Země: Jihoafrická republika
Jazyk: angličtina
Zdroj: South African Health Products Regulatory Authority (SAHPRA)
Akromed
MUCAINE* TABLETS SCHEDULING STATUS: S1 PROPRIETARY NAME (and dosage form): MUCAINE* TABLETS COMPOSITION: Each tablet contains: Oxethazaine 5,0 mg (N,N-bis-(N-methyl-N- phenyl-t-butylacetamido)- beta-hydroxyethylamine). Aluminium hydroxide 125,0 mg Magnesium carbonate 83,8 mg PHARMACOLOGICAL CLASSIFICATION: Category A,11.4.3- Antacids - Other PHARMACOLOGICAL ACTION: Oxethazaine is a topical anaesthetic. A dilute solution of oxethazaine hydrochloride applied to mucous membranes produces anaesthesia of longer duration than either cocaine hydrochloride or lignocaine hydrochloride. A solution of 0,0005% oxethazaine hydrochloride induces anaesthesia of rabbit cornea for the same duration as a 0,25% solution of cocaine hydrochloride, a 1% solution of lignocaine hydrochloride, or a 2% solution of procaine hydrochloride. The high potency of oxethazaine permits clinical use of dilute solutions; a 0,2% concentration of oxethazaine in alumina gel is therapeutically effective. In vitro oxethazaine produces an antispasmodic action on smooth muscle. It antagonizes the action of histamine serotonin, physostigmine and barium sulphate on smooth muscle. In vivo, with a balloon in a dog’s duodenum, oxethazaine hydrochloride given intravenously does not affect the motility of the intestine nor does it inhibit the action of neostigmine bromide on this motility. A wide margin of safety exists between the effective dose of oxethazaine in alumina gel and the oral toxic dose of this compound. In mice, the oral LD 50 of oxethazaine is approximately 400 mg of base per kg; when suspended in alumina gel as a vehicle the oral LD 50 in mice is 1012 mg of base per kg. The effective dose, five or ten mL, contains 10 or 20 mg of oxethazaine respectively; this is only 0,2 or 0,4 mg per kg of body mass for Přečtěte si celý dokument