NOVO-BENZYDAMINE SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

BENZYDAMINE HYDROCHLORIDE

Disponible depuis:

NOVOPHARM LIMITED

Code ATC:

A01AD02

DCI (Dénomination commune internationale):

BENZYDAMINE

Dosage:

1.5MG

forme pharmaceutique:

SOLUTION

Composition:

BENZYDAMINE HYDROCHLORIDE 1.5MG

Mode d'administration:

BUCCAL

Unités en paquet:

100ML/250ML

Type d'ordonnance:

Prescription

Domaine thérapeutique:

NONSTEROIDAL ANTI-INFLAMMATORY AGENTS

Descriptif du produit:

Active ingredient group (AIG) number: 0113801001; AHFS:

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2018-05-17

Résumé des caractéristiques du produit

1
PRODUCT MONOGRAPH
Pr
NOVO-BENZYDAMINE
(Benzydamine Hydrochloride Oral Rinse 0.15% w/v)
Local Analgesic
Novopharm Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Submission Control No: 121722
Date of Preparation:
May 14, 2008
2
PRODUCT MONOGRAPH
PR
NOVO-BENZYDAMINE
(Benzydamine Hydrochloride Oral Rinse 0.15% w/v)
THERAPEUTIC CLASSIFICATION
Local Analgesic
ACTIONS AND CLINICAL PHARMACOLOGY
Animal studies using parenteral route have shown that benzydamine
hydrochloride
possesses properties of an analgesic/anti-inflammatory agent. This
effect is not mediated
through the pituitary-adrenal axis. Studies using the topical route
have demonstrated local
anesthetic properties of benzydamine hydrochloride. In controlled
studies in humans with
oro-pharyngeal mucosity due to radiation therapy, benzydamine
hydrochloride oral rinse
use has provided relief through reduction of pain and edema. Similar
studies in patients
with acute sore throat demonstrated relief from pain.
Benzydamine hydrochloride has been detected in blood and urine after
gargling four
times for 20 2seconds, in rapid succession, each time with a volume
equivalent to 25.5
mg benzydamine per 70 kg body weight (approximately 17 mL per gargle).
The average
maximum plasma level of 59 ng/mL (range 17 to 173) was obtained 2
hours after
gargling. For comparison, one dose of 17 mL, when swallowed, yielded
an average
maximum plasma level of 180 ng/ mL (range 102 to 324), also at 2 hours
after ingestion.
Benzydamine was still detectable 24 hours later in 7 out of 10
subjects after the gargling
(average plasma level of 7 ng/mL) and in 9 out of 10 subjects after
the ingestion (average
32 ng/mL).
The urinary excretion was completed within 3-4 days after the single
dose in both groups;
about 46% of the dose was recovered in garglers, about 26% in
ingestors. Repeated
administration for 7 days did not result in a significant accumulation
of benzydamine
hydrochloride in plasma.
INDICATIONS AND CLINICAL USE
NOVO-BENZYDAMINE (benzydamine hydrochloride) Oral Rinse is indicat