pseudoephedrine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
sympathomimetics	2326	90-82-4

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: pseudoephedrine (+)-Pseudoephedrine pseudophedrine sulphate pseudoephedrine hydrochloride pseudoephedrine sulfate pseudoephedrine HCl pseudoephedrine polistirex	A phenethylamine that is an isomer of EPHEDRINE which has less central nervous system effects and usage is mainly for respiratory tract decongestion. Molecular weight: 165.24 Formula: C10H15NO CLOGP: 0.89 LIPINSKI: 0 HAC: 2 HDO: 2 TPSA: 32.26 ALOGS: -1.30 ROTB: 3 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

pseudoephedrine
(+)-Pseudoephedrine
pseudophedrine sulphate
pseudoephedrine hydrochloride
pseudoephedrine sulfate
pseudoephedrine HCl
pseudoephedrine polistirex

A phenethylamine that is an isomer of EPHEDRINE which has less central nervous system effects and usage is mainly for respiratory tract decongestion.

Molecular weight: 165.24
Formula: C10H15NO
CLOGP: 0.89
LIPINSKI: 0
HAC: 2
HDO: 2
TPSA: 32.26
ALOGS: -1.30
ROTB: 3

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
0.24	g	O
0.24	g	O

ADMET properties:

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Property	Value	Reference
EoM (Fraction excreted unchanged in urine)	43 %	Benet LZ, Broccatelli F, Oprea TI
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Benet LZ, Broccatelli F, Oprea TI

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Approvals:

Date	Agency	Company	Orphan
Oct. 18, 1963	FDA	SCHERING PLOUGH

FDA Adverse Event Reporting System (Female)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Pemphigus	3390.40	26.82	2995	138907	180731	63166389
Systemic lupus erythematosus	3130.51	26.82	3032	138870	205886	63141234
Glossodynia	2980.29	26.82	2754	139148	176122	63170998
Hand deformity	2927.04	26.82	2593	139309	156864	63190256
Wound	2850.55	26.82	2581	139321	160682	63186438
Pericarditis	2838.89	26.82	2348	139554	129231	63217889
Anti-cyclic citrullinated peptide antibody positive	2466.62	26.82	2055	139847	114157	63232963
Discomfort	2427.15	26.82	2388	139514	164986	63182134
Abdominal discomfort	2173.74	26.82	3099	138803	317786	63029334
Arthropathy	2128.37	26.82	2617	139285	232175	63114945

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FDA Adverse Event Reporting System (Male)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Sudden infant death syndrome	62.49	16.60	13	5521	235	34951162
Cardiac septal defect	53.71	16.60	12	5522	307	34951090
Kidney duplex	50.77	16.60	12	5522	396	34951001
Multiple allergies	47.92	16.60	18	5516	2985	34948412
Toxicity to various agents	43.53	16.60	97	5437	200265	34751132
Asthma-chronic obstructive pulmonary disease overlap syndrome	41.24	16.60	13	5521	1274	34950123
Symmetrical drug-related intertriginous and flexural exanthema	36.70	16.60	9	5525	348	34951049
Mycobacterial infection	33.46	16.60	13	5521	2361	34949036
Substance abuser	28.46	16.60	6	5528	116	34951281
Hypoxic-ischaemic encephalopathy	28.33	16.60	14	5520	4518	34946879

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FDA Adverse Event Reporting System (Geriatric)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Pemphigus	2897.62	22.94	1733	102396	97849	79542410
Systemic lupus erythematosus	2677.57	22.94	1771	102358	119378	79520881
Pericarditis	2616.56	22.94	1651	102478	102585	79537674
Glossodynia	2559.41	22.94	1623	102506	101714	79538545
Hand deformity	2483.88	22.94	1596	102533	102323	79537936
Anti-cyclic citrullinated peptide antibody positive	2337.43	22.94	1416	102713	81727	79558532
Wound	2232.19	22.94	1558	102571	114621	79525638
Discomfort	1987.97	22.94	1498	102631	124119	79516140
Synovitis	1944.29	22.94	1593	102536	149141	79491118
Duodenal ulcer perforation	1897.20	22.94	1142	102987	65069	79575190

