DOTTI
These highlights do not include all the information needed to use DOTTI safely and effectively. See full prescribing information for DOTTI. DOTTI (estradiol transdermal system) Initial U.S. Approval: 1996
779751dc-243a-4dc2-ae67-3669f196b205
HUMAN PRESCRIPTION DRUG LABEL
May 30, 2023
Bryant Ranch Prepack
DUNS: 171714327
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Estradiol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (5)
Drug Labeling Information
INDICATIONS & USAGE SECTION
1 INDICATIONS AND USAGE
DOTTI is indicated for:
1.1 Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause
1.2 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy
Due to Menopause
Limitations of Use: When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy, first consider the use of topical vaginal products.
1.3 Treatment of Hypoestrogenism Due to Hypogonadism, Castration, or
Primary Ovarian Failure
1.4 Prevention of Postmenopausal Osteoporosis
Limitations of Use: When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis.
DOTTI is an estrogen indicated for:
- Treatment of moderate to severe vasomotor symptoms due to menopause (1.1)
- Treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause (1.2)
Limitations of Use
When prescribing solely for the treatment of moderate to severe vaginal atrophy, first consider the use of topical vaginal products.
- Treatment of hypoestrogenism due to hypogonadism, castration, or primary ovarian failure (1.3)
- Prevention of postmenopausal osteoporosis (1.4)
Limitations of Use
When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis.
NONCLINICAL TOXICOLOGY SECTION
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term, continuous administration of natural and synthetic estrogens in certain animal species increases the frequency of carcinomas of the breast, uterus, cervix, vagina, testis, and liver.
PATIENT MEDICATION INFORMATION SECTION
PATIENT INFORMATION
DOTTI (dahʹ tee)
****(estradiol transdermal system)
Read this Patient Information before you start using DOTTI and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your menopausal symptoms or your treatment. | |
What is the most important information I should know about****DOTTI (an estrogen hormone)?
Because other products and doses have not been studied in the same way, it is not known how the use of DOTTI will affect your chances of these conditions. You and your healthcare provider should talk regularly about whether you still need treatment with DOTTI. | |
What is** DOTTI?** ****DOTTI is a prescription medicine patch (transdermal system) that contains the estrogen hormone estradiol. When applied to the skin, estradiol is absorbed through the skin into the bloodstream. | |
What is****DOTTI used for? ****DOTTI is used after menopause to: *Reduce moderate to severe hot flashes Estrogens are hormones made by a woman’s ovaries. The ovaries normally stop making estrogens when a woman is between 45 and 55 years old. This drop in body estrogen levels causes the “change of life” or menopause (the end of monthly menstrual periods). Sometimes, both ovaries are removed during an operation before natural menopause takes place. The sudden drop in estrogen levels causes “surgical menopause.” When estrogen levels begin dropping, some women develop very uncomfortable symptoms, such as feelings of warmth in the face, neck, and chest or sudden intense feelings of heat and sweating (“hot flashes” or “hot flushes”). In some women the symptoms are mild, and they will not need to use estrogens. In other women, symptoms can be more severe. *Treat moderate to severe menopausal changes in and around the vagina You and your healthcare provider should talk regularly about whether you still need treatment with DOTTI to control these problems. If you use DOTTI only to treat your menopausal changes in and around your vagina, talk with your healthcare provider about whether a topical vaginal product would be better for you. *Treat certain conditions in women before menopause if their ovaries do not produce enough estrogens naturally *Help reduce your chances of getting osteoporosis (thin weak bones) Osteoporosis from menopause is a thinning of the bones that makes them weaker and easier to break. If you use DOTTI to prevent osteoporosis due to menopause, talk with your healthcare provider about whether a different treatment or medicine without estrogens might be better for you. You and your healthcare provider should talk regularly about whether you should continue treatment with DOTTI. | |
Who should not use** DOTTI? Do not start using****DOTTI if you:** *have 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. *have been diagnosed with a bleeding disorder *currently have or have had certain cancers Estrogens may increase the chances of getting certain types of cancers, including cancer of the breast or uterus (womb). If you have or have had cancer, talk with your healthcare provider about whether you should use DOTTI. *had a stroke or heart attack *currently have or have had blood clots *currently have or have had liver problems *are allergic to DOTTI or any of the ingredients in it See the list of ingredients in DOTTI at the end of this leaflet. Before you use** DOTTI, tell your healthcare provider about all of your medical conditions, including 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. *have any other medical conditions that may become worse while you are using DOTTI 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, angioedema (swelling of face and tongue); problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood. *are going to have surgery or will be on bed rest Your healthcare provider will let you know if you need to stop using DOTTI. *are pregnant or think you may be pregnant. DOTTI is not for pregnant women. *are breastfeeding The hormone in DOTTI can pass into your breast milk. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines may affect how DOTTI works. DOTTI may also affect how your other medicines work. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get new medicine. | |
How should I use** DOTTI?** ******For detailed instructions, see the step-by-step instructions for using **DOTTI at the end of this Patient Information.
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How to change****DOTTI
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What are the possible side effects of** DOTTI?** ****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: | |
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Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you:
Common side effects of DOTTI include: | |
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These are not all the possible side effects of DOTTI. For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider if you have any side effects that bother you or do not go away. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to Amneal Pharmaceuticals (1-877-835-5472). | |
What can I do to lower my chances of getting a serious side effect with** DOTTI?**
Ask your healthcare provider for ways to lower your chances for getting heart disease. | |
How should I store and throw away used****DOTTI patches?
Keep****DOTTI and all medicines out of the reach of children. ****General information about safe and effective use ofDOTTI ****Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use DOTTI for conditions for which it was not prescribed. Do not give DOTTI to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about DOTTI that is written for health professionals. For more information, call the toll- free number Amneal Pharmaceuticals (1-877-835-5472). | |
What are the ingredients in** DOTTI?** ****Active ingredient: estradiol, USP Inactive ingredients: a polyester and ethylene vinyl acetate copolymer film, acrylic and silicone adhesives, oleyl alcohol, NF, povidone, USP, dipropylene glycol and a polyester release liner. Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 03-2022-02 |
This Patient Information has been approved by the U.S. Food and Drug Administration.