Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/522
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ORTHO-NOVUM 7/7/7 (Kit)
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To achieve maximum contraceptive effectiveness, ORTHO-NOVUM
Tablets and MODICON Tablets must be taken exactly as directed and at intervals
not exceeding 24 hours. ORTHO-NOVUM Tablets and MODICON Tablets are available
in the DIALPAK Tablet Dispenser which is preset for a Sunday
Start. Day 1 Start is also available.<br/>Sunday Start: When taking ORTHO-NOVUM 7/7/7, ORTHO-NOVUM 1/35, and MODICON,
the first "active" tablet should be taken on the first Sunday after menstruation
begins. If period begins on Sunday, the first "active" tablet should be taken
that day. Take one active tablet daily for 21 days followed by one green "reminder"
tablet daily for 7 days. After28 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 such as condoms or spermicide 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).<br/>Day 1 Start: The dosage of ORTHO-NOVUM 7/7/7, ORTHO-NOVUM 1/35, and MODICON,
for the 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 flow as "Day 1" followed by one green "reminder" 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-upmethod of birth control such as condoms or spermicide 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-NOVUM
7/7/7, ORTHO-NOVUM 1/35, and MODICON 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 concerning
thromboembolic disease. See also PRECAUTIONS for "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.)
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COMBINATION ORAL CONTRACEPTIVES: Combination oral contraceptives act by suppression of gonadotropins.
Although the primary mechanism of this action is inhibition of ovulation,
other alterations include changes in the cervical mucus (which increase the
difficulty of sperm entry into the uterus) and the endometrium (which reduce
the likelihood of implantation).
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ORTHO-NOVUM 7/7/7 Tablets
are available in a DIALPAK Tablet Dispenser (NDC 0062-1781-15) containing
28 tablets, as follows: 7 white, round, flat-faced beveled edged tablets imprinted
with "Ortho 535" on both sides (0.5 mg norethindrone and 0.035 mg ethinyl
estradiol), 7 light peach, round, flat-faced, beveled edged tablets imprinted
with "Ortho 75" on both sides (0.75 mg norethindrone and0.035 mg ethinyl
estradiol), 7 peach, round, flat-faced, beveled edged tablets imprinted with
"Ortho 135" on both sides (1 mg norethindrone and 0.035 mg ethinyl estradiol)
and 7 green, round, flat-faced, beveled edged tablets imprinted "Ortho" on
both sides containing inert ingredients. ORTHO-NOVUM
7/7/7 is available for clinic usage in a VERIDATE Tablet Dispenser
(unfilled) and VERIDATE Refills (NDC 0062-1781-20). ORTHO-NOVUM 1/35 Tablets are available in a DIALPAK
Tablet Dispenser (NDC 0062-1761-15) containing 28 tablets, as follows: 21
peach, round, flat-faced, beveled edged tablets imprinted "Ortho 135" on both
sides (1 mg norethindrone and 0.035 mg ethinyl estradiol) and 7 green, round,
flat-faced, beveled edged tablets imprinted "Ortho" on both sides containing
inert ingredients. MODICON
Tablets are available in a DIALPAK Tablet Dispenser (NDC 0062-1714-15)
containing 28 tablets, as follows: 21 white, round, flat-faced, beveled edged
tablets imprinted "Ortho 535" on both sides (0.5 mg norethindrone and 0.035
mg ethinyl estradiol) and 7 green, round, flat-faced, beveled edged tablets
imprinted "Ortho" on both sides containing inert ingredients. MODICON is available for clinic usage in a VERIDATE
Tablet Dispenser (unfilled) and VERIDATE Refills (NDC 0062-1714-20). Store
at 25��C (77��F), excursions permitted to 15�����30��C
(59�����86��F).
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Cigarette smoking increases the
risk of serious cardiovascular side effects from oral contraceptive use. This
risk increases with age and with heavy smoking (15 or more cigarettes per
day) and is quite marked in women over 35 years of age. Women who use oral
contraceptives should be strongly advised not to smoke.
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1. GENERAL: Patients should be counseled that
this product does not protect against HIV infection (AIDS) and other sexually
transmitted diseases.<br/>2. PHYSICAL EXAMINATION AND FOLLOW
UP: It is good medical practice for all women to have annual
history and physical examinations, including women using oral contraceptives.
The physical examination, however, may be deferred until after initiation
of oral contraceptives if requested by the woman and judged appropriate by
the clinician. The physical examination should include special reference to
blood pressure, breasts, abdomen and pelvic organs, including cervical cytology,
and relevant laboratory tests. In case of undiagnosed, persistent or recurrent
abnormal vaginal bleeding, appropriate measures should be conducted to rule
out malignancy. Women with a strong family history of breast cancer or who
have breast nodules should be monitored with particular care.<br/>3. LIPID DISORDERS: Women who are being treated for hyperlipidemias should be
followed closely if they elect to use oral contraceptives. Some progestogens
may elevate LDL levels and may render the control of hyperlipidemias more
difficult.<br/>4. LIVER FUNCTION: If jaundice develops in any woman receiving such drugs, the
medication should be discontinued. Steroid hormones may be poorly metabolized
in patients with impaired liver function.<br/>5. FLUID RETENTION: Oral contraceptives may cause some degree of fluid retention.
They should be prescribed with caution, and only with careful monitoring,
in patients with conditions which might be aggravated by fluid retention.<br/>6. EMOTIONAL DISORDERS: Women with a history of depression should be carefully observed
and the drug discontinued if depression recurs to