pharmacopeia

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Receptor Interactions; Unknown Cellular or Molecular Interaction.

Indications

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  • & 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.

Contraindications

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  • Doxapram is contraindicated in patients with known hypersensitivity to the drug or any of the injection components. Doxapram should not be used in patients with epilepsy or other convulsive disorders.contraindicated

Dosage & administration

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DOSAGE & ADMINISTRATION NOTE: CONTAINS BENZYL ALCOHOL (see PRECAUTIONS ) In Postanesthetic Use Table I. Dosage for postanesthetic use-I.V. and infusion. * Dose not to exceed 3 grams/24 hours. BY I.V. INJECTION (See Table I. Dosage for postanesthetic use—I.V.) The recommended dose for I.V. administration is 0.5 – 1 mg/kg for a single injection and at 5-minute intervals. Careful observation of the patient during administration and for some time subsequently are advisable. The maximum total dosage by I.V. injection is 2 mg/kg. BY INFUSION The solution is prepared by adding 250 mg of doxapram (12.5 mL) to 250 mL of dextrose 5% or 10% in water or normal saline solution. The infusion is initiated at a rate of approximately 5 mg/minute until a satisfactory respiratory response is observed, and maintained at a rate of 1 to 3 mg/minute. The rate of infusion should be adjusted to sustain the desired level of respiratory stimulation with a minimum of side effects. The maximum total dosage by infusion is 4 mg/kg, or approximately 300 mg for the average adult. In the Management of Drug-Induced CNS Depression (See Table II. Dosage for drug-induced CNS depression.) Table II. Dosage for drug-induced CNS depression. * Mild Depression Class 0: Asleep, but can be aroused and can answer questions. Class 1: Comatose, will withdraw from painful stimuli, reflexes intact. † Moderate Depression Class 2: Comatose, will not withdraw from painful stimuli, reflexes intact. Class 3: Comatose, reflexes absent, no depression of circulation or respiration. METHOD ONE Using Single and/or Repeat Single I.V.

Warnings & precautions

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Doxapram should not be used in conjunction with mechanical ventilation. Exposure to excessive amounts of benzyl alcohol has been associated with toxicity (hypotension, metabolic acidosis), particularly in neonates, and an increased incidence of kernicterus, particularly in small preterm infants. There have been rare reports of deaths, primarily in preterm infants, associated with exposure to excessive amounts of benzyl alcohol. The amount of benzyl alcohol from medications is usually considered negligible compared to that received in flush solutions containing benzyl alcohol. Administration of high dosages of medications containing this preservative must take into account the total amount of benzyl alcohol administered. The amount of benzyl alcohol at which toxicity may occur is not known. If the patient requires more than the recommended dosages or other medications containing this preservative, the practitioner must consider the daily metabolic load of benzyl alcohol from these combined sources (see PRECAUTIONS , Pediatric Use). In Postanesthetic Use Doxapram is neither an antagonist to muscle relaxant drugs nor a specific narcotic antagonist. More specific tests (eg, peripheral nerve stimulation, airway pressures, head lift, pulse oximetry, and end-tidal carbon dioxide) to assess adequacy of ventilation are recommended before administering doxapram. Doxapram should be administered with great care and only under careful supervision to patients with hypermetabolic states such as hyperthyroidism or pheochromocytoma.

Adverse reactions

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Adverse reactions reported coincident with the administration of DOPRAM (doxapram hydrochloride, USP) include: 1. Central and Autonomic Nervous Systems Pyrexia, flushing, sweating; pruritus and paresthesia, such as a feeling of warmth, burning, or hot sensation, especially in the area of genitalia and perineum; apprehension, disorientation, pupillary dilatation, hallucinations, headache, dizziness, hyperactivity, involuntary movements, muscle spasticity, muscle fasciculations, increased deep tendon reflexes, clonus, bilateral Babinski, and convulsions. 2. Respiratory Dyspnea, cough, hyperventilation, tachypnea, laryngospasm, bronchospasm, hiccough, and rebound hypoventilation. 3. Cardiovascular Phlebitis, variations in heart rate, lowered T-waves, arrhythmias (including ventricular tachycardia and ventricular fibrillation), chest pain, tightness in chest. A mild to moderate increase in blood pressure is commonly noted and may be of concern in patients with severe cardiovascular diseases. 4. Gastrointestinal Nausea, vomiting, diarrhea, desire to defecate. 5. Genitourinary Stimulation of urinary bladder with spontaneous voiding; urinary retention. Elevation of BUN and albuminuria. 6. Hemic and Lymphatic Hemolysis with rapid infusion. A decrease in hemoglobin, hematocrit, or red blood cell count has been observed in postoperative patients. In the presence of pre-existing leukopenia, a further decrease in WBC has been observed following anesthesia and treatment with doxapram hydrochloride.

Overdosage

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Signs and Symptoms Symptoms of overdosage are extensions of the pharmacologic effects of the drug. Excessive pressor effect, such as hypertension, tachycardia, skeletal muscle hyperactivity, and enhanced deep tendon reflexes may be early signs of overdosage. Therefore, the blood pressure, pulse rate, and deep tendon reflexes should be evaluated periodically and the dosage or infusion rate adjusted accordingly. Other effects may include agitation, confusion, sweating, cough, and dyspnea. Convulsive seizures are unlikely at recommended dosages. In unanesthetized animals, the convulsant dose is 70 times greater than the respiratory stimulant dose. Intravenous LD50 values in the mouse and rat were approximately 75 mg/kg and in the cat and dog were 40 to 80 mg/kg. Except for management of chronic obstructive pulmonary disease associated with acute hypercapnia, the maximum recommended dosage is 3 GRAMS/24 HOURS. (See DOSAGE & ADMINISTRATION .) Management There is no specific antidote for doxapram. Management should be symptomatic.

Approval history

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  • Jun 23, 1965NDANDA014879Hikma

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
22 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Depressed Level Of Consciousness523%
  2. 2Atrial Fibrillation418%
  3. 3Respiratory Failure418%
  4. 4Electrocardiogram Qt Prolonged314%
  5. 5Hepatic Failure314%
  6. 6Hepatitis Fulminant314%
  7. 7Bradycardia29.1%
  8. 8Cardiac Failure29.1%
  9. 9Delayed Recovery From Anaesthesia29.1%
  10. 10Ejection Fraction Decreased29.1%
  11. 11Hypokalaemia29.1%
  12. 12Hypoxia29.1%
  13. 13Respiratory Arrest29.1%
  14. 14Respiratory Depression29.1%
  15. 15Accidental Overdose14.5%

Literature

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Recent PubMed references pinned to Doxapram as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 12 ClinicalTrials.gov registrations naming Doxapram as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Doxapram work?
Mechanism-of-action classes: Receptor Interactions; Unknown Cellular or Molecular Interaction.
What is Doxapram used for?
According to FDA labeling, Doxapram carries indications including: & 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Doxapram?
Doxapram is classified as Respiratory stimulants, Respiratory Stimulant, Receptor Interactions, Unknown Cellular or Molecular Interaction, Increased Medullary Respiratory Drive, Increased Organized Electrical Activity.
What are the brand names for Doxapram?
Doxapram is marketed under brand names including Dopram.
What are the contraindications for Doxapram?
Doxapram labeling lists contraindications including: Doxapram is contraindicated in patients with known hypersensitivity to the drug or any of the injection components. Doxapram should not be used in patients with epilepsy or other convulsive disorders.. Always consult the full prescribing information and a clinician.
Note. Data for doxapram is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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