INDICATIONS
ORTHO-CYCLEN and ORTHO TRI-CYCLEN Tablets are indicated
for the prevention of pregnancy in women who elect to
use oral contraceptives as a method of contraception.
ORTHO TRI-CYCLEN is indicated for the treatment of moderate
acne vulgaris in females, ³15 years of age, who have
no known contraindications to oral contraceptive therapy,
desire contraception, have achieved menarche and are unresponsive
to topical anti-acne medications.
Oral contraceptives are highly effective. Table I lists
the typical accidental pregnancy rates for users of combination
oral contraceptives and other methods of contraception.
The efficacy of these contraceptive methods, except sterilization,
depends upon the reliability with which they are used.
Correct and consistent use of methods can result in lower
failure rates.
|
TABLE I: LOWEST EXPECTED AND TYPICAL FAILURE
RATES DURING THE FIRST YEAR OF CONTINUOUS USE
OF A METHOD
% of Women Experiencing an Accidental Pregnancy
in the First Year of Continuous Use
|
| Method
|
Lowest Expected*
|
Typical**
|
| (No Contraceptive) |
(85)
|
(85)
|
| Oral contraceptives |
|
3
|
| combined |
0.1
|
N/ A***
|
| progestin only |
0.5
|
N/ A***
|
| Diaphragm with spermicidal
cream or jelly |
6
|
18
|
| Spermicides alone (foams,
creams, gels, jellies, vaginal suppositories, and
vaginal film) |
6
|
21
|
| Vaginal sponge |
|
|
| nulliparous |
9
|
18
|
| parous |
20
|
36
|
| Implant |
0.09
|
0.09
|
| Injection: depot medroxyprogesterone
acetate |
0.3
|
0.3
|
| IUD |
|
|
| progesterone |
1.5
|
2.0
|
| copper T 380A |
0.6
|
0.8
|
| Condom without spermicides
|
|
|
| female |
5
|
21
|
| male |
3
|
12
|
| Cervical Cap with spermicidal
cream or jelly |
|
|
| nulliparous |
9
|
18
|
| parous |
26
|
36
|
| Periodic abstinence (all
methods) |
1- 9
|
20
|
| Female sterilization
|
0.4
|
0.4
|
| Male sterilization |
0.10
|
0.15
|
| Adapted from RA Hatcher
et al., Table 5- 2, (1994) ref. #1. |
|
|
* The authors' best guess of the percentage of women
expected to experience an accidental pregnancy among couples
who initiate a method (not necessarily for the first time)
and who use it consistently and correctly during the first
year if they do not stop for any other reason.
** This term represents "typical" couples who
initiate use of a method (not necessarily for the first
time), who experience an accidental pregnancy during the
first year if they do not stop use for any other reason.
*** N/ A Ð Data not available.
In clinical trials with ORTHO-CYCLEN, 1,651 subjects completed
24,272 cycles and a total of 18 pregnancies were reported.
This represents an overall use-efficacy (typical user efficacy)
pregnancy rate of 0.96 per 100 women-years. This rate includes
patients who did not take the drug correctly.
In four clinical trials with ORTHO TRI-CYCLEN, the use-efficacy
pregnancy rate ranged from 0.68 to 1.47 per 100 women-years.
In total, 4,756 subjects completed 45,244 cycles and a
total of 42 pregnancies were reported. This represents
an overall use-efficacy rate of 1.21 per 100 women-years.
One of these 4 studies was a randomized comparative clinical
trial in which 4,633 subjects completed 22,312 cycles.
Of the 2,312 patients on ORTHO TRI-CYCLEN, 8 pregnancies
were reported. This represents an overall use-efficacy
pregnancy rate of 0.94 per 100 women-years.
