Details of the Drug

General Information of Drug (ID: DMIVJ0D)

• Drug Name: Pseudoephedrine
• Synonyms: Balminil Decongestant Syrup; Dimetapp Decongestant; Dimetapp Decongestant Pediatric Drops; Drixoral Nasal Decongestant; Pseudoephedrine Ephedrine; Sudafed Decongestant Extra Strength; Triaminic AM Decongestant Formula; Triaminic Infant Oral Decongestant Drops; Efidac 24 PseudoephedrineHcl; Sudafed Decongestant 12 Hour; Pseudoefedrina [INN-Spanish]; Pseudoephedrine (INN); Pseudoephedrine [INN:BAN]; Pseudoephedrine d-form; Pseudoephedrinum [INN-Latin]; Sudafed (TN); Alpha-(1-(Methylamino)ethyl)benzyl alcohol; D-psi-2-Methylamino-1-phenyl-1-propanol; Benzenemethanol, alpha-((1S)-1-(methylamino)ethyl)-, (alpha-S)-(9CI); (+)-(1S,2S)-Pseudoephedrine; (1S,2S)-(+)-Pseudoephedrine; (1S,2S)-2-(methylamino)-1-phenylpropan-1-ol; (1S,2S)-2-Methylamino-1-phenyl-1-propanol; (1S,2S)-Pseudoephedrine; (1S,2S)-Pseudoephedrine, polymer-bound

Indication

Disease Entry	ICD 11	Status	REF
Allergic rhinitis	CA08.0	Approved	[1]
Common cold	CA00	Approved	[1]
Headache	8A80-8A84	Approved	[1]
Nasal congestion	MD11.9	Approved	[2]
Rhinitis	FA20	Approved	[1]
Seasonal allergic rhinitis	CA08.01	Approved	[1]
Vasomotor/allergic rhinitis	CA08	Approved	[1]
Sinusitis	CA0A.Z	Investigative	[1]

• Drug Type: Small molecular drug
• #Ro5 Violations (Lipinski): 0:
  Molecular Weight (mw); 165.23
  Logarithm of the Partition Coefficient (xlogp); 0.9
  Rotatable Bond Count (rotbonds); 3
  Hydrogen Bond Donor Count (hbonddonor); 2
  Hydrogen Bond Acceptor Count (hbondacc); 2
• ADMET Property:
  Absorption AUC: The area under the plot of plasma concentration (AUC) of drug is 6862.0 +/- 334.1 mcgh/L [3]
  Absorption Cmax: The maximum plasma concentration (Cmax) of drug is 246.3 +/- 10.5 mcg/L [3]
  Absorption Tmax: The time to maximum plasma concentration (Tmax) is 6.60 +/- 1.38 h [3]
  BDDCS Class: Biopharmaceutics Drug Disposition Classification System (BDDCS) Class 3: high solubility and low permeability [4]
  Clearance: The clearance of drug is 5.9 +/- 1.7 mL/min/kg [5]
  Elimination: 55-75% of an oral dose is detected in the urine as unchanged pseudoephedrine [5]
  Half-life: The concentration or amount of drug in body reduced by one-half in 6.0 hours [6]
  Vd: The volume of distribution (Vd) of drug is 2.6-3.3 L/kg [6]
• Chemical Identifiers:
  Formula: C10H15NO
  IUPAC Name: (1S,2S)-2-(methylamino)-1-phenylpropan-1-ol
  Canonical SMILES: C[C@@H]([C@H](C1=CC=CC=C1)O)NC
  InChI: InChI=1S/C10H15NO/c1-8(11-2)10(12)9-6-4-3-5-7-9/h3-8,10-12H,1-2H3/t8-,10+/m0/s1
  InChIKey: KWGRBVOPPLSCSI-WCBMZHEXSA-N
• Cross-matching ID:
  PubChem CID: 7028
  ChEBI ID: CHEBI:51209
  CAS Number: 90-82-4
  DrugBank ID: DB00852
  TTD ID: D00HHS
  INTEDE ID: DR1369
  ACDINA ID: D00568
• Repurposed Drugs (RPD): Click to Jump to the Detailed RPD Information of This Drug

