Vivelle-dot

— THERAPEUTIC CATEGORIES —
  • Bone disorders
  • Menopause and HRT
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Vivelle-dot Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Estradiol 0.025mg/day, 0.0375mg/day, 0.05mg/day, 0.075mg/day, 0.1mg/day; transdermal system.

    Pharmacological Class

    Estrogen.

    See Also

      How Supplied

      Patches—8

      Storage

      Store at 20–25°C (68–77°F). Excursions permitted to 15–30°C (59–86°F). Do not store unpouched.

      Manufacturer

      Novartis Pharmaceuticals Corp

      Generic Availability

      YES

      Mechanism of Action

      Estrogens act through binding to nuclear receptors in estrogen-responsive tissues. Circulating estrogens modulate the pituitary secretion of the gonadotropins, luteinizing hormone (LH) and follicle stimulating hormone (FSH) through a negative feedback mechanism. Estrogens act to reduce the elevated levels of these hormones seen in postmenopausal women.

      Vivelle-dot Indications

      Indications

      Prevention of postmenopausal osteoporosis. 

      Vivelle-dot Dosage and Administration

      Adult

      Apply to clean, dry, intact skin (not to breasts or waist) on lower abdomen; rotate application sites. Use lowest effective dose for shortest duration. Initially one 0.025mg/day patch twice weekly. With intact uterus: usually give cyclically (3 weeks on, 1 week off); without uterus: may give continuously. Transferring from oral estrogens: apply 1st patch up to 1 week after last oral dose. 

      Children

      Not established.

      Vivelle-dot Contraindications

      Contraindications

      Undiagnosed abnormal genital bleeding. Breast cancer or history of. Estrogen-dependent neoplasia. Active DVT, PE or history of. Active arterial thromboembolic disease (eg, stroke, MI) or a history of. Hepatic impairment or disease. Protein C, protein S, or antithrombin deficiency or other thrombophilic disorders.

      Vivelle-dot Boxed Warnings

      Boxed Warning

      Endometrial cancer. Cardiovascular disorders. Probable dementia. Breast cancer.

      Vivelle-dot Warnings/Precautions

      Warnings/Precautions

      Increased risk of endometrial carcinoma or hyperplasia in women with intact uterus (adding progestin is essential). Not for prevention of cardiovascular disease or dementia. Increased risk of cardiovascular disorders (eg, stroke, DVT, VTE); discontinue if occurs or suspected. Manage risk factors for cardiovascular disease and venous thromboembolism appropriately. Discontinue at least 4–6 weeks before surgery type associated with increased risk of thromboembolism or during prolonged immobilization. Increased risk of breast or ovarian cancer. Risk of probable dementia in women ≥65yrs of age. Gallbladder disease. Severe hypercalcemia in breast cancer or bone metastases. Visual abnormalities. Permanently discontinue if papilledema or retinal vascular lesions reveals on exam. Preexisting hypertriglyceridemia. History of cholestatic jaundice. Discontinue if pancreatitis, hypercalcemia, or recurrence of cholestatic jaundice occurs. Monitor thyroid function. Monitor conditions that may predispose to fluid retention. Hypoparathyroidism. Endometriosis. Hereditary angioedema. Asthma. Diabetes. Epilepsy. Migraine. Porphyria. SLE. Hepatic hemangiomas. Do initial complete physical and repeat annually (include Pap smear, mammogram, BP). Reevaluate periodically. Pregnancy: not indicated. Nursing mothers.

      Vivelle-dot Pharmacokinetics

      Distribution

      Estrogens are widely distributed in the body and are generally found in higher concentrations in the sex hormone target organs. Estrogens circulate in blood largely bound to SHBG and albumin.

      Metabolism

      Hepatic (CYP1A2, CYP3A4).

      Elimination

      Renal. Half-life: 5.9–7.7 hours.

      Vivelle-dot Interactions

      Interactions

      May be antagonized by CYP3A4 inducers (eg, phenobarbital, carbamazepine, rifampin, St. John’s wort). May be potentiated by CYP3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, and grapefruit juice). Concomitant thyroid replacement; may need to increase thyroid dose. May interfere with lab tests (eg, thyroid, PT, coagulation factors, glucose tolerance, HDL/LDL, triglycerides, hormone concentrations, other binding or plasma proteins).

      Vivelle-dot Adverse Reactions

      Adverse Reactions

      Headache, local reactions (eg, erythema, pruritus, rash), back pain, irregular vaginal bleeding, spotting, breast tenderness, nasopharyngitis, sinusitis, upper RTI, depression; thromboembolism, neoplasms, anaphylaxis.

      Vivelle-dot Clinical Trials

      See Literature

      Vivelle-dot Note

      Not Applicable

      Vivelle-dot Patient Counseling

      See Literature

      Vivelle-dot Generic Name & Formulations

      Legal Class

      Rx

      General Description

      Estradiol 0.025mg/day, 0.0375mg/day, 0.05mg/day, 0.075mg/day, 0.1mg/day; transdermal system.

