NDAORALCONCENTRATE
Approved
Mar 1963
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
2/8 — Basic
PROKETAZINE (carphenazine maleate) by Thayer Medical is clinical pharmacology dextromethorphan: dextromethorphan is an antitussive agent and, unlike the isomeric levorphanol, it has no analgesic or addictive properties. First approved in 1963.
Drug data last refreshed 2d ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PROKETAZINE (Carphenazine Maleate) is an oral concentrate combination product containing dextromethorphan (antitussive) and promethazine (antihistamine with sedative and antiemetic properties). It is indicated for cough suppression and symptomatic relief of upper respiratory conditions. The formulation leverages dextromethorphan's central cough-threshold elevation and promethazine's H1-receptor antagonism without significant dopamine blockade.
LOE Approaching
Approaching loss of exclusivity signals potential team consolidation and shift toward generic transition or discontinuation planning within commercial and regulatory departments.
Mechanism of Action
CLINICAL PHARMACOLOGY Dextromethorphan: Dextromethorphan is an antitussive agent and, unlike the isomeric levorphanol, it has no analgesic or addictive properties. The drug acts centrally and elevates the threshold for coughing. It is about equal to codeine in depressing the cough reflex. In…
Indications
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.