CARBINOXAMINE MALEATE
Carbinoxamine maleate is indicated for the symptomatic treatment of seasonal and perennial allergic rhinitis, as well as vasomotor rhinitis. It is used to manage allergic conjunctivitis caused by inhalant allergens and foods, and mild skin manifestations of urticaria, angioedema, and dermatographism. Additionally, it serves as adjunctive therapy to epinephrine for anaphylactic reactions after acute symptoms are controlled. It is also indicated to ameliorate the severity of allergic reactions to blood or plasma transfusions.
How CARBINOXAMINE MALEATE Works
Carbinoxamine maleate is an ethanolamine-derivative antihistamine with significant anticholinergic (drying) and sedative properties. It acts as a competitive antagonist at H1 receptor sites on effector cells within the gastrointestinal tract, blood vessels, and respiratory tract. By blocking these receptors, it inhibits histamine-mediated effects such as vasodilation, increased capillary permeability, and pruritus.
Details
- Status
- Discontinued
- First Approved
- 2003-03-19
- Routes
- ORAL
- Dosage Forms
- TABLET, SOLUTION
CARBINOXAMINE MALEATE Approval History
What CARBINOXAMINE MALEATE Treats
7 indicationsCARBINOXAMINE MALEATE is approved for 7 conditions since its original approval in 2003. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Allergic Rhinitis
- Vasomotor Rhinitis
- Allergic Conjunctivitis
- Urticaria
- Angioedema
- Dermatographism
- Anaphylactic Reaction
CARBINOXAMINE MALEATE 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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Active Pipeline
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Key Completed Trials
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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.
CARBINOXAMINE MALEATE FDA Label Details
Indications & Usage
CARBINOXAMINE MALEATE is indicated for the treatment of Allergic Rhinitis; Vasomotor Rhinitis; Allergic Conjunctivitis; Urticaria; Angioedema; Dermatographism; Anaphylactic Reaction.
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KARBINAL ER
Full clinical data, patents, trials, and competitive landscape for carbinoxamine maleate.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.