Ospemifenedrug info
ospemifene 60 MG Oral Tablet [Osphena]
What it is used for
OSPHENA is indicated for: OSPHENA is an estrogen agonist/antagonist indicated for: The treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. The treatment of moderate to severe vaginal dryness, a symptom of vulvar and vaginal atrophy, due to menopause.
1.1 The Treatment of
Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy, due to Menopause.
1.2 The Treatment of
Moderate to Severe Vaginal Dryness, a Symptom of Vulvar and Vaginal Atrophy, due to Menopause.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective February 14, 2025. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Description
OSPHENA is an estrogen agonist/antagonist. OSPHENA is not a hormone. The chemical structure of ospemifene is shown in Figure 1.
Figure 1: Chemical Structure The chemical designation is Z-2-[4-(4-chloro-1,2-diphenylbut-1-enyl)phenoxy]ethanol, and has the empirical formula C 24 H 23 ClO 2, which corresponds to a molecular weight of 378.9. Ospemifene is a white to off-white crystalline powder that is insoluble in water and soluble in ethanol. Each OSPHENA tablet contains 60 mg of ospemifene. Inactive ingredients include colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, and triacetin. Figure 1
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective February 14, 2025. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
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