DIPHENHYDRAMINE HYDROCHLORIDE- 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:

General Injectables and Vaccines

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. 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

Product summary:

Diphenhydramine Hydrochloride Injection, USP is available as: Carpuject Single-use 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 reusalbe Carpuject Holder, List 2019-02. Carpuject Single-use 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. Revised: 9/2015 Hospira, Inc., Lake Forest, IL 60045 US

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DIPHENHYDRAMINE HYDROCHLORIDE- DIPHENHYDRAMINE HYDROCHLORIDE
INJECTION,
SOLUTION
GENERAL INJECTABLES AND VACCINES
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DIPHENHYDRAMINE HYDROCHLORIDE 50MG/ML 1ML
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:
17
21
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
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.
_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 allergi