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Drug ReportsDiphenoxylate
Diphenoxylate
Atropine / Diphenoxylate, Lomotil (diphenoxylate) is a small molecule pharmaceutical. Diphenoxylate was first approved as Lomotil on 1982-01-01. It is used to treat diarrhea in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Combinations
Lomotil (generic drugs available since 1982-01-01, discontinued: Colonaid, Di-atro, Lo-trol, Logen, Lomanate, Lonox, Low-quel)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Atropine sulfate
+
Diphenoxylate hydrochloride
Tradename
Company
Number
Date
Products
LOMOTILMylanN-012462 RX1982-01-01
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
diphenoxylate hcl and atropine sulfateANDA2010-03-24
diphenoxylate hydrochloride and atropine sulfateANDA2024-02-01
direct rxANDA2015-08-05
lomotilNew Drug Application2023-09-12
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
diarrheaHP_0002014D003967R19.7
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
A: Alimentary tract and metabolism drugs
A07: Antidiarrheals, intestinal antiinflammatory/antiinfective agents
A07D: Antipropulsives
A07DA: Antipropulsives
A07DA01: Diphenoxylate
HCPCS
No data
Clinical
Clinical Trials
6 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Short bowel syndromeD012778K90.8222
Postoperative nausea and vomitingD020250EFO_000488811
LymphomaD008223C85.911
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Breast neoplasmsD001943EFO_0003869C5011
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDiphenoxylate
INNdiphenoxylate
Description
Diphenoxylate is a piperidinecarboxylate ester that is the ethyl ester of difenoxin. It has a role as an antidiarrhoeal drug. It is a nitrile, a piperidinecarboxylate ester, a tertiary amine and an ethyl ester. It is functionally related to a difenoxin.
Classification
Small molecule
Drug classOpioid Antidiarrheal
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Structure (InChI/SMILES or Protein Sequence)
CCOC(=O)C1(c2ccccc2)CCN(CCC(C#N)(c2ccccc2)c2ccccc2)CC1
Identifiers
PDB
CAS-ID915-30-0
RxCUI
ChEMBL IDCHEMBL1201294
ChEBI ID4639
PubChem CID13505
DrugBankDB01081
UNII ID73312P173G (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
£
No data
Estimated US medical usage
Diphenoxylate
+
Atropine
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,404 documents
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Safety
Black-box Warning
Black-box warning for: Direct rx
Adverse Events
Top Adverse Reactions
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1,513 adverse events reported
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