Molecular Interaction Atlas of This Drug

Drug Therapeutic Target (DTT)

DTT Name	DTT ID	UniProt ID	MOA	REF
Dopamine D2 receptor (D2R)	TTEX248	DRD2_HUMAN	Stimulator	[7]

Drug-Metabolizing Enzyme (DME)

DME Name	DME ID	UniProt ID	MOA	REF
Sulfotransferase 1A1 (SULT1A1) Main DME	DEYWLRK	ST1A1_HUMAN	Substrate	[8]

Molecular Expression Atlas of This Drug

• The Studied Disease: Allergic rhinitis
• ICD Disease Classification: CA08.0

Molecule Name	Molecule Type	Gene Name	p-value	Fold-Change	Z-score
Dopamine D2 receptor (D2R)	DTT	DRD2	2.50E-02	-0.08	-0.49
Sulfotransferase 1A1 (SULT1A1)	DME	SULT1A1	8.47E-01	3.57E-02	1.73E-01

Drug-Drug Interaction (DDI) Information of This Drug

Coadministration of a Drug Treating the Disease Different from Pseudoephedrine (Comorbidity)

DDI Drug Name	DDI Drug ID	Severity	Mechanism	Comorbidity	REF
Sodium bicarbonate	DMMU6BJ	Moderate	as urine pH determines the ionization state of weakly acidic or weakly alkaline drugs. Pseudoephedrine caused by Sodium bicarbonate mediated altered urine pH.	Acidosis [5C73]	[9]
Tromethamine	DMOBLGK	Moderate	as urine pH determines the ionization state of weakly acidic or weakly alkaline drugs. Pseudoephedrine caused by Tromethamine mediated altered urine pH.	Acidosis [5C73]	[9]
Methylene blue	DMJAPE7	Major	Increased risk of hyperpyrexia by the combination of Pseudoephedrine and Methylene blue.	Acquired methaemoglobinaemia [3A93]	[10]
Droxidopa	DM5YF4M	Moderate	Additive hypertensive effects by the combination of Pseudoephedrine and Droxidopa.	Autonomic nervous system disorder [8D87]	[11]
Levomilnacipran	DMV26S8	Moderate	Increased risk of rapid heart rate by the combination of Pseudoephedrine and Levomilnacipran.	Chronic pain [MG30]	[12]
Selegiline	DM6034S	Major	Additive hypertensive effects by the combination of Pseudoephedrine and Selegiline.	Depression [6A70-6A7Z]	[10]
Isocarboxazid	DMAF1NB	Major	Additive hypertensive effects by the combination of Pseudoephedrine and Isocarboxazid.	Depression [6A70-6A7Z]	[10]
Milnacipran	DMBFE74	Moderate	Increased risk of rapid heart rate by the combination of Pseudoephedrine and Milnacipran.	Depression [6A70-6A7Z]	[12]
Desvenlafaxine	DMHD4PE	Moderate	Increased risk of rapid heart rate by the combination of Pseudoephedrine and Desvenlafaxine.	Depression [6A70-6A7Z]	[12]
SODIUM CITRATE	DMHPD2Y	Moderate	as urine pH determines the ionization state of weakly acidic or weakly alkaline drugs. Pseudoephedrine caused by SODIUM CITRATE mediated altered urine pH.	Discovery agent [N.A.]	[9]
Procarbazine	DMIK367	Major	Increased risk of hyperpyrexia by the combination of Pseudoephedrine and Procarbazine.	Hodgkin lymphoma [2B30]	[10]
Sodium acetate anhydrous	DMH21E0	Moderate	as urine pH determines the ionization state of weakly acidic or weakly alkaline drugs. Pseudoephedrine caused by Sodium acetate anhydrous mediated altered urine pH.	Hypo-osmolality/hyponatraemia [5C72]	[9]
Ozanimod	DMT6AM2	Major	Increased risk of hyperpyrexia by the combination of Pseudoephedrine and Ozanimod.	Multiple sclerosis [8A40]	[10]
Sibutramine	DMFJTDI	Moderate	Increased risk of rapid heart rate by the combination of Pseudoephedrine and Sibutramine.	Obesity [5B80-5B81]	[13]
Safinamide	DM0YWJC	Moderate	Decreased metabolism of Pseudoephedrine caused by Safinamide mediated inhibition of non-CYP450 enzyme.	Parkinsonism [8A00]	[14]
Rasagiline	DM3WKQ4	Moderate	Additive hypertensive effects by the combination of Pseudoephedrine and Rasagiline.	Parkinsonism [8A00]	[10]
Bromocriptine	DMVE3TK	Moderate	Additive dopaminergic effects by the combination of Pseudoephedrine and Bromocriptine.	Parkinsonism [8A00]	[15]
Ergonovine	DM0VEC1	Major	Additive hypertensive effects by the combination of Pseudoephedrine and Ergonovine.	Postpartum haemorrhage [JA43]	[16]

