DIPHENHYDRAMINE HYDROCHLORIDE injection

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Cardinal Health 107, LLC

Via de administração:

INTRAVENOUS

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Diphenhydramine Hydrochloride Injection is effective in adults and pediatric patients, other than premature infants and neonates, for the following conditions when 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. Hypersensitivity to diphenhydramine hydrochloride and other antihistamines of similar chemical structure.

Resumo do produto:

Diphenhydramine Hydrochloride Injection, USP 50 mg/mL Available: Overbagged with 5 x 1 mL vials, NDC 55154-5102-5 Protect from light. Keep covered in carton until time of use. Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For Product Inquiry call 1-877-845-0689. Manufactured by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 Distributed By: Cardinal Health Dublin, OH 43017 Revised December 2019 L25632450124 462-220-02

Status de autorização:

Abbreviated New Drug Application

Características técnicas

DIPHENHYDRAMINE HYDROCHLORIDE- DIPHENHYDRAMINE
HYDROCHLORIDE INJECTION
CARDINAL HEALTH 107, LLC
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DIPHENHYDRAMINE HYDROCHLORIDE INJECTION, USP
RX ONLY
DESCRIPTION
Diphenhydramine Hydrochloride Injection is a sterile, nonpyrogenic
solution for
intravenous or deep intramuscular use as an antihistaminic agent. Each
mL contains
diphenhydramine hydrochloride 50 mg and benzethonium chloride 100 mcg
in Water for
Injection. pH 4.0-6.5; sodium hydroxide and/or hydrochloric acid
added, if needed, for
pH adjustment.
The chemical name of diphenhydramine hydrochloride is
2-(Diphenylmethoxy)-N,N-
dimethylethylamine hydrochloride. The structural formula is as
follows:
C
H
NO • HCl MW 291.82
Diphenhydramine hydrochloride occurs as a white crystalline powder and
is freely
soluble in water and alcohol.
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 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 Injection is effective in adults and
pediatric patients,
other than premature infants and neonates, for the following
conditions when the oral
17
21
form is impractical:
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