Doxapram Hydrochloride

Indications

INDICATIONS AND 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, hasten arousal, and to encourage the return of laryngopharyngeal reflexes in patients with mild to moderate respiratory and CNS depression due to drug overdosage. Chronic Pulmonary Disease Associated with Acute Hypercapnia Doxapram is indicated as a temporary measure in hospitalized patients with acute respiratory insufficiency superimposed on chronic obstructive pulmonary disease.

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION NOTE: CONTAINS BENZYL ALCOHOL (see PRECAUTIONS ) In Postanesthetic Use Table I. Dosage for postanesthetic use-I.V. and infusion. I.V. Administration Recommended Dosage mg/kg Maximum dose per single injection mg/kg Maximum total dose Dose not to exceed 3 grams/24 hours. mg/kg Single Injection 0.5-1 1.5 Repeat Injections (5 min. intervals) 0.5-1 1.5 2 Infusion 0.5-1 – 4 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.

Contraindications

CONTRAINDICATIONS 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. Doxapram is contraindicated in patients with proven or suspected pulmonary embolism.

Warnings and precautions

WARNINGS 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.

Pregnancy

Pregnancy PREGNANCY CATEGORY B Reproduction studies have been performed in rats at doses up to 1.6 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to doxapram. There are, however, no adequate and well-controlled studies in pregnant women.

Storage and supply

HOW SUPPLIED DOPRAM Injection (doxapram hydrochloride injection, USP) is available in cartons of one 20 mL multiple dose vial containing 20 mg of doxapram hydrochloride per mL with benzyl alcohol 0.9% as the preservative (NDC 0641-6018-01). Store at Controlled Room Temperature, Between 20˚C to 25˚C (68˚F to 77˚F). See USP.

Source: Doxapram Hydrochloride (Dopram) — US FDA prescribing information, 2024-04-09, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.