H

55. Aeroseb-hc

56. Cortolotion

57. Cortoxide

58. Cremesone

59. Eldercort

60. Heb-cort

61. Maintasone

62. Nutracort

63. Delacort

64. Dioderm

65. Mildison

66. Rectoid

67. Synacort

68. Anflam

69. Hydrocorticosterone

70. Hydroxycortisone

71. H-cort

72. Hydro-colisona

73. Cortisol Alcohol

74. Incortin-hydrogen

75. Ala-cort

76. Barseb Hc

77. Dermocortal

78. Flexicort

79. Texacort

80. Timocort

81. Evacort

82. Komed Hc

83. Hydrocortisone Base

84. Lacticare-hc

85. Texacort Lotion 25

86. Anti-inflammatory Hormone

87. Hydrocortisone Alcohol

88. Algicirtis

89. Aquacort

90. Colocort

91. Cortesal

92. Cortisolonum

93. Hidalone

94. Hytisone

95. Kyypakkaus

96. Lactisona

97. Lubricort

98. Meusicort

99. Milliderm

100. Sanatison

101. Schericur

102. Sigmacort

103. Stiefcorcil

104. Amberin

105. Cutisol

106. Dermil

107. Glycort

108. Uniderm

109. Foille Insetti

110. Gyno-cortisone

111. Balneol-hc

112. Transderma H

113. Basan-corti

114. Clear Aid

115. Cremicort-h

116. Dome-cort

117. Stie-cort

118. Beta-hc

119. Neosporin-h Ear

120. Remederm Hc

121. Aquanil Hc

122. Cortisporin Otico

123. Derm-aid

124. Heb Cort

125. Nogenic Hc

126. Scalpicin Capilar

127. Systral Hydrocort

128. Prevex Hc

129. Cortisporin

130. Efcortelin

131. Fiocortril

132. Hidrocortisona

133. Hydrocortisone Free Alcohol

134. Hydrocortisonum

135. Proctofoam

136. Alphaderm

137. Hydracort

138. Medicort

139. Otocort

140. Zenoxone

141. Drotic

142. Vytone

143. 11beta-hydroxycortisone

144. Nystaform-hc

145. Aeroseb Hc

146. Caldecort Spray

147. Anusol Hc

148. Pediotic Suspension

149. Vosol Hc

150. Idrocortisone

151. 17alpha-hydroxycorticosterone

152. Hydrocortal

153. Hydroskin

154. Otalgine

155. Otobiotic

156. Plenadren

157. Protocort

158. Hysone

159. Racet

160. Ef Corlin

161. 11beta-hydrocortisone

162. Compound F

163. Lacticare Hc

164. Compound F (kendall)

165. 11-beta-hydrocortisone

166. 11-beta-hydroxycortisone

167. Hydrocortisone (cortisol)

168. Chronocort

169. Hydrocort

170. Preparation H Hydrocortisone Cream

171. Neo-cort-dome

172. 11beta,17alpha,21-trihydroxy-4-pregnene-3,20-dione

173. Otic-neo-cort-dome

174. 11beta,17,21-trihydroxypregn-4-ene-3,20-dione

175. Nsc 10483

176. Hc

177. [3h]cortisol

178. Nsc-10483

179. (11beta)-11,17,21-trihydroxypregn-4-ene-3,20-dione

180. Prestwick_265

181. (8s,9s,10r,11s,13s,14s,17r)-11,17-dihydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl-2,6,7,8,9,11,12,14,15,16-decahydro-1h-cyclopenta[a]phenanthren-3-one

182. 4-pregnene-11beta,17alpha,21-triol-3,20-dione

183. Chebi:17650

184. 11beta,17alpha,21-trihydroxypregn-4-ene-3,20-dione

185. Nsc10483

186. 11.beta.-hydrocortisone

187. Dermaspray

188. Wi4x0x7bpj

189. 11beta,17,21-trihydroxyprogesterone

190. 11.beta.-hydroxycortisone

191. Ophthocort

192. Terra-cortril

193. Mls000069609

194. 17.alpha.-hydroxycorticosterone

195. Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11.beta.)-

196. Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11beta)-

197. 4-pregnen-11beta,17alpha,21-triol-3,20-dione

198. Idrocortisone [dcit]

199. Genacort (lotion)

200. Anucort

201. Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11b)-

202. Prepcort

203. Smr000059022

204. Dsstox_cid_714

205. Hydrocortisonum [inn-latin]

206. Proctozone Hc

207. Scalp-cort

208. Hidrocortisona [inn-spanish]

209. Rectasol-hc

210. Anucort-hc

211. Hydro-rx

212. Dsstox_rid_75753

213. Dsstox_gsid_20714

214. (8s,9s,10r,11s,13s,14s,17r)-11,17-dihydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-1h-cyclopenta[a]phenanthren-3(2h)-one

