“ALERT: US Boxed Warning
Cardiovascular disorders (capsule):
Estrogens plus progestin therapy should not be used for the prevention of cardiovascular disorders. The Women’s Health Initiative (WHI) estrogen plus progestin substudy reported increased risks of myocardial infarction (MI), stroke, pulmonary embolism (PE), and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogens 0.625 mg combined with medroxyprogesterone 2.5 mg relative to placebo.
Probable dementia (capsule):
Estrogens plus progestin therapy should not be used for the prevention of dementia. The Women’s Health Initiative Memory Study (WHIMS) estrogen plus progestin ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years and older during 4 years of treatment with daily conjugated estrogens 0.625 mg combined with medroxyprogesterone 2.5 mg, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.
Breast cancer (capsule):
The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer.
Risks versus benefits (capsule):
In the absence of comparable data, assume these risks to be similar for other doses of conjugated estrogens and medroxyprogesterone and other combinations and dosage forms of estrogens and progestins. Prescribe progestins with estrogens at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.”
CSA NA – FDA Approved – REMS (N) – Can Ship
How Does It Work
Progesterone is a steroid hormone that plays a regulatory role in the female reproductive system by allowing the endometrium to transition from a proliferative to the secretory stage, facilitates blastocyst nesting and is essential to the maintenance of pregnancy. Progesterone also plays an important role in several tissues not belonging to the reproductive system, such as the mammary gland in preparation for breastfeeding, the cardiovascular system, the central nervous system, and bones.
Indications For Use
Progesterone (Vaginal Gel)/Crinone is officially indicated for the treatment of amenorrhea or abnormal uterine bleeding and as part of assisted reproductive technology (ART) for infertile women with progesterone deficiency.
Use with caution in postmenopausal women using conjugated estrogens in combination with medroxyprogesterone acetate
Use with caution in patients who perform tasks that require mental alertness
Use with caution in patients who may have asthma, cardiac impairment, epilepsy, migraines, and diabetes due to a higher risk of fluid retention
Use with caution in patients who may have depression
Do not use in cases of hepatic and/or renal impairment
Insert/Apply intravaginal gel 45mg (4%) gel every other day for up to a total of 6 doses; if the response if inadequate you can increase to using 90mg (8%) gel every other day for up to a total of 6 doses.
ART in women requiring progesterone supplementation
Intravaginal Gel: Insert/Apply 90mg (8%) gel once daily. If pregnancy occurs, may continue treatment for up to 10 to 12 weeks.
ART in women with partial or complete ovarian failure
Intravaginal Gel: Insert/Apply 90mg (8%) gel twice daily. If pregnancy occurs, continue treatment for up to 10 to 12 weeks.
Pharmacist Tips On Using
How to Use: It is recommended that you fill the applicator with the vaginal gel and insert the applicator inside the vagina. Administer the gel directly into the vagina by pressing down on the plunger.
Contact Your Doctor if You Ever Experience: If you experience a sudden, intense, severe headache or chest pain; sudden loss of coordination; sudden loss of vision or speech disturbances; chest or calf pain; weakness in the extremities; sudden shortness of breath of pain with breathing (may indicate thromboembolic disorder); persistent or recurrent vaginal bleeding (may indicate endometrial cancer); edema; abdominal pain or jaundice (may indicate hepatitis or gallbladder disease).
Central Nervous System: Drowsiness (27%), headache (13% to 17%), nervousness (16%), depression (11%)
Gastrointestinal: Constipation (27%), nausea (7% to 22%), muscle cramps (15%), abdominal pain (12%)
Genitourinary: Breast hypertrophy (40%), perineal pain (17%), mastalgia (13%), nocturia (13%)