, May 29, 2014
/PRNewswire/ -- Mission Pharmacal Company
has begun exclusive promotion of Elestrin®
(estradiol gel) 0.06% in the United States
through an agreement with Meda AB
. Elestrin is a prescription medicine approved by the Food and Drug Administration (FDA) for use as a topical hormone replacement gel to treat moderate-to-severe hot flashes due to menopause. Using estrogen-alone may increase your chance of getting cancer of the uterus (womb).
The addition of Elestrin complements and expands Mission Pharmacal's existing line of branded products for women. Established in 1946 in San Antonio, Texas, the company has a long history of service and expansion in the women's health sector. Mission Pharmacal therapies for women include a premier line of prescription prenatal vitamins, an innovative bone health product, anti-infectives, an iron supplement, a urinary analgesic, and now Elestrin.
"Mission Pharmacal's commitment to women's health has never been stronger," says Dan Kibbe, Senior Vice President, Pharmaceutical Division, Mission Pharmacal. "The addition of Elestrin further enhances our position as one of the most valuable partners in providing healthcare solutions for obstetricians and gynecologists (OB/GYNs) and their patients in the women's healthcare community."
Elestrin also directly supports Mission's vision to offer innovative, science-based products that meet the nutritional and healthcare needs of people at every life stage.
"The value we bring to physicians' offices continues to grow with our expanded offerings in women's health," says Brian Card, Executive Director of Women's Health and Urology Sales, Mission Pharmacal. "Our experienced women's health sales force is able to help general practitioners and OB/GYNs address a full range of everyday clinical situations."
Elestrin provides women with an option to treat moderate-to-severe hot flashes due to menopause with a low dose of estrogen in a topical format. Do not use estrogen-alone to prevent heart disease, heart attacks, strokes, or dementia (decline in brain function). The safety and effectiveness of Elestrin was demonstrated in clinical trials, and it has been available by prescription in the United States since 2006. Women generally enter menopause in their 40s or 50s. The American College of Obstetricians and Gynecologists (ACOG) reports that the most common symptom of menopause is hot flashes.*
For more information about Elestrin, including full prescribing information, please visit elestrin.com.
ELESTRIN (estradiol gel) 0.06% Important Safety Information CONSUMER
- Using estrogen-alone may increase your chance of getting cancer of the uterus (womb) Report any unusual vaginal bleeding right away while you are using ELESTRIN. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
- Do not use estrogen-alone to prevent heart disease, heart attacks, strokes, or dementia (decline in brain function)
- Using estrogen-alone may increase your chances of getting strokes or blood clots
- Using estrogen-alone may increase your chance of getting dementia, based on a study of women age 65 years or older
- Do not use estrogens with progestins to prevent heart disease, heart attacks, strokes or dementia
- Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots
- Using estrogens with progestins may increase your chance of getting dementia, based on a study of women age 65 years or older
- You and your healthcare provider should talk regularly about whether you still need treatment with ELESTRIN
Do not start using ELESTRIN if you:
- Have unusual vaginal bleeding
- Currently have or have had certain cancers
Estrogens may increase the chance of getting certain types of cancers, including cancer of the breast or uterus. If you have or have had cancer, talk with your healthcare provider about whether you should use ELESTRIN.
- Had a stroke or heart attack
- Currently have or have had blood clots
- Currently have or have had liver problems
- Have been diagnosed with a bleeding disorder
- Are allergic to ELESTRIN or any of its ingredients
Elestrin contains the Active ingredient, estradiol, an estrogen hormone. The Inactive ingredients in Elestrin are listed in the FDA-Approved Patient Labeling.
- Think you may be pregnant
Tell your healthcare provider:
- If you have any unusual vaginal bleeding
Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb).
Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
- About all of your medical problems
Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), diabetes, migraine, endometriosis, lupus, or problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.
- About all the medicines you take
This includes prescription and nonprescription medicines, vitamins, and herbal supplements.
Some medicines may affect how ELESTRIN works. ELESTRIN may also affect how your other medicines work.
- If you are going to have surgery or will be on bed rest
You may need to stop using ELESTRIN.
The hormone in ELESTRIN can pass into your breast milk.
What are the possible side effects of ELESTRIN?
Side effects are grouped by how serious they are and how often they happen when you are treated.
Serious, but less common side effects include:
- Heart attack
- Blood clots
- Breast cancer
- Cancer of the lining of the uterus (womb)
- Cancer of the ovary
- High blood pressure
- High blood sugar
- Gallbladder disease
- Liver problems
- Enlargement of benign tumors of the uterus ("fibroids")
Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you:
- New breast lumps
- Unusual vaginal bleeding
- Changes in vision or speech
- Sudden new severe headaches
- Severe pains in your chest or legs with or without shortness of breath, weakness and fatigue
Less serious, but common side effects include:
- Breast pain
- Irregular vaginal bleeding or spotting
- Stomach or abdominal cramps, bloating
- Nausea and vomiting
- Hair loss
- Fluid retention
- Vaginal yeast infection
Important things to remember when using ELESTRIN
Wash your hands with soap and water after applying the gel to reduce the chance that the medicine will be spread from your hands to other people.
Do not allow others to come in contact with the area of skin where you applied the gel for at least two hours after you apply ELESTRIN.
Never apply ELESTRIN to the breast. Never apply ELESTRIN in or around the vagina.
Do not allow others to apply the gel for you.
Avoid fire, flame or smoking until the gel has dried. ELESTRIN contains alcohol. Alcohol based gels are flammable.
It is important that you read and follow the detailed "Patient Instructions for Use" on how to use the ELESTRIN pump and apply the dose. These are not all the possible side effects of ELESTRIN. For more information, ask your healthcare provider or pharmacist for advice about side effects. You may report side effects to Meda Pharmaceuticals at 1-800-890-3098 or to FDA at 1-800-FDA-1088.
APPROVED USES FOR ELESTRIN (estradiol gel) 0.06%
ELESTRIN (estradiol gel) is used after menopause to reduce moderate to severe hot flashes.
About Mission Pharmacal Company
About Meda AB
MEDA AB (publ) is a leading international specialty pharma company. Meda's products are sold in more than 120 countries worldwide and the company is represented by its own organizations in close to 60 countries. The Meda share is listed under Large Cap on the Nasdaq OMX Nordic Stock Exchange in Stockholm. To find out more, visit www.meda.se.
*The American College of Obstetricians and Gynecologists. (http://www.acog.org/~/media/For%20Patients/faq047.pdf?dmc=1&ts=20140318T1632520842) Accessed, March 19, 2014.
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SOURCE Mission Pharmacal Company