DIPHENHYDRAMINE HYDROCHLORIDE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

diphenhydramine hydrochloride (UNII: TC2D6JAD40) (diphenhydramine - UNII:8GTS82S83M)

Available from:

Cardinal Health 107, LLC

INN (International Name):

diphenhydramine hydrochloride

Composition:

diphenhydramine hydrochloride 50 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Diphenhydramine hydrochloride in the injectable form is effective in adults and pediatric patients, other than premature infants and neonates, for the following conditions when diphenhydramine hydrochloride in the oral form is impractical. For amelioration of allergic reactions to blood or plasma, in anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled, and for other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated. For active treatment of motion sickness. For use in parkinsonism, when oral therapy is impossible or contraindicated, as follows:  parkinsonism in the elderly who are unable to tolerate more potent agents; mild cases of parkinsonism in other age groups, and in other cases of parkinsonism in combination with centrally acting anticholinergic agents. This drug should not be used in neonates or premature infants. Because of the higher risk of antihistamines for infants generally, and for neonates and prematures in particular, antihistamine therapy is contraindicated in nursing mothers. Because of the risk of local necrosis, this drug should not be used as a local anesthetic.  Antihistamines are also contraindicated in the following conditions:   Hypersensitivity to diphenhydramine hydrochloride and other antihistamines of similar chemical structure.

Product summary:

DiphenhydrAMINE Hydrochloride Injection, USP in parenteral form is supplied as: NDC No. Strength Volume 55154-9363-5 50 mg/mL 1 mL fill in a 2 mL vial. It is supplied as a sterile, pyrogen-free solution containing 50 mg diphenhydramine hydrochloride in each milliliter of solution. The container closure is not made with natural rubber latex. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light.  Keep from freezing.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DIPHENHYDRAMINE HYDROCHLORIDE- DIPHENHYDRAMINE
HYDROCHLORIDE INJECTION, SOLUTION
CARDINAL HEALTH 107, LLC
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DIPHENHYDRAMINE HYDROCHLORIDE INJECTION, USP
Rx only
DESCRIPTION:
Diphenhydramine hydrochloride is an antihistamine drug having the
chemical name 2-
(Diphenylmethoxy)-N,N-dimethylethylamine hydrochloride. It occurs as a
white,
crystalline powder, is freely soluble in water and alcohol.
The structural formula is as follows:
C
H NO•HCL M.W. 291.82
Diphenhydramine hydrochloride in the parenteral form is a sterile,
pyrogen-free solution
available in a concentration of 50 mg of diphenhydramine hydrochloride
per mL. pH 4.0
to 6.5; sodium hydroxide and/or hydrochloric acid added, if needed,
for pH adjustment.
CLINICAL PHARMACOLOGY:
Diphenhydramine hydrochloride is an antihistamine with anticholinergic
(drying) and
sedative side effects. Antihistamines appear to compete with histamine
for cell receptor
sites on effector cells.
Diphenhydramine hydrochloride in the injectable form has a rapid onset
of action.
Diphenhydramine hydrochloride is widely distributed throughout the
body, including the
CNS. A portion of the drug is excreted unchanged in the urine, while
the rest is
metabolized via the liver. Detailed information on the
pharmacokinetics of
diphenhydramine hydrochloride injection is not available.
INDICATIONS AND USAGE:
Diphenhydramine hydrochloride in the injectable form is effective in
adults and pediatric
patients, other than premature infants and neonates, for the following
conditions when
diphenhydramine hydrochloride in the oral form is impractical.
17
21
_ANTIHISTAMINIC_
For amelioration of allergic reactions to blood or plasma, in
anaphylaxis as an adjunct to
epinephrine and other standard measures after the acute symptoms have
been
controlled, and for other uncomplicated allergic conditions of the
immediate type when
oral therapy is impossible or contraindicated.
_MOTION SICKNESS_
For active treatment of motion sickness.
_ANTIPARKINSONISM_
For use in parkinsonism, when oral therapy is impos