Progesterone: 90 mg/dose, 8.0% w/w.
Each applicator contains 1.45 g of gel and delivers 1.125 g of gel.
Excipients/Inactive Ingredients: Glycerin, Light Paraffin, Hydrogenated Palm Oil Glyceride, Carbopol 974P, Sorbic acid, Polycarbophil, Sodium hydroxide, Purified water.
Pharmacology: Pharmacodynamics: The pharmacological particulars of the product are those of the naturally occurring progesterone with induction of a full secretory endometrium.
Pharmacokinetics: The progesterone vaginal gel is based on a polycarbophil delivery system which attaches to the vaginal mucosa and provides a prolonged release of progesterone for at least three days.
Toxicology: Preclinical safety data: In rabbits, Crinone was an eye irritant categorised as class IV (minimal effects clearing in less than 24 hours), but not a dermal irritant.
A moderate vaginal irritation was found in rabbits after application of 2.0 ml/day of 8% gel for 5 days.
Treatment of disorders associated with progesterone deficiency, such as: infertility due to inadequate luteal phase; for use during in vitro fertilisation, where infertility is mainly due to tubal, idiopathic or endometriosis linked sterility associated with normal ovulatory cycles.
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.
The Elderly: Not applicable.
Method of Administration: Crinone is applied directly from the specially designed sealed applicator into the vagina. Remove the applicator from the sealed wrapper. DO NOT remove the twist-off cap at this time.
1. Grip the applicator firmly by the thick end. Shake down like a thermometer to ensure that the contents are at the thin end.
2. Twist off the tab and discard.
3. The applicator may be inserted while the patient is in a sitting position or when lying on the back with knees bent. Gently insert the thin end of applicator well into the vaginal cavity.
4. Press the thick end of the applicator firmly to deposit gel. Remove the applicator and discard in a waste container.
5. Crinone coats the vaginal mucosa to provide long-lasting release of progesterone.
Known hypersensitivity to progesterone or to any of the excipients.
Undiagnosed vaginal bleeding.
Known or suspected progesterone-sensitive malignant tumours.
Cautious use in severe hepatic insufficiency.
In cases of breakthrough bleeding, as in all cases of irregular vaginal bleeding, non-functional causes should be considered. In cases of undiagnosed vaginal bleeding, adequate diagnostic measures should be undertaken.
Crinone is not indicated in threatened abortion. Treatment should be discontinued in the event of a missed abortion.
Although risk of thromboembolism has been associated with estrogens, a link with progestins remains questionable. Therefore, in women with generally recognized risk factors for thrombo-embolic events, such as personal or family history, treatment with Crinone may further increase the risk. In these women, the benefits of Crinone administration need to be weighed against the risks. It should be noted, however, that pregnancy itself carries an increased risk of thrombo-embolic events.
Avoid concurrent use with other intravaginal preparations. See Interactions.
The excipient sorbic acid may cause local skin reactions (e.g. contact dermatitis) or vaginal irritation.
Effects on ability to drive and use machines: Drivers and users of machines are warned that risk of somnolence may occur.
In case of corpus luteum deficiency, Crinone can be used during the first month of pregnancy.
Do not use during lactation.
Common (>1/100 - 1/10):
Headache, Somnolence, Breast Tenderness, Vaginal irritation, Itching or Burning.
In addition, intermenstrual bleeding (spotting), hypersensitivity reactions usually manifesting as skin rash, and other mild application site reactions have been reported post-marketing. Rare events of urticaria and pruritis were noted.
Crinone is not recommended for use concurrently with other vaginal preparations.
Although there is evidence of interaction between oral progestogens and CYP3A4 inducers, resulting in a decrease of serum progestogen levels, no significant consequences on progesterone levels is expected from concurrent administration of CRINONE vaginal gel with CYP3A inducers.
Incompatibilities: No incompatibilities were found with the usual contraceptive devices.
Store below 30°C.
Shelf-life: 36 months.
G03DA04 - progesterone ; Belongs to the class of pregnen (4) derivative progestogens.
Vag gel 8% x 1.125 g x 15's.