PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE (phenylephrine hydrochloride) · Hikma
Promethazine hydrochloride and phenylephrine hydrochloride oral solution is indicated for the temporary relief of upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.
Details
- Status
- Discontinued
- First Approved
- 2006-12-07
- Routes
- ORAL
- Dosage Forms
- SYRUP
Companies
PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE Approval History
What PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE Treats
8 indicationsPHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE is approved for 8 conditions since its original approval in 2006. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cough
- Nasal Congestion
- Pain
- Sore Throat
- Headache
- Runny Nose
- Sneezing
- Fever
PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE Boxed Warning
WARNING PROMETHAZINE HYDROCHLORIDE SHOULD NOT BE USED IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION. POSTMARKETING CASES OF RESPIRATORY DEPRESSION, INCLUDING FATALITIES, HAVE BEEN REPORTED WITH USE OF PROMETHAZINE HYDROCHLORIDE IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HYDROCHLORIDE HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS. CAUTION SHOULD BE EXERCISED WHEN ADMINIST...
WARNING PROMETHAZINE HYDROCHLORIDE SHOULD NOT BE USED IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION. POSTMARKETING CASES OF RESPIRATORY DEPRESSION, INCLUDING FATALITIES, HAVE BEEN REPORTED WITH USE OF PROMETHAZINE HYDROCHLORIDE IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HYDROCHLORIDE HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS. CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HYDROCHLORIDE TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. IT IS RECOMMENDED THAT THE LOWEST EFFECTIVE DOSE OF PROMETHAZINE HYDROCHLORIDE BE USED IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER AND CONCOMITANT ADMINISTRATION OF OTHER DRUGS WITH RESPIRATORY DEPRESSANT EFFECTS BE AVOIDED.
PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05997732 STARS | Pro00126600 | Ph 4 | recruiting | Sympathetic Neurovascular Transduction: Role of Adrenergic Receptors and Sex Differences |
| NCT03098680 PRIME | PRIME (A094136) | Ph 1 | terminated | A Study of the Pharmacokinetic and Pharmacodynamic Responses in Healthy and Altered Human Cardiovascular Systems |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE FDA Label Details
Indications & Usage
Promethazine hydrochloride and phenylephrine hydrochloride oral solution is indicated for the temporary relief of upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.
WARNING PROMETHAZINE HYDROCHLORIDE SHOULD NOT BE USED IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION. POSTMARKETING CASES OF RESPIRATORY DEPRESSION, INCLUDING FATALITIES, HAVE BEEN REPORTED WITH USE OF PROMETHAZINE HYDROCHLORIDE IN PEDIATRIC ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.