215. Hc (hydrocortisone)

216. 11.beta.,17,21-trihydroxypregn-4-ene-3,20-dione

217. Corhydron

218. (11alpha,14beta)-11,17,21-trihydroxypregn-4-ene-3,20-dione

219. Duocort

220. Hydrocortisone In Absorbase

221. Proctosol-hc

222. Hc #1

223. Hc #4

224. Acticort (tn)

225. Colocort (tn)

226. (1s,2r,10s,11s,14r,15s,17s)-14,17-dihydroxy-14-(2-hydroxyacetyl)-2,15-dimethyltetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadec-6-en-5-one

227. Smr000653523

228. Cortef (tn)

229. Hytone (tn)

230. Ccris 5854

231. Component Of Otalgine

232. Anusol Hc (tn)

233. Component Of Lubricort

234. Cor-oticin

235. Hsdb 3339

236. Einecs 200-020-1

237. Unii-wi4x0x7bpj

238. Mfcd00011654

239. Component Of Neo-cort-dome

240. Cortizol

241. Efmody

242. Ai3-25006

243. 3h-cortisol

244. 11beta-cortisol

245. Cas-50-23-7

246. 11-hydrocortisone

247. Plenadren (tn)

248. Ncgc00022848-06

249. 11b-hydrocortisone

250. Hydrocortisone [usp:inn:ban:jan]

251. Drotic (salt/mix)

252. 11b-hydroxycortisone

253. Otocort (salt/mix)

254. Pregn-4-ene-3,20-dione, 11beta,17,21-trihydroxy-

255. Otalgine (salt/mix)

256. Hydrocortisone, 98%

257. 11,17,21-trihydroxypregn-4-ene-3,20-dione

258. Alkindi Sprinkle

259. Alphaderm (salt/mix)

260. Hydrocortisone, Topical

261. Otobiotic (salt/mix)

262. 4p6x

263. Cort-quin (salt/mix)

264. Cortisporin (salt/mix)

265. Vosol Hc (salt/mix)

266. 11a-hydroxycorticosterone

267. 17a-hydroxycorticosterone

268. Opera_id_1292

269. Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11-beta)-

270. Prestwick0_000447

271. Prestwick1_000447

272. Prestwick2_000447

273. Prestwick3_000447

274. Epitope Id:174851

275. Upcmld-dp133

276. Ec 200-020-1

277. H 4001

278. Hydrocortisone [ii]

279. Hydrocortisone [mi]

280. Schembl4148

281. Neo-cort-dome (salt/mix)

282. Hydrocortisone [inn]

283. Hydrocortisone [jan]

284. Lopac0_000594

285. 11alpha-hydroxycorticosterone

286. Bspbio_000494

287. Hydrocortisone [hsdb]

288. Mls001148103

289. Mls002207135

290. Mls002222189

291. Mls002548868

292. Hydrocortisone [vandf]

293. Spbio_002433

294. Hydrocortisone [mart.]

295. Bpbio1_000544

296. Chembl389621

297. Gtpl2868

298. Hydrocortisone [usp-rs]

299. Hydrocortisone [who-dd]

300. Hydrocortisone [who-ip]

301. Pediotic Suspension (salt/mix)

302. Dtxsid7020714

303. Upcmld-dp133:001

304. Bdbm13775

305. Otic-neo-cort-dome (salt/mix)

306. 2v95

307. Hydrocortisone (jp17/usp/inn)

308. Hms1569i16

309. Hms2090m04

310. Hms2096i16

311. Hms2230b18

312. Hms2235f17

313. Hms3259c05

314. Hms3261h10

315. Hms3713i16

316. Hydrocortisone, >=98% (hplc)

317. Vioform-hydrocortisone (salt/mix)

318. 11b,17,21-trihydroxyprogesterone

319. Hydrocortisone [green Book]

320. Bcp09054

321. Hy-n0583

322. Hydrocortisone [orange Book]

323. Tox21_110883

324. Tox21_200815

325. Tox21_500594

326. Hydrocortisone [ep Monograph]

327. Lmst02030001

328. S1696

329. Zinc13540519

330. Hydrocortisone [usp Monograph]

331. Akos001582651

332. Hydrocortisonum [who-ip Latin]

333. Oticair Component Hydrocortisone

334. Otocort Component Hydrocortisone

335. Tox21_110883_1

336. Ccg-204683

337. Db00741

338. Lp00594

339. Nc00456

340. Sdccgsbi-0050576.p003

341. 11.beta.,17,21-trihydroxyprogesterone

342. Cipro Hc Component Hydrocortisone

343. Orlex Hc Component Hydrocortisone

344. Otobione Component Hydrocortisone

