TARO-IMIQUIMOD PUMP CREAM

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Viambatanisho vya kazi:

IMIQUIMOD

Inapatikana kutoka:

TARO PHARMACEUTICALS INC

ATC kanuni:

D06BB10

INN (Jina la Kimataifa):

IMIQUIMOD

Kipimo:

5%

Dawa fomu:

CREAM

Tungo:

IMIQUIMOD 5%

Njia ya uendeshaji:

TOPICAL

Vitengo katika mfuko:

15G/50G

Dawa ya aina:

Prescription

Eneo la matibabu:

MISC. SKIN AND MUCOUS MEMBRANE AGENTS

Bidhaa muhtasari:

Active ingredient group (AIG) number: 0135820001; AHFS:

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2018-11-22

Tabia za bidhaa

PRODUCT MONOGRAPH
PR
TARO-IMIQUIMOD
PR
TARO-IMIQUIMOD PUMP
IMIQUIMOD CREAM USP, 5% W/W
Immune response modifier
Date of Preparation:
Taro Pharmaceuticals Inc.
130 East Drive, Brampton
November 19, 2018
Ontario, L6T 1C1
SUBMISSION CONTROL NO: 212515
_________________________________________________________________________________
Taro-Imiquimod
Page
2
of
33
PRODUCT MONOGRAPH
Pr
Taro-Imiquimod
Pr
Taro-Imiquimod Pump
Imiquimod Cream USP, 5% w/w
Immune response modifier
ACTION AND CLINICAL PHARMACOLOGY
_ _
_In vitro_
studies have demonstrated that imiquimod induces the release of
interferon alpha
(IFNα) and other cytokines from human monocytes/macrophages and
keratinocytes. The
panel of cytokines induced varied with the cell’s tissue origin.
Topical
_in vivo_
application of
imiquimod cream on mouse skin resulted in increased concentrations of
IFN and tumour
necrosis factor (TNF) compared with skin of untreated mice. The
cytokine inducing
properties of imiquimod may be responsible for its activity against
genital/perianal warts, as
imiquimod does not have a direct antiviral activity in cell cultures.
The clinical relevance of
these findings is, however, unknown.
PHARMACODYNAMICS
SUPERFICIAL BASAL CELL CARCINOMA (SBCC)
The mechanism of action of imiquimod in treating superficial basal
cell carcinoma (sBCC)
lesions is unknown. One clinical study in 6 subjects has suggested
that imiquimod stimulates
the infiltration of T-cell lymphocytes, dendritic cells, and
macrophages into the basal cell
carcinoma lesion.
ACTINIC KERATOSIS
The mechanism of action of imiquimod in treating actinic keratosis
(AK) lesions is unknown.
While the following have been observed, the clinical significance of
these observations in
AK is not known. In a study of 58 patients with AK treated with
imiquimod 3 times per
week, the response of biomarkers sensitive to imiquimod after 16 weeks
of dosing increased
compared to the response after the first dose. For interleukin-1
antagonist, the median
concentration observed following multiple dosing was