Monograph Details

Ob/Gyn > Menopause and HRT
PROCHIEVE
Manufacturer
Columbia Laboratories
Legal Classification
Rx
Generic Name
Progesterone (micronized) 4% (45mg/applicatorful), 8% (90mg/applicatorful); vaginal gel; contains mineral oil.
Indications
Secondary amenorrhea.
Children
Not applicable.
Adults
Initially one applicatorful of 4% (45mg) intravaginally every other day up to a total of 6 doses. If inadequate response may give 1 applicatorful of 8% (90mg) intravaginally every other day for a total of 6 doses.
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
Cramps, emotional lability, fatigue, sleep disorders, depression, headache, bloating, vaginal discharge, nausea, changes in appetite, back or abdominal pain, myalgia, pruritus genital, others.
How Supplied
Prefilled applicators 4%—6
Prefilled applicators 8%—6, 18
Additional Resources
Related Prescribing Note