Monograph Details
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Ob/Gyn
> Menopause and HRT
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PROCHIEVE |
| Manufacturer |
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Columbia Laboratories |
| Legal Classification |
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Rx
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| Generic Name |
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Progesterone (micronized) 4% (45mg/applicatorful), 8% (90mg/applicatorful); vaginal gel; contains mineral oil. |
| Indications |
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Secondary amenorrhea. |
| Children |
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Not applicable. |
| Adults |
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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 |
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Undiagnosed vaginal bleeding. Breast or genital carcinoma. Liver dysfunction or disease. Missed abortion. Thrombophlebitis or thromboembolic disorders. |
| Precautions |
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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 |
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Allow at least 6 hours between administration of this and other vaginally-administered products. |
| Adverse Reactions |
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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 |
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• Related Prescribing Note |
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