NOVO-BENZYDAMINE SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

BENZYDAMINE HYDROCHLORIDE

Tersedia dari:

NOVOPHARM LIMITED

Kode ATC:

A01AD02

INN (Nama Internasional):

BENZYDAMINE

Dosis:

1.5MG

Bentuk farmasi:

SOLUTION

Komposisi:

BENZYDAMINE HYDROCHLORIDE 1.5MG

Rute administrasi :

BUCCAL

Unit dalam paket:

100ML/250ML

Jenis Resep:

Prescription

Area terapi:

NONSTEROIDAL ANTI-INFLAMMATORY AGENTS

Ringkasan produk:

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

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2018-05-17

Karakteristik produk

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