345. Pediotic Component Hydrocortisone

346. Pyocidin Component Hydrocortisone

347. Smp1_000156

348. Vosol Hc Component Hydrocortisone

349. Alphaderm Component Hydrocortisone

350. Ncgc00022848-07

351. Ncgc00022848-09

352. Ncgc00022848-10

353. Ncgc00022848-11

354. Ncgc00022848-12

355. Ncgc00022848-13

356. Ncgc00022848-14

357. Ncgc00022848-15

358. Ncgc00022848-17

359. Ncgc00022848-26

360. Ncgc00258369-01

361. Ncgc00261279-01

362. Otobiotic Component Hydrocortisone

363. (1s,10s,11s,15s,17s,2r,14r)-14,17-dihydroxy-14-(2-hydroxyacetyl)-2,15-dimethyl Tetracyclo[8.7.0.0<2,7>.0<11,15>]heptadec-6-en-5-one

364. (8s,9s,10r,11s,13s,14s,17r)-11,17-dihydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl-1,2,6,7,8,9,10,11,12,13,14,15,16,17-tetradecahydro-3h-cyclopenta[a]phenanthren-3-one

365. Ac-12902

366. As-11651

367. Bp-20390

368. Hydrocortisone 100 Microg/ml In Methanol

369. Hydrocortisone Component Of Oticair

370. Hydrocortisone Component Of Otocort

371. Nci60_000118

372. Acetasol Hc Component Hydrocortisone

373. Calmurid Hc Component Hydrocortisone

374. Hydrocortisone Component Of Otobione

375. Hydrocortisone Component Of Pediotic

376. Hydrocortisone Component Of Pyocidin

377. 4-pregnene-11alpha,21-triol 3,20-dione

378. Hydrocortisone Component Of Alphaderm

379. Hydrocortisone Component Of Cipro Hc

380. Hydrocortisone Component Of Orlex Hc

381. Hydrocortisone Component Of Otobiotic

382. Hydrocortisone Component Of Vosol Hc

383. B1951

384. Eu-0100594

385. Prednisolone Impurity A [ep Impurity]

386. 4-pregnene-11b,17a,21-triol-3,20-dione

387. Hydrocortisone 100 Microg/ml In Acetonitrile

388. Hydrocortisone Component Of Acetasol Hc

389. Hydrocortisone Component Of Calmurid Hc

390. 50h237

391. C00735

392. D00088

393. U 1851

394. Hydrocortisone, Meets Usp Testing Specifications

395. Pregn-4-ene-3, 11.beta.,17,21-trihydroxy-

396. 11?,17?,21-trihydroxypregn-4-ene-3,20-dione

397. A929789

398. Hydrocortisone, Vetranal(tm), Analytical Standard

399. Q190875

400. Sr-01000000139

401. Q-201211

402. Sr-01000000139-3

403. Brd-k93568044-001-03-1

404. Brd-k93568044-001-11-4

405. Brd-k93568044-001-32-0

406. Hydrocortisone Acetate Impurity A [ep Impurity]

407. Hydrocortisone, Bioreagent, Suitable For Cell Culture

408. 4-pregnen-11.beta.,17.alpha.,21-triol-3,20-dione

409. 4-pregnene-11.beta.,17.alpha.,21-triol-3,20-dione

410. Pregn-4-ene-3,20-dione, 11.beta.,17,21-trihydroxy-

411. Z2786051549

412. (11beta)-11,17,21-trihydroxy-pregn-4-ene-3,20-dione

413. 11.beta.,17.alpha.,21-trihydroxy-4-pregnene-3,20-dione

414. 11.beta.,17.alpha.,21-trihydroxypregn-4-ene-3,20-dione

415. B48448a1-24ba-47ca-8d9e-43e5bc949386

416. Hydrocortisone, British Pharmacopoeia (bp) Assay Standard

417. Pregn-4-ene-3, 11,17,21-trihydroxy-, (11.beta.)-

418. 11,17,21-trihydroxypregn-4-ene-3,20-dione, (11.beta.)-

419. Hydrocortisone Sodium Succinate Impurity A [ep Impurity]

420. Hydrocortisone, European Pharmacopoeia (ep) Reference Standard

421. Hydrocortisone Hydrogen Succinate Impurity A [ep Impurity]

422. Hydrocortisone, United States Pharmacopeia (usp) Reference Standard

423. Hydrocortisone-water Soluble, Bioreagent, Suitable For Cell Culture

424. Hydrocortisone, Gamma-irradiated, Powder, Bioxtra, Suitable For Cell Culture

425. 4-(6-chloro-4-oxoquinazolin-3(4h)-yl)-n-(3-methoxyphenyl)piperidine-1-carboxamide