Drug Inactive Ingredient(s) (DIG) and Formulation(s) of This Drug

DIG

DIG Name	DIG ID	PubChem CID	Functional Classification
Allura red AC dye	E00338	33258	Colorant
D&C red no. 27	E00381	83511	Colorant
FD&C blue no. 1	E00263	19700	Colorant
Quinoline yellow WS	E00309	24671	Colorant
Stearic acid	E00079	5281	Emulsifying agent; Solubilizing agent; Viscosity-controlling agent; lubricant
Sunset yellow FCF	E00255	17730	Colorant
Beta-D-lactose	E00099	6134	Diluent; Dry powder inhaler carrier; Lyophilization aid
Brushite	E00392	104805	Diluent
Calcium hydrogenphosphate	E00294	24441	Diluent
Calcium sulfate anhydrous	E00303	24497	Desiccant; Diluent
Carmellose sodium	E00625	Not Available	Disintegrant
Crospovidone	E00626	Not Available	Disintegrant
Eisenoxyd	E00585	56841934	Colorant
Ferric hydroxide oxide yellow	E00539	23320441	Colorant
Ferrosoferric oxide	E00231	14789	Colorant
Hexahydric alcohol	E00083	5780	Diluent; Flavoring agent; Humectant; Plasticizing agent
Hydroxypropyl cellulose	E00632	Not Available	Binding agent; Coating agent; Emulsifying agent; Film/Membrane-forming agent; Modified-release agent; Suspending agent; Viscosity-controlling agent
Kaolin	E00586	56841936	Adsorbent; Diluent; Suspending agent
Lactose monohydrate	E00393	104938	Binding agent; Diluent; Dry powder inhaler carrier; Lyophilization aid
Magnesium aluminum silicate	E00462	3084116	Adsorbent; Binding agent; Disintegrant; Suspending agent; Viscosity-controlling agent
Magnesium silicate	E00596	72941442	Anticaking agent; Glidant; Lubricant
Magnesium stearate	E00208	11177	lubricant
Polyethylene glycol 3350	E00652	Not Available	Coating agent; Diluent; Ointment base; Plasticizing agent; Solvent; Suppository base; lubricant
Polyethylene glycol 400	E00653	Not Available	Coating agent; Diluent; Ointment base; Plasticizing agent; Solvent; Suppository base; lubricant
Polysorbate 80	E00665	Not Available	Dispersing agent; Emollient; Emulsifying agent; Plasticizing agent; Solubilizing agent; Surfactant; Suspending agent
Polyvinyl alcohol	E00666	Not Available	Coating agent; Emulsion stabilizing agent; Film/Membrane-forming agent
Propylene glycol	E00040	1030	Antimicrobial preservative; Humectant; Plasticizing agent; Solvent
Saccharose	E00091	5988	Binding agent; Coating agent; Cryoprotectant; Diluent; Flavoring agent; Suspending agent; Viscosity-controlling agent
Silicon dioxide	E00670	Not Available	Anticaking agent; Opacifying agent; Viscosity-controlling agent
Sodium chloride	E00077	5234	Diluent; Tonicity agent
Soybean lecithin	E00637	Not Available	Other agent
Talc	E00520	16211421	Anticaking agent; Diluent; Glidant; lubricant
Titanium dioxide	E00322	26042	Coating agent; Colorant; Opacifying agent
Triacetin	E00080	5541	Humectant; Plasticizing agent; Solvent
Water	E00035	962	Solvent

