DIPHENHYDRAMINE HYDROCHLORIDE injection, solution

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

HF Acquisition Co LLC, DBA HealthFirst

Администрация маршрут:

INTRAMUSCULAR

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

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. 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 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. Use in Neonates or Premature Infants This drug should not be used in neonates or prema

Обзор продуктов:

DIPHENHYDRAMINE HYDROCHLORIDE INJECTION, USP is supplied in the following dosage forms. NDC 51662-1374-1 DIPHENHYDRAMINE HYDROCHLORIDE INJECTION, USP 50 mg PER mL, 1mL in VIAL HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms DiphenhydrAMINE Hydrochloride Injection, USP in parenteral form is supplied as: 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.

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

DIPHENHYDRAMINE HYDROCHLORIDE- DIPHENHYDRAMINE
HYDROCHLORIDE INJECTION, SOLUTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
----------
DIPHENHYDRAMINE HYDROCHLORIDE INJECTION, USP 50 MG PER ML 1ML
VIAL
SPL UNCLASSIFIED
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:
C17H21NO•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 & 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.
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 pa