426. Cortisol Solution, 1.0 Mg/ml In Methanol, Ampule Of 1 Ml, Certified Reference Material

427. Hydrocortisone For Peak Identification, European Pharmacopoeia (ep) Reference Standard

428. Hydrocortisone Solution, 50 Mum, Sterile-filtered, Bioxtra, Suitable For Cell Culture

429. Hydrocortisone, Pharmaceutical Secondary Standard; Certified Reference Material

430. (10r,13s,17r)-11,17-dihydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl-2,6,7,8,9,11,12,14,15,16-decahydro-1h-cyclopenta[a]phenanthren-3-one

2.4 Create Date
2004-09-16
3 Chemical and Physical Properties
Molecular Weight 362.5 g/mol
Molecular Formula C21H30O5
XLogP31.6
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count5
Rotatable Bond Count2
Exact Mass362.20932405 g/mol
Monoisotopic Mass362.20932405 g/mol
Topological Polar Surface Area94.8 Ų
Heavy Atom Count26
Formal Charge0
Complexity684
Isotope Atom Count0
Defined Atom Stereocenter Count7
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 22  
Drug NameALA-CORT
Active IngredientHYDROCORTISONE
CompanyCROWN LABS (Application Number: A080706)

2 of 22  
Drug NameALA-SCALP
Active IngredientHYDROCORTISONE
CompanyCROWN LABS (Application Number: A083231)

3 of 22  
Drug NameANUSOL HC
Active IngredientHYDROCORTISONE
CompanySALIX PHARMS (Application Number: A088250)

4 of 22  
Drug NameCOLOCORT
Active IngredientHYDROCORTISONE
CompanyPADDOCK LLC (Application Number: A075172)

5 of 22  
Drug NameCORTEF
Active IngredientHYDROCORTISONE
CompanyPHARMACIA AND UPJOHN (Application Number: N008697)

6 of 22  
Drug NameCORTENEMA
Active IngredientHYDROCORTISONE
CompanyANI PHARMS (Application Number: N016199)

7 of 22  
Drug NameHYDROCORTISONE IN ABSORBASE
Active IngredientHYDROCORTISONE
CompanyCMP PHARMA INC (Application Number: A088138)

8 of 22  
Drug NameHYDROCORTISONE
Active IngredientHYDROCORTISONE
CompanyACTAVIS MID ATLANTIC (Application Number: A087795); ACTAVIS MID ATLANTIC (Application Number: A087796); ACTAVIS MID ATLANTIC (Application Number: A089682); FOUGERA PHARMS INC (Application Number: A080693); FOUGERA PHARMS INC (Application Number: A081203); FOUGERA PHARMS INC (Application Number: A089414); FOUGERA PHARMS (Application Number: A040351); FOUGERA PHARMS (Application Number: A080692); HIKMA INTL PHARMS (Application Number: A083365); IMPAX LABS INC (Application Number: A040646); PERRIGO NEW YORK (Application Number: A085025); PERRIGO NEW YORK (Application Number: A085027); PII (Application Number: A207029); RISING PHARMS INC (Application Number: A040879); TARO (Application Number: A040247); TARO (Application Number: A086257); TARO (Application Number: A088799); TEVA PHARMS (Application Number: A074171); VINTAGE PHARMS (Application Number: A040417); VINTAGE PHARMS (Application Number: A040503); VINTAGE (Application Number: A040761)

9 of 22  
Drug NameSTIE-CORT
Active IngredientHYDROCORTISONE
CompanyPERRIGO CO (Application Number: A089074)

10 of 22  
Drug NameTEXACORT
Active IngredientHYDROCORTISONE
CompanyMISSION PHARMA (Application Number: A081271)

11 of 22  
Drug NameACETASOL HC
Active IngredientACETIC ACID, GLACIAL; HYDROCORTISONE
CompanyACTAVIS MID ATLANTIC (Application Number: A087143)

12 of 22  
Drug NameHYDROCORTISONE AND ACETIC ACID
Active IngredientACETIC ACID, GLACIAL; HYDROCORTISONE
CompanyTARO (Application Number: A088759); VINTAGE (Application Number: A040609)

13 of 22  
Drug NameVOSOL HC
Active IngredientACETIC ACID, GLACIAL; HYDROCORTISONE
CompanyHI TECH PHARMA (Application Number: N012770)

14 of 22  
Drug NameXERESE
Active IngredientACYCLOVIR; HYDROCORTISONE
CompanyVALEANT BERMUDA (Application Number: N022436. Patents: 6514980, 7223387)

15 of 22  
Drug NameCIPRO HC
Active IngredientCIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE
CompanyNOVARTIS PHARMS CORP (Application Number: N020805)

16 of 22  
Drug NameCORTISPORIN
Active IngredientHYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
CompanyMONARCH PHARMS (Application Number: N050218)

17 of 22  
Drug NameCASPORYN HC
Active IngredientHYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
CompanyCASPER PHARMA LLC (Application Number: N060613)

18 of 22  
Drug NameCORTISPORIN
Active IngredientHYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
CompanyMONARCH PHARMS (Application Number: N050479)

