DOPRAM- doxapram hydrochloride injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DOXAPRAM HYDROCHLORIDE (UNII: P5RU6UOQ5Y) (DOXAPRAM - UNII:94F3830Q73)

Available from:

Hikma Pharmaceuticals USA Inc.

INN (International Name):

DOXAPRAM HYDROCHLORIDE

Composition:

DOXAPRAM HYDROCHLORIDE 20 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

- 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.) 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. Doxapram is indicated as a temporary measure in hospitalized patients with acute respiratory insufficiency superimposed on chronic obstructive pulmonary disease. Its use should be for a short period of time (see DOSAGE AND ADMINISTRATION ) as an aid in the prevention of elevation of arterial CO2 tension during the administration of oxygen.

Product summary:

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.

Authorization status:

New Drug Application

Summary of Product characteristics

DOPRAM- DOXAPRAM HYDROCHLORIDE INJECTION
HIKMA PHARMACEUTICALS USA INC.
----------
DOPRAM INJECTION
(DOXAPRAM HYDROCHLORIDE INJECTION, USP)
NOT FOR USE IN NEONATES
CONTAINS BENZYL ALCOHOL
RX ONLY
DESCRIPTION
DOPRAM Injection (doxapram hydrochloride injection, USP) is a clear,
colorless, sterile,
non-pyrogenic, aqueous solution with pH 3.5 to 5, for intravenous
administration.
Each 1 mL contains:
Doxapram Hydrochloride, USP
................................................................. 20
mg
Benzyl Alcohol, NF (as preservative)
......................................................... 0.9%
Water for Injection, USP
...........….................................................................
q.s.
Doxapram Injection is a respiratory stimulant.
Doxapram hydrochloride is a white to off-white, crystalline powder,
sparingly soluble in
water, alcohol and chloroform. Chemically, doxapram hydrochloride is
1-ethyl-4-[2-(4-
morpholinyl)ethyl]-3,3-diphenyl-2-pyrrolidinone monohydrochloride,
monohydrate.
The chemical structure is:
C
H
ClN O • H O M.W. 432.98
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Doxapram hydrochloride produces respiratory stimulation mediated
through the
24
31
2
2
2
peripheral carotid chemoreceptors. As the dosage level is increased,
the central
respiratory centers in the medulla are stimulated with progressive
stimulation of other
parts of the brain and spinal cord.
The onset of respiratory stimulation following the recommended single
intravenous
injection of doxapram hydrochloride usually occurs in 20 to 40 seconds
with peak effect
at 1 to 2 minutes. The duration of effect may vary from 5 to 12
minutes.
The respiratory stimulant action is manifested by an increase in tidal
volume associated
with a slight increase in respiratory rate.
A pressor response may result following doxapram administration.
Provided there is no
impairment of cardiac function, the pressor effect is more marked in
hypovolemic than
in normovolemic states. The pressor response is due to the improved
cardiac output
rather than peri