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
Clomid Indications, Dosage, Storage, Stability - Clomiphene
Clomid Indications, Dosage, Storage, Stability - Clomiphene
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.
There are no adequate or well-controlled studies that demonstrate the effectiveness of clomiphene citrate
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 is not known.
Although the medical literature suggests various methods, there is no universally accepted standard regimen
for combined therapy (i.e., clomiphene citrate in conjunction with other ovulation-inducing drugs).
Similarly, there is no standard clomiphene citrate regimen for ovulation induction in vitro fertilization
programs to produce ova for fertilization and reintroduction. Therefore, clomiphene citrate 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
Clomiphene citrate tablets USP, 50 mg are round, off-white, debossed ”Par 701” with bisect on one side
and plain on the other. They are supplied in cartons of 10 (NDC 49884-701-54) and cartons of 30 (NDC
49884-701-55).
Storage - Store at controlled room temperature 15°-30°C (59°-86°F). Protect from heat, light, and
excessive humidity, and store in closed containers.
Manufactured by:
PAR PHARMACEUTICAL, INC.
Spring Valley, NY 10977
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