19 of 22  
Drug NameNEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
Active IngredientHYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
CompanyAMRING PHARMS (Application Number: A065216); AMRING PHARMS (Application Number: A065219); BAUSCH AND LOMB (Application Number: A064053); SANDOZ INC (Application Number: A062423); SANDOZ INC (Application Number: A062488); SANDOZ INC (Application Number: A062874)

20 of 22  
Drug NameOTICAIR
Active IngredientHYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
CompanyBAUSCH AND LOMB (Application Number: A064065)

21 of 22  
Drug NameCORTISPORIN
Active IngredientBACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
CompanyMONARCH PHARMS (Application Number: N050168)

22 of 22  
Drug NameNEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE
Active IngredientBACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
CompanyAKORN (Application Number: A065213); BAUSCH AND LOMB (Application Number: A064068)

4.2 Therapeutic Uses

Anti-Inflammatory Agents, Steroidal

National Library of Medicine's Medical Subject Headings online file (MeSH, 1999)


MEDICATION (VET): Acute urticaria /can be treated by/ rapid-acting adrenocorticosteroids, eg, hydrocortisone ... .

Kahn, C.M. (Ed.); The Merck Veterinary Manual 9th ed. Merck & Co. Whitehouse Station, NJ. 2005, p. 690


MEDICATION (VET): /USED/ IV, IN PREVENTING OR TREATING ADRENAL FAILURE & SHOCK-LIKE CONDITIONS IN SURGICAL CASES WHICH HAVE BEEN ON CORTICOSTEROIDS, IN ACUTE ALLERGIC REACTIONS...IN POOR SURGICAL RISKS, & IN CASES WHICH HAVE HAD OVERWHELMING SYSTEMIC INFECTIONS...IN DOGS OR CATTLE...

Rossoff, I.S. Handbook of Veterinary Drugs. New York: Springer Publishing Company, 1974., p. 266


MEDICATION (VET) /EXPL:/: 5 Standardbreds and 4 Dutch Warmblood horses /were/ used to examine sensitivity of peripheral tissues to exogenous insulin 24 hours after administration of a single dose of hydrocortisone (0.06 mg/kg), eGH (20 ug/kg), or saline (0.9% NaCl) solution and after long-term administration (11 to 15 days) of eGH to horses. The amounts of metabolized glucose (M) and plasma insulin concentration (I) were determined. Values for M and the M-to-I ratio were significantly higher 24 hours after administration of a single dose of hydrocortisone than after single-dose administration of eGH or saline solution. After long-term administration of eGH, basal I concentration was increased and the mean M-to-I ratio was 22% lower, compared with values for horses treated with saline solution. Increases in M and the M-to-I ratio after a single dose of hydrocortisone imply that short-term hydrocortisone treatment increases glucose use by, and insulin sensitivity of, peripheral tissues. Assuming a single dose of hydrocortisone improves sensitivity of peripheral tissues to insulin, it may be an interesting candidate for use in reducing insulin resistance in peripheral tissues of horses with several disease states.

PMID:6334949 de Graaf-Roelfsema E et al; Am J Vet Res 66 (11): 1907-13 (2005)


For more Therapeutic Uses (Complete) data for HYDROCORTISONE (23 total), please visit the HSDB record page.


4.3 Drug Warning

It is not known whether rectal corticosteroids are distributed into breast milk. Systemic corticosteroids are distributed into breast milk and may cause unwanted effects, such as growth suppression, in the infant. Rectal corticosteroids are not recommended for use by breast-feeding mothers. /Corticosteroids, rectal/

Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007., p. 913


The results of a prospective randomized controlled trial, which looked at the incidence of postoperative diabetes insipidus following the use of three different hydrocortisone protocols, and the results of a study, on the incidence of diabetes insipidus and cortisol response in patients not given hydrocortisone /was reported/. In study 1, 114 patients with pituitary macroadenoma were randomized into three groups: conventional dose (injected hydrocortisone 100 mg IV 6-hourly for 3 days); intermediate dose (injected hydrocortisone 100 mg IV 6-hourly on day 1, 100 mg IV 8-hourly on day 2, and 100 mg IV 12-hourly on day 3); low dose protocol (injected hydrocortisone 25 mg IV 6-hourly on day 1, 25 mg IV 8-hourly on day 2 and 25 mg IV 12-hourly on day 3). Radical excision was achieved in 92 patients. The incidence of diabetes insipidus with the conventional dose was 52%, intermediate dose, 36% and low dose, 24% (p = 0.025). Study 2 included 16 consecutive patients with Hardy's grade A & B pituitary adenoma. These patients were randomized to receive (Group I) or not receive (Group II) hydrocortisone. Patients in Group II demonstrated normal cortisol response intraoperatively and no patient developed features of hypocortisolism; the incidence of diabetes insipidus in this group was 14%. The low dose hydrocortisone protocol reduced the incidence of diabetes insipidus by 46% when compared with the conventional dose hydrocortisone protocol. In patients with grade A and B tumor with normal preoperative cortisol levels, the use of perioperative hydrocortisone can be avoided.

