betamethasone dipropionate indications/contra

Stem definitionDrug idCAS RN
prednisone and prednisolone derivatives 353 5593-20-4

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • betamethasone dipropionate
  • diproderm
  • diprosone
  • Molecular weight: 504.60
  • Formula: C28H37FO7
  • CLOGP: 3.92
  • LIPINSKI: 1
  • HAC: 7
  • HDO: 1
  • TPSA: 106.97
  • ALOGS: -5.04
  • ROTB: 8

Drug dosage:

None

Approvals:

DateAgencyCompanyOrphan
Jan. 29, 1975 FDA SCHERING

FDA Adverse Event Reporting System

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MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug ineffective 83.92 43.19 38 294 116052 3269475
Cushing's syndrome 60.57 43.19 11 321 1135 3384392
Purpura senile 50.81 43.19 6 326 26 3385501
Glaucoma 45.71 43.19 10 322 2646 3382881
Erythrodermic psoriasis 44.30 43.19 7 325 311 3385216

Pharmacologic Action:

None

Drug Use (View source of the data)

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DiseaseRelationSNOMED_IDDOID
Tinea pedis indication 6020002 DOID:12403
Atopic dermatitis indication 24079001 DOID:3310
Contact dermatitis indication 40275004 DOID:2773
Seborrheic dermatitis indication 50563003 DOID:8741
Lichen simplex chronicus indication 53891004
Granuloma annulare indication 65508009 DOID:3777
Tinea corporis indication 84849002 DOID:12179
Pruritus ani indication 90446007
Discoid lupus erythematosus indication 200938002
Plaque psoriasis indication 200965009
Scalp psoriasis indication 238608008
Pruritus of genital organs indication 267802000
Eruption of skin indication 271807003 DOID:0050486
Tinea cruris indication 399029005
Primary cutaneous T-cell lymphoma indication 400122007
Congenital ichthyosis of skin contraindication 13059002
Hypervitaminosis D contraindication 27712000 DOID:9971
Guttate psoriasis contraindication 37042000
Hypercalcemia contraindication 66931009 DOID:12678
Disorder of calcium metabolism contraindication 71638002 DOID:10575
Hypercalciuria contraindication 71938000
Pustular psoriasis contraindication 200973000 DOID:8503
Telangiectasia disorder contraindication 247479008 DOID:1272
Adrenal cortical hypofunction contraindication 386584007 DOID:10493
Atrophoderma contraindication 399979006 DOID:2733
Peripheral vascular disease contraindication 400047006
Psoriasis off-label use 9014002 DOID:8893

Acid dissociation constants calculated using MoKa v3.0.0

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Dissociation levelDissociation constantType (acidic/basic)
pKa1 11.48 acidic

Orange Book patent data (new drug applications)

