DRUG STUDY

Generic Brand Dosage and Frequency Mechanism of Action

Name Name

Estrogen  Use of ESTRACE (estradiol

vaginal cream, USP, 0.01%),
alone or in combination with Drug interactions may change how
a progestin, should be limited your medications work or increase your
to the shortest duration risk for serious side effects. This
consistent with treatment document does not contain all
goals and risks for the possible drug interactions. Keep a list of
individual woman. Patients all the products you use (including
should reevaluate periodically
prescription/nonprescription drugs and
as clinically appropriate (for
example, 3-month to 6- herbal products) and share it with your
month intervals) to determine doctor and pharmacist. Do not start, stop,
Estradiol
if treatment is still necessary or change the dosage of any medicines
vaginal
Estrace (see BOX without your doctor's approval.
cream WARNING and WARNING
vaginal Some products that may interact with this
S). For treatment of vulvar drug include: aromatase inhibitors (such
cream and vaginal atrophy
associated with as anastrozole, exemestane, letrozole), fu
the menopause, the lowest lvestrant,
dose and regimen that will ospemifene, raloxifene, tamoxifen, torem
control symptoms should be ifene, tranexamic acid.
chosen and medication should This medication may interfere with
be discontinued as promptly certain laboratory tests (including
as possible. For women who
metyrapone test), possibly causing false
have a uterus, adequate
diagnostic measures, such as test results. Make sure laboratory
endometrial sampling, when personnel and all your doctors know you
indicated, should be use this drug.
undertaken to rule
out malignancy in cases of
undiagnosed persistent or
recurring abnormal vaginal
bleeding.
 Attempts to discontinue or
taper medication should be
made at 3-month to 6-month
intervals.

Indication Contraindication Adverse Effect Nursing Responsibility

ESTRACE ESTRACE (estradiol vaginal nausea, Administer cyclically for short-term
(estradiol vaginal cream, USP, 0.01%) should not vomiting, stomach only when treating postmenopausal
cream, USP, be used in women with any of cramps; conditions because of the risk of
0.01%) is indicated the following conditions: bloating, endometrial neoplasm; taper to the
in the treatment swelling, weight lowest effective dose and provide a
of vulvar and 1. Undiagnosed gain; drug-free week each month.
vaginal atrophy. abnormal genital bleedi breast pain Apply transdermal system to a clean,
ng. or tenderness; dry area of skin on the trunk of the
2. Known, suspected, or headache; body, preferably the abdomen; do not
history of cancer of the vaginal apply to breasts; rotate the site at least
breast. itching or discharge, 1 wk between applications; avoid the
3. Known or suspected changes in your waistline because clothing may rub
estrogen-dependent neo menstrual the system off; apply immediately
plasia. periods, breakthro after opening and compress for about
4. Active deep vein ugh bleeding; 10 sec to attach.
thrombosis, pulmonary thinning Insert vaginal ring as deeply as
embolism or history of scalp hair; or. possible into upper one-third of
these conditions. cold vagina. Ring will remain in place for
5. Active or recent (for symptoms such as 3 mo. Then, remove and evaluate
example, within the stuffy nose, need for continued therapy. If a ring
past year) arterial sneezing, sore falls out during 3 mo, rinse with
thromboembolic throat. warm water and reinsert.
disease (for WARNING: Arrange for the
example, stroke, myoca concomitant use of progestin therapy
rdial infarction). during long-term estrogen therapy in
6. Liver dysfunction or women with a uterus; this will mimic
disease. normal physiologic cycling and allow
7. ESTRACE (estradiol for a cyclic uterine bleeding that may
vaginal cream, USP, decrease the risk of endometrial
0.01%) should not be cancer. Women without a uterus do
used in patients with not need progestin.
known hypersensitivity Administer parenteral preparations by
to its ingredients. deep IM injection only. Monitor
8. Known or suspected injection sites and rotate with each
pregnancy. There is no injection to decrease development of
indication for abscesses.
ESTRACE (estradiol
vaginal cream, USP,
0.01%) in pregnancy.
There appears to be
little or no increased
risk of birth defects in
children born to women
who have
used estrogens and
progestins from oral
contraceptives
inadvertently during
early pregnancy
(see PRECAUTIONS).
Classification Generic Name Brand Name Dosage and Mechanism of Action
Frequency

Estrogen Vagifem
Estradiol (Vaginal .
inserts)

