Monograph Details

Ob/Gyn > Infertility
CRINONE
Manufacturer
EMD Serono, Inc.
Legal Classification
Rx
Generic Name
Progesterone (micronized) 8% (90mg/applicatorful); vaginal gel; contains mineral oil.
Indications
Progesterone supplementation or replacement as part of an Assisted Reproductive Technology (ART) treatment for infertile women with progesterone deficiency.
Children
Not applicable.
Adults
Supplementation: 1 applicatorful intravaginally once daily. Replacement: 1 applicatorful intravaginally twice daily. If pregnancy occurs, may continue treatment until placental autonomy is achieved (10–12 weeks).
Contraindications
Undiagnosed vaginal bleeding. Breast or genital carcinoma. Liver dysfunction or disease. Missed abortion. Thrombophlebitis or thromboembolic disorders.
Precautions
Conditions aggravated by fluid retention. Depression. Include Pap smear with pretreatment exam. Discontinue if signs of thrombotic disorders (eg, thrombophlebitis, cerebrovascular disorders, pulmonary embolism, retinal thrombosis) occur. Pregnancy: see literature. Nursing mothers.
Interactions
Allow at least 6 hours between administration of this and other vaginally-administered products.
Adverse Reactions
Mastodynia, constipation, somnolence, GI upset, headache, abdominal/perineal pain, nervousness, cramps, nocturia, depression, decreased libido, arthralgia, bloating, pain, vaginal candidiasis/discharge, dizziness, dyspareunia, pruritus genital, allergy, fatigue, urinary tract infection, others.
How Supplied
Prefilled applicators—18
Additional Resources
Related Prescribing Note