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Prochieve Generic Name & Formulations
Legal Class
Rx
General Description
Progesterone (micronized) 4% (45mg/applicatorful), 8% (90mg/applicatorful); vaginal gel; contains mineral oil.
How Supplied
Prefilled applicators 4%—6; 8%—6, 18
Manufacturer
Prochieve Indications
Indications
8% strength: Progesterone supplementation or replacement as part of an Assisted Reproductive Technology (ART) treatment for infertile women with progesterone deficiency.
Prochieve Dosage and Administration
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.
Prochieve Contraindications
Contraindications
Undiagnosed vaginal bleeding. Breast or genital carcinoma. Liver dysfunction or disease. Missed abortion. Thrombophlebitis or thromboembolic disorders.
Prochieve Boxed Warnings
Not Applicable
Prochieve Warnings/Precautions
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.
Prochieve Pharmacokinetics
See Literature
Prochieve Interactions
Interactions
Allow at least 6 hours between administration of this and other vaginally-administered products.
Prochieve Adverse Reactions
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.
Prochieve Clinical Trials
See Literature
Prochieve Note
Not Applicable
Prochieve Patient Counseling
See Literature
Prochieve Generic Name & Formulations
Legal Class
Rx
General Description
Progesterone (micronized) 4% (45mg/applicatorful), 8% (90mg/applicatorful); vaginal gel; contains mineral oil.
How Supplied
Prefilled applicators 4%—6; 8%—6, 18
Manufacturer
Prochieve Indications
Indications
Secondary amenorrhea.
Prochieve Dosage and Administration
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.
Prochieve Contraindications
Contraindications
Undiagnosed vaginal bleeding. Breast or genital carcinoma. Liver dysfunction or disease. Missed abortion. Thrombophlebitis or thromboembolic disorders.
Prochieve Boxed Warnings
Not Applicable
Prochieve Warnings/Precautions
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.
Prochieve Pharmacokinetics
See Literature
Prochieve Interactions
Interactions
Allow at least 6 hours between administration of this and other vaginally-administered products.
Prochieve Adverse Reactions
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.
Prochieve Clinical Trials
See Literature
Prochieve Note
Not Applicable
Prochieve Patient Counseling
See Literature