In two double-blind, placebo-controlled, six month, multicenter
clinical trials, ORTHO TRI-CYCLEN showed a statistically
significant decrease in inflammatory lesion count and
total lesion count (Table II). The adverse reaction profile
of ORTHO TRI-CYCLEN from these two controlled clinical
trials is consistent with what has been noted from previous
studies involving ORTHO TRI-CYCLEN and are the known risks
associated with oral contraceptives.
|
TABLE II: Acne Vulgaris Indication
Combined Results: Two Multicenter, Placebo- Controlled
Trials
Primary Efficacy Variables: Evaluable- for- Efficacy
Population
|
| |
ORTHO TRI - CYCLEN ®
|
Placebo
|
| |
N = 163
|
N = 161
|
| Mean Age at Enrollment
|
27.3 years
|
28.0
|
Inflammatory
Lesions –
Mean Percent Reduction |
56.6
|
36.6
|
Total Lesions
–
Mean Percent Reduction |
49.6
|
30.3
|
DOSAGE AND ADMINISTRATION
ORAL CONTRACEPTION
To achieve maximum contraceptive effectiveness, ORTHO
TRI-CYCLEN Tablets and ORTHO-CYCLEN Tablets must be taken
exactly as directed and at intervals not exceeding 24
hours. ORTHO TRI-CYCLEN and ORTHO-CYCLEN are available
in the DIALPAK ®Tablet Dispenser which is preset for
a Sunday Start. Day 1 Start is also provided.
21-Day Regimen (Sunday Start)
When taking ORTHO TRI-CYCLEN® 21 and ORTHO-CYCLEN®
21, the first tablet should be taken on the first Sunday
after menstruation begins. If period begins on Sunday,
the first tablet is taken on that day. One tablet is taken
daily for 21 days. For subsequent cycles, no tablets are
taken for 7 days, then a tablet is taken the next day
(Sunday). For the first cycle of a Sunday Start regimen,
another method of contraception should be used until after
the first 7 consecutive days of administration. If the
patient misses one (1) active tablet in Weeks 1, 2, or
3, the tablet should be taken as soon as she remembers.
If the patient misses two (2) active tablets in Week 1
or Week 2, the patient should take two (2) tablets the
day she remembers and two (2) tablets the next day; and
then continue taking one (1) tablet a day until she finishes
the pack. The patient should be instructed to use a back-up
method of birth control if she has sex in the seven (7)
days after missing pills. If the patient misses two (2)
active tablets in the third week or misses three (3) or
more active tablets in a row, the patient should continue
taking one tablet every day until Sunday. On Sunday the
patient should throw out the rest of the pack and start
a new pack that same day. The patient should be instructed
to use a back-up method of birth control if she has sex
in the seven (7) days after missing pills.
Complete instructions to facilitate patient counseling
on proper pill usage may be found in the Detailed Patient
Labeling (" How to Take the Pill" section).
21-Day Regimen (Day 1 Start)
The dosage of ORTHO TRI-CYCLEN® 21 and ORTHO-CYCLEN®
21, for the initial cycle of therapy is one tablet administered
daily from the 1st day through the 21st day of the menstrual
cycle, counting the first day of menstrual flow as "Day
1." For subsequent cycles, no tablets are taken for
7 days, then a new course is started of one tablet a day
for 21 days. The dosage regimen then continues with 7
days of no medication, followed by 21 days of medication,
instituting a three-weeks-on, one-week-off dosage regimen.
If the patient misses one (1) active tablet in Weeks
1, 2, or 3, the tablet should be taken as soon as she
remembers. If the patient misses two (2) active tablets
in Week 1 or Week 2, the patient should take two (2) tablets
the day she remembers and two (2) tablets the next day;
and then continue taking one (1) tablet a day until she
finishes the pack. The patient should be instructed to
use a back-up method of birth control if she has sex in
the seven (7) days after missing pills. If the patient
misses two (2) active tablets in the third week or misses
three (3) or more active tablets in a row, the patient
should throw out the rest of the pack and start a new
pack that same day. The patient should be instructed to
use a back-up method of birth control if she has sex in
the seven (7) days after missing pills.
Complete instructions to facilitate patient counseling
on proper pill usage may be found in the Detailed Patient
Labeling (" How to Take the Pill" section).
