Dextromethorphan

Generic Name: Dextromethorphan

Brand Names: Auvelity, Benylin DM, Bromfed DM, Broncotron, Cepacol Sore Throat Plus Cough, Cheracol D, Children's Nyquil Cold and Cough, Chloraseptic Sore Throat + Cough, Coricidin Hbp Chest Congestion, Coricidin Hbp Cough and Cold, Creomulsion, DM, Dayquil Cough, Delsym, Delsym Cough Plus Chest Congestion DM, Delsym Cough Plus Soothing Action, Delsym Cough Relief Plus Soothing Action, Despec Reformulated Jun 2008, Diabetic Tussin DM, Dimetapp Long Acting Cough Plus Cold, Diphen, G-zyncof, Mucinex Children's Cough, Mucinex Cough, Mucinex DM, Nuedexta, Nyquil Cough, Pediacare Children's Cough and Congestion, Promethazine DM, Robafen Cough, Robafen DM, Robitussin 12 Hour Cough Relief, Robitussin Cough & Congestion, Robitussin Maximum Strength Cough Plus Chest Congestion DM, Robitussin Nighttime Cough DM, Robitussin Pediatric Cough & Cold LA, Robitussin Pediatric Cough Suppressant, Safetussin DM, Safetussin PM, Scot-tussin DM, Scot-tussin Diabetic CF, Scot-tussin Sugar Free DM, Sudafed PE Children's Cold & Cough, Triaminic Day Time Cold & Cough, Tusnel Diabetic

Drug Type: Small Molecule

Chemical Formula: C_₁₈H_₂₅NO

CAS Number: 125-71-3

Unique Ingredient Identifier: 7355X3ROTS

Background: Dextromethorphan is a levorphanol derivative and codeine analog commonly used as a cough suppressant and also a drug of abuse. Although similar in structure to other opioids, it has minimal interaction with opioid receptors.

Dextromethorphan was granted FDA approval before 3 December 1957.

Indication: Dextromethorphan is indicated in combination with brompheniramine and pseudoephedrine in the treatment of coughs and upper respiratory symptoms associated with allergies or the common cold. Dextromethorphan is also used in combination with guaifenesin as an over-the-counter product to relieve a cough. Dextromethorphan in combination with quinidine is indicated in the treatment of pseudobulbar affect.

Associated Conditions: Allergic cough, Common Cold, Cough, Cough caused by Common Cold, Coughing caused by Allergies, Coughing caused by Bronchitis, Coughing caused by Flu caused by Influenza, Fever, Flu caused by Influenza, Headache, Irritative cough, Itching of the nose, Itching of the throat, Major Depressive Disorder (MDD), Nasal Congestion, Pseudobulbar Affect (PBA), Rhinorrhoea, Sneezing, Cold or flu syndrome, Upper respiratory symptoms, Watery itchy eyes

Associated Therapies: Airway secretion clearance therapy, Bronchodilation, Oropharyngeal antisepsis

Clinical Trials

A Study to Evaluate the Effect of Oral Doses of JNJ-54175446 on the Inhibition of Cytochrome P450 CYP3A4, CYP2C9, CYP1A2 and CYP2D6 Activity and the Induction of CYP2B6 and CYP2C19 Activity Using a Multiple Probe Substrate Cocktail in Healthy Subjects

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: JNJ-54175446 150 mg
Drug: JNJ-54175446 600 mg
Drug: Midazolam 2 mg
Drug: Warfarin 10 mg
Drug: Caffeine 50 mg
Drug: Dextromethorphan 30 mg
Drug: Bupropion 150 mg
Drug: Omeprazole 20 mg

First Posted Date: 2017-02-20

Last Posted Date: 2017-06-08

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 16

Registration Number: NCT03058419

Locations: 🇧🇪
Clinical Pharmacology Unit, Merksem, Belgium

Impact of Genetic Polymorphism on Drug-Drug Interactions Involving CYP2D6

Not Applicable

Completed

Conditions: Healthy

Interventions: Drug: Dextromethorphan 5 MG
Drug: Tramadol 10 mg
Drug: Duloxetine 60mg
Drug: Paroxetine 20 mg

