Estradiol Patch

Estradiol Patch Manufacturers

• Sandoz Inc
  

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  Estradiol Patch | Sandoz Inc

  

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  Generally, when estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should be considered to reduce the risk of endometrial cancer. A woman without a uterus does not need a progestin. In some cases, however, hysterectomized women with a history of endometriosis may need a progestin [see Warnings and Precautions (5.2, 5.14)].

  Use of estrogen-alone or in combination with a progestin, should be with the lowest effective dose and the shortest duration consistent with treatment goals and risks for the individual woman. Postmenopausal women should be reevaluated periodically as clinically appropriate to determine whether treatment is still necessary.

  The adhesive side of estradiol transdermal system should be placed on a clean, dry area of the trunk of the body (including the abdomen or buttocks). Estradiol transdermal system should not be applied to the breasts.

  Estradiol transdermal system should be replaced twice weekly. The sites of application must be rotated, with an interval of at least 1 week allowed between applications to a particular site. The area selected should not be oily, damaged, or irritated. The waistline should be avoided, since tight clothing may rub the system off. The system should be applied immediately after opening the pouch and removing the protective liner. The system should be pressed firmly in place with the palm of the hand for about 10 seconds, making sure there is good contact, especially around the edges. In the event that a system should fall off, the same system may be reapplied. If the same system cannot be reapplied, a new system should be applied to another location. In either case, the original treatment schedule should be continued. If a woman has forgotten to apply a patch, she should apply a new patch as soon as possible. The new patch should be applied on the original treatment schedule. The interruption of treatment in women taking estradiol transdermal system might increase the likelihood of breakthrough bleeding, spotting and recurrence of symptoms.

  2.1 Moderate to Severe Vasomotor Symptoms

  Start therapy with estradiol transdermal system 0.0375 mg per day applied to the skin twice weekly. Dosage adjustment should be guided by the clinical response. In women not currently taking oral estrogens or in women switching from another estradiol transdermal therapy, treatment with estradiol transdermal system may be initiated at once. In women who are currently taking oral estrogens, treatment with estradiol transdermal system should be initiated 1 week after withdrawal of oral hormone therapy, or sooner if menopausal symptoms reappear in less than 1 week. Attempts to taper or discontinue the medication should be made at 3 to 6 month intervals.

  Estradiol transdermal system may be given continuously in patients who do not have an intact uterus. In those patients with an intact uterus, estradiol transdermal system may be given on a cyclic schedule (for example, 3 weeks on drug followed by 1 week off drug).

  2.2 Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy

  Start therapy with estradiol transdermal system 0.0375 mg per day applied to the skin twice weekly. Dosage adjustment should be guided by the clinical response. Attempts to taper or discontinue the medication should be made at 3 to 6 month intervals.

  In women not currently taking oral estrogens or in women switching from another estradiol transdermal therapy, treatment with estradiol transdermal system may be initiated at once. In women who are currently taking oral estrogens, treatment with estradiol transdermal system should be initiated 1 week after withdrawal of oral hormone therapy, or sooner if menopausal symptoms reappear in less than 1 week.

  Estradiol transdermal system may be given continuously in patients who do not have an intact uterus. In those patients with an intact uterus, estradiol transdermal system may be given on a cyclic schedule (for example, 3 weeks on drug followed by 1 week off drug).

  2.3 Hypoestrogenism Due to Hypogonadism, Castration, or Primary Ovarian Failure

   

  2.4 Prevention of Postmenopausal Osteoporosis

  Start therapy with estradiol transdermal system 0.025 mg per day applied to the skin twice weekly.

  In women not currently taking oral estrogen or in women switching from another estradiol transdermal therapy, treatment with estradiol transdermal system may be initiated at once. In women who are currently taking oral estrogens, treatment with estradiol transdermal system should be initiated 1 week after withdrawal of oral hormone therapy, or sooner if menopausal symptoms reappear in less than 1 week.

  Estradiol transdermal system may be given continuously in patients who do not have an intact uterus. In those patients with an intact uterus, estradiol transdermal system may be given on a cyclic schedule (for example, 3 weeks on drug followed by 1 week off drug).

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• Physicians Total Care, Inc.
  

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  Estradiol Patch | Physicians Total Care, Inc.

