A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Climara Indications, Dosage, Storage, Stability - Estradiol transdermal
Climara Indications, Dosage, Storage, Stability - Estradiol transdermal
INDICATIONS AND USAGE
Climara® is indicated in the:
1. Treatment of moderate to severe vasomotor symptoms associated
with the menopause.
2. Treatment of vulvar and vaginal atrophy.
3. Treatment of hypoestrogenism due to hypogonadism, castration
or primary ovarian failure.
4. Prevention of postmenopausal osteoporosis (loss of bone
mass). The mainstays of prevention of postmenopausal osteoporosis are weight
bearing exercise, an adequate calcium and vitamin D intake, and when indicated,
estrogen. Postmenopausal women absorb dietary calcium less efficiently than
premenopausal women and require an average of 1500 mg/day of elemental calcium
to remain in neutral calcium balance. The average calcium intake in the USA
is 400-600 mg/day. Therefore, when not contraindicated, calcium supplementation
may be helpful for women with suboptimal dietary intake.
Estrogen replacement therapy reduces bone resorption and retards
or halts postmenopausal bone loss. 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. Early menopause is one of the strongest
predictors for the development of osteoporosis in all women. Other factors associated
with osteoporosis include genetic factors, lifestyle and nutrition.
DOSAGE AND ADMINISTRATION
The adhesive side of the Climara® system should
be placed on a clean, dry area of the lower abdomen or the upper quandrant 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. 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
Climara®‚ system has not been studied, and these activities may
decrease the adhesion of the system and the delivery of estradiol.
Initiation of Therapy
Six (6.5, 9.375, 12.5, 15.0, 18.75 and 25.0 cm2)
Climara® systems are available. For the treatment of vasomotor
symptoms, treatment should be initiated with the 6.5 cm2 (0.025 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.
HOW SUPPLIED
Climara® (estradiol transdermal system),
0.025 mg/day — each 6.5 cm2 system contains 2.0 mg of estradiol USP NDC
50419-454-04 Individual Carton of 4 systems Shelf Pack Carton of 6 Individual
Cartons of 4 systems
Climara® (estradiol transdermal system),
0.0375 mg/day — each 9.375 cm2 system contains 2.85 mg of estradiol
USP NDC 50419-456-04 Individual Carton of 4 systems Shelf Pack Carton of
6 Individual Cartons of 4 systems
Climara® (estradiol transdermal system),
0.05 mg/day — each 12.5 cm2 system contains 3.8 mg of estradiol USP NDC
50419-451-04 Individual Carton of 4 systems Shelf Pack Carton of 6 Individual
Cartons of 4 systems
Climara® (estradiol transdermal system),
0.06 mg/day — each 15.0 cm2 system contains 4.55 mg of estradiol
USP NDC 50419-459-04 Individual Carton of 4 systems Shelf Pack Carton of
6 Individual Cartons of 4 systems
Climara® (estradiol transdermal system),
0.075 mg/day — each 18.75 cm2 system contains 5.7 mg of estradiol
USP NDC 50419-453-04 Individual Carton of 4 systems Shelf Pack Carton of
6 Individual Cartons of 4 systems
Climara® (estradiol transdermal system),
0.1 mg/day — each 25.0 cm2 system contains 7.6 mg of estradiol USP NDC
50419-452-04 Individual Carton of 4 systems Shelf Pack Carton of 6 Individual
Cartons of 4 systems Do not store above 86°F (30°C). Do not store unpouched.
Apply immediately upon removal from the protective pouch.
© 2003, Berlex Laboratories. All rights
reserved., Manufactured for: Laboratories, Montville, NJ 07045, Manufactured
by 3M Pharmaceuticals, St. Paul, MN 55144, 6005000 (3M #673100)
May 2003
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