DOPRAM (doxapram hydrochloride)
Dopram (doxapram hydrochloride) is a respiratory stimulant indicated for use in three specific clinical scenarios. First, it is used to treat drug-induced postanesthesia respiratory depression or apnea, provided the depression is not due to muscle relaxant drugs. Second, it is indicated to hasten arousal and restore protective laryngopharyngeal reflexes in patients with mild to moderate CNS and respiratory depression resulting from drug overdosage. Third, it serves as a temporary, short-term measure for hospitalized patients with acute respiratory insufficiency superimposed on chronic obstructive pulmonary disease (COPD) to prevent the elevation of arterial CO2 tension during oxygen therapy. It is not indicated for use with mechanical ventilation.
How DOPRAM Works
Doxapram hydrochloride is a potent respiratory stimulant. At lower intravenous doses, it primarily mediates its effect by stimulating the peripheral carotid chemoreceptors; at higher doses, it acts centrally on the respiratory centers in the medulla. This stimulation increases tidal volume and slightly increases respiratory rate, resulting in increased alveolar ventilation and decreased arterial CO2 levels. In the context of CNS depression, it promotes pharmacological arousal and the return of airway reflexes. Doxapram does not function as a pharmacological antagonist to specific sedative agents (like flumazenil or naloxone) and does not reverse respiratory depression induced by neuromuscular blocking agents.
Details
- Status
- Prescription
- First Approved
- 1965-06-23
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
DOPRAM Approval History
What DOPRAM Treats
6 indicationsDOPRAM is approved for 6 conditions since its original approval in 1965. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Postanesthesia Respiratory Depression
- Apnea
- Drug-Induced Central Nervous System Depression
- Chronic Obstructive Pulmonary Disease
- Acute Respiratory Insufficiency
- Acute Hypercapnia
DOPRAM Competitive Set
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Indication competitors
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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
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06585163 | QEV-817-101 5R44DA055336 | Ph 1 | not yet recruiting | Study to Investigate the Safety, Tolerability and Pharmacokinetics of QEV-817 Oral Suspension |
Active Pipeline
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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.
DOPRAM FDA Label Details
Indications & Usage
FDA Label (PDF)DOPRAM is indicated for the treatment of Postanesthesia Respiratory Depression; Apnea; Drug-Induced Central Nervous System Depression; Chronic Obstructive Pulmonary Disease; Acute Respiratory Insufficiency; Acute Hypercapnia.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.