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	R01BA02	RESPIRATORY SYSTEM NASAL PREPARATIONS NASAL DECONGESTANTS FOR SYSTEMIC USE Sympathomimetics
ATC	R01BA52	RESPIRATORY SYSTEM NASAL PREPARATIONS NASAL DECONGESTANTS FOR SYSTEMIC USE Sympathomimetics
CHEBI has role	CHEBI:35470	central nervous system agents
CHEBI has role	CHEBI:35523	bronchodilator
CHEBI has role	CHEBI:35524	sympathomimetic
CHEBI has role	CHEBI:35703	Xenobiotic
CHEBI has role	CHEBI:49167	anti-asthmatic drugs
CHEBI has role	CHEBI:76924	plant metabolites
CHEBI has role	CHEBI:77715	nasal decongestants
FDA EPC	N0000175552	alpha-Adrenergic Agonist

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Drug Use | Suggest Off label Use Form| |View source of the data|

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Disease	Relation	SNOMED_ID	DOID
Sinus headache	indication	4969004
Vasomotor rhinitis	indication	8229003	DOID:4730
Allergic rhinitis	indication	61582004
Nasal discharge	indication	64531003
Nasal congestion	indication	68235000
Rhinitis	indication	70076002	DOID:4483
Common cold	indication	82272006	DOID:10459
Headache disorder	indication	230461009
Influenza-like symptoms	indication	315642008
Seasonal allergic rhinitis	indication	367498001

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	9.22	Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Bioact source	MoA source
Sodium-dependent noradrenaline transporter	Transporter	P23975	SC6A2_HUMAN	RELEASING AGENT	CHEMBL	CHEMBL
Alpha-1A adrenergic receptor	GPCR	P35348	ADA1A_HUMAN		WOMBAT-PK
Beta-2 adrenergic receptor	GPCR	P07550	ADRB2_HUMAN		WOMBAT-PK
Alpha-2A adrenergic receptor	GPCR	P08913	ADA2A_HUMAN		WOMBAT-PK

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External reference:

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ID	Source
001831	NDDF
001832	NDDF
001833	NDDF
005972	NDDF
10595003	SNOMEDCT_US
1061	INN_ID
12177002	SNOMEDCT_US
2354	MMSL
345-78-8	SECONDARY_CAS_RN
372900003	SNOMEDCT_US

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Aleve-D Sinus and Cold	HUMAN OTC DRUG LABEL	2	0280-6090	TABLET	120 mg	ORAL	ANDA	17 sections
Aleve-D Sinus and Cold	HUMAN OTC DRUG LABEL	2	0280-6090	TABLET	120 mg	ORAL	ANDA	17 sections
Aleve-D Sinus and Headache	HUMAN OTC DRUG LABEL	2	0280-6045	TABLET	120 mg	ORAL	ANDA	17 sections
Aleve-D Sinus and Headache	HUMAN OTC DRUG LABEL	2	0280-6045	TABLET	120 mg	ORAL	ANDA	17 sections
All Day Allergy-D	HUMAN OTC DRUG LABEL	2	0113-2176	TABLET, EXTENDED RELEASE	120 mg	ORAL	ANDA	16 sections
Allergy and Congestion Relief	HUMAN OTC DRUG LABEL	2	0113-2007	TABLET, FILM COATED, EXTENDED RELEASE	120 mg	ORAL	ANDA	14 sections
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide	HUMAN PRESCRIPTION DRUG LABEL	3	0121-0933	SOLUTION	30 mg	ORAL	ANDA	21 sections
Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide	HUMAN PRESCRIPTION DRUG LABEL	3	0121-0933	SOLUTION	30 mg	ORAL	ANDA	21 sections
Dimetapp	HUMAN OTC DRUG LABEL	2	0031-2231	ELIXIR	15 mg	ORAL	Export only	15 sections
Dimetapp	HUMAN OTC DRUG LABEL	2	0031-2231	ELIXIR	15 mg	ORAL	Export only	15 sections

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