PMID:14635749 Rajaratnam S et al; Br J Neurosurg 17 (5): 437-42 (2003)


ACUTE ADRENAL INSUFFICIENCY RESULTS FROM TOO RAPID WITHDRAWAL OF CORTICOSTEROID THERAPY. /CORTICOSTEROIDS/

Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 1496


POTENTIAL ADVERSE EFFECTS ON FETUS: Cleft palate, spontaneous abortions, and intrauterine growth retardation in animals. Potential for cleft palate formation and adrenal suppression in humans, although teratogenic effects have not been confirmed. POTENTIAL SIDE EFFECTS ON BREAST-FED INFANT: Passes into breast milk in small amounts. Administration of physiologic doses unlikely to adversely affect infant. FDA Category: C (C = Studies in laboratory animals have revealed adverse effects on the fetus (teratogenic, embryocidal, etc.) but there are no controlled studies in pregnant women. The benefits from use of the drug in pregnant women may be acceptable despite its potential risks, or there are no laboratory animal studies or adequate studies in pregnant women.) /Adrenocorticosteroids/ /from table II/

PMID:2195076 Stockton DL, Palle AS; J Am Acad Dermatol 23 (1): 87-103 (1990)


For more Drug Warnings (Complete) data for HYDROCORTISONE (31 total), please visit the HSDB record page.


4.4 Drug Indication

Otic solutions are indicated for infections of the external auditory canal caused by susceptible organisms and with inflammation. Hydrocortisone tablets are indicated for certain endocrine, rheumatic, collagen, allergic, ophthalmic, respiratory, hematologic, neoplastic, edematous, gastrointestinal, and other conditions. A hydrocortisone enema is indicated for ulcerative colitis, a topical ointment with antibiotics is indicated for corticosteroid responsive dermatoses with infections, and a topical cream with [acyclovir] is indicated to treat cold sores. Oral granules of hydrocortisone are used as a replacement therapy for Adrenocortical Insufficiency (AI) in children under 17 years of age.


FDA Label


Replacement therapy of adrenal insufficiency in infants, children and adolescents (from birth to < 18 years old).


Treatment of adrenal insufficiency in adults.


Treatment of adrenocortical insufficiency


Treatment of congenital adrenal hyperplasia (CAH) in adolescents aged 12 years and over and adults.


5 Pharmacology and Biochemistry
5.1 Pharmacology

Hydrocortisone binds to the glucocorticoid receptor leading to downstream effects such as inhibition of phospholipase A2, NF-kappa B, other inflammatory transcription factors, and the promotion of anti-inflammatory genes. Hydrocortisone has a wide therapeutic index and a moderate duration of action. Patients should stop taking the medication if irritation or sensitization occurs.


5.2 MeSH Pharmacological Classification

Anti-Inflammatory Agents

Substances that reduce or suppress INFLAMMATION. (See all compounds classified as Anti-Inflammatory Agents.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
HYDROCORTISONE
5.3.2 FDA UNII
WI4X0X7BPJ
5.3.3 Pharmacological Classes
Corticosteroid [EPC]; Corticosteroid Hormone Receptor Agonists [MoA]
5.4 ATC Code

H02AB09


H02AB09


H02AB09


D07AA02

S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355


A - Alimentary tract and metabolism

A01 - Stomatological preparations

A01A - Stomatological preparations

A01AC - Corticosteroids for local oral treatment

A01AC03 - Hydrocortisone


A - Alimentary tract and metabolism

A07 - Antidiarrheals, intestinal antiinflammatory/antiinfective agents

A07E - Intestinal antiinflammatory agents

A07EA - Corticosteroids acting locally

A07EA02 - Hydrocortisone


C - Cardiovascular system

C05 - Vasoprotectives

C05A - Agents for treatment of hemorrhoids and anal fissures for topical use

C05AA - Corticosteroids

C05AA01 - Hydrocortisone


D - Dermatologicals

D07 - Corticosteroids, dermatological preparations

D07A - Corticosteroids, plain

D07AA - Corticosteroids, weak (group i)

