DIPHENHYDRAMINE HYDROCHLORIDE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Hospira, Inc.

INN (International Name):

DIPHENHYDRAMINE HYDROCHLORIDE

Composition:

DIPHENHYDRAMINE HYDROCHLORIDE 50 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. 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, an

Product summary:

Diphenhydramine Hydrochloride Injection, USP is available as: Carpuject™ Single-dose cartridges with Luer Lock are packaged in a Slim-Pak™ tamper detection package. Note that a needle is not included. Instructions for Use of the Syringe Systems Instructions for using the Carpuject™ Syringe are available with the reusable Carpuject™ Holder, List 2049-02. Carpuject™ Single-dose cartridges are to be used ONLY with Carpuject™ Holders, List 2049-02. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing and light. Retain in carton until time of use.   Distributed by Hospira, Inc., Lake Forest, IL 60045 USA                                                                                      LAB-1300-3.0 Revised 05/2019

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DIPHENHYDRAMINE HYDROCHLORIDE- DIPHENHYDRAMINE HYDROCHLORIDE
INJECTION,
SOLUTION
HOSPIRA, INC.
----------
DIPHENHYDRAMINE
HYDROCHLORIDE INJECTION, USP
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 and has a molecular weight of
291.82. The molecular formula is
C
H NO • HCl and 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 for
intramuscular or intravenous use.
The solution for parenteral use has been adjusted to a pH between 4
and 6.5 with either sodium
hydroxide or hydrochloric acid.
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 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.
17
21
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
Fo