NEO-ZOL VAGINAL CREAM 2%

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

CLOTRIMAZOLE

Dostopno od:

PRESTIGE PHARMA INC

Koda artikla:

G01AF02

INN (mednarodno ime):

CLOTRIMAZOLE

Odmerek:

2%

Farmacevtska oblika:

CREAM

Sestava:

CLOTRIMAZOLE 2%

Pot uporabe:

VAGINAL

Enote v paketu:

25G

Tip zastaranja:

OTC

Terapevtsko območje:

AZOLES

Povzetek izdelek:

Active ingredient group (AIG) number: 0110231003; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2012-10-26

Lastnosti izdelka

1
PRODUCT
MONOGRAPH
NEO-ZOL
VAGINAL
CREAM
1%
CLOTRIMAZOLE VAGINAL CREAM USP 1%
NEO-ZOL
VAGINAL
CREAM
2%
CLOTRIMAZOLE VAGINAL CREAM USP 2%
ANTIFUNGAL AGENT
PRESTIGE PHARMA INC.
DATE OF PREPARATION:
6565 DUNCAN STREET
NOVEMBER 13
, 2015
MONTREAL, QUEBEC
H4B 1#8
CONTROL #187895
2
PRODUCT
MONOGRAPH
NEO-ZOL
VAGINAL
CREAM
1%
Clotrimazole Vaginal Cream USP 1%
NEO-ZOL
VAGINAL
CREAM
2%
Clotrimazole Vaginal Cream USP 2%
THERAPEUTIC
CLASSIFICATION
Antifungal Agent
ACTION
Clotrimazole acts primarily by damaging the permeability barrier in
the cell membrane of
fungi. Clotrimazole brings about inhibition of ergosterol
biosynthesis, an essential constituent
of fungal cell membranes. If ergosterol synthesis is completely or
partially inhibited, the cell is
no longer able to construct an intact cell membrane. This leads to
death of the fungus.
Exposure
of
Candida
albicans
to
clotrimazole
causes
leakage
of
intracellular
phosphorus compounds into the ambient medium with a concomitant
breakdown of cellular
nucleic acids and potassium eflux. The onset of these events is rapid
and extensive after
exposure
of
the
organism
to the
drug,
and
causes
a
time-dependent
and
concentration-
dependent inhibition of fungal growth.
INDICATIONS
Neo-Zol
Vaginal
Cream
1%
is
indicated
for
the
6-day
treatment
of
vaginal
candidiasis
and associated
vulval
candidiasis. Neo-Zol
Vaginal
Cream
2%
is
indicated
for
the
3-day
treatment of vaginal candidiasis and associated vulval candidiasis.
CONTRAINDICATIONS
Neo-Zol Vaginal Cream is contraindicated in patients who are
hypersensitive to clotrimazole or
any nonmedicinal ingredients in the formulation of Neo-Zol vaginal
cream. For a complete
listing, see the Composition section of the product monograph.
3
PRECAUTIONS
Neo-Zol Vaginal Cream is not for ophthalmic use. Neo-Zol Vaginal Cream
is not for oral use.
As
with
all
topical
agents,
skin
sensitization
may
result.
Use
of
Neo-Zol
topical
preparations should be discontinued should such reactions occur, and
appropriate therapy
instituted.
Treatment
during
the
menst