Pharmaceutical Formulation

Formulation Name	Drug Dosage	Dosage Form	Route
Pseudoephedrine 30 mg tablet	30 mg	Oral Tablet	Oral
Pseudoephedrine 30 mg capsule	30 mg	Oral Capsule	Oral
Pseudoephedrine 120 mg tablet	120 mg	12 HR Extended Release Oral Tablet	Oral
Pseudoephedrine 60 mg tablet	60 mg	Oral Tablet	Oral
Pseudoephedrine 240 mg tablet	240 mg	24 HR Extended Release Oral Tablet	Oral

Jump to Detail Pharmaceutical Formulation Page of This Drug

References

• [1] Ephedrine FDA Label
• [2] URL: http://www.guidetopharmacology.org Nucleic Acids Res. 2015 Oct 12. pii: gkv1037. The IUPHAR/BPS Guide to PHARMACOLOGY in 2016: towards curated quantitative interactions between 1300 protein targets and 6000 ligands. (Ligand id: 7286).
• [3] Chao ST, Prather D, Pinson D, Coen P, Pruitt B, Knowles M, Place V: Effect of food on bioavailability of pseudoephedrine and brompheniramine administered from a gastrointestinal therapeutic system. J Pharm Sci. 1991 May;80(5):432-5. doi: 10.1002/jps.2600800507.
• [4] BDDCS applied to over 900 drugs
• [5] FDA Approved Drug Products: Semprex Avacristine and Pseudoephedrine Oral Capsules
• [6] FDA Approved Drug Products: Zyrtec Cetirizine and Pseudoephedrine Oral Tablets (OTC)
• [7] Cetirizine/pseudoephedrine. Drugs. 2001;61(15):2231-40; discussion 2241-2.
• [8] Benzylic alcohols as stereospecific substrates and inhibitors for aryl sulfotransferase. Chirality. 1991;3(2):104-11.
• [9] Brater DC, Kaojarern S, Benet LZ, et al "Renal excretion of pseudoephedrine." Clin Pharmacol Ther 28 (1980): 690-4. [PMID: 7438686]
• [10] Ban TA "Drug interactions with psychoactive drugs." Dis Nerv Syst 36 (1975): 164-6. [PMID: 1116424]
• [11] Product Information. Northera (droxidopa). Chelsea Therapeutics Inc, Charlotte, NC.
• [12] Product Information. Cymbalta (duloxetine). Lilly, Eli and Company, Indianapolis, IN.
• [13] Product Information. Meridia (sibutramine). Knoll Pharmaceutical Company, Whippany, NJ.
• [14] Agencia Espaola de Medicamentos y Productos Sanitarios Healthcare "Centro de informacion online de medicamentos de la AEMPS - CIMA.".
• [15] Reeves RR, Pinkofsky HB "Postpartum psychosis induced by bromocriptine and pseudoephedrine." J Fam Pract 45 (1997): 164-6. [PMID: 9267376]
• [16] Barthel W, Glusa E, Koth W "Interactions of dihydroergotamine with etilefrine in human leg veins in vitro and in situ." Int J Clin Pharmacol Ther Toxicol 25 (1987): 63-9. [PMID: 2881898]