Details of the Active Pharmaceutical Ingredient (API)

General Information of API (ID: D00282)
Name
Fludrocortisone
Synonyms    Click to Show/Hide the Synonyms of This API
fludrocortisone; Fluorocortisone; Fluohydrisone; Fluorocortisol; Florinef; 127-31-1; Astonin-H; Fluohydrocortisone; Fludrocortone; 9alpha-Fluorocortisol; Alflorone; Fludrone; Fludronef; Fluodrocortisone; F-Cortef; 9-Fluorocortisol; Fludrocortisona; Fludrocortisonum; 9-Fluorohydrocortisone; Cortisol, 9-fluoro-; StC 1400; 9 .alpha. FF; 9.alpha.-Fluorocortisol; 9.alpha.-Fluorohydrocortisone; Corticosterone, 9-fluoro-17-hydroxy-; U 5963; NSC 11318; UNII-U0476M545B; 9-Fluoro-11beta,17,21-trihydroxypregn-4-ene-3,20-dione; 9.alpha.-Fluoro-17-hydroxycorticosterone; 127-31-1 (free); CHEBI:50885; 9 alpha FF; (11beta)-9-Fluoro-11,17,21-trihydroxypregn-4-ene-3,20-dione; LMST02030103; U0476M545B; NCGC00181081-01; 9alpha-Fludrocortisone; 9-alpha-Fluorocortisol; 9alpha-fluoro-11beta,17alpha,21-trihydroxy-pregn-4-ene-3,20-dione; DSSTox_CID_3061; 9-alpha-Fludrocortisone; Fludrocortisonum [INN-Latin]; Fludrocortisona [INN-Spanish]; DSSTox_RID_76858; DSSTox_GSID_23061; Fludrocortisone [INN:BAN]; 9-alpha-Fluorohydrocortisone; 9alpha-Fluoro-hydrocortisone; Hydrocortisone-9alpha-fluoro; CAS-127-31-1; 9alpha-Fluoro-17-hydroxycorticosterone; 9-alpha-Fluoro-17-hydroxycorticosterone; Astonin-H (TN); C21H29FO5; HSDB 3332; Fludrocortisone (INN); EINECS 204-833-2; BRN 3014278; 9-Fluoro-11-beta,17,21-trihydroxypregn-4-ene-3,20-dione; 9alpha-Fluoro-11beta,17alpha,21-trihydroxy-4-pregnene-3,20-dione; Pregn-4-ene-3,20-dione, 9-fluoro-11,17,21-trihydroxy-, (11beta)-; Prestwick_648; 9alpha-Flourocortisol; 9.alpha.-Fluorcortisol; Pregn-4-ene-3,20-dione, 9-fluoro-11beta,17,21-trihydroxy-; bmse000987; bmse001009; SCHEMBL4545; 4-08-00-03427 (Beilstein Handbook Reference); GTPL2873; CHEMBL1201388; DTXSID7023061; 9-Fluoro-11.beta.,17,21-trihydroxypregn-4-ene-3,20-dione; HY-B1203; NSC11318; Pregn-4-ene-3,20-dione, 9-fluoro-11-beta,17,21-trihydroxy-; ZINC4097304; Tox21_112700; Tox21_113344; NSC-11318; 9.alpha.-Fluoro-11.beta.,17.alpha.,21-trihydroxy-4-pregnene-3,20-dione; Tox21_113344_1; A-Fludrocortisone;9; A-Fluorcortisol; CS-4832; DB00687; NCGC00274078-01; C07004; D07967; 20529-EP2314585A1; Q2697578; W-108386; Pregn-4-ene-3, 9-fluoro-11.beta.,17,21-trihydroxy-; WLN: L E5 B666 OV MUTJ A1 BF CQ E1 FV1Q FQ; 9-Fluoro-11.beta.,21-trihydroxypregn-4-ene-3,20-dione; (11.beta.)-9-Fluoro-11,17,21-trihydroxypregn-4-ene-3,20-dione; (11alpha)-9-fluoro-11,17,21-trihydroxypregn-4-ene-3,20-dione; 9.alpha.-Fluoro-11.beta.,21-trihydroxy-4-pregnene-3,20-dione; Pregn-4-ene-3, 9-fluoro-11,17,21-trihydroxy-, (11.beta.)-; Pregn-4-ene-3,20-dione, 9-fluoro-11.beta.,17,21-trihydroxy-; Pregn-4-ene-3,20-dione,9-fluoro-11,17,21-trihydroxy-,(11; 9-Fluoro-11,17,21-trihydroxypregn-4-ene-3,20-dione, (11.beta.)- #; Pregn-4-ene-3,20-dione, 9-fluoro-11beta,17,21-trihydroxy- (8CI)
Clinical Status
Approved
Disease Indication Hyponatraemia ICD-11: 5C72 [1]
PubChem CID
31378
Formula
C21H29FO5
Canonical SMILES
C[C@]12CCC(=O)C=C1CC[C@@H]3[C@@]2([C@H](C[C@]4([C@H]3CC[C@@]4(C(=O)CO)O)C)O)F
InChI
1S/C21H29FO5/c1-18-7-5-13(24)9-12(18)3-4-15-14-6-8-20(27,17(26)11-23)19(14,2)10-16(25)21(15,18)22/h9,14-16,23,25,27H,3-8,10-11H2,1-2H3/t14-,15-,16-,18-,19-,20-,21-/m0/s1
InChIKey
AAXVEMMRQDVLJB-BULBTXNYSA-N
   Click to Show/Hide the Molecular Data (Structure/Property) of This API
Structure
<iframe style="width: 300px; height: 300px;" frameborder="0" src="https://embed.molview.org/v1/?mode=balls&cid=31378"></iframe>
3D MOL 2D MOL
Physicochemical Properties Molecular Weight 380.4 Topological Polar Surface Area 94.8
XlogP 1.7 Complexity 734
Heavy Atom Count 27 Rotatable Bond Count 2
Hydrogen Bond Donor Count 3 Hydrogen Bond Acceptor Count 6
Full List of Drug Formulations (DFMs) Containing This API
          Fludrocortisone 0.1 mg tablet Click to Show/Hide the Full List of Formulation(s):          5 Formulation(s)
             Drug Formulation 1 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Anhydrous lactose; D&c yellow no. 10; Magnesium stearate; Anhydrous dibasic calcium phosphate; Talc; Aluminum oxide; Sodium starch glycolate type a potato; Starch, corn
                   Dosage Form Oral Tablet
                   Company RemedyRepack
