DIPHENHYDRAMINE HYDROCHLORIDE injection, solution

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Mylan Institutional LLC

INN (국제 이름):

DIPHENHYDRAMINE HYDROCHLORIDE

구성:

DIPHENHYDRAMINE HYDROCHLORIDE 50 mg in 1 mL

관리 경로:

INTRAVENOUS

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Diphenhydramine hydrochloride injection, 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 combinations 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 neonat

제품 요약:

Diphenhydramine Hydrochloride Injection, USP is supplied as a sterile solution containing 50 mg diphenhydramine hydrochloride in each milliliter of solution with 0.1 mg/mL benzethonium chloride as a germicidal agent. Available in multi-dose 10 mL (NDC 67457-124-10) vials. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from freezing and light. Manufactured for: Mylan Institutional LLC Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Institutional Galway, Ireland 1012L101 MI:DIHYIJ:R4 Revised: 6/2021

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

DIPHENHYDRAMINE HYDROCHLORIDE- DIPHENHYDRAMINE
HYDROCHLORIDE INJECTION, SOLUTION
MYLAN INSTITUTIONAL LLC
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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 and has a
molecular weight of
291.82. The molecular formula is C
H
NO • HCl. The structural formula is as follows:
Diphenhydramine hydrochloride in the parenteral form is a sterile,
pyrogen-free solution
available in a concentration of 50 mg of diphenhydramine hydrochloride
per mL. The
solutions for parenteral use have been adjusted to a pH between 5.0
and 6.0 with either
sodium hydroxide or hydrochloric acid and contains 0.1 mg/mL
benzethonium chloride
as a germicidal agent.
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 injection, 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
17
21
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 mo