DIPHENHYDRAMINE- diphenhydramine hydrochloride injection, solution

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Micro Labs Limited

Via de administração:

INTRAMUSCULAR

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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 infan

Resumo do produto:

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 42571-169-54 Carton of 10 x 1 mL Ampule                         NDC 42571-169-55 Clear, colorless solution, free from any visible particles, no visible leaks or damage to the container closure system filled in tubular USP Type I glass vials. 1 mL fill in 2 mLVial                                       NDC 42571-337-95 Carton of 25 x 1 mL Vial                              NDC 42571-337-87 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. Rx only Manufactured by:       Micro Labs Limited Bangalore-560 099, India. Manufactured for: Micro Labs USA Inc. Basking Ridge, NJ 07920 Revised: September 2018

Status de autorização:

Abbreviated New Drug Application

Características técnicas

DIPHENHYDRAMINE - DIPHENHYDRAMINE HYDROCHLORIDE INJECTION, SOLUTION
MICRO LABS LIMITED
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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.
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
17
21
oral therapy is impossible or contraindicated.
MOTION SICKNESS
For active treatment of motion sickness.
ANTIPARKINSONISM
For use in parkinsonism, when ora