Vagifem should be Endogenous estrogens are
administered largely responsible for the
intravaginally using the development and
supplied applicator: 1 maintenance of the
tablet daily for 2 female reproductive
weeks, followed by 1 system and secondary
tablet twice weekly (for sexual characteristics.
example, Tuesday and Although circulating
Friday). Generally, estrogens exist in a
women should be dynamic equilibrium of
started at the 10-mcg metabolic
dosage strength. interconversions, estradiol
is the principal
Vagifem is a small, intracellular
white, round, film- human estrogen and is
coated, bi-convex substantially more potent
vaginal tablet than its metabolites,
containing 10 mcg or estrone and estriol, at the
25 mcg of estradiol. receptor level.
Each vaginal tablet is 6
mm in diameter and is The primary source of
administered in a estrogen in normally
disposable applicator. cycling adult women is
the ovarian follicle, which
Each Vagifem secretes 70 to 500 mcg of
(estradiol vaginal estradiol daily, depending
inserts), 10 mcg and 25 on the phase of the
mcg, is contained in a menstrual cycle.
disposable, single-use After menopause, most
applicator, packaged in endogenous estrogen is
a blister pack. Cartons produced by conversion
contain 8 or 18 of androstenedione,
applicators with inset secreted by the
tablets. adrenal cortex, to estrone
in the peripheral tissues.
Vagifem 25 mcg Thus, estrone and the
sulfate conjugated form,
8 estrone sulfate, are the
applicators: NDC 0169- most abundant circulating
5173-03 estrogens
18 in postmenopausal women.
applicators: NDC 0169-
5173-04 Estrogens act through
binding to nuclear
Vagifem 10 mcg receptors in estrogen-
 8
applicators: NDC 0169- responsive tissues. To
5176-03 date, two estrogen
receptors have been
identified. These vary in
proportion from tissue to
tissue.

Circulating estrogens
modulate
the pituitary secretion of
the
gonadotropins, luteinizing
hormone (LH), and FSH,
through a negative
feedback mechanism.
Estrogens act to reduce the
elevated levels of these
hormones seen in
postmenopausal women.

Indication Contraindication Adverse Effect Nursing Responsibility

Treatment of Vagifem should not nausea, Administer cyclically for short-term only
Atrophic Vaginitis be used in women stomach when treating postmenopausal conditions
Due to Menopause with any of the cramps, because of the risk of endometrial
following conditions: neoplasm; taper to the lowest effective dose
vomiting,
and provide a drug-free week each month.
Undiagnosed bloating, Apply transdermal system to a clean, dry
abnormal genital blee diarrhea, area of skin on the trunk of the body,
ding breast swelling preferably the abdomen; do not apply to
Known, or tenderness, breasts; rotate the site at least 1 wk between
suspected, or history nipple applications; avoid the waistline because
of breast cancer discharge, clothing may rub the system off; apply
Known or immediately after opening and compress for
vaginal itching
suspected estrogen- about 10 sec to attach.
or discharge,
dependent neoplasia Insert vaginal ring as deeply as possible into
Active DVT, upper one-third of vagina. Ring will remain
PE, or history of in place for 3 mo. Then, remove and
these conditions evaluate need for continued therapy. If a
Active ring falls out during 3 mo, rinse with warm
arterial water and reinsert.
thromboembolic WARNING: Arrange for the concomitant
disease (for use of progestin therapy during long-term
example, stroke, estrogen therapy in women with a uterus;
and myocardial this will mimic normal physiologic cycling
infarction), or a and allow for a cyclic uterine bleeding that
history of may decrease the risk of endometrial
these conditions cancer. Women without a uterus do not
Known need progestin.
anaphylactic reaction Administer parenteral preparations by deep
 or angioedema to IM injection only. Monitor injection sites
Vagifem and rotate with each injection to decrease
Known liver development of abscesses.
impairment or
disease
Known protei
n C, protein S, or
antithrombin
deficiency, or other
known thrombophilic
disorders
Known or
suspected pregnancy

Classification Generic Name Brand Name Dosage and Mechanism of Action

Frequency

Antifungal
medication
This medication is used to treat vaginal
yeast
infections. Clotrimazole reduces vaginal
burning, itching, and discharge that may
One
occur with this condition. This
Clotrimazole Clotrimazole 3 applicatorful
medication is an azole antifungal. It
Cream of 1%
works by stopping the growth of yeast
clotrimazole
(fungus) that causes the infection. The
vaginal cream
vaginal product comes in 2 forms (a
intravaginally
vaginal cream or tablet). Some products
once daily
come with a skin cream to be applied to
(preferably at
the area around the outside of
bedtime) for 7
the vagina.
consecutive
days.
Ask your doctor before using this
One medication for self-treatment if this is
applicatorful your first vaginal infection. This
of 2% medication only works for vaginal
clotrimazole fungal infections. You may have a
vaginal cream different type of infection (such
intravaginally as bacterial vaginosis) and may need a
once daily different medication.
(preferably at
bedtime) for 3 If you have fever, chills, flu-like
consecutive symptoms, stomach/abdominal pain, or
days. a bad-smelling vaginal discharge, do not
> 3 years: Apply use this medication. Contact your doctor
clotrimazole right away because these may be signs
topical in a of a more serious infection.
quantity sufficient
 to cover the
affected area and
immediately
surrounding skin

Indication Contraindication Adverse Effect Nursing Responsibility

GI: Abnormal liver  Evaluate
This medication is used to treat vaginal function tests; occasional effectiveness of
yeast nausea and vomiting treatment. Report
infections. Clotrimazole reduces vagina (with oral any signs of skin
l burning, itching, and discharge that Safe use during
troche). Skin: Stinging, irritation with
may occur with this condition. This pregnancy
erythema, edema, dermal
medication (category C for oral
vesication, desquamation, preparations.
troches, category B
pruritus, urticaria, skin
for topical
fissures. Urogenital: Mil
preparations),
d burning sensation, lower
lactation, and in
abdominal cramps,
children <3 y not
bloating, cystitis,
established.
urethritis, mild urinary
frequency, vulval
.
erythema and itching,
pain and vaginal soreness
during intercourse.