Composition:1 g vaginal gel contains 80 mg of progesterone. Each applicator delivers 1.125 g of vaginal gel containing 90 mg of progesterone.
Progesterone supplementation of the luteal phase in adults as part of an ART (assisted reproductive technology) procedure.
From the day of embryo transfer, 1.125 g Crinone vaginal gel (90 mg progesterone) should be inserted into the vagina once daily. Once the laboratory findings confirm pregnancy, this therapy should be continued for a total treatment duration of 30 days. Small white globules may appear as vaginal discharge possibly due to gel accumulation, up to several days after usage.
Hypersensitivity to progesterone or any of the excipients, undiagnosed vaginal bleeding, porphyria, known or suspected malignancy of the breast or genital organs, thrombophlebitis, thromboembolic disorder, cerebral apoplexy, or patients with a history of these conditions, missed abortion.
Crinone includes sorbic acid as an excipient. Sorbic acid may cause local skin reactions (e.g.contact dermatitis). Local skin reactions might also occur on the penis of the partner when having intercourse following vaginal application of Crinone. This may be prevented by the use of condoms. Gynaecological check-ups are required before and regularly under therapy with the drug; endometrial hyperplasia in particular should be ruled out as part of these controls under longer-term treatment.
The pre-treatment physical examination should include special reference to breast and pelvic organs, as well as Papanicolaou smear.
If during therapy with Crinone, threatened abortion occurs, embryo viability should be established using rising HCG titers and/or ultrasound. 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. Because progestogens may cause some degree of fluid retention, conditions that might be influenced by this factor (e.g. epilepsy, migraine, asthma, cardiac or renal dysfunction) require careful observation. The pathologist should be advised of progesterone therapy when relevant specimens are submitted.
Careful use in the event of severe liver impairment.
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 number 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.
The physician should be alert to the early manifestations of thrombotic disorders (thrombophlebitis, cerebrovascular disorder, pulmonary embolism and retinal thrombosis). Should any of these thrombotic disorders occur or be suspected, the drug should be discontinued immediately. Patients who have risk factors for thrombotic disorders should be kept under careful observation.
The drug should not be administered simultaneously with other intravaginal therapies. No interaction studies have been performed.
Common: somnolence, cramps, breast tenderness, headache. Uncommon to very rare: intermenstrual bleeding (spotting), vaginal irritation and other mild application site reactions.
Frequency not known: hypersensitivity reactions e.g. generalized itchy skin rash.
During post-marketing surveillance, clumping/coagulation/accumulation of Crinone gel has been reported. These events are usually non-serious and appear with beige to brownish clumpy or sometimes cloudy white discharge. The gel clumping/coagulation/accumulation can be associated with vaginal irritation, pain and swelling; very rarely, it might also cause cramps and vaginal bleeding.
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