Estragyn Vaginal Cream

(Estrone)

The active ingredient in Estragyn Vaginal Cream is estrone. Estrone is a form of estrogen, a hormone that helps maintain healthy vaginal tissue. In postmenopausal women, estrogen levels drop, which can cause thinning and dryness of vaginal tissues. By supplying vaginal estrogen locally, Estragyn Vaginal Cream helps restore estrogen levels in the vaginal area and improve moisture, elasticity, and comfort. This local treatment helps relieve symptoms while using a low-dose approach compared to some systemic hormone replacement therapy options.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Estragyn Vaginal Cream. However, the following is a synopsis of the general guidelines for the use of Estragyn Vaginal Cream:

• Use the applicator provided to measure the prescribed dose. Insert the cream into the vagina as directed by your healthcare professional. Wash the applicator with warm water after each use unless otherwise directed.
• Estragyn Vaginal Cream may be prescribed for daily use at first, followed by a reduced maintenance schedule. It may be recommended to use it at bedtime to reduce leakage. Use the medication exactly as prescribed and do not increase the dose on your own.
• Estragyn Vaginal Cream is for vaginal use only.
• Do not use over-the-counter vaginal products unless approved by your healthcare provider.

Some mild or common side effects of Estragyn Vaginal Cream seen in clinical trials as compared to placebo include:

• Vaginal discharge.
• Vaginal irritation or itching.
• Breast tenderness.
• Headache or migraine headaches.
• Nausea.
• Abdominal bloating or fluid retention.
• Mild vaginal bleeding or spotting.

Some individuals may experience serious side effects while using Estragyn Vaginal Cream. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• New or unusual vaginal bleeding.
• Chest pain, shortness of breath, or sudden weakness may be signs of a heart attack or blood clots.
• Severe headache, vision changes, or dizziness.
• Signs of breast cancer such as a new breast lump.
• Yellowing of the skin or eyes may indicate liver disease.
• Swelling, pain, or redness in the legs.
• Signs of an allergic reaction, including rash, itching, or swelling.

These are not all of the possible side effects of Estragyn Vaginal Cream. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Estragyn Vaginal Cream, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• A history of breast cancer, uterine cancer, or endometrial cancer.
• Unexplained vaginal bleeding.
• Blood clots, stroke, or heart disease.
• High blood pressure or cholesterol problems.
• Liver disease or gallbladder disease.
• Migraine headaches.
• Thyroid disorders.
• Porphyria.

• Known or suspected breast cancer.
• Known or suspected estrogen-dependent tumors, including uterine cancer.
• Undiagnosed abnormal vaginal bleeding.
• Active or past blood clots or clotting disorders.
• Active liver disease.
• Known hypersensitivity to estrone or any inactive ingredients.

Some women may notice improvement in vaginal dryness and discomfort within a few weeks of starting Estragyn Vaginal Cream. Full symptom relief may take several weeks of regular use. Response time can vary depending on estrogen levels and the severity of symptoms of menopause.

When Estragyn Vaginal Cream is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• St. John’s wort may reduce estrogen levels and lower effectiveness.
• Thyroid medications, as estrogen can affect thyroid hormone levels.
• Other estrogen-containing products may increase the risk of side effects.

Estragyn Vaginal Cream is available as a vaginal cream containing estrone. The prescribed dose is measured using the applicator and is individualized based on symptoms and response. It may range between 0.5 and 4 grams. Your healthcare provider will determine the lowest effective dose.

Estragyn Vaginal Cream should be stored at room temperature. Keep the container tightly closed and away from excessive heat. It should be stored at room temperature, away from the reach of children or pets.

Estragyn Vaginal Cream is manufactured by Searchlight Pharma Inc.

There is no direct generic equivalent to Estragyn Vaginal Cream. Other vaginal estrogen products, such as vaginal tablets, vaginal rings, estradiol creams, conjugated estrogens, Vagifem, Premarin, or Estrace, may be available as alternatives.

Do not stop using Estragyn Vaginal Cream without first speaking to your healthcare provider. Symptoms may return if treatment is stopped suddenly. Your healthcare professional may recommend adjusting the dose or switching therapy if needed.

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you. Estragyn Vaginal Cream is not intended for use during pregnancy.

Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you. Estrogens may pass into breast milk and could reduce milk production.