DIPHENHYDRAMINE HYDROCHLORIDE injection

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)

Tilgjengelig fra:

Rebel Distributors Corp

Administreringsrute:

INTRAMUSCULAR

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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, ant

Produkt oppsummering:

Diphenhydramine Hydrochloride Injection, USP 50 mg/mL 1 mL vials packaged in 25s (NDC 42254-190-01) Protect from light. Keep covered in carton until time of use. Store at 20˚-25˚C (68˚-77˚F), excursions permitted to 15˚-30˚C (59˚-86˚F) [See USP Controlled Room Temperature]. To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceutical Corp. 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: WEST-WARD PHARMACEUTICALS Eatontown, NJ 07724 USA Revised May 2011 462-220-01 Repackaged by: REBEL DISTRIBUTORS CORP Thousand Oaks, CA 91320

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

DIPHENHYDRAMINE HYDROCHLORIDE- DIPHENHYDRAMINE HYDROCHLORIDE INJECTION
REBEL DISTRIBUTORS CORP
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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 form is impractical:
ANTIHIS TAMINIC
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.
17
21
ANTIPARKINS ONIS M
For use in parkinsonism, when oral thera