Apex Pharma Marketing
Full Prescribing Info
Each 8% gel contains progesterone 90 mg/dose. Each applicator delivers 1.125 g of gel.
Crinone also contains the following excipients: Glycerin, light liquid paraffin, hydrogenated palm oil glyceride, carbomer 974P, sorbic acid, polycarbophil, sodium hydroxide and 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 3 days.
Toxicology: Preclinical Safety Data: In rabbits, Crinone was an eye irritant categorized as class IV (minimal effects clearing in <24 hrs), but not a dermal irritant.
A moderate vaginal irritation was found in rabbits after application of 2 mL/day of 8% gel for 5 days.
Treatment of disorders associated with progesterone deficiency eg, 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
Treatment of Infertility Due to Inadequate Luteal Phase: Intravaginal Application: 1 application daily, starting after documented ovulation or arbitrarily on the 18th-21st day of the cycle.
When used during in vitro fertilisation, daily application 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.
Hypersensitivity to progesterone or to any of the excipients of Crinone.
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.
Use in lactation: Do not use during lactation.
Special Precautions
Crinone should be used with caution in patients with severe hepatic impairment.
Discontinue Crinone immediately if thrombophlebitis, cerebrovascular disorders, pulmonary embolism and retinal thrombosis occurs.
The pre-treatment 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 (eg, 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 the Ability to Drive or Operate Machinery: Drivers and users of machines are warned that risk of somnolence may occur.
Use in pregnancy: In case of corpus luteum deficiency, Crinone can be used during the 1st trimester of pregnancy.
Use In Pregnancy & Lactation
In case of corpus luteum deficiency, Crinone can be used during the 1st trimester of pregnancy.
Adverse Reactions
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: Abdominal pain, perineal pain, headache, constipation, diarrhoea, nausea, joint pain, depression, decreased libido, nervousness, somnolence, breast tenderness/pain, dyspaerunia, nocturia; allergy, bloating, cramps, fatigue, pain, dizziness, vomiting, genital moniliasis/pruritus, aggressive reactions, forgetfulness, vaginal dryness, cystitis, urinary tract infection, vaginal discharge.
The adverse reactions of Crinone are qualitatively identical to those described in the medical literature for natural progesterone, but their frequency appears to be lower. Most adverse events are mild and transient in nature, frequently resolving during continued exposure to Crinone.
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. For adverse reactions identified during post-marketing surveillance, quantification of frequency has not been attempted, but it is most likely uncommon to very rare.
Drug Interactions
Although no interaction with other drugs have been reported, Crinone is not recommended for use concurrently with other vaginal preparations.
Incompatibilities: No incompatibilities were found with the usual contraceptive devices.
Caution For Usage
Instructions for 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.
Grip the applicator firmly by the thick end. Shake down like a thermometer to ensure that the contents are at the thin end.
Twist off the tab and discard.
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 the applicator well into the vagina.
Press the thick end of the applicator firmly to deposit the gel. Remove the applicator and discard in a waste container.
Crinone coats the vaginal mucosa to provide long-lasting release of progesterone.
Do not store above 30°C.
Shelf-Life: 36 months.
ATC Classification
G03DA04 - progesterone ; Belongs to the class of pregnen (4) derivative progestogens.
Vag gel (in a single-use applicator) 8% x 1.125 g x 15's.
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