CANDIVA V GEL 2% w / w (20mg / g) Vaginal Gel

Country: Philippines

Language: English

Source: FDA (Food And Drug Administration)

Active ingredient:

Clotrimazole

Available from:

Glenmark Philippines, Inc.; Distributor: Glenmark Philippines, Inc.

INN (International Name):

Clotrimazole

Dosage:

2% w / w (20mg / g)

Pharmaceutical form:

Vaginal Gel

Units in package:

Aluminum Collapsible Tube with applicator x 30g (Box of 1's)

Manufactured by:

Glenmark Pharmaceuticals Ltd., India

Authorization date:

2017-01-24

Patient Information leaflet

Tube
Applicator with
cylinder & plunger
Cylinder
Plunger
Bladder
Womb
Vagina
SAME SIZE ARTWORK
LEAFLET SIZE: 140 mm x 176 mm
FORMULATION:
Each gram contains
Clotrimazole 20mg (2% w/w)
DESCRIPTION
CANDIVA V Gel is an imidazole antifungal drug for vaginal use in
candidial
vulvovaginitis. Clotrimazole was first synthesized in 1967 and has the
chemical
name
1-(o-chloro-diphenyl-benzyl)
imidazole.
The
molecular
formula
of
Clotrimazole is C H ClN with a molecular weight of 344.8. The chemical
22
17
2
structure is as follows:
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
_MECHANISM OF ACTION_
Clotrimazole, an imidazole derivative, exerts antifungal effects by
inhibition of
fungal
sterol
synthesis.
Clotrimazole
appears
to
inhibit
the
enzymatic
conversion of 2,4-methylenedihydrolanosterol to demethylsterol, the
precursor
to ergosterol, which is an essential building block of the cytoplasmic
membrane
of the fungi.
At
minimum
fungicidal
concentrations,
Clotrimazole
causes
leakage
of
intracellular
phosphorus
compounds
into
the
ambient
medium
with
concomitant breakdown of cellular nucleic acids and accelerated
potassium
efflux. Its postulated action has also been described as resulting in
leakage of
essential intracellular components leading to inhibition of synthesis
of such
macromolecules as protein, lipid, DNA, and polysaccharides.
Other proposed mechanisms for antimycotic activity of Clotrimazole
include
alteration
of
plasma
membrane
ATPase,
alteration
of
other
membrane
enzymes, alterations in membrane transport, and fatty acid metabolism.
ANTIMICROBIAL SPECTRUM
_FUNGI:_
Clotrimazole is a broad spectrum antifungal agent that inhibits the
growth of
most fungi pathogenic to man, including the following:
_a) Blastomyces dermatitidis _
_b) Candida spp: _Clotrimazole is as active as nystatin against_
Candida spp _
_c) Coccidioides immitis _
_d) Cryptococcus neoformans (Torula histolytica) _
_e) Dermatophytes (Trichophyton, Microsporum, Epidermophyton) _
_f) Histoplasma capsulatum _
_g) Malassezia furfur _
_h) Naegleria fowleri_
_i) N