DIPHENHYDRAMINE HYDROCHLORIDE INJECTION, USP SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

DIPHENHYDRAMINE HYDROCHLORIDE

Disponible depuis:

FRESENIUS KABI CANADA LTD

Code ATC:

R06AA02

DCI (Dénomination commune internationale):

DIPHENHYDRAMINE

Dosage:

50MG

forme pharmaceutique:

SOLUTION

Composition:

DIPHENHYDRAMINE HYDROCHLORIDE 50MG

Mode d'administration:

INTRAMUSCULAR

Unités en paquet:

15G/50G

Type d'ordonnance:

Ethical

Domaine thérapeutique:

ETHANOLAMINE DERIVATIVES

Descriptif du produit:

Active ingredient group (AIG) number: 0102639001; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2015-03-06

Résumé des caractéristiques du produit

PRESCRIBING INFORMATION
DIPHENHYDRAMINE HYDROCHLORIDE INJECTION, USP
50 MG / ML
STERILE SOLUTION
FOR INTRAVENOUS OR DEEP INTRAMUSCULAR USE
ANTIHISTAMINIC
FRESENIUS KABI CANADA LTD.
Date of Preparation:
165 Galaxy Blvd, Suite 100
September 7, 2023
Toronto, ON M9W 0C8
Submission Control Number: 269697
_Prescribing Information - DiphenhydrAMINE Hydrochloride Injection,
USP_
_ _
Page 1 of 3
DIPHENHYDRAMINE HYDROCHLORIDE INJECTION, USP
50 MG / ML
Sterile Solution
Antihistaminic
ACTION
Diphenhydramine is a potent antihistaminic agent which possesses
antipruritic,
anticholinergic (antispasmodic), antiemetic and sedative effects.
INDICATIONS
Parenteral administration of diphenhydramine is indicated for its
antiallergic, antiemetic
and antispasmodic actions, where, in the judgement of the physician,
prompt action is
necessary and oral therapy would be inadequate.
PRECAUTIONS
Avoid subcutaneous or perivascular injection. Single parenteral dosage
greater than 100
mg should be avoided, particularly in hypertension and cardiac
disease. Patients should
be cautioned not to operate vehicles or hazardous machinery until
their response to the
drug has been determined. Patients receiving diphenhydramine
hydrochloride should be
cautioned about additive effects with alcohol and other central
nervous system
depressants (hypnotics, sedatives and tranquilizers).
Diphenhydramine has an atropine-like effect which should be considered
when
prescribing this product. Use with caution in patients with history of
asthma. Safety for
use in pregnancy and lactation has not been established. Its use,
therefore, in such
patients should involve consideration of expected benefits and
possible risks.
ADVERSE EFFECTS
Drowsiness, dizziness, dryness of mouth, nausea and nervousness may
occur. Other
infrequently reported effects are vertigo, palpitation, blurring of
vision, headache,
restlessness, insomnia and thickening of bronchial secretions.
Allergic reactions,
diarrhea, vomiting and excitation may also occur.
_Prescribing Information - DiphenhydrAMIN