  

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  When estrogen is prescribed for a postmenopausal woman with a uterus, progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be reevaluated periodically as clinically appropriate (e.g., 3 month to 6 month intervals) to determine if treatment is still necessary. (See BOXED WARNINGS and WARNINGS.) For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.

  Patients should be started at the lowest dose. Six (7.75 cm2, 11.625 cm2, 15.5 cm2, 18.6 cm2, 23.25 cm2 and 31 cm2) Estradiol Transdermal Systems Continuous Delivery (Once-Weekly) are available. For the treatment of vasomotor symptoms, treatment should be initiated with the 7.75 cm2 (0.025 mg/day) Estradiol Transdermal System Continuous Delivery (Once-Weekly) applied to the skin once weekly. The dose should be adjusted as necessary to control symptoms. Clinical responses (relief of symptoms) at the lowest effective dose should be the guide for establishing administration of the Estradiol Transdermal System Continuous Delivery (Once-Weekly), especially in women with an intact uterus. Attempts to taper or discontinue the medication should be made at 3 month to 6 month intervals. In women who are not currently taking oral estrogens, treatment with Estradiol Transdermal System Continuous Delivery (Once-Weekly) can be initiated at once. In women who are currently taking oral estrogen, treatment with the Estradiol Transdermal System Continuous Delivery (Once-Weekly) can be initiated one week after withdrawal of oral therapy or sooner if symptoms reappear in less than one week. For the prevention of postmenopausal osteoporosis, the minimum dose that has been shown to be effective is the 7.75 cm2 (0.025 mg/day) Estradiol Transdermal System Continuous Delivery (Once-Weekly). Response to therapy can be assessed by biochemical markers and measurement of bone mineral density.

  Application of the System

  The adhesive side of the Estradiol Transdermal System Continuous Delivery (Once-Weekly) should be placed on a clean, dry area of the lower abdomen or the upper quadrant of the buttock. The Estradiol Transdermal System Continuous Delivery (Once-Weekly) should not be applied to or near the breasts. The sites of application must be rotated, with an interval of at least one week allowed between applications to a particular site. The area selected should not be oily, damaged, or irritated. The waistline should be avoided, since tight clothing may rub and remove the system. Application to areas where sitting would dislodge the system should also be avoided. The system should be applied immediately after opening the pouch and removing the protective liner. The system should be pressed firmly in place with the fingers for about 10 seconds, making sure there is good contact, especially around the edges. If the system lifts, apply pressure to maintain adhesion. In the event that a system should fall off, a new system should be applied for the remainder of the 7 day dosing interval. Only one system should be worn at any one time during the 7 day dosing interval. Swimming, bathing, or using a sauna while using the Estradiol Transdermal System Continuous Delivery (Once-Weekly) has not been studied, and these activities may decrease the adhesion of the system and the delivery of estradiol.

  Removal of the System

  Removal of the system should be done carefully and slowly to avoid irritation of the skin. Should any adhesive remain on the skin after removal of the system, allow the area to dry for 15 minutes. Then gently rubbing the area with an oil-based cream or lotion should remove the adhesive residue.

  Used patches still contain some active hormones. Each patch should be carefully folded in half so that it sticks to itself before throwing it away.

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• Mylan Pharmaceuticals Inc.
  

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  Estradiol Patch | Mylan Pharmaceuticals Inc.

  

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  2.1 Dosage in Adults

  Use the lowest dose effective for the patient, as important adverse effects of flurazepam hydrochloride capsules are dose related.

  The recommended initial dose is 15 mg for women and either 15 mg or 30 mg for men. The 15 mg dose can be increased to 30 mg if necessary for efficacy.

  The recommended initial doses for women and men are different because flurazepam clearance is lower in women [see Pharmacokinetics (12.3)].

  2.2 Dosage in Elderly or Debilitated Patients

  Elderly or debilitated patients may be especially sensitive to flurazepam. Since the risk of the development of oversedation, dizziness, confusion and/or ataxia increases substantially with larger doses in elderly or debilitated patients, it is recommended that in such patients the dosage be limited to 15 mg. Staggering and falling have also been reported, particularly in geriatric patients [see Warnings and Precautions (5.1)].

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