DIPHENHYDRAMINE HYDROCHLORIDE injection, solution

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M)

Sẵn có từ:

General Injectables & Vaccines, Inc

Tuyến hành chính:

INTRAVENOUS

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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: 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 at 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 premature infants. USE IN NURSING MOTHERS Becaus

Tóm tắt sản phẩm:

Diphenhydramine Hydrochloride Injection, USP 50 mg/mL 1 mL vials packaged in 25s (NDC 0641-0376-25) STORAGE 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 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 Revised December 2019 462-220-02

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

DIPHENHYDRAMINE HYDROCHLORIDE- DIPHENHYDRAMINE
HYDROCHLORIDE INJECTION, SOLUTION
GENERAL INJECTABLES & VACCINES, INC
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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:
C17H21NO • 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:
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 parkinsoni