DIPHENHYDRAMINE HYDROCHLORIDE INJECTION, USP SOLUTION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

DIPHENHYDRAMINE HYDROCHLORIDE

Commercializzato da:

FRESENIUS KABI CANADA LTD

Codice ATC:

R06AA02

INN (Nome Internazionale):

DIPHENHYDRAMINE

Dosaggio:

50MG

Forma farmaceutica:

SOLUTION

Composizione:

DIPHENHYDRAMINE HYDROCHLORIDE 50MG

Via di somministrazione:

INTRAMUSCULAR

Confezione:

15G/50G

Tipo di ricetta:

Ethical

Area terapeutica:

ETHANOLAMINE DERIVATIVES

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2015-03-06

Scheda tecnica

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