PROSTIN E2 VAGINAL GEL

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DINOPROSTONE

Available from:

PFIZER CANADA ULC

ATC code:

G02AD02

INN (International Name):

DINOPROSTONE

Dosage:

1MG

Pharmaceutical form:

GEL

Composition:

DINOPROSTONE 1MG

Administration route:

VAGINAL

Units in package:

3GM

Prescription type:

Prescription

Therapeutic area:

OXYTOCICS

Product summary:

Active ingredient group (AIG) number: 0111999001; AHFS:

Authorization status:

APPROVED

Authorization date:

1997-09-04

Summary of Product characteristics

_Prostin_
_ _
_E_
_2_
_ Vaginal Gel (dinoprostone vaginal gel)_
_ Product Monograph _
_Page 1 of 21_
PRODUCT MONOGRAPH
PROSTIN® E
2 VAGINAL GEL
DINOPROSTONE VAGINAL GEL
1 MG PER 3 GRAM (SYRINGE)
2 MG PER 3 GRAM (SYRINGE)
PROSTAGLANDIN
Pfizer Canada Inc
17,300 Trans-Canada Highway
Kirkland, Quebec
H9J 2M5
Date of revision:
September 13, 2012
CONTROL NO. 156848
®
TM Pfizer Enterprises, SARL
Pfizer Canada Inc, Licensee

Pfizer Canada Inc 2012
Distributed by:
Paladin Labs Inc.
Montreal, Quebec
_Prostin_
_ _
_E_
_2_
_ Vaginal Gel (dinoprostone vaginal gel)_
_ Product Monograph _
_Page 2 of 21_
PRODUCT MONOGRAPH
PROSTIN® E
2 VAGINAL GEL
DINOPROSTONE VAGINAL GEL
1 MG PER 3 GRAM (SYRINGE)
2 MG PER 3 GRAM (SYRINGE)
THERAPEUTIC CLASSIFICATION
PROSTAGLANDIN
ACTION, CLINICAL PHARMACOLOGY
Dinoprostone is a synthetic analogue of Prostaglandin E
2
(PGE
2
). The major clinical application
of PGE
2
relates to its effect on uterine smooth muscle. This property has led
to its obstetrical use
for term labour induction and preterm evacuation of uterine contents
(for fetal death
_in utero_
,
hydatidiform mole, and abortion). Similarly, this effect on other
smooth muscle beds results in
prominent dose-related side effects of nausea, vomiting, and abdominal
cramping. It also acts as
a vasodilator and may be associated with modest hypotension. Changes
that occur in the cervix
during pharmacologically induced softening, effacement, and dilatation
(collectively referred to
as cervical ripening) appear to involve more than smooth muscle
contraction. While a small
amount of smooth muscle is found in this structure, the body of the
cervix is composed mainly of
fibrous connective tissue and surrounding collagenous matrix.
Although the exact mechanisms are not fully understood, it is
theorized that the pharmacologic
action of PGE
2
is related to its ability to regulate intracellular cyclic 3’,
5’-adenosine
monophosphate (cAMP) levels and cellular membrane calcium ion
transport. In many tissues,
PGE
2
appears to stimulate the syntheses