CRINONE PROGESTERONE VAGINAL GEL 8%

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

PROGESTERONE

Available from:

MERCK PTE. LTD.

ATC code:

G03DA04

Dosage:

8.00%

Pharmaceutical form:

GEL

Composition:

PROGESTERONE 8%

Administration route:

VAGINAL

Prescription type:

Prescription Only

Manufactured by:

DENDRON BRANDS LTD

Authorization status:

ACTIVE

Authorization date:

1999-04-21

Patient Information leaflet

PAGE 1
40405660001
•
thrombophlebitis, thromboembolic disorders, cerebral
apoplexy or patients with a history of these conditions
•
missed abortion
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
•
Crinone
®
should be used with caution in patients with
severe hepatic impairment.
•
Discontinue
drug
immediately
if
thrombophlebitis,
cerebrovascular disorders, pulmonary embolism and retinal
thrombosis occur.
•
The pretreatment physical examination should include
special reference to breast and pelvic organs, as well as
Papanicolaou smear.
•
In cases of breakthrough bleeding, as in all cases of
irregular vaginal bleeding, non-function causes should
be considered. In cases of undiagnosed vaginal bleeding
adequate diagnostic measures should be undertaken.
•
The pathologist should be advised of progesterone therapy
when relevant specimens are submitted.
•
Because progestogens may cause some degree of fluid
retention,
conditions which might be influenced by this
factor (e.g.
epilepsy,
migraine,
asthma,
cardiac or renal
dysfunction) require careful observation.
•
Patients who have a history of psychic depression should
be carefully observed and the drug discontinued if the
depression recurs to a serious degree.
•
A decrease in glucose tolerance has been observed in a
small percentage of patients on oestrogen-progestin
combination drugs. The mechanism of this decrease is
not known. For this reason, diabetic patients should be
carefully observed while receiving progestin therapy.
INTERACTION
Although no interaction with other drugs have been reported.
Crinone
®
is not recommended for use concurrently with other
vaginal preparations.
PREGNANCY AND LACTATION
_Use during pregnancy_
In case of corpus luteum deficiency, Crinone
®
can be used
during the first trimester of pregnancy.
_Use during lactation_
Do not use during lactation.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
Drivers
and users
of
machines
are warned that
risk of
somnolence may occur.
UNDESIRABLE EFFECTS
Crinone is generally well tolerated

Summary of Product characteristics

NAME OF THE MEDICINAL PRODUCT
Crinone® progesterone vaginal gel 8%.
QUALITATIVE AND QUANTITATIVE COMPOSITION
90 mg Progesterone
PHARMACEUTICAL FORM
Vaginal gel
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Treatment of disorders associated with progesterone deficiency, such
as:
• infertility due to inadequate luteal phase.
• for use during in-vitro fertilisation, where infertility ismainly
due to tubal, idiopathic or endometriosis linked sterility associated
with
normal ovulatory cycles.
POSOLOGY AND METHOD OF ADMINISTRATION
Intravaginal application
• Treatment of infertility due to inadequate luteal phase: one
application (1.125 g 8 %gel) every day, starting after documented
ovulation
or arbitrarily on the 18th-21st day of the cycle.
• When used during in-vitro fertilisation, daily application of
Crinone® 8 % gel should be continued for 30 days if there is
laboratory
evidence of pregnancy. Children: not applicable.
CONTRA-INDICATIONS
• known sensitivity to Crinone® (progesterone or any of the other
ingredient)
• undiagnosed vaginal bleeding
• known or suspected malignancy of the breast or genital organ
• acute porphyria
• thrombophlebitis, thromboembolic disorders, cerebral apoplexy or
patients with a history of these conditions
• missed abortion
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
• Crinone® should be used with caution in patients with severe
hepatic impairment.
• Discontinue drug immediately if thrombophlebitis, cerebrovascular
disorders, pulmonary embolism and retinal thrombosis occur.
• The pretreatment physical examination should include special
reference to breast and pelvic organs, as well as Papanicolaou smear.
• In cases of breakthrough bleeding, as in all cases of irregular
vaginal bleeding, non-function causes should be considered. In cases
of
undiagnosed vaginal bleeding adequate diagnostic measures should be
undertaken.
• The pathologist should be advised of progesterone therapy when
relevant specimens are submitted.
• Because progestogens may cause so