DOXAPRAM HYDROCHLORIDE · WATSON LABS INC
Doxapram Hydrochloride is a respiratory stimulant indicated for the treatment of drug-induced respiratory depression or apnea in postanesthesia patients (excluding depression caused by muscle relaxants) and to encourage postoperative deep breathing. It is also used to hasten arousal and restore laryngopharyngeal reflexes in patients with mild to moderate CNS depression due to drug overdosage. Additionally, it is indicated 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 administration. It should not be used in conjunction with mechanical ventilation.
How DOXAPRAM HYDROCHLORIDE Works
Doxapram hydrochloride produces respiratory stimulation by activating peripheral carotid chemoreceptors at lower doses and the central respiratory centers in the medulla at higher doses. This stimulation increases tidal volume and, to a lesser extent, the respiratory rate. As a non-specific CNS stimulant, higher doses may also affect the spinal cord and other brain regions. The drug's effect is rapid in onset but has a short duration of action.
Details
- Status
- Prescription
- First Approved
- 1965-06-23
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
DOXAPRAM HYDROCHLORIDE Approval History
What DOXAPRAM HYDROCHLORIDE Treats
6 indicationsDOXAPRAM HYDROCHLORIDE is approved for 6 conditions since its original approval in 1992. 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
DOXAPRAM HYDROCHLORIDE Competitive Set
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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 |
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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.
DOXAPRAM HYDROCHLORIDE FDA Label Details
Indications & Usage
INDICATIONS & USAGE Postanesthesia When the possibility of airway obstruction and/or hypoxia have been eliminated, doxapram may be used to stimulate respiration in patients with drug-induced postanesthesia respiratory depression or apnea other than that due to muscle relaxant drugs. To pharmacologically stimulate deep breathing in the postoperative patient. (A quantitative method of assessing oxygenation, such as pulse oximetry, is recommended.) Drug-Induced Central Nervous System Depression Exercising care to prevent vomiting and aspiration, doxapram may be used to stimulate respiration, hast...
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DOPRAM
Full clinical data, patents, trials, and competitive landscape for doxapram hydrochloride.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.