FLAGYSTATIN CREAM

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

METRONIDAZOLE; NYSTATIN

Beschikbaar vanaf:

SANOFI-AVENTIS CANADA INC

ATC-code:

G01AA51

INN (Algemene Internationale Benaming):

NYSTATIN, COMBINATIONS

Dosering:

500MG; 100000UNIT

farmaceutische vorm:

CREAM

Samenstelling:

METRONIDAZOLE 500MG; NYSTATIN 100000UNIT

Toedieningsweg:

VAGINAL

Eenheden in pakket:

55G

Prescription-type:

Prescription

Therapeutisch gebied:

ANTIBIOTICS

Product samenvatting:

Active ingredient group (AIG) number: 0202573002; AHFS:

Autorisatie-status:

CANCELLED POST MARKET

Autorisatie datum:

2017-08-24

Productkenmerken

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_Page 1 of 23_
PRODUCT MONOGRAPH
PR
FLAGYSTATIN
®
(500 mg metronidazole and 100,000 IU nystatin)
Vaginal Ovules
Vaginal Cream
Trichomonacide – Moniliacide
sanofi-aventis Canada Inc.
2905 Place Louis R.-Renaud
Laval, Quebec H7V 0A3
Date of Revision:
February 21, 2017
Submission Control No.: 200324
_ _
_Page 2 of 23_
PRODUCT MONOGRAPH
PR
FLAGYSTATIN
®
(500 mg metronidazole and 100,000 IU nystatin)
Vaginal Ovules
Vaginal Cream
Trichomonacide – Moniliacide
ACTION AND CLINICAL PHARMACOLOGY
Metronidazole is bactericidal against anaerobic bacteria; it exerts
trichomonacidal activity and is
also active against _Giardia lamblia_ and _Entamoeba histolytica_. Its
exact mechanism of action
has not been entirely determined as yet. It has been proposed that an
intermediate in the
reduction of metronidazole, produced only in anaerobic bacteria and
protozoa is bound to
deoxyribonucleic acid and electron-transport proteins, inhibits
subsequent nucleic acid synthesis.
At present, the mechanism by which topical metronidazole reduces the
lesions and erythema
associated with acne rosacea is not precisely known. Despite the
established antimicrobial
effects of metronidazole, there is no evidence that the suppression of
bacteria or parasitic mites
harbored in the skin is directly responsible for its beneficial
effects in rosacea. _In vitro_ and _in _
_vivo_ studies indicate that metronidazole has direct antiinflammatory
activity and affects
neutrophil chemotaxis and cell-mediated immunity. An antioxidant
action via inhibition of
neutrophil-generated reactive oxygen species has also been
demonstrated; this action is believed
to underlie its antiinflammatory effect. It has been proposed that the
reduction in rosacea lesions
and erythema is the result of antiinflammatory or immunosuppressive
actions of metronidazole.
Nystatin is an antifungal antibiotic, produced by a strain of
_Streptomyces noursei_, active against
yeasts and yeast like fungi, including Candida albicans. The
antifungal activity is probably due
to the binding of