TANTUM MOUTHWASH/GARGLE

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

BENZYDAMINE HYDROCHLORIDE

Disponibil de la:

BAUSCH HEALTH, CANADA INC.

Codul ATC:

A01AD02

INN (nume internaţional):

BENZYDAMINE

Dozare:

0.15%

Forma farmaceutică:

MOUTHWASH/GARGLE

Compoziție:

BENZYDAMINE HYDROCHLORIDE 0.15%

Calea de administrare:

BUCCAL

Unități în pachet:

250ML

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

MOUTHWASHES AND GARGLES

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2012-01-03

Caracteristicilor produsului

PRESCRIBING INFORMATION
PR
TANTUM
TM
Benzydamine Mouthwash, BP
Benzydamine Hydrochloride
1.5 mg/mL (0.15% w/v)
ORAL RINSE
LOCAL ANALGESIC
BAUSCH HEALTH, CANADA INC.
DATE OF REVISION:
2150 St-Elzear Blvd. West
October 7, 2021
Laval, Quebec
H7L 4A8
Control #: 256416
NAME OF DRUG
PR
TANTUM
TM
Benzydamine Mouthwash, BP
Benzydamine Hydrochloride
1.5 mg/mL (0.15% w/v)
ACTION
Animal studies using the parenteral route have shown that TANTUM
(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 the local
analgesic
properties of benzydamine hydrochloride. In controlled studies in
humans with oro- pharyngeal
mucositis due to radiation therapy, TANTUM Oral Rinse provided relief
through reduction of pain
and edema. Similar studies in patients with acute sore throat
demonstrated relief from pain.
Benzydamine HCl has been detected in blood and urine after gargling
four times for 20 seconds, 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 ingestion. Benzydamine was still
detectable 24 hours later in
7 out of 10 subjects after gargling (average plasma level of 7 ng/ml)
and in 9 out of 10 subjects
after 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 gurglers, and 26% in ingestors.
Repeated administration for 7
days did not result in a significant accumulation of benzydamine in
plasma.
INDICATIONS
TANTUM Oral Rinse (benzydamine HCl) is indicated for the relief of
pain in acute sore throat and
for the symptomatic relief of oro-pharyngeal mucositis caused by
radiation therapy.
CONTRAINDICATIONS
TANTUM (benzydamine HCl) is contraindicated in subjects with a history
of hypersensitivity
to
benzydamine hydr