Vivelle-Dot
Generic Name:
Brand Names:
Vivelle-Dot, Vivelle
Vivelle-Dot Description:
Vivelle-Dot is an estrogen hormone patch used to treat symptoms and conditions caused by low estrogen levels in postmenopausal women as well as younger women with estrogen deficiencies.
Estrogen hormones play a key role in the female reproductive system and bone preservation. In premenopausal women, the ovarian follicle secretes large amounts of estrogen that are used to maintain menstrual and reproductive cycles. However, after menopause, overall estrogen levels drop, commonly causing hot flashes, vaginal dryness and an increased risk of osteoporosis. Vivelle-Dot helps prevent these complications by increasing the amount of estrogen in the body.
Vivelle-Dot Side Effects:
Common side effects of Vivelle-Dot include:
- Headache
- Breast tenderness
- Abnormal vaginal bleeding or spotting
- Stomach cramps or bloating
- Nausea
- Vomiting
- Hair loss
For more information, see our Vivelle-Dot side effects page.
Vivelle-Dot Uses:
Vivelle-Dot is used in the treatment of moderate to severe hot flashes in menopausal women.
Vivelle-Dot is used in the treatment of moderate to severe vaginal dryness, itching or irritation in menopausal women. Patients should consider the use of topical vaginal products before undergoing treatment with Vivelle-Dot for this purpose.
Vivelle-Dot is used to prevent osteoporosis in postmenopausal women. When prescribed for this purpose alone, Vivelle-Dot should only be used in women at significant risk of osteoporosis after non-estrogen medications have been considered.
Vivelle-Dot is also used in the treatment of younger women with low estrogen levels due to hypogonadism, castration or primary ovarian failure.
Vivelle-Dot Interactions:
The following medications and substances may interact with Vivelle-Dot:
- Phenobarbital
- Carbamazepine
- Rifampin
- St. John's wort
- Erythromycin
- Clarithromycin
- Ketoconazole
- Itraconazole
- Ritonavir
- Grapefruit juice
Vivelle-Dot may interact with other medications or substances that are not listed above. Patients should talk with their doctor about the use of all other medications, vitamins or supplements before beginning treatment with Vivelle-Dot.
Vivelle-Dot Dosage Information:
Typical Dosage Recommendations
Vivelle-Dot is administered in the form of a patch applied to the skin. It comes in five different dosage strengths, which release 0.025, 0.0375, 0.05, 0.075 or 0.1 mg of estradiol per day. Due to the risks associated with the medication, patients generally undergo treatment with the lowest effective dose.
Women using Vivelle-Dot for the treatment of menopausal hot flashes or vaginal dryness usually initiate treatment with 0.0375 mg patches. Patients using Vivelle-Dot to prevent postmenopausal osteoporosis generally begin treatment with 0.025 mg patches. Your doctor will establish the appropriate strength for your needs.
Vivelle-Dot patches should be placed on the skin and kept there until it is time to administer a new patch. Patches should be replaced once a week. Patients should alter the application location of the patches regularly, allowing a rest period of at least a week between applications to a particular site.
Missing a Dose of Vivelle-Dot
If you forget to apply a patch of Vivelle-Dot, do so as soon as you remember. However, do not apply two patches of Vivelle-Dot at once to compensate for a missed or late patch.
Vivelle-Dot Overdose
An overdose of Vivelle-Dot may result in nausea, vomiting, withdrawal bleeding and other complications. Seek medical attention if you believe you may have administered an overdose of Vivelle-Dot.
Vivelle-Dot FDA Approval:
July 13, 1996
Vivelle-Dot Recall/Black Box Warning Information:
Black Box Warnings
Vivelle-Dot carries a black box warning informing consumers and physicians that the medication increases the risk of uterine cancer and may increase the risk of serious cardiovascular complications and breast cancer. Studies have shown that women taking estrogen medications may be at an increased risk of heart attack, stroke, invasive breast cancer, blood clots in the lungs or legs and dementia. Patients and physicians should weigh the benefits and risks of Vivelle-Dot before beginning treatment. Once treatment with Vivelle-Dot has been initiated, patients should be closely monitored and should be prescribed the lowest effective dosage.
Recalls
In 2004, Novartis Pharmaceuticals recalled certain lots of Vivelle-Dot patches due to the possibility that the medications had been tampered during packaging. The actions constituted a Class II recall, meaning the medications did not pose a serious threat to consumers. In 2005, Novartis Pharmaceuticals again recalled certain lots of Vivelle-Dot patches due to stability failures. The actions constituted a Class III recall, meaning exposure to the medications was unlikely to cause harm to consumers.
-
September 7, 2010, 9:59 am
-
September 2, 2010, 12:51 pm
-
September 1, 2010, 3:16 pm
-
August 31, 2010, 2:01 pm