      Pharmacological Class

      Estrogen.

      See Also

        How Supplied

        Patches—8

        Storage

        Store at 20–25°C (68–77°F). Excursions permitted to 15–30°C (59–86°F). Do not store unpouched.

        Manufacturer

        Novartis Pharmaceuticals Corp

        Generic Availability

        YES

        Mechanism of Action

        Estrogens act through binding to nuclear receptors in estrogen-responsive tissues. Circulating estrogens modulate the pituitary secretion of the gonadotropins, luteinizing hormone (LH) and follicle stimulating hormone (FSH) through a negative feedback mechanism. Estrogens act to reduce the elevated levels of these hormones seen in postmenopausal women.

        Vivelle-dot Indications

        Indications

        Moderate to severe vasomotor symptoms of menopause. Vulvar or vaginal atrophy due to menopause. Hypoestrogenism due to hypogonadism, castration, or primary ovarian failure.

        Vivelle-dot Dosage and Administration

        Adult

        Apply to clean, dry, intact skin (not to breasts or waist) on lower abdomen; rotate application sites. Use lowest effective dose for shortest duration. Menopause: Initially one 0.0375mg/day patch twice weekly; adjust dose based on clinical response. Hypoestrogenism: see full labeling. With intact uterus: usually give cyclically (3 weeks on, 1 week off); without uterus: may give continuously. Transferring from oral estrogens: apply 1st patch up to 1 week after last oral dose. For vasomotor, vulvar/vaginal atrophy symptoms: attempt to taper or discontinue at 3–6 month intervals.

        Children

        Not established.

        Vivelle-dot Contraindications

        Contraindications

        Undiagnosed abnormal genital bleeding. Breast cancer or history of. Estrogen-dependent neoplasia. Active DVT, PE or history of. Active arterial thromboembolic disease (eg, stroke, MI) or a history of. Hepatic impairment or disease. Protein C, protein S, or antithrombin deficiency or other thrombophilic disorders.

        Vivelle-dot Boxed Warnings

        Boxed Warning

        Endometrial cancer. Cardiovascular disorders. Probable dementia. Breast cancer.

        Vivelle-dot Warnings/Precautions

        Warnings/Precautions

        Increased risk of endometrial carcinoma or hyperplasia in women with intact uterus (adding progestin is essential). Not for prevention of cardiovascular disease or dementia. Increased risk of cardiovascular disorders (eg, stroke, DVT, VTE); discontinue if occurs or suspected. Manage risk factors for cardiovascular disease and venous thromboembolism appropriately. Discontinue at least 4–6 weeks before surgery type associated with increased risk of thromboembolism or during prolonged immobilization. Increased risk of breast or ovarian cancer. Risk of probable dementia in women ≥65yrs of age. Gallbladder disease. Severe hypercalcemia in breast cancer or bone metastases. Visual abnormalities. Permanently discontinue if papilledema or retinal vascular lesions reveals on exam. Preexisting hypertriglyceridemia. History of cholestatic jaundice. Discontinue if pancreatitis, hypercalcemia, or recurrence of cholestatic jaundice occurs. Monitor thyroid function. Monitor conditions that may predispose to fluid retention. Hypoparathyroidism. Endometriosis. Hereditary angioedema. Asthma. Diabetes. Epilepsy. Migraine. Porphyria. SLE. Hepatic hemangiomas. Do initial complete physical and repeat annually (include Pap smear, mammogram, BP). Reevaluate periodically. Pregnancy: not indicated. Nursing mothers.

        Vivelle-dot Pharmacokinetics

        Distribution

        Estrogens are widely distributed in the body and are generally found in higher concentrations in the sex hormone target organs. Estrogens circulate in blood largely bound to SHBG and albumin.

        Metabolism

        Hepatic (CYP1A2, CYP3A4).

        Elimination

        Renal. Half-life: 5.9–7.7 hours.

        Vivelle-dot Interactions

        Interactions

        May be antagonized by CYP3A4 inducers (eg, phenobarbital, carbamazepine, rifampin, St. John’s wort). May be potentiated by CYP3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, and grapefruit juice). Concomitant thyroid replacement; may need to increase thyroid dose. May interfere with lab tests (eg, thyroid, PT, coagulation factors, glucose tolerance, HDL/LDL, triglycerides, hormone concentrations, other binding or plasma proteins).

        Vivelle-dot Adverse Reactions

        Adverse Reactions

        Headache, local reactions (eg, erythema, pruritus, rash), back pain, irregular vaginal bleeding, spotting, breast tenderness, nasopharyngitis, sinusitis, upper RTI, depression; thromboembolism, neoplasms, anaphylaxis.

        Vivelle-dot Clinical Trials

        See Literature

        Vivelle-dot Note

        Not Applicable

        Vivelle-dot Patient Counseling

        See Literature

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