What CRINONE is
CRINONE is a specially formulated gel that you insert in your vagina. It contains the natural female hormone called progesterone. CRINONE 8% is used as part of a program for women who are undergoing fertility treatment.
Understanding the role of CRINONE in your infertility treatment
Progesterone is one of the hormones essential for maintaining a pregnancy. If you are undergoing ART treatment and your doctor has determined your body does not produce enough progesterone on its own, CRINONE may be prescribed to provide the progesterone you need. The progesterone in CRINONE will help prepare the lining of your uterus so that it is ready to receive and nourish a fertilized egg. If pregnancy occurs, CRINONE may be supplemented for 10- 12-weeks until production of progesterone by the placenta is adequate.
When you should not use CRINONE .
- If you are allergic to progesterone, progesterone-like drugs, or any of the inactive ingredients in the gel (ask a pharmacist if you are not sure about the inactive ingredients in CRINONE).
- If you have unusual vaginal bleeding which has not been evaluated by a doctor.
- If you have a liver disease
- If you have known or suspected cancer of the breast or genital organs.
- If you have a miscarriage and your physician suspects some tissue is still in the uterus.
- If you have or have had blood clots in the legs, lungs, eyes, or elsewhere.
Risks of CRINONE .
Risk to the fetus. Birth defects have been reported in the offspring of women who were using CRINONE during early pregnancy. These included an abdominal wall defect and a cleft palate. A causal association has been neither confirmed nor refuted. You should check with your doctor about the risks to your unborn child of any medication used during pregnancy. . Blood clots and related health problems. Blood clots have been reported with the use of estrogens and progestational drugs (alone or in combination). If blood clots do form in your bloodstream, they can cut off the blood supply to vital organs, causing serious problems. These problems may include a stroke (by cutting off blood to part of the brain), a heart attack (by cutting off blood to part of the heart), a pulmonary embolus (by cutting off blood to part of the lungs), or other problems. Any of these conditions may cause death or serious long-term disability. Call your doctor immediately if you suspect you have any of these conditions. He or she may advise you to stop using this drug.
Be alert for unusual signs and symptoms. If any of these warning signals (or any other unusual symptoms) happen while you are using CRINONE, call your doctor immediately:
- Abnormal bleeding from the vagina.
- Pains in the calves or chest, a sudden shortness of breath or coughing blood indicating possible clots in the legs, heart, or lungs.
- Severe headache or vomiting, dizziness, faintness, or changes in vision or speech,
- weakness or numbness of an arm or leg indicating possible clots in the brain or eye.
- Breast lumps, which could be associated with fibrocystic disorders, fibroadenoma, or breast cancer. (Ask your doctor or health-care provider to show you how to examine your breasts monthly.)
- Yellowing of the skin and/or white of the eyes indicating possible liver problems.
You should also notify your doctor if you experience depression, worsening of your diabetic condition, or fluid retention.
Possible side effects of CRINONE
In addition to the risks listed above, the following side effects have been reported with CRINONE used either for progesterone supplementation or for replacement as part of an ART treatment for infertile women with progesterone deficiency. Consult your doctor if you experience any of the side effects mentioned below, or other side effects.
SIDE EFFECTS REPORTED AT A FREQUENCY OF 5% OR GREATER
- abdominal pain; perineal pain (the perineum is the area between the vagina and the rectum)
- constipation; diarrhea; nausea
- joint pain
- depression; decreased libido; nervousness; sleepiness
- breast enlargement
- excessive urination at night
SIDE EFFECTS REPORTED AT A FREQUENCY RANGING FROM 1% TO 5%
- allergy; bloating; cramps; fatigue; pain
- mood swings
- breast pain
- difficult or painful intercourse; genital itching; genital yeast infection; vaginal discharge
- urinary tract infection
SIDE EFFECTS REPORTED AT A FREQUENCY OF LESS THAN 1%
- fever; flu-like symptoms
- water retention
- gastrointestinal discomfort; gas; abdominal swelling
- back pain; leg pain
- sinusitis; upper respiratory tract infection
- acne; itching
- painful or difficult urination; frequent urination
If you experience dizziness or sleepiness, do not drive or operate machinery.
This may worsen some conditions such as asthma, epilepsy, migraine, heart disease, or kidney disease.
How CRINONE works
CRINONE has been formulated to be administered through the vagina. The moisturizing gel in CRINONE forms a coating on the walls of the vagina which allows for absorption of progesterone through the vaginal tissue. Small, white globules may appear as a discharge, even several days after usage. CRINONE contains no irritating perfumes or dyes.