INDICATIONS
Estraderm
Estraderm is indicated for the treatment of the following:
moderate-to-severe vasomotor symptoms associated with
menopause; female hypogonadism; female castration; primary
ovarian failure; atrophic conditions caused by deficient
endogenous estrogen production, such as atrophic vaginitis
and kraurosis vulvae; and prevention of osteoporosis (loss
of bone mass).
Estrogen replacement therapy is the most effective single
modality for the prevention of postmenopausal osteoporosis
in women. Case-controlled studies have shown a reduction
of approximately 60% in the incidence of hip and wrist
fractures in women who began estrogen replacement therapy
within a few years of menopause. A recent, well-controlled,
double-blind, prospective trial conducted at the Mayo
Clinic has demonstrated that treatment with Estraderm
prevents bone loss in postmenopausal women at a dosage
of 0.05 mg per day.
Treatment with Estraderm 0.05 mg showed full maintenance
of bone density with slight (0.8%), but not significant,
increase. Placebo treatment resulted in a significant
loss of more than 6% below baseline vertebral bone mass.
Patients using either Estraderm 0.1 mg, or 0.05 mg, had
significantly greater bone densities than those using
placebo.
Other studies suggest that estrogen replacement therapy
reduces the rate of vertebral fracture.
Peak bone mass is reached at age 30 to 35 and can best
be maximized by adequate calcium intake and exercise during
the adolescent and early adult years. Early menopause
is one of the best predictors for the development of osteoporosis.
White women are at higher risk for osteoporosis than white
men, black women are at higher risk than black men, and
thin women are at higher risk than obese women. Cigarette
smoking may be an additional risk factor. Calcium deficiency
has been implicated in the pathogenesis of this disease.
Therefore, when not contraindicated, a calcium intake
of 1000-1500 mg/day either by diet or supplements is recommended
for postmenopausal women.
Immobilization and prolonged bedrest produce rapid bone
loss, while weight-bearing exercise has been shown to
both reduce bone loss and to increase bone mass. The optimal
type and amount of physical activity that might lower
the risk for osteoporosis have not been established.
Climara
Climara is indicated in the:
1. Treatment of moderate to severe vasomotor
symptoms associated with the menopause. There is no adequate
evidence that estrogens are effective for nervous symptoms
or depression which might occur during menopause and they
should not be used to treat these conditions.
2. Treatment of vulval and vaginal atrophy.
3. Treatment of hypoestrogenism due
to hypogonadism, castration or primary ovarian failure.
4. Treatment of abnormal uterine bleeding
due to hormonal imbalance in the absence of organic pathology
and only when associated with a hypoplastic or atrophic
endometrium.
5. Prevention of Postmenopausal Osteoporosis
(loss of bone mass). The mainstays of prevention of postmenopausal
osteoporosis are estrogen, an adequate lifetime calcium
and vitamin Dy intake, and exercise.
Estrogen replacement therapy reduces bone resorption
and retards or halts postmenopausal bone loss. Case-controlled
studies have shown an approximately 60% reduction in hip
and wrist fractures in women whose estrogen replacement
was begun within a few years of menopause. Studies also
suggest that estrogen reduces the rate of vertebral fractures.
Even when started as late as 6 years after menopause,
estrogen prevents further loss of bone mass for as long
as treatment is continued. When estrogen therapy is discontinued,
bone mass declines at a rate comparable to the immediate
postmenopausal period.
DOSAGE AND ADMINISTRATION
The adhesive side of the system should be placed on a
clean, dry area of the lower abdomen or the upper quadrant
of the buttock. The Climara system should not be applied
to the breasts. 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 and remove the system. Applications
to areas where sitting would dislodge the system should
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. Additional Information for the Climara System:
Swimming, bathing, or using a sauna while using the Climara
system has not been studied, and these activities may
decrease the adhesion of the system and the delivery of
estradiol.
Initiation of Therapy
Estraderm
Treatment of menopausal symptoms is usually initiated
with Estraderm 0.05 mg applied to the skin twice weekly.
The dosage should be adjusted as necessary to control
of symptoms. The lowest dosage necessary for the control
of symptoms should be used, especially in women with an
intact uterus. Attempts to taper or discontinue the medication
should be made at 3-to 6-month intervals.
Prophylactic therapy with Estraderm to prevent postmenopausal
bone loss should be initiated with the 0.05 mg/day dosage
as soon as possible after menopause. The dosage may be
adjusted if necessary to control concurrent menopausal
symptoms. Discontinuation of estrogen replacement therapy
may reestablish the natural rate of bone loss.
In women not currently taking oral estrogens, treatment
with Estraderm may be initiated at once. In women who
are currently taking oral estrogen, treatment with Estraderm
should be initiated 1 week after withdrawal of oral hormone
replacement therapy, or sooner if menopausal symptoms
reappear in less than 1 week.
Climara
Four (6.5, 12.5, 18.75, and 25.0 cm2) Climara systems
are available. For the treatment of vasomotor symptoms,
treatment is usually initiated with the 12.5 cm2 (0.05
mg/day) Climara system 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 Climara system, especially in women with an intact
uterus. Attempts to taper or discontinue the medication
should be made at 3- to 6-month intervals. In women who
are not currently taking oral estrogens, treatment with
the Climara system can be initiated at once.
In women who are currently taking oral estrogen, treatment
with the Climara system can be initiated 1 week after
withdrawal of oral therapy or sooner if symptoms reappear
in less than 1 week.
For the prevention of postmenopausal osteoporosis, the
minimum dose that has been shown to be effective is the
6.5 cm2 (0.025 mg/day) Climara system. Response to therapy
can be assessed by biochemical markers and measurement
of bone mineral density.
Therapeutic Regimen
Estraderm: Estraderm system
therapy may be given continuously in patients who do not
have an intact uterus. In those patients with an intact
uterus, Estraderm may be given on a cycle schedule (e.g.,
3 weeks on drug followed by 1 week off drug).
Do not store above 86°F (30°C)
Do not store unpouched. Apply immediately upon removal
from the protective pouch.
HOW SUPPLIED
Do not store above 86°F (30°C). Do not store
unpouched. Apply immediately upon removal from the protective
pouch.
REFERENCES
1. Murad, F., Kuret, J. Estrogens and
progestins. In: The Pharmacological basis of Therapeutics.
Goodman L.S., Gilman, A., Rall, T., Nies, A.S. Eds. Pergamon
Press, New York 1990; pg 1384-93.
2. Barnes, R.B., Lobo, R.A. Pharmacology
of estrogens. In: menopause: Physiology and Pharmacology.
Mishell, D.R. Eds. Yearbook Medical Publishers, Inc.,
Chicago 1987; pg 301-15.
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