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Quinoline yellow WS DIG Info Estrogen receptor alpha (IC50 = 18 uM) [2]
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [3]
Calcium hydrogenphosphate DIG Info Albendazole monooxygenase (Protein expression downregulation) [3]
             Drug Formulation 2 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Anhydrous lactose; D&c yellow no. 10; Magnesium stearate; Calcium phosphate, dibasic, dihydrate; Talc; Aluminum oxide; Sodium starch glycolate type a potato; Starch, corn
                   Dosage Form Oral Tablet
                   Company PD-Rx Pharmaceuticals
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Quinoline yellow WS DIG Info Estrogen receptor alpha (IC50 = 18 uM) [2]
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [3]
             Drug Formulation 3 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Anhydrous lactose; D&c yellow no. 10; Magnesium stearate; Dibasic calcium phosphate dihydrate; Talc; Sodium starch glycolate type a potato; Starch, corn
                   Dosage Form Oral Tablet
                   Company Teva Pharmaceuticals
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Quinoline yellow WS DIG Info Estrogen receptor alpha (IC50 = 18 uM) [2]
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [3]
             Drug Formulation 4 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Lactose monohydrate; Magnesium stearate; Croscarmellose sodium; Cellulose, microcrystalline
                   Dosage Form Oral Tablet
                   Company American Health Packaging; AvKARE; AvPAK; Cardinal Health; Impax Generics; NCS HealthCare of KY, Inc dba Vangard Labs; Physicians Total Care
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [3]
Carmellose sodium DIG Info Albendazole monooxygenase (Protein expression upregulation) [3]
             Drug Formulation 5 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Anhydrous lactose; Lactose monohydrate; Magnesium stearate; Talc; Corn starch 3-e-dodecenyl succinic anhydride modified
                   Dosage Form Oral Tablet
                   Company West-Ward Pharmaceticals
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [3]
          Fludrocortisone Acetate 0.1mg tablet Click to Show/Hide the Full List of Formulation(s):          3 Formulation(s)
             Drug Formulation 1 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Anhydrous Lactose; Starch, Corn; Dibasic Calcium Phosphate Dihydrate; D&C Yellow No. 10 Aluminum Lake; Magnesium Stearate; Sodium Starch Glycolate Type A Potato; Talc
                   Dosage Form Tablet
                   Company Teva Pharmaceuticals Usa
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Quinoline yellow WS DIG Info Estrogen receptor alpha (IC50 = 18 uM) [2]
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [3]
             Drug Formulation 2 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Croscarmellose Sodium; Lactose Monohydrate; Magnesium Stearate; Cellulose, Microcrystalline
                   Dosage Form Tablet
                   Company Amneal Pharmaceuticals Ny
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [3]
Carmellose sodium DIG Info Albendazole monooxygenase (Protein expression upregulation) [3]
             Drug Formulation 3 DFM Info click to show the detail info of this DFM
                   All DIGs    Click to Show/Hide the Full List of DIGs in This DFM
Croscarmellose Sodium; Lactose Monohydrate; Magnesium Stearate; Microcrystalline Cellulose
                   Dosage Form Tablet
                   Company Cardinal Health
                   DIG(s) with
                   Biological Activity
DIG Name DIG Info Representative Biological Activity of This DIG REF
Magnesium stearate DIG Info Albendazole monooxygenase (Protein expression downregulation) [3]
Carmellose sodium DIG Info Albendazole monooxygenase (Protein expression upregulation) [3]
References
1 Management of adrenal insufficiency in different clinical settings. Expert Opin Pharmacother. 2005 Nov;6(14):2407-17.
2 The activities of drug inactive ingredients on biological targets. Science. 2020 Jul 24;369(6502):403-413.
3 Effects of commonly used excipients on the expression of CYP3A4 in colon and liver cells. Pharm Res. 2010 Aug;27(8):1703-12.

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