D07AA02 - Hydrocortisone


D - Dermatologicals

D07 - Corticosteroids, dermatological preparations

D07X - Corticosteroids, other combinations

D07XA - Corticosteroids, weak, other combinations

D07XA01 - Hydrocortisone


H - Systemic hormonal preparations, excl. sex hormones and insulins

H02 - Corticosteroids for systemic use

H02A - Corticosteroids for systemic use, plain

H02AB - Glucocorticoids

H02AB09 - Hydrocortisone


S - Sensory organs

S01 - Ophthalmologicals

S01B - Antiinflammatory agents

S01BA - Corticosteroids, plain

S01BA02 - Hydrocortisone


S - Sensory organs

S01 - Ophthalmologicals

S01C - Antiinflammatory agents and antiinfectives in combination

S01CB - Corticosteroids/antiinfectives/mydriatics in combination

S01CB03 - Hydrocortisone


S - Sensory organs

S02 - Otologicals

S02B - Corticosteroids

S02BA - Corticosteroids

S02BA01 - Hydrocortisone


5.5 Absorption, Distribution and Excretion

Absorption

Oral hydrocortisone at a dose of 0.2-0.3mg/kg/day reached a mean Cmax of 32.69nmol/L with a mean AUC of 90.63h\*nmol/L A 0.4-0.6mg/kg/day dose reached a mean Cmax of 70.81nmol/L with a mean AUC of 199.11h\*nmol/L. However, the pharmacokinetics of hydrocortisone can vary by 10 times from patient to patient. Topical hydrocortisone cream is 4-19% bioavailable[8546995] with a Tmax of 24h. Hydrocortisone retention enemas are have a bioavailability of 0.810 for slow absorbers and 0.502 in rapid absorbers. Slow absorbers take up hydrocortisone at a rate of 0.3610.255/h while fast absorbers take up hydrocortisone at a rate of 1.050.255/h. A 20mg IV dose of hydrocortisone has an AUC of 1163277ng\*h/mL.


Route of Elimination

Corticosteroids are eliminated predominantly in the urine. However, data regarding the exact proportion is not readily available.


Volume of Distribution

Total hydrocortisone has a volume of distribution of 39.82L, while the free fraction has a volume of distribution of 474.38L.


Clearance

Total hydrocortisone by the oral route has a mean clearance of 12.85L/h, while the free fraction has a mean clearance of 235.78L/h. A 20mg IV dose of hydrocortisone has a clearance of 18.24.2L/h.


Following percutaneous penetration of a topical corticosteroid, the drug that is systemically absorbed probably follows the metabolic pathways of systemically administered corticosteroids. Corticosteroids usually are metabolized in the liver and excreted by the kidneys. Some topical corticosteroids and their metabolites are excreted in bile. /Topical corticosteroids/

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2007., p. 3525


Topical application of corticosteroids to the mucosa of the genitourinary or lower intestinal tract may result in substantial systemic absorption of the drugs. In healthy individuals, as much as 30-90% of rectally administered hydrocortisone as a retention enema may be absorbed. Greater amounts of hydrocortisone may be absorbed rectally if the intestinal mucosa is inflamed.

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2007., p. 3525


Following topical application of a corticosteroid to most areas of normal skin, only minimal amounts of the drug reach the dermis and subsequently the systemic circulation; however, absorption is markedly increased when the skin has lost its keratin layer and can be increased by inflammation and/or diseases of the epidermal barrier (e.g., psoriasis, eczema). The drugs are absorbed to a greater degree from the scrotum, axilla, eyelid, face, and scalp than from the forearm, knee, elbow, palm, and sole. Even after washing the area being treated, prolonged absorption of the corticosteroid occurs, possibly because the drug is retained in the stratum corneum. /Topical corticosteroids/

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2007., p. 3525


Percutaneous penetration of corticosteroids varies among individual patients and can be increased by the use of occlusive dressings, by increasing the concentration of the corticosteroid, and by using different vehicles. The use of an occlusive dressing with hydrocortisone for 96 hours substantially enhances percutaneous penetration of the drug; however, such use for up to 24 hours does not appear to alter penetration of topically applied hydrocortisone.

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2007., p. 3525


For more Absorption, Distribution and Excretion (Complete) data for HYDROCORTISONE (15 total), please visit the HSDB record page.


5.6 Metabolism/Metabolites

Hydrocortisone is metabolised to 6-beta hydrocortisol via CYP3A, 5-beta tetrahydrocortisol via 3-oxo-5-beta-steroid 4-dehydrogenase, 5-alpha tetrahydrocortisol via 3-oxo-5-alpha-steroid 4-dehydrogenase 2, cortisone via Corticosteroid 11-beta-dehydrogenase isozyme 1 and Corticosteroid 11-beta-dehydrogenase isozyme 2, and glucuronide products. Cortisone is further metabolized to tetrahydrocortisone and dihydrocortisol.


A study was made of the absorption of exogenous hydrocortisone and formation of its metabolites in isolated liver of intact and exposed rats in conditions of recirculating perfusion. It was shown that the absorption of the hormone by the liver of irradiated rats was greatly lowered but the content of most metabolites found in the perfused medium of irradiated liver increased as compared to the control. It is suggested that irradiation inhibits subsequent transformations of the hydrocortisone metabolism products.

