|
Prochieve(progesterone gel)
Prochieve(progesterone gel)
PROCHIEVE Rx
Generic Name and Formulations:
Progesterone (micronized) 4% (45mg/applicatorful), 8% (90mg/applicatorful); vaginal gel; contains mineral oil.
Company:
Columbia Laboratories
Indications for PROCHIEVE:
8% strength: Progesterone supplementation or replacement as part of an Assisted Reproductive Technology (ART) treatment for infertile women with progesterone deficiency.
Adult:
Supplementation: 1 applicatorful of 8% (90mg) intravaginally once daily. Replacement: 1 applicatorful of 8% (90mg) intravaginally twice daily. If pregnancy occurs, may continue treatment until placental autonomy is achieved (10–12 weeks).
Children:
Not applicable.
Contraindications:
Undiagnosed vaginal bleeding. Breast or genital carcinoma. Liver dysfunction or disease. Missed abortion. Thrombophlebitis or thromboembolic disorders.
Warnings/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 4%—6
Prefilled applicators 8%—6, 18
Indications for PROCHIEVE:
Secondary amenorrhea.
Adult:
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.
Children:
Not applicable.
Contraindications:
Undiagnosed vaginal bleeding. Breast or genital carcinoma. Liver dysfunction or disease. Missed abortion. Thrombophlebitis or thromboembolic disorders.
Warnings/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 |
|