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Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
0.064% TACLONEX LEO PHARMA AS N021852 Jan. 9, 2006 RX OINTMENT TOPICAL 6753013 Jan. 27, 2020 PSORIASIS
0.064% TACLONEX LEO PHARMA AS N021852 Jan. 9, 2006 RX OINTMENT TOPICAL 6753013 Jan. 27, 2020 TREATMENT OF MODERATE PLAQUE PSORIASIS
0.064% TACLONEX LEO PHARMA AS N022185 May 9, 2008 RX SUSPENSION TOPICAL 6753013 Jan. 27, 2020 PLAQUE PSORIASIS
0.064% TACLONEX LEO PHARMA AS N022185 May 9, 2008 RX SUSPENSION TOPICAL 6753013 Jan. 27, 2020 PSORIASIS
0.064% TACLONEX LEO PHARMA AS N022185 May 9, 2008 RX SUSPENSION TOPICAL 6753013 Jan. 27, 2020 TREATMENT OF MODERATE PLAQUE PSORIASIS
0.064% TACLONEX LEO PHARMA AS N022185 May 9, 2008 RX SUSPENSION TOPICAL 6787529 Jan. 27, 2020 PLAQUE PSORIASIS
0.064% TACLONEX LEO PHARMA AS N022185 May 9, 2008 RX SUSPENSION TOPICAL 6787529 Jan. 27, 2020 PSORIASIS
0.064% TACLONEX LEO PHARMA AS N022185 May 9, 2008 RX SUSPENSION TOPICAL 6787529 Jan. 27, 2020 TREATMENT OF MODERATE PLAQUE PSORIASIS
0.064% ENSTILAR LEO PHARMA AS N207589 Oct. 16, 2015 RX AEROSOL, FOAM TOPICAL 6753013 Jan. 27, 2020 PLAQUE PSORIASIS
EQ 0.05% BASE/SPRAY SERNIVO PROMIUS PHARMA LLC N208079 Feb. 5, 2016 RX SPRAY TOPICAL 9364485 Aug. 31, 2030 TREATMENT OF PLAQUE PSORIASIS
EQ 0.05% BASE/SPRAY SERNIVO PROMIUS PHARMA LLC N208079 Feb. 5, 2016 RX SPRAY TOPICAL 9433630 Aug. 31, 2030 TREATMENT OF PLAQUE PSORIASIS
EQ 0.05% BASE/SPRAY SERNIVO PROMIUS PHARMA LLC N208079 Feb. 5, 2016 RX SPRAY TOPICAL 9439911 Aug. 31, 2030 TREATMENT OF PLAQUE PSORIASIS
EQ 0.05% BASE/SPRAY SERNIVO PROMIUS PHARMA LLC N208079 Feb. 5, 2016 RX SPRAY TOPICAL 9655907 Aug. 31, 2030 TREATMENT OF PLAQUE PSORIASIS
EQ 0.05% BASE/SPRAY SERNIVO PROMIUS PHARMA LLC N208079 Feb. 5, 2016 RX SPRAY TOPICAL 9775851 Aug. 31, 2030 TREATMENT OF PLAQUE PSORIASIS
EQ 0.05% BASE/SPRAY SERNIVO PROMIUS PHARMA LLC N208079 Feb. 5, 2016 RX SPRAY TOPICAL 9877974 Aug. 31, 2030 TREATMENT OF PLAQUE PSORIASIS
0.064% ENSTILAR LEO PHARMA AS N207589 Oct. 16, 2015 RX AEROSOL, FOAM TOPICAL 9119781 June 10, 2031 PLAQUE PSORIASIS

Orange Book exclusivity data (new drug applications)

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Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
0.064% ENSTILAR LEO PHARMA AS N207589 Oct. 16, 2015 RX AEROSOL, FOAM TOPICAL Oct. 16, 2018 NEW PRODUCT
EQ 0.05% BASE/SPRAY SERNIVO PROMIUS PHARMA LLC N208079 Feb. 5, 2016 RX SPRAY TOPICAL Feb. 5, 2019 NEW DOSAGE FORM

Bioactivity Summary:

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TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Glucocorticoid receptor Nuclear hormone receptor AGONIST CHEMBL CHEMBL
Glucocorticoid receptor Transcription factor IC50 8.28 CHEMBL

External reference:

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IDSource
4018642 VUID
N0000179052 NUI
C0053523 UMLSCUI
D01637 KEGG_DRUG
4018642 VANDF
19254 RXNORM
N0000146955 NDFRT
N0000179052 NDFRT
002171 NDDF
88736007 SNOMEDCT_US
4273 MMSL
3190 MMSL
826Y60901U UNII
21800 PUBCHEM_CID
CHEMBL1200384 ChEMBL_ID
C011175 MESH_SUPPLEMENTAL_RECORD_UI
DB00443 DRUGBANK_ID

Pharmaceutical products:

