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
Ortho-Novum Indications, Dosage, Storage, Stability - Norethindrone and Ethinyl Estradiol
Ortho-Novum Indications, Dosage, Storage, Stability - Norethindrone and Ethinyl Estradiol
INDICATIONS
Oral contraceptives are indicated for the prevention
of pregnancy in women who elect to use the products as a method
of contraception.
Oral contraceptives are highly effective. TABLE 1 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
upon the reliability with which they are used. Correct and consistent
use of methods can result in lower failure
rates.
| TABLE 1 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 contraception |
(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 (foam, creams, gels, jellies,
vaginal suppositories and vaginal
film) |
6 |
21 |
| Vaginal Sponge |
|
|
| nulliparous |
9 |
18 |
| parous |
20 |
36 |
| Implant (6 capsules) |
0.09 |
0.09 |
| Injection: depot
medroxyprogesterone acetate |
0.3 |
0.3 |
| IUD |
|
|
| progesterone T |
1.5 |
2.0 |
| copper T 380 A |
0.6 |
0.8 |
| LN g 20 |
0.1 |
0.1 |
| Condom without spermicides |
|
|
| female |
5 |
21 |
| male |
3 |
12 |
| Cervical Cap with spermacidal cream
or jelly |
2 |
12 |
| nulliparous |
9 |
18 |
| parous |
26 |
36 |
| Periodic abstinence
(all methods) |
1-9 |
20 |
| Withdrawl |
4 |
19 |
| Female sterilization |
0.4 |
0.4 |
| Male sterilization |
0.10 |
0.15 |
| * 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 first year if they do not stop for any other
reason. |
| † This term
represents "typical" couples who initiate 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 - Data not available |
| Adapted from RA
Hatcher et al, Reference 7. |
DOSAGE AND ADMINISTRATION
To achieve maximum contraceptive
effectiveness, tablets must be taken exactly as directed and at intervals
not exceeding 24 hours.
The patient should be instructed
to use an additional method
of protection until after the first week of administration
in the initial cycle
when utilizing the Sunday-Start Regimen. Most dispensors are preset for
Sunday Start. Day 1 Start is also available.
The possibility of ovulation
and conception prior to
initiation of use should be considered.
21-Day Regimen (Sunday Start)
The first tablet should be
taken on the first Sunday after menstruation begins. If period
begins on Sunday, the first tablet
is taken on the same 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.
21-Day Regimen (Day 1 Start)
The initial cycle
of therapy is one tablet administered
daily from the 1st day through 21st day of the menstrual cycle, counting
the first day of menstrual wflow
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.
28-Day Regimen (Sunday Start)
The fist 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
placebo tablet daily for 7 days. After 28 tablets have been taken, a new
course is started the next (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.
28-Day Regimen (Day 1 Start)
The first initial cycle
of therapy is one active tablet
administered daily from the 1st through the 21st day of the menstrual
cycle, counting the first day of menstrual wflow
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.
The use of Ortho-Novum 7/7/7, Ortho-Novum 10/11, Ortho-Novum 1/35, Modicon
and Ortho-Novum 1/50 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 CONTRAINDICATIONS
and WARNINGS,
Thromboembolic diseases.) (See also PRECAUTIONS,
Nursing Mothers.) The possibility of ovulation
and conception prior to
initiation of medication
should considered.
See WARNINGS:
Dose-Related Risk of Vascular Disease From Oral Contraceptives.
Norethindrone (Continuous Regimen)
Norethindrone is administered on a continuous daily dosage
regimen starting on the first
day of menstruation (i.e.,
one tablet each day) every
day of the year. Tablets should be taken at the same time
each day and continued daily. The patient
should be advised that if prolonged bleeding occurs she should consult
her physician.
The use of norethindrone
for contraception may
be initiated postpartum (see WARNINGS).
When norethindrone is administered during postpartum
period, the increased risk of
thromboembolic disease associated with the postpartum
period must be considered.
(see CONTRAINDICATIONS
and WARNINGS)
concerning thromboembolic disease.
If the patient misses one
tablet, norethindrone
should be discontinued immediately and a method
or nonhormonal contraception
should be used until menses has appeared or pregnancy has been excluded.
Alternatively, if the patient
has taken the tablets correctly, and if menses does not appear when expected,
a nonhormonal method of contraception
should be substituted until an appropriate
diagnostic procedure
is performed to rule out pregnancy.
Additional Instructions for all Dosing Regimens
Breakthrough bleeding, spotting
and amenorrhea are frequent
reasons for patients discontinuing oral
contraceptives. 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.
Special Notes on Administration
Menstruation usually begins two or three days, but may begin as late
as the fourth or fifth day, after discontinuing medication. If spotting
occurs while on the usual regimen
of ont tablet daily, the patient
should continue medication
without interruption.
If the patient forgets to
take one or more active tablets,
the following is suggested:
One tablet missed:
- Take tablet as soon as
remembered.
- Take next tablet at the
regular time.
Two consecutive tablets are missed (week one or week two):
- Take two tablets as soon as remembered.
- Take two tablets the next day.
- Use another birth control
method for seven days following
the missed tablets.
Two consecutive tablets are missed (week three):
- Take one tablet daily until
Sunday.
- Discard remaining tablets.
- Start a new pack of tablets
immediately (Sunday).
- Use another birth control
method for seven days following
the missed tablets.
Three or more consecutive tablets are missed:
- Take one tablet daily until
Sunday.
- Discard remaining tablets.
- Start a new pack of tablets
immediately (Sunday).
- Use another birth control
method for seven days following
the missed tablets.
The possibility of ovulation
increases with each sucessive day that scheduled tablets are missed. While
there is little likelihood of ovulation occurring if only one tablet
is missed, the possibility of spotting
or bleeding is increased. This is particularly likely if two or more consecutive
tablets are missed.
In rare cases of bleeding
which resembles menstruation, the patinet should be advised to discontinue
medication and then begin
taking tablets from a new tablet
dispenser on the next Sunday. Persistent bleeding
which is not controlled by this method
indicates the need for reexaminstion
of the patient, at which time
nonfunctional causes should be considered.
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 after the first missed period (or upon missing one
Micronor Tablet) and oral contraceptive
use should be withheld until pregnancy is ruled out.
2. If the patient
has adhered to the prescribed regimen
and misses two consecutive periods (or after 45 days from the last menstrual
period if the progestogen-only oral
contraceptives are used), pregnancy should be ruled out before continuing
the contraceptive regimen.
Non-Contraceptive Health Benefits: The following non-contraceptive
health benefits related to the use of oral
contraceptives are supported by epidemiological studies which largely
utilized oral contraceptive
formulations containing estrogen
doses exceeding 0.035 mg of ethinyl estradiol
or 0.05 mg of mestranol.79-84
Effects on Menses:
- Increased menstrual cycle
regularity.
- Decreased blood loss
and decreased incidence
of iron deficiency anemia.
- Decreased incidence
of dysmenorrhea.
Effects Related to Inhibition of Ovulation:
- Decreased incidence
of functional ovarian
cysts.
- Decreased incidence
of ectopic pregnancies.
Effects from Long-term Use:
- Decreased incidence
of fibroadenomas and fibrocystic
disease of the breast.
- Decreased incidence
of acute pelvic
inflammatory disease.
- Decreased incidence
of endometrial cancer.
- Decreased incidence
of ovarian cancer.
FDA Recommended Dosage Guidelines for Postcoital Emergency Contraception
See Ethinyl Estradiol; Levonorgestrel and Ethinyl Estradiol; Norgestrel
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