DIPHENHYDRAMINE HYDROCHLORIDE capsule

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Cardinal Health

INN (Internationale Bezeichnung):

DIPHENHYDRAMINE HYDROCHLORIDE

Zusammensetzung:

DIPHENHYDRAMINE HYDROCHLORIDE 50 mg

Verschreibungstyp:

PRESCRIPTION DRUG

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

DIPHENHYDRAMINE HYDROCHLORIDE- DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE
CARDINAL HEALTH
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DIPHENHYDRAMINE HYDROCHLORIDE CAPSULES, 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, odorless crystalline
powder and is freely soluble in water and alcohol. The structural
formula is as follows:
C H NO • HCL MOLECULAR WEIG HT: 291.82
Each capsule contains 50 mg of diphenhydramine hydrochloride for oral
administration.
INACTIVE INGREDIENTS:
Anhydrous lactose, lactose monohydrate and magnesium stearate.
The 50 mg capsule shell contains D&C red no. 28, FD&C blue no. 1, FD&C
red no. 40, gelatin, silicon
dioxide and sodium lauryl sulfate.
The imprinting ink contains D&C yellow no. 10 aluminum lake, FD&C blue
no. 1 aluminum lake, FD&C
blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake,
pharmaceutical glaze, propylene glycol and
synthetic black iron oxide.
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.
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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;
de