Cenestin Prescribing Information Highlights.pdf

# Cenestin® (Synthetic Conjugated Estrogens) Prescribing Information Highlights:

Indications:
- Treatment of moderate to severe vasomotor symptoms due to menopause.
- Treatment of moderate to severe symptoms of vulvar and vaginal atrophy caused by menopause.

Dosage and Administration:
- 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg, and 1.25 mg tablets are taken orally once daily.
- Dosage depends on the specific indication (vasomotor symptoms or vulvar/vaginal atrophy).

Contraindications:
- Undiagnosed abnormal genital bleeding.
- Known or suspected breast cancer or estrogen-dependent neoplasia.
- Active or history of deep vein thrombosis (DVT), pulmonary embolism (PE), arterial thromboembolic disease, or stroke.
- Known anaphylactic reaction or angioedema with Cenestin.
- Known liver impairment or disease.
- Protein C, protein S, or antithrombin deficiency.
- Known or suspected pregnancy.

Warnings and Precautions:
- Increased risk of endometrial cancer in women with a uterus using unopposed estrogens.
- Estrogen-alone therapy not indicated for cardiovascular disease or dementia prevention.
- The Women’s Health Initiative (WHI) studies reported increased risks of stroke, DVT, deep vein thrombosis, and other serious conditions.
- An increased risk of probable dementia in postmenopausal women aged 65 and older was observed.

Adverse Reactions:
- Common side effects include headache, paresthesia, breast pain, abdominal pain, endometrial thickening, metrorrhagia, dizziness, leg cramps, dyspepsia, vaginitis, and nausea.

Drug Interactions:
- Inducers or inhibitors of cytochrome P450 3A4 (CYP3A4) may affect estrogen metabolism.

Specific Populations:
- Nursing mothers: Estrogen administration may reduce breast milk production and quality.
- Geriatric use: Increased risk of probable dementia reported in women over 65 years old.