DIPHEN- diphenhydramine hydrochloride solution

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Foxland Pharmaceuticals, Inc.

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Diphenhydramine hydrochloride in the oral form is effective for the following indications: For allergic conjunctivitis due to foods; mild, uncomplicated allergic skin manifestations of urticaria and angioedema; amelioration of allergic reactions to blood or plasma; dermatographism; as therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled. For active and prophylactic treatment of motion sickness. For parkinsonism (including drug-induced) in the elderly unable to tolerate more potent agents; mild cases of parkinsonism (including drug-induced) in other age groups; in other cases of parkinsonism (including drug-induced) in combination with centrally acting anticholinergic agents. Nighttime Sleep-aid. This drug should not be used in neonates or premature infants. Because of the higher risk of antihistamines for infants generally, and for neonates and prematures in particular, antihistamine therapy

Produktsammanfattning:

Each 5mL of Diphen Elixir (clear purple/red liquid, cinnamon/anise flavor) contains 12.5 mg diphenhydramine hydrochloride with 14% alcohol and is supplied in the following oral dosage forms: NDC 69067-092-04:    118 mL bottle

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

DIPHEN- DIPHENHYDRAMINE HYDROCHLORIDE SOLUTION
FOXLAND PHARMACEUTICALS, INC.
----------
DIPHEN ELIXIR
RX ONLY
DESCRIPTION
Diphenhydramine hydrochloride is an antihistamine drug having the
chemical name 2-
(diphenylmethoxy)-N,N -dimethylethylamine hydrochloride and has the
molecular formula C
H
NO·HCl (molecular weight 291.82). It occurs as a white odorless,
crystalline powder and is freely
soluble in water and alcohol. The structural formula is as follows:
Each 5 mL contains 12.5 mg of diphenhydramine hydrochloride and
alcohol 14% for oral administration.
Inactive Ingredients: Citric acid, D&C Red No. 33, FD&C Red No. 40,
flavoring, purified water,
sodium citrate, and sucrose.
CLINICAL PHARMACOLOGY
Diphenhydramine hydrochloride is an antihistamine with anticholinergic
(drying) and sedative effects.
Antihistamines appear to compete with histamine for cell receptor
sites on effector cells.
A single oral dose of diphenhydramine hydrochloride is quickly
absorbed with maximum activity
occurring in approximately one hour. The duration of activity
following an average dose of
diphenhydramine hydrochloride is from four to six hours.
Diphenhydramine is widely distributed
throughout the body, including the CNS. Little, if any, is excreted
unchanged in the urine; most appears
as the degradation products of metabolic transformation in the liver,
which are almost completely
excreted within 24 hours.
INDICATIONS AND USAGE
Diphenhydramine hydrochloride in the oral form is effective for the
following indications:
ANTIHIS TAMINIC
For allergic conjunctivitis due to foods; mild, uncomplicated allergic
skin manifestations of urticaria
and angioedema; amelioration of allergic reactions to blood or plasma;
dermatographism; as therapy for
anaphylactic reactions _adjunctive_ to epinephrine and other standard
measures after the acute
manifestations have been controlled.
MOTION SICKNESS
For active and prophylactic treatment of motion sickness.
17
21
For active and prophylactic treatment of motion sickness.
ANTIPARKINS ONIS M
For parkinso