NIZORAL SHAMPOO

Երկիր: Կանադա

Լեզու: անգլերեն

Աղբյուրը: Health Canada

Ակտիվ բաղադրիչ:

KETOCONAZOLE

Հասանելի է:

KRAMER LABORATORIES, INC

ATC կոդը:

D01AC08

INN (Միջազգային անվանումը):

KETOCONAZOLE

Դոզան:

2%

Դեղագործական ձեւ:

SHAMPOO

Կազմը:

KETOCONAZOLE 2%

Կառավարման երթուղին:

TOPICAL

Միավորները փաթեթում:

6/60/120ML

Ռեկվիզորի տեսակը:

OTC

Թերապեւտիկ տարածք:

AZOLES

Ապրանքի ամփոփագիր:

Active ingredient group (AIG) number: 0116793002; AHFS:

Լիազորման կարգավիճակը:

APPROVED

Հաստատման ամսաթիվը:

2007-07-04

Ապրանքի հատկությունները

1
PRODUCT MONOGRAPH
NIZORAL®
(ketoconazole 2% shampoo)
Therapeutic Classification
Topical Antifungal Agent
Date of Revision:
March 5, 2019
Kramer Laboratories, Inc.
440 Route 22 East, Suite 130
Bridgewater, NJ 08807 USA
Distributed by:
Aurium Pharma Inc.
7941 Jane St. # 105
Concord, Ontario
L4K 4L6
Submission Control No.: 223778
2
NAME OF DRUG
NIZORAL® shampoo (ketoconazole 2% shampoo)
THERAPEUTIC CLASSIFICATION
Topical antifungal agent
ACTIONS
In vitro studies suggest that the antifungal properties of NIZORAL®
(ketoconazole) may be related
to its ability to impair the synthesis of ergosterol, a component of
fungal and yeast cell membranes.
Without the availability of this essential sterol, there are
morphological alterations of the fungal
and yeast cell membranes manifested as abnormal membranous inclusions
between the cell wall
and
the
plasma
membrane.
The
inhibition
of
ergosterol
synthesis
has
been
attributed
to
interference with the reactions involved in the removal of the 14-

-methyl group of the precursor
of ergosterol, lanosterol.
Except for its specific pharmacologic effect, i.e., a sporicidal or
fungicidal activity, ketoconazole
when formulated in a 2% shampoo is not expected to exert any other
pharmacodynamic effect
when applied topically on the skin or hair.
INDICATIONS
NIZORAL® (ketoconazole) 2% shampoo is indicated for the topical
treatment and prophylaxis of
conditions in which the yeast Pityrosporum is involved, such as
pityriasis capitis (dandruff).
NIZORAL® shampoo is also indicated for seborrheic dermatitis.
3
CONTRAINDICATIONS
NIZORAL®
(ketoconazole)
2%
shampoo
is
contraindicated
in
persons
who
have
shown
hypersensitivity to the active or excipient ingredients of this
formulation.
WARNINGS
Irritation may occur when NIZORAL® (ketoconazole) 2% shampoo is used
immediately after
prolonged treatment with topical corticosteroids. To prevent a rebound
effect after stopping a
prolonged treatment with topical corticosteroids, it is recommended to
continue applying a mild
topical corticosteroi