Apex Pharma Marketing
Full Prescribing Info
Each 8% gel contains 90 mg Progesterone. Each applicator delivers 1.125 g of gel.
Excipients/Inactive Ingredients: Glycerin, Light Liquid Paraffin, Hydrogenated Palm Oil Glyceride, Carbomer 974P, Sorbic acid, Polycarbophil, Sodium hydroxide, Purified water.
Pharmacology: Pharmacodynamics: 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 categorized 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.
Dosage/Direction for Use
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.
In the case of overdose, discontinue Crinone, treat the patient symptomatically, and institute supportive measures.
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 Precautions
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.
Effects on ability to drive and use machines: Crinone has no influence on the ability to drive and use machines.
Use In Pregnancy & Lactation
Use during pregnancy: In case of corpus luteum deficiency, Crinone can be used during the first trimester of pregnancy. Controlled studies in women have not revealed foetal risks in the course of the first trimester.
Use during lactation: Do not use during lactation.
Adverse Reactions
The adverse reactions reported below are classified according to frequency of occurrence as follows: Very common (≤ 1/10), Common (≤ 1/100 to < 1/10), Uncommon (≤ 1/1,000 to < 1/100), Rare (≤ 1/10,000 to < 1/1,000), Very rare (< 1/10,000).
Crinone is generally well tolerated. In clinical studies, the following adverse events have been reported during Crinone therapy. Most adverse events observed in clinical studies cannot be distinguished from the symptoms common in early pregnancy.
Common: Breast tenderness, itching or burning.
Post Marketing Reports: For adverse reactions identified during post-marketing surveillance, the frequency is not known (cannot be estimated from the available data).
In addition, intermenstrual bleeding (spotting), hypersensitivity reactions usually manifesting as skin rash, vaginal irritation and other mild application site reactions have been reported post marketing.
Drug Interactions
Although no interaction with other drugs have been reported. Crinone is not recommended for use concurrently with other vaginal preparations.
Caution For Usage
Incompatibilities: No incompatibilities were found with the usual contraceptive devices.
Instructions of use/handling: 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 the knees bent. Gently insert the thin end of applicator well into the vagina.
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.
Do not store above 30°C.
Shelf life: 36 months.
MIMS Class
Oestrogens, Progesterones & Related Synthetic Drugs
ATC Classification
G03DA04 - progesterone ; Belongs to the class of pregnen (4) derivative progestogens.
Crinone vag gel 8 %
1.13 g x 15 × 1's
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