Šalis: Kanada
kalba: anglų
Šaltinis: Health Canada
BENZYDAMINE HYDROCHLORIDE
BAUSCH HEALTH, CANADA INC.
A01AD02
BENZYDAMINE
0.15%
MOUTHWASH/GARGLE
BENZYDAMINE HYDROCHLORIDE 0.15%
BUCCAL
250ML
Prescription
MOUTHWASHES AND GARGLES
Active ingredient group (AIG) number: 0113801001; AHFS:
APPROVED
2012-01-03
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 Perskaitykite visą dokumentą