DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride injection, solution

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Armas Pharmaceuticals Inc.

Vía de administración:

INTRAMUSCULAR

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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, and

Resumen del producto:

Diphenhydramine Hydrochloride Injection, USP in parenteral form is supplied as:  Sterile, pyrogen-free solution containing 50 mg diphenhydramine hydrochloride USP in a 1 mL amber color glass ampule with yellow bands and white OPC mark, and available in packages of ten packed in a PVC rondo tray in a single carton. 1 mL fill in 1 mL Ampule                              NDC 72485-102-01 Carton of 10 x 1 mL Ampule                       NDC 72485-102-10 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. Keep this and all drugs out of the reach of children Rx only HIGH POTENCY Manufactured by: Micro Labs Limited Bangalore-560 099. INDIA M. L. No. : KTK/28/357/2006 Distributed by: Armas Pharmaceuticals, Inc. Manalapan, NJ 07726 (USA) Revised: January 2016

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

DIPHENHYDRAMINE HYDROCHLORIDE- DIPHENHYDRAMINE HYDROCHLORIDE
INJECTION,
SOLUTION
ARMAS PHARMACEUTICALS INC.
----------
DIPHENHYDRAMINE HYDROCHLORIDE INJECTION, USP
DESCRIPTION
Diphenhydramine hydrochloride USP 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 • HCI. The structural formula is as follows:
Diphenhydramine hydrochloride USP in the parenteral form is a sterile,
pyrogen-free solution available
in a concentration of 50 mg of diphenhydramine hydrochloride USP per
mL. The solutions for
parenteral use have 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.
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
For active treatment of motio