28-Day Regimen (Sunday Start)
When taking ORTHO TRI-CYCLEN® 28 and ORTHO-CYCLEN®
28 the first tablet should be taken on the first Sunday
after menstruation begins. If period begins on Sunday,
the first tablet should be taken that day. Take one active
tablet daily for 21 days followed by one green tablet
daily for 7 days. After 28 tablets have been taken, a
new course is started the next day (Sunday). For the first
cycle of a Sunday Start regimen, another method of contraception
should be used until after the first 7 consecutive days
of administration.
If the patient misses one (1) active tablet in Weeks
1, 2, or 3, the tablet should be taken as soon as she
remembers. If the patient misses two (2) active tablets
in Week 1 or Week 2, the patient should take two (2) tablets
the day she remembers and two (2) tablets the next day;
and then continue taking one (1) tablet a day until she
finishes the pack. The patient should be instructed to
use a back-up method of birth control if she has sex in
the seven (7) days after missing pills. If the patient
misses two (2) active tablets in the third week or misses
three (3) or more active tablets in a row, the patient
should continue taking one tablet every day until Sunday.
On Sunday the patient should throw out the rest of the
pack and start a new pack that same day. The patient should
be instructed to use a back-up method of birth control
if she has sex in the seven (7) days after missing pills.
Complete instructions to facilitate patient counseling
on proper pill usage may be found in the Detailed Patient
Labeling (" How to Take the Pill" section).
28-Day Regimen (Day 1 Start)
The dosage of ORTHO TRI-CYCLEN® 28 and ORTHO-CYCLEN®
28, for the initial cycle of therapy is one active tablet
administered daily from the 1st day through the 21st day
of the menstrual cycle, counting the first day of menstrual
flow as "Day 1" followed by one green tablet
daily for 7 days. Tablets are taken without interruption
for 28 days. After 28 tablets have been taken, a new course
is started the next day.
If the patient misses one (1) active tablet in Weeks
1, 2, or 3, the tablet should be taken as soon as she
remembers. If the patient misses two (2) active tablets
in Week 1 or Week 2, the patient should take two (2) tablets
the day she remembers and two (2) tablets the next day;
and then continue taking one (1) tablet a day until she
finishes the pack. The patient should be instructed to
use a back-up method of birth control if she has sex in
the seven (7) days after missing pills. If the patient
misses two (2) active tablets in the third week or misses
three (3) or more active tablets in a row, the patient
should throw out the rest of the pack and start a new
pack that same day. The patient should be instructed to
use a back-up method of birth control if she has sex in
the seven (7) days after missing pills.
Complete instructions to facilitate patient counseling
on proper pill usage may be found in the Detailed Patient
Labeling ("How to Take the Pill" section).
The use of ORTHO TRI-CYCLEN and ORTHO-CYCLEN for contraception
may be initiated 4 weeks postpartum in women who elect
not to breast feed. When the tablets are administered
during the postpartum period, the increased risk of thromboembolic
disease associated with the postpartum period must be
considered. (See CONTRA
INDICATIONS
and WARNINGS concerning thromboembolic
disease. See also PRECAUTIONS, Nursing Mothers) The possibility
of ovulation and conception prior to initiation of medication
should be considered. (See Discussion of Dose-Related
Risk of Vascular Disease from Oral Contraceptives.)
ADDITIONAL INSTRUCTIONS FOR ALL DOSING REGIMENS
Breakthrough bleeding, spotting, and amenorrhea are frequent
reasons for patients discontinuing oral contra-ceptives.
In breakthrough bleeding, as in all cases of irregular
bleeding from the vagina, nonfunctional causes should
be borne in mind. In undiagnosed persistent or recurrent
abnormal bleeding from the vagina, adequate diagnostic
measures are indicated to rule out pregnancy or malignancy.
If pathology has been excluded, time or a change to another
formulation may solve the problem. Changing to an oral
contraceptive with a higher estrogen content, while potentially
useful in minimizing menstrual irregularity, should be
done only if necessary since this may increase the risk
of thromboembolic disease.
Use of oral contraceptives in the event of a missed menstrual
period:
1. If the patient has not adhered to the prescribed schedule,
the possibility of pregnancy should be considered at the
time of the first missed period and oral contraceptive
use should be discontinued until pregnancy is ruled out.
