INDICATIONS
Clomiphene citrate tablets USP is indicated for the treatment
of ovulatory dysfunction in women desiring pregnancy.
Impediments to achieving pregnancy must be excluded or
adequately treated before beginning elomiphene citrate
tablets USP therapy. Those patients most likely to achieve
success wi th clomiphene therapy include patients with
polycystic ovary syndrome (see WARNINGS: Ovarian Hyperstimulatron
Syndrome), amenorrhea-galactorrhea syndrome, psychogenic
amenorrhea, post-oral-contraceptlve amenorrhea, and certain
cases of secondary amenorrhea of undetermined etiology.
Properly timed coitus in relationship to ovulation is
important. A basal body temperature graph or other appropriate
tests may help the patient and her physician determine
if ovulation occurred, once ovulation has been established
each course of clomiphene crtrate tablets USP should be
started on or about the 5th day of the cycle. Long-term
cyclic therapy is not recommended beyond a total of about
six cycles (including three ovulatory cycles). (See
DOSAGE AND ADMINISTRATION
and PRECAUTIONS.)
Clomiphene citrate tablets USP is indicated only in patients
with demonstrated ovulatory dysfunction who meet the conditions
described below (see CONTRA
INDICATIONS
):
1 Patients who are not pregnant.
2. Patients without ovarian cysts. Clomiphene citrate
tablets USP should not be used in patients with ovarian
enlargement except those with polycystic ovary syndrome.
Pelvic examination is necessary prior to the first and
each subsequent course of clomiphene citrate tablets USP
treatment.
3. Patients without abnormal vaginal bleeding. if abnormal
vaginal bleeding is present, the patient should be carefully
evaluated to ensure that neoplastic lesions are not present.
4. Patients with normal liver function.
In addition, patients selected for clomiphene citrate
tablets USP therapy should be evaluated in regard to the
following:
1. Estrogen Levels. Patients
should have adequate levels of endogenous estrogen (as
estimated from vaginal smears, endometrial biopsy, assay
of urinary estrogen, or from bleeding in response to progesterone).
Reduced estrogen levels, while less favorable, do not
preclude successful therapy.
2. Primary Pituitary or Ovarian Failure.
Clomiphene citrate tablets USP therapy cannot be expected
to substitute for specific treatment of other causes of
ovulatory failure.
3. Endometriosis and Endomettial Carcinoma.
The incidence of endometriosis and endometrial carcinoma
increases with age as does the incidence of ovulatory
disorders. Endometrial biopsy should always be performed
prior to clomiphene citrate tablets USP therapy in this
population.
4. Other Impediments to Pregnancy.
Impediments to pregnancy can include thyroid disorders,
adrenal disorders, hyperprolactinemia, and male factor
infertility.
5. Uterine Fibroids. Caution
should be exercised when using clomiphene citrate tablets
USP in patients with uterine fibroids due to the potential
for further enlargement of the fibroids, There are no
adequate or well-controlled studies that demonstrate the
effectiveness of clomiphene citrate tablets USP in the
treatment of male infertility. In addition, testicular
tumors and gynecomastia have been reported in males using
clomiphene. The cause and effect relationship between
reports of testicular tumors and the administration of
clomiphene citrate tablets USP is not known. Although
the medical literature suggests various methods, there
is no universally accepted standard regimen for combined
therapy (ie. clomiphene citrate tablets USP in conjunction
with other ovulation inducing drugs). Similarly, there
is no standard clomiphene citrate tablets USP regimen
for ovulation induction in vitro fertilization programs
to produce ova for fertilization and reintroduction. Therefore,
clomiphene citrate tablets USP is not recommended for
these uses.
DOSAGE AND ADMINISTRATION
General Consideration:
The workup and treatment of candidates for clomiphene
citrate tablets USP therapy should be supervised by physicians
experienced in management of gynecolic or endocrine disorders.
Patients should be chosen for therapy with clomiphene
citrate only after careful diagnostic evaluation (see
INDICATION AND USAGE). The plan of therapy should be outlined
in advance. Impediments to achieving the goal of therapy
must be excluded or adequately treated before beginning
clomiphene citrate tablets USP. The therapeutic objective
should be balaced with potential risks and discussed with
the patient and others involved in the achievement of
a pregnancy.
Ovulation most often occurs from 5 to 10 days after a
course of clomiphene citrate tablets USP. Coitus should
be timed to coincide with the expected time of ovulation.
Appropriate tests to determine ovulation may be useful
during this time.
Recommended Dosage
Treatment of the selected patient should begin with a
low dose, 50 mg daily (1 tablet) for 5 days. The dose
should be increased only in those patients who do not
ovulate in response to cyclic 50 mg clomiphene citrate
tablets USP. A low dosage or duration of treatment course
is particularly recommended if unusual sensitivity to
pituitary gonadotropin is suspected, such as in patients
with potycystic ovary syndrome (see WARNINGS, Ovarian
Hyperstimulation Syndrome).
The patient should be evaluated carefully to exclude
pregnancy, ovarian enlargement, or ovarian cyst formation
between each treatment cycle.
If progestin-induced bleeding is planned, or if spontaneous
uterine bleeding occurs prior to therapy, the regimen
of 50 mg daily for 5 days should be started on or about
the 5th day of the cycle. Therapy may be started at any
time in the patient who has had no recent uterine bleeding.
When ovulation occurs at this dosage, there is no advantage
to increasing the dose in subsequent cycles of treatment.
If ovulation does not appear to occur after the first
course of therapy, a second course of 100 mg daily (two
50 mg tablets given as a single daily dose) for 5 days
should be given. This course may be started as early as
30 days after the previous one after precautions are taken
to exclude the presence of pregnancy, Increasing the dosage
or duration of therapy beyond 100 mg/day for 5 days is
not recommended.
The majority of patients who are going to ovulate will
do so after the first course of therapy. If ovulation
does not occur after three courses of therapy, further
treatment with clomiphene citrate tablets USP is not recommended
and the patient should be reevaluated. If three ovulatory
responses occur, but pregnancy has not been achieved,
further treatment is not recommended. If menses does not
occur after an ovulatory response, the patient should
be reevaluated. Long-term cyclic therapy is not recommended
beyond a total of about 6 cycles (see PRECAUTIONS).
HOW SUPPLIED
NDC 52544-781-30: 50 mg tablets in cartons of 30
Tablets are round, white, scored, and debossed “Watson”
over “781” or ‘Rugby” over “3109”.
Store tablets at controlled room temperature 59°-
86° F (15°- 30° C).
Protect from heat, light, and excessive humidity, and
store in dosed containers.
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