DIPHENHYDRAMINE HYDROCHLORIDE injection

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

HF Acquisition Co. LLC, DBA Health First

Rotta amministrattiva:

INTRAMUSCULAR

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

Diphenhydramine Hydrochloride Injection is effective in adults and pediatric patients, other than premature infants and neonates, for the following conditions when 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 or premature infants. Use in Nursing Mothers Because of the higher risk of antihistamines for infants generally, and for neonates and prematures in particular, antihistamine therapy is contraindicated in nursing mothers. Use as a Local Anesthetic Because of the risk of local necrosis, this drug should not be used as a local anesthetic. Antihistamines are also Contraindicated in the Following Conditions Hypersensitivity to diphenhydramine hydrochloride and other antihistamines of similar chemical structure.

Sommarju tal-prodott:

DIPHENHYDRAMINE HCI INJECTION, USP is supplied in the following dosage forms. NDC 51662-1219-1. DIPHENHYDRAMINE HCI INJECTION, USP 50mg/mL 1mL VIAL NDC 51662-1219-2 Pouch containing a single DIPHENHYDRAMINE HCI INJECTION, USP 50mg/mL 1mL VIAL NDC 51662-1219-3 Case of 25 pouches of DIPHENHYDRAMINE HCI INJECTION, USP 50mg/mL 1mL VIAL HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufactures dosage forms Diphenhydramine Hydrochloride Injection, USP 50 mg/mL 1 mL vials packaged in 25s (NDC 0641-0376-25) Storage Protect from light. Keep covered in carton until time of use. Store at 20˚-25˚C (68˚-77˚F), excursions permitted to 15˚-30˚C (59˚-86˚F) [See USP Controlled Room Temperature]. To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceutical Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For Product Inquiry call 1-877-845-0689. Manufactured by: [West-Ward logo] WEST-WARD PHARMACEUTICALS Eatontown, NJ 07724 USA Revised May 2011 462-220-01

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

DIPHENHYDRAMINE HYDROCHLORIDE- DIPHENHYDRAMINE HYDROCHLORIDE INJECTION
HF ACQUISITION CO. LLC, DBA HEALTH FIRST
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DIPHENHYDRAMINE HYDROCHLORIDE- DIPHENHYDRAMINE HYDROCHLORIDE INJECTION
DESCRIPTION
Diphenhydramine Hydrochloride Injection is a sterile, nonpyrogenic
solution for intravenous or deep
intramuscular use as an antihistaminic agent. Each mL contains
diphenhydramine hydrochloride 50 mg and
benzethonium chloride 100 mcg in Water for Injection. pH 4.0-6.5;
sodium hydroxide and/or hydrochloric acid
added, if needed, for pH adjustment.
The chemical name of diphenhydramine hydrochloride is
2-(Diphenylmethoxy)-N,N-dimethylethylamine
hydrochloride. The structural formula is as follows:
C17H21NO • HCl MW 291.82
Diphenhydramine hydrochloride occurs as a white crystalline powder and
is freely soluble in water and
alcohol.
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 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 & USAGE
Diphenhydramine Hydrochloride Injection is effective in adults and
pediatric patients, other than premature
infants and neonates, for the following conditions when 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 park