2. If the patient has adhered to the prescribed regimen
and misses two consecutive periods, pregnancy should be
ruled out before continuing oral contraceptive use.
ACNE
The timing of initiation of dosing with ORTHO TRI-CYCLEN
for acne should follow the guidelines for use of ORTHO
TRI-CYCLEN as an oral contraceptive. Consult the
DOSAGE AND ADMINISTRATION
section for oral contraceptives. The dosage regimen for
ORTHO TRI-CYCLEN for treatment of facial acne, as available
in a DIALPAK® Tablet Dispenser, utilizes a 21-day
active and a 7-day placebo schedule. Take one active tablet
daily for 21 days followed by one green tablet for 7 days.
After 28 tablets have been taken, a new course is started
the next day.
HOW SUPPLIED
ORTHO TRI-CYCLEN® 21 Tablets are available in a DIALPAK®
Tablet Dispenser (NDC 0062-1902-15) containing 21 tablets.
Each white tablet contains 0.180 mg of the progestational
compound, norgestimate, together with 0.035 mg of the
estrogenic compound, ethinyl estradiol. Each light blue
tablet contains 0.215 mg of the progestational compound,
norgestimate, together with 0.035 mg of the estrogenic
compound, ethinyl estradiol. Each blue tablet contains
0.250 mg of the progestational compound, norgestimate,
together with 0.035 mg of the estrogenic compound, ethinyl
estradiol.
The white tablets are unscored, with "Ortho"
and "180" debossed on each side; the light blue
tablets are unscored with "Ortho" and "215"
debossed on each side; the blue tablets are unscored with
"Ortho" and "250" debossed on each
side.
ORTHO TRI-CYCLEN® 21 Tablets are available for clinic
usage in a VERIDATE® Tablet Dispenser (unfilled) and
VERIDATE Refills (NDC 0062-1902-20).
ORTHO TRI-CYCLEN® 28 Tablets are available in a DIALPAK®
Tablet Dispenser (NDC 0062-1903-15) containing 28 tablets.
Each white tablet contains 0.180 mg of the progestational
compound, norgestimate, together with 0.035 mg of the
estrogenic compound, ethinyl estradiol. Each light blue
tablet contains 0.215 mg of the progestational compound,
norgestimate, together with 0.035 mg of the estrogenic
compound, ethinyl estradiol. Each blue tablet contains
0.250 mg of the progestational compound, norgestimate,
together with 0.035 mg of the estrogenic compound, ethinyl
estradiol. Each green tablet contains inert ingredients.
The white tablets are unscored, with "Ortho"
and "180" debossed on each side; the light blue
tablets are unscored with "Ortho" and "215"
debossed on each side; the blue tablets are unscored with
"Ortho" and "250" debossed on each
side.
ORTHO TRI-CYCLEN® 28 Tablets are available for clinic
usage in a VERIDATE® Tablet Dispenser (unfilled) and
VERIDATE Refills (NDC 0062-1903-20).
ORTHO-CYCLEN® 21 Tablets are available in a DIALPAK®
Tablet Dispenser (NDC 0062-1900-15) containing 21 tablets.
Each blue tablet contains 0.250 mg of the progestational
compound, norgestimate, together with 0.035 mg of the
estrogenic compound, ethinyl estradiol which are unscored
with "Ortho" and "250" debossed on
each side.
ORTHO-CYCLEN® 21 Tablets are available for clinic
usage in a VERIDATE® Tablet Dispenser (unfilled) and
VERIDATE Refills (NDC 0062-1900-20).
ORTHO-CYCLEN® 28 Tablets are available in a DIALPAK®
Tablet Dispenser (NDC 0062-1901-15) containing 28 tablets
as follows: 21 blue tablets as described under ORTHO-CYCLEN®
21 Tablets, and 7 green tablets containing inert ingredients.
ORTHO-CYCLEN ® 28 Tablets are available for clinic
usage in a VERIDATE® Tablet Dispenser (unfilled) and
VERIDATE Refills (NDC 0062-1901-20).
Caution: Federal law prohibits dispensing without prescription.
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