Crinone Special Precautions

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.
Careful use in the event of severe liver impairment.
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.
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.
Effects on ability to drive and use machines: Fatigue can arise during the use of Crinone.
Caution is required when driving and operating machinery during pregnancy.
It should be remembered in particular that alcohol could further worsen the ability to drive.