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| Bradoral |
Bradoral ‘ "
Mouth and throat antiseptic
Composition and forms of issue
Dodecyldimethyl -i2- phenoxyethyl 1- am-
mon. bromat. (=domiphen. bromat.l
Eucalyptol., menthol., olea aether., quant.
minimal.;
excip. pro compr. buccal.
Lozenges oi 0.5 mg domiphen bromide
Dorniphen bromide belongs to the class of
the long-chain quaternary ammonium
compounds.
Properties! effects
Bradoral has an antiseptic efiect against
most bacteria and fungi that are liable to
cause infections oi the mouth and throat.
Gram-positive micro-organisms prove
more sensitive to it than gram-negative
ones. Bradoral is generally believed to
exert its efiect mainly by acting on the
cell membrane oi the pathogens.
Pharmacokinetics
Few pharmacokinetic data are available
on long-chain quaternary ammonium com-
pounds such as domiphen. The low con-
centrations of active substance reached
in the body fluids cannot be measured by
the usual analytical methods.
Such data as are available suggest that
systemic absorption of domiphen bromide
occurs only on an insignificant scale.
Indications
Bradoral serves to prevent inflammation
of the mouth and throat at times when
there is an increased risk of infection. In
cases where infection has already occur-
red, it alleviates difficulty in swallowing,
soreness of the throat, hoarseness, gin-
givitis, and aphthous stomatitis, thereby
promoting the healing process.
Dosage
Bradoral is well tolerated by the oral
mucosa and has a pleasant taste which
children also find acceptable.
For prophylactic use: 1 lozenge 4-6 times
daily, to be slowly dissolved in the mouth.
For use where infection has already
occurred : Suck 1 lozenge every 1-2 hours
[up to a maximum of B lozenges per day).
It'll I
Restrictions on use
Contra - indications
Known hypersensitivity to the active subs-
tance andlor the auxiliary substances.
Precautions
in the unlikely event that difficulty in
swallowing either sets in or becomes
aggravated during treatment with Brado-
ral, the treatment should be discontinued.
Where Bradoral is being taken as self-
medication, the patient should consult a
doctor if the symptoms are still present
after about 5 days of treatment andlor if
fever develops.
Pregnancy and lactation
No animal-experimental data on terato-
genic effects have been reported, nor has
therapeutic experience extending over
many years yielded evidence of any
harmful influence on development of the
embryo andior foetus.
During the first Bmonths of pregnancy,
Bradoral should nevertheless only be
employed for compelling reasons.
Unwanted effects
Only in very rare cases have there been
reports of local hypersensitivity reactions
in the form of local reddening of the
mucous membranes and swelling of the
pharyngeal mucosa giving rise to difficulty
in swallowing.
interactions
Anionic surfactants, e.g. soaps, as well as
protein-containing organic material, e.g.
blood and purulent secretions, diminish
the antiseptic activity of Bradoral.
Overdosage
No cases of overdosage have been
reported to date.
Storage
Protect from moisture and heat
{store below 30°C).
Packages
Lozenges : Packs of 20
Medicines should be kept out of the
reach of children.
Produced bx
NOVARTIS HARMA S.A.E.-Cairo
under licence from
Novartis Consumer Health SA,
Nyon,Switzerland
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