First Posted Date: 2017-02-15

Last Posted Date: 2019-04-19

Lead Sponsor: Jules Desmeules

Target Recruit Count: 34

Registration Number: NCT03054220

Combination of Dextromethorphan and Memantine in Treating Bipolar Disorder

Phase 3

Conditions: Bipolar Disorder II

Interventions: Drug: placebo+valproate
Drug: dextromethorphan+memantine
Drug: Dextromethorphan
Drug: Memantine

First Posted Date: 2017-02-01

Last Posted Date: 2017-07-11

Lead Sponsor: National Cheng-Kung University Hospital

Target Recruit Count: 300

Registration Number: NCT03039842

Locations: 🇨🇳
National Cheng Kung University Hospital, Tainan, Taiwan

Dextromethorphan Use in Multimodal Analgesia Regimens for Total Knee Arthroplasty

Phase 4

Terminated

Conditions: Pain, Postoperative

Interventions: Drug: Placebo - Concentrate
Drug: Dextromethorphan
Drug: Acetaminophen
Drug: Oxycodone
Drug: Celecoxib
Drug: Pantoprazole
Drug: Ketorolac
Drug: Gabapentin
Drug: Hydromorphone

First Posted Date: 2016-12-09

Last Posted Date: 2019-05-14

Lead Sponsor: University of Southern California

Target Recruit Count: 23

Registration Number: NCT02987920

A Trial of Dextromethorphan for Treatment of Major Depressive Disorder

Phase 1

Completed

Conditions: Major Depressive Disorder

Interventions: Drug: Dextromethorphan Hydrobromide

First Posted Date: 2016-08-10

Last Posted Date: 2018-10-25

Lead Sponsor: Medical University of South Carolina

Target Recruit Count: 4

Registration Number: NCT02860962

DEX Combined With RTX, CSA and IVIG in the Management of Newly Diagnosed ITP Patients

Phase 3

Conditions: Immune Thrombocytopenia

Interventions: Drug: DEX Combined With RTX, CSA and IVIG

First Posted Date: 2016-07-15

Last Posted Date: 2016-07-15

Lead Sponsor: Shandong University

Target Recruit Count: 100

Registration Number: NCT02834468

Locations: 🇨🇳
Qilu Hospital, Shandong University, Jinan, China

Study of SHP620 (Maribavir) in Healthy Adults

Phase 1

Completed

Conditions: Cytomegalovirus (CMV)

Interventions: Drug: Digoxin
Drug: Maribavir
Drug: Dextromethorphan

First Posted Date: 2016-05-17

Last Posted Date: 2021-06-03

Lead Sponsor: Shire

Target Recruit Count: 18

Registration Number: NCT02775240

Locations: 🇺🇸
Clinical Pharmacology of Miami, Inc., Miami, Florida, United States

Phase 4, Vedolizumab-4002 Post-marketing, Disease-Drug-Drug Interaction Study

Phase 4

Withdrawn

Conditions: Colitis, Ulcerative
Crohn Disease

Interventions: Drug: Caffeine
Drug: Losartan
Drug: Omeprazole
Drug: Dextromethorphan
Drug: Midazolam
Drug: Vedolizumab

First Posted Date: 2016-05-03

Last Posted Date: 2020-10-27

Lead Sponsor: Takeda

Registration Number: NCT02760615

Locations: 🇺🇸
WCCT, Cypress, California, United States
🇺🇸
QPS MRA, Miami, Florida, United States

Does Pre and Postoperative Dextromethorphan Reduce Post-tonsillectomy Pain in Children?

Phase 4

Completed

Conditions: Pain, Postoperative

Interventions: Drug: Placebo
Drug: Dextromethorphan

First Posted Date: 2016-04-04

Last Posted Date: 2020-09-21

Lead Sponsor: Dr. Rachel Rooney

Target Recruit Count: 85

Registration Number: NCT02727491

Dextromethorphan Pediatric Acute Cough Study

Phase 4

Terminated

Conditions: Cough

Interventions: Drug: Placebo
Drug: Dextromethorphan Hydrobromide
Device: Cough recording device

First Posted Date: 2016-01-08

Last Posted Date: 2021-04-28

Lead Sponsor: Pfizer

Target Recruit Count: 131

Registration Number: NCT02651116

Locations: 🇺🇸
Kentucky Pediatric/Adult Research, Bardstown, Kentucky, United States
🇺🇸
Rapid Medical Research, Inc, Cleveland, Ohio, United States
🇺🇸
Meridian Clinical Research LLC, Omaha, Nebraska, United States

and more 13 locations

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