Elestrin

The active ingredient in Elestrin is estradiol, a form of estrogen. In postmenopausal women, hormone replacement therapy (HRT) supplements are used to increase estrogen levels to relieve symptoms such as vaginal dryness or hot flashes.

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 Elestrin. However, the following is a synopsis of the general guidelines for the use of Elestrin:

1. Wash and dry your hands before use.

2. Prepare the application site by cleaning and drying your upper arm and shoulder. The site should be unbroken.

3. Remove the cap and unlock the pump by turning the spout a quarter turn in either direction.

4. Prime the pump by fully pressing the spout for ten actuations. Throw away unused gel in the trash.

5. Hold the pump with the tip facing your arm and press down on the pump firmly.

6. Spread the gel with two fingers, gently rubbing it over clean, dry skin on the upper arm, from the elbow to the shoulder.

7. Wash and dry your hands.

8. Allow the gel to dry for at least 5 minutes or more before dressing. Don’t allow anyone to come in contact with the area for at least 2 hours.

9. If you are putting on sunscreen, wait at least 25 minutes before applying. Do not use sunscreen on this area for more than 7 consecutive days.

10. This product contains alcohol, which is flammable. Avoid fire, flame, or smoking when using the product and until it has dried.

11. You may need to stop using estradiol for 4-6 weeks before surgery or if you’re on bed rest.

12. If you have a uterus, you may also need a progestin to lower your risk of uterine cancer.

13. Do not drink grapefruit juice while taking this medication.

14. Have a breast exam and mammogram yearly, as this medication may increase your risk of breast cancer.

Some mild or common side effects of Elestrin seen in clinical trials include:

• Breast tenderness/breast pain.
• Abnormal vaginal bleeding.
• Vaginitis and vaginal yeast infection.
• Abdominal pain.
• Local skin irritation.
• Upper respiratory tract infections.

Estradiol can put you at an increased risk of serious side effects. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Severe allergic reaction or angioedema presenting with swelling of the face, lips, tongue, or throat, hives, and trouble breathing.
• Signs of a heart attack include chest pain, shortness of breath, and pain radiating to your shoulder, neck, or jaw.
• Signs of a stroke include numbness on one side of your body, a severe headache, or trouble speaking.
• Signs of a blood clot (deep vein thrombosis or pulmonary embolism), including severe leg pain, swelling or redness, chest pain, or a fast heart rate.
• Signs of cancer include breast lumps/ pain, swollen lymph nodes, or unusual vaginal bleeding.
• Signs of gallbladder disease or liver problems, such as fever, pain or tenderness in your stomach, nausea or vomiting, or a yellowing of your skin and eyes (jaundice)

These are not all of the possible side effects of Elestrin. 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 Elestrin, 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 history, including whether you have:

High triglyceride levels.

High blood pressure or cardiovascular disease.

Reduced liver function or liver disease.

Kidney disease.

Low thyroid levels (hypothyroidism).

Fluid retention/ edema.

Asthma.

Migraine headaches.

Systemic lupus erythematosus.

Epilepsy.

Heart disease.

High cholesterol

High calcium levels.

Endometriosis.

Diabetes.

Undiagnosed genital bleeding - endometrial cancer must be ruled out before you can start this medication.

Active blood clot or blood clotting disorder, such as protein C or protein S deficiency.

Porphyria.

Breastfeeding.

Active or recent stroke or heart attack.

Liver dysfunction.

Hereditary angioedema.

History of serious hypersensitivity reaction to estrogens.

Known or suspected pregnancy.

Elestrin typically starts to relieve menopausal symptoms within the first 2 weeks of use. However, it can take months to feel the full effects.

When Elestrin 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:

• Strong liver enzyme inducers such as St John’s Wort, carbamazepine, and rifampin may reduce levels of estrogen in your body and make it less effective.
• Strong liver enzyme inhibitors, such as itraconazole, clarithromycin, ritonavir, and grapefruit juice, increase levels of estrogen and cause more side effects.

Brand-name Elestrin contains 0.06% estradiol. Each actuation provides 0.87g containing 0.52mg estradiol.

It should be stored at room temperature out of the reach of children or pets.

It is manufactured by Meda Pharmaceuticals Inc.

Yes, it is available from many manufacturers of generic drugs, and under the brand name Estrogel. It is also available in other dosage forms such as patches or tablets.

Barring any serious side effects as listed above, or under the direction of a physician, you should not stop using estradiol suddenly.

Estradiol should not be used during pregnancy.

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.

This medication may reduce the quantity and quality of breast milk and pass into breast milk. It should not be used during lactation.

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.