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Promethazine
Fortis, Mepergan, Phenergan, Pherazine, Prometh, Prometh Fortis, Remsed, Zipan (promethazine) is a small molecule pharmaceutical. Promethazine was first approved as Mepergan on 1982-01-01. It is used to treat allergic conjunctivitis, allergic rhinitis perennial, anaphylaxis, motion sickness, and nausea amongst others in the USA. The pharmaceutical is active against histamine H1 receptor.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
respiratory tract diseasesD012140
otorhinolaryngologic diseasesD010038
eye diseasesD005128
skin and connective tissue diseasesD017437
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
psychological phenomenaD011579
musculoskeletal and neural physiological phenomenaD055687
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Codeine phosphate
+
Phenylephrine hydrochloride
+
Promethazine hydrochloride
Tradename
Company
Number
Date
Products
PHENERGAN VC W/ CODEINEANI PHARMSN-008306 DISCN1984-04-02
1 products, RLD
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Codeine phosphate
+
Promethazine hydrochloride
Tradename
Company
Number
Date
Products
PHENERGAN W/ CODEINEANI PHARMSN-008306 DISCN1984-04-02
1 products, RLD
Hide discontinued
Dextromethorphan hydrobromide
+
Promethazine hydrochloride
Tradename
Company
Number
Date
Products
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEANI PHARMSN-011265 DISCN1984-04-02
1 products, RLD
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Meperidine hydrochloride
+
Promethazine hydrochloride
Tradename
Company
Number
Date
Products
MEPERGANHikma PharmaceuticalsN-011730 DISCN1982-01-01
1 products
Hide discontinued
Phenylephrine hydrochloride
+
Promethazine hydrochloride
Tradename
Company
Number
Date
Products
PHENERGAN VCANI PHARMSN-008604 DISCN1984-04-02
1 products, RLD
Hide discontinued
Promethazine hydrochloride
Tradename
Company
Number
Date
Products
PROMETHAZINE HYDROCHLORIDE PLAINANI PHARMSN-008381 DISCN1982-01-01
2 products, RLD
PHENERGANDelcor AssetN-007935 DISCN1982-01-01
3 products, RLD
PHENERGANMylanN-010926 DISCN1982-01-01
2 products, RLD
PHENERGANMylanN-011689 DISCN1982-01-01
1 products, RLD
PHENERGANWyethN-008857 DISCN1982-01-01
2 products
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Labels
FDA
EMA
Brand Name
Status
Last Update
phenerganANDA2022-12-01
promethazine hydrochlorideANDA2023-06-08
prometheganANDA2022-07-21
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
allergic conjunctivitisEFO_0007141D003233H10.44
allergic rhinitis perennialEFO_1001417D012221J30.89
anaphylaxis—D000707T78.2
motion sickness—D009041T75.3
nauseaHP_0002018D009325R11.0
painEFO_0003843D010146R52
postoperative complications—D011183—
urticariaEFO_0005531D014581L50
vomitingHP_0002013D014839R11.1
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
D: Dermatologicals
— D04: Antipruritics, incl. antihistamines, anesthetics, etc.
— D04A: Antipruritics, incl. antihistamines, anesthetics, etc.
— D04AA: Antihistamines for topical use
— D04AA10: Promethazine
R: Respiratory system drugs
— R06: Antihistamines for systemic use
— R06A: Antihistamines for systemic use
— R06AD: Phenothiazine derivatives, systemic antihistamines
— R06AD02: Promethazine
— R06AD52: Promethazine, combinations
V: Various drug classes in atc
— V03: All other therapeutic products
— V03A: All other therapeutic products
— V03AB: Antidotes
— V03AB05: Prednisolone and promethazine
HCPCS
Code
Description
J2180
Injection, meperidine and promethazine hcl, up to 50 mg
J2550
Injection, promethazine hcl, up to 50 mg
Q0169
Promethazine hydrochloride, 12.5 mg, oral, fda approved prescription anti-emetic, for use as a complete therapeutic substitute for an iv anti-emetic at the time of chemotherapy treatment, not to exceed a 48 hour dosage regimen
Clinical
Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
No data
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 namePROMETHAZINE
INNpromethazine
Description
Promethazine is a tertiary amine that is a substituted phenothiazine in which the ring nitrogen at position 10 is attached to C-3 of an N,N-dimethylpropan-2-amine moiety. It has a role as a H1-receptor antagonist, a sedative, an antiemetic, a local anaesthetic, an antipruritic drug, an anti-allergic agent and an anticoronaviral agent. It is a member of phenothiazines and a tertiary amine. It is a conjugate base of a promethazine(1+).
Classification
Small molecule
Drug class—
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CC(CN1c2ccccc2Sc2ccccc21)N(C)C
Identifiers
PDB—
CAS-ID60-87-7
RxCUI—
ChEMBL IDCHEMBL643
ChEBI ID8461
PubChem CID4927
DrugBankDB01069
UNII IDFF28EJQ494 (ChemIDplus, GSRS)
Target
Agency Approved
HRH1
HRH1
Organism
Homo sapiens
Gene name
HRH1
Gene synonyms
NCBI Gene ID
3269
Protein name
histamine H1 receptor
Protein synonyms
histamine receptor, subclass H1
Uniprot ID
Q6P9E5
Mouse ortholog
Hrh1 (15465)
histamine H1 receptor (Q91XN3)
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 945 documents
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Safety
Black-box Warning
Black-box warning for: Promethazine hydrochloride, Promethegan
Adverse Events
Top Adverse Reactions
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7,245 adverse events reported
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