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ProductCategoryIngredientsNDCFormQuantityRoute MarketingLabel
DIPROLENE AF HUMAN PRESCRIPTION DRUG LABEL 1 0085-0517 CREAM 0.50 mg TOPICAL NDA 15 sections
DIPROLENE HUMAN PRESCRIPTION DRUG LABEL 1 0085-0575 OINTMENT 0.50 mg TOPICAL NDA 15 sections
Lotrisone HUMAN PRESCRIPTION DRUG LABEL 2 0085-0924 CREAM 0.50 mg TOPICAL NDA 16 sections
DIPROLENE HUMAN PRESCRIPTION DRUG LABEL 1 0085-0962 LOTION 0.50 mg TOPICAL NDA 15 sections
Betamethasone Dipropionate HUMAN PRESCRIPTION DRUG LABEL 1 0168-0055 CREAM 0.50 mg TOPICAL NDA 11 sections
Betamethasone Dipropionate HUMAN PRESCRIPTION DRUG LABEL 1 0168-0056 OINTMENT 0.50 mg TOPICAL NDA 11 sections
Betamethasone Dipropionate HUMAN PRESCRIPTION DRUG LABEL 1 0168-0057 LOTION 0.50 mg TOPICAL ANDA 11 sections
Clotrimazole and Betamethasone Dipropionate HUMAN PRESCRIPTION DRUG LABEL 2 0168-0258 CREAM 0.50 mg TOPICAL ANDA 15 sections
Betamethasone Dipropionate HUMAN PRESCRIPTION DRUG LABEL 1 0168-0265 CREAM, AUGMENTED 0.50 mg TOPICAL ANDA 15 sections
Betamethasone Dipropionate HUMAN PRESCRIPTION DRUG LABEL 1 0168-0266 GEL 0.50 mg TOPICAL ANDA 11 sections
Betamethasone Dipropionate HUMAN PRESCRIPTION DRUG LABEL 1 0168-0267 LOTION, AUGMENTED 0.50 mg TOPICAL ANDA 15 sections
Betamethasone Dipropionate HUMAN PRESCRIPTION DRUG LABEL 1 0168-0268 OINTMENT, AUGMENTED 0.50 mg TOPICAL ANDA 15 sections
Clotrimazole and Betamethasone Dipropionate HUMAN PRESCRIPTION DRUG LABEL 2 0168-0370 LOTION 0.50 mg TOPICAL ANDA 13 sections
Clotrimazole and Betamethasone Dipropionate HUMAN PRESCRIPTION DRUG LABEL 2 0472-0379 CREAM 0.50 mg TOPICAL ANDA 15 sections
Betamethasone Dipropionate HUMAN PRESCRIPTION DRUG LABEL 1 0472-0380 CREAM 0.50 mg TOPICAL ANDA 10 sections
Betamethasone Dipropionate HUMAN PRESCRIPTION DRUG LABEL 1 0472-0381 OINTMENT 0.50 mg TOPICAL ANDA 10 sections
Betamethasone Dipropionate HUMAN PRESCRIPTION DRUG LABEL 1 0472-0382 OINTMENT, AUGMENTED 0.50 mg TOPICAL ANDA 14 sections
Betamethasone Dipropionate HUMAN PRESCRIPTION DRUG LABEL 1 0713-0807 LOTION 0.50 mg TOPICAL ANDA 11 sections
CALCIPOTRIENE 0.005% AND BETAMETHASONE DIPROPIONATE 0.064% HUMAN PRESCRIPTION DRUG LABEL 2 0781-7165 OINTMENT 0.50 mg TOPICAL ANDA 16 sections
RRB Pak HUMAN PRESCRIPTION DRUG LABEL 1 15455-9552 KIT 0.50 mg TOPICAL unapproved drug other 13 sections
BETAMETHASONE DIPROPIONATE HUMAN PRESCRIPTION DRUG LABEL 1 16590-032 CREAM 0.64 mg TOPICAL ANDA 11 sections
BETAMETHASONE CLOTRIMAZOLE HUMAN PRESCRIPTION DRUG LABEL 2 16590-033 CREAM 0.64 mg TOPICAL ANDA 12 sections
Clotrimazole and Betamethasone Dipropionate HUMAN PRESCRIPTION DRUG LABEL 2 16714-496 CREAM 0.64 mg TOPICAL ANDA 16 sections
Clotrimazole and Betamethasone Dipropionate HUMAN PRESCRIPTION DRUG LABEL 2 21695-333 CREAM 0.64 mg TOPICAL ANDA 12 sections
Betamethasone Dipropionate HUMAN PRESCRIPTION DRUG LABEL 1 21695-521 CREAM 0.64 mg TOPICAL ANDA 11 sections
Betamethasone Dipropionate HUMAN PRESCRIPTION DRUG LABEL 1 21695-614 OINTMENT 0.05 mg TOPICAL ANDA 10 sections
Betamethasone Dipropionate HUMAN PRESCRIPTION DRUG LABEL 1 45802-021 LOTION 0.50 mg TOPICAL ANDA 12 sections
Betamethasone Dipropionate HUMAN PRESCRIPTION DRUG LABEL 1 45802-376 CREAM 0.50 mg TOPICAL ANDA 12 sections
Calcipotriene and Betamethasone Dipropionate HUMAN PRESCRIPTION DRUG LABEL 2 45802-989 OINTMENT 0.50 mg TOPICAL NDA authorized generic 16 sections
Betamethasone Dipropionate HUMAN PRESCRIPTION DRUG LABEL 1 49999-222 CREAM 0.50 mg TOPICAL ANDA 11 sections