Food and Drug Administration. With a wide range of additional products in development, Noven is committed to becoming the world's premier developer, manufacturer, and marketer of transdermal drug delivery systems. This release contains forward-looking statements relating to the business of Noven that can be identified by the use of forward-looking terminology such as "expects" and "will help". Such statements are qualified by and subject to the risks and uncertainties specified by Noven in its most recent filings with the Securities and Exchange Commission and those specified herein, including the risk that the new dosage strength may not be launched in a timely manner because of manufacturing issues, marketing strategies or other matters, and that the new dosage strength may not be accepted by patients or physicians or may not compete effectively with products offering similar dosing ranges.
Jones Noven Pharmaceuticals, Inc. All rights reserved. For U. Audience Only. Home Career Center Contact Us. Archive Usual initial dose is 0. A switch between transdermal system types can be done immediately; if on oral therapy, begin a week after oral treatment stopped or when symptoms reappear.
Generally, when used in a postmenopausal woman with an intact uterus, a progestin should also be considered to reduce the risk of endometrial hyperplasia. Use lowest effective dose. A switch between transdermal system types can be done immediately; if on oral therapy, begin 1 week after oral treatment is discontinued or when symptoms reappear. Initially, one 0. Subsequent dosage adjustments may be made based upon the individual patient response; 0.
Initially, apply 1 actuation of the pump 0. Adjust based upon the individual patient response. Usual dose range is 1 to 2 pump actuations per day. Apply 1 complete actuation of the pump 1. Initially, apply 1 spray pump actuation, which supplies 1. Each spray should be administered to adjacent, but non-overlapping sections of the inner surface of the forearm, starting near the elbow. Insert 1 vaginal ring delivering either 50 or mcg per 24 hours vaginally into the upper third of the vaginal vault; keep in place continuously for 3 months, then remove.
If appropriate, insert a new ring. While Femring may be used to treat isolated genitourinary symptoms, consider other vaginal products of lower estradiol dosage first. Initially, 2 grams to 4 grams mcg to mcg of estradiol vaginally once daily for 1 to 2 weeks; then gradually reduce over 1 to 2 weeks. Usual maintenance: 1 gram estradiol mcg vaginally 1 to 3 times per week.
Treatment is cyclic 3 weeks on, then 1 week off. When isolated genitourinary symptoms caused by menopause are present, treatment guidelines recommend low-dose vaginal estrogens over systemic estrogens as first-line therapy. Insert 1 vaginal ring delivering estradiol 7. Keep in place continuously for 3 months, then remove. The dosage of Estring vaginal ring is not effective at treating vasomotor symptoms. Insert 1 tablet 10 mcg vaginally once daily for 2 weeks into the upper third of the vaginal vault using the supplied applicator. After 2 weeks, give a maintenance dose of 1 tablet vaginally twice weekly e.
Place 1 insert vaginally once daily at approximately the same time of day for 2 weeks, followed by 1 insert twice weekly e. Generally, initiate with the 4 mcg insert.
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Dosage range is 0. Only consider for women at significant risk for osteoporosis and for whom non-estrogen medications are not considered to be appropriate.
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Continuous unopposed estrogen administration is acceptable in those without a uterus. In women with an intact uterus, consider a progestin to reduce the risk of endometrial hyperplasia. Re-evaluate the need and appropriateness of therapy at 3 to 6 month intervals. In postmenopausal women with low bone mineral density, there is good evidence that standard-dose estrogen therapy reduces reduces the risk for osteoporotic fractures, including hip, spine, and all non-spine fractures; however, estrogens are not generally recommended as a first-line prevention tactic due to the known risks of estrogen treatment e.
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Women who need osteoporosis prophylaxis who are younger than 60 years or who are within 10 years of menopause onset may be given consideration for estrogen therapy, based on individual assessment of risk vs. Beyond the age of 60 years, other agents are preferred due to the known risks associated with hormonal therapy. Consider each woman's net balance of individual benefits and harms.
If estrogen with or without a progestin is prescribed, use the lowest effective dose for the shortest duration that is consistent with an individual's treatment goals and risks. Estrogen therapy should not be used in patients with known osteoporosis; the risks outweigh the moderate benefit seen in postmenopausal women with established osteoporosis. Initially, 1 patch 0.
For women at significant risk of osteoporosis after careful consideration of non-estrogen medications.
May adjust dose to therapeutic goals. For women with an intact uterus, consider a progestin to reduce the risk of endometrial hyperplasia. Alternatively, a cyclic schedule of 3 weeks on drug and 1 week off drug may be used. Reevaluate the need for the current dose and the appropriateness of therapy at 3 to 6 month intervals.
Menostar is only indicated for osteoporosis prophylaxis and only comes in 0. May adjust dose to achieve therapeutic goals. Continuous unopposed estrogen is acceptable in those without a uterus. Consider a progestin to reduce the risk of endometrial hyperplasia in women with an intact uterus. Re-evaluate the need for the current dose and the appropriateness of therapy at 3 to 6 month intervals.
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For hypogonadism, women are treated for the period of reproductive life until the time of natural menopause, which maintains feminization and prevents bone loss. Begin at a low dose e. Replacement is usually begun at one-tenth to one-eighth of the usual adult dose and then increased to the usual adult dose gradually over a period of about 2 years. Usual range: 0. To allow for normal breast and uterine development, guidelines advise the delay of the addition of progestin given for 1 week per month at least 1 to 2 years after starting estrogen or when breakthrough bleeding occurs.
Treatment continues for reproductive life.
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Apply transdermally as directed; replace patch twice weekly every 3 to 4 days ; give cyclically or continuously. Begin with a low dose patch e. Dose is increased over time to meet the goals of the individual patient based on age, sexual development, bone age and height, and other treatment goals.
Gradually increase dose over about 2 years e. Pubertal induction can be accomplished with transdermal estradiol at an off-label dose as low as 3. Initially, 0. Adjust as needed, dose is 1 patch delivering 0. Dose is then increased over time to meet the goals of the individual patient based on age, sexual development, bone age and height, and other treatment goals.
For female hypogonadism, the usual dose is estradiol cypionate 1. For women with hypogonadism, estrogen treatment continues for reproductive life up until natural menopausal age to maintain feminization and prevent bone loss, but choices of treatment often change from IM depot dosing to other dosage forms.
Begin with a low dose e. Gradually increase dose over about 2 years to usual adult maintenance dose for female hypogonadism, i. Treatment continues for reproductive life, but choices of treatment often change from IM depot dosing to other dosage forms as the adolescent matures. The usual dose is estradiol valerate 10 mg to 20 mg IM every 4 weeks. For women with hypogonadism, estrogen treatment continues for reproductive life up until the time of menopause to maintain feminization and prevent bone loss, but choices of treatment often change from IM depot dosing to other dosage forms.
Not commonly used. Treatment continues for reproductive life, but choices of treatment often change from intramuscular depot dosing to other dosage forms as the adolescent matures. Suggested dosage is 1 to 2 mg 3 times daily. The effectiveness of therapy can be judged by specific prostate antigen PSA determinations as well as by symptomatic improvement of the patient. Efficacy is evaluated according to patient clinical response and serial prostate specific antigen PSA levels.
A response to estrogen treatment, if it will occur, will usually be noted within 3 months. Continued until a significant advancement of the disease occurs.
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