PMID:4001319 Litskevich LA, Dokshina GA; Radiobiologiia 25 (2): 200-3 (1985)


Subcellular distribution of (3)H-hydrocortisone and its metabolites in the liver and kidney of intact and alloxan diabetic rats was investigated. Ten minutes after the administration of this hormone several metabolites (mostly tetrahydrocortisol) and the native hormone were found in liver cytosol, microsomes, mitochondria and nuclei, the relative content of individual compounds in various subcellular fractions being different. In liver mitochondria, microsomes and nuclei of alloxan diabetic rats the concentration of tetrahydrocortisol was decreased, while that of native hormone was increased as compared to normal animals. It was suggested that such changes found in diabetic animals may be one of the causes of increased sensitivity of transcription and translation processes to glucocorticoids. In kidney cytosol and microsomes of intact rats cortisone and tetrahydrocortisol were found. In diabetic animals, however, the concentration of tetrahydrocortisol increased, while that of cortisone was undetectable.

PMID:3259502 Minchenko AG, Tronjko ND; Endocrinol Exp 22 (1): 19-28 (1988)


5.7 Biological Half-Life

Total hydrocortisone via the oral route has a half life of 2.15h while the free fraction has a half life of 1.39h. A 20mg IV dose of hydrocortisone has a terminal half life of 1.90.4h.


... After IV administration, hydrocortisone was eliminated with a total body clearance of 18 L/hr and a half-life of 1.7 hr.

PMID:2050835 Derendorf H et al; J Clin Pharmacol 31 (5): 473-6 (1991)


5.8 Mechanism of Action

The short term effects of corticosteroids are decreased vasodilation and permeability of capillaries, as well as decreased leukocyte migration to sites of inflammation. Corticosteroids binding to the glucocorticoid receptor mediates changes in gene expression that lead to multiple downstream effects over hours to days. Glucocorticoids inhibit neutrophil apoptosis and demargination; they inhibit phospholipase A2, which decreases the formation of arachidonic acid derivatives; they inhibit NF-Kappa B and other inflammatory transcription factors; they promote anti-inflammatory genes like interleukin-10. Lower doses of corticosteroids provide an anti-inflammatory effect, while higher doses are immunosuppressive. High doses of glucocorticoids for an extended period bind to the mineralocorticoid receptor, raising sodium levels and decreasing potassium levels.


Following topical application, corticosteroids produce anti-inflammatory, antipruritic, and vasoconstrictor actions. The activity of the drugs is thought to result at least in part from binding with a steroid receptor. Corticosteroids decrease inflammation by stabilizing leukocyte lysosomal membranes, preventing release of destructive acid hydrolases from leukocytes; inhibiting macrophage accumulation in inflamed areas; reducing leukocyte adhesion to capillary endothelium; reducing capillary wall permeability and edema formation; decreasing complement components; antagonizing histamine activity and release of kinin from substrates; reducing fibroblast proliferation, collagen deposition, and subsequent scar tissue formation; and possibly by other mechanisms as yet unknown. Corticosteroids, especially the fluorinated corticosteroids, have antimitotic activity on cutaneous fibroblasts and the epidermis. /Corticosteroids/

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2007., p. 3525


Reactive oxygen species (ROS) generation by polymorphonuclear leukocytes (PMNL) and mononuclear cells (MNC) is inhibited following the intravenous administration of hydrocortisone. This is associated with a parallel decrease in intranuclear NFkappaB, known to modulate inflammatory responses including ROS generation. Plasma levels of interleukin-10 (IL-10), an anti-inflammatory and immunosuppressive cytokine produced by TH2 cells, are also increased after hydrocortisone administration. In this study, we have investigated the effect of hydrocortisone on p47(phox) subunit, a key component of nicotinamide adenine dinucleotide phosphate (NADPH) oxidase, in MNC and the pharmacodynamics of this effect with ROS generation and plasma IL-10 levels /were investigated/. p47(phox) subunit protein levels in MNC showed a progressive decrease after hydrocortisone administration. It reached a nadir at 4 hours and increased thereafter to a baseline level at 24 hours. ROS generation also decreased, reached a nadir between 2 and 4 hours, and returned to a baseline level at 24 hours. IL-10 concentrations increased, peaked at 4 hours, and reverted to the baseline levels at 24 hours. In conclusion, p47(phox) subunit suppression may contribute to the inhibition of ROS generation in MNC after hydrocortisone administration. This suppression occurs in parallel with the suppression of NFkappaB and an increase in IL-10 plasma levels. Therefore, it would appear that the decrease in intranuclear NFkappaB and an increase in IL-10 may cause the inhibitory modulation on p47(phox) subunit and ROS generation by MNC following hydrocortisone and other glucocorticoids.

PMID:11319715 Dandona P et al; Metabolism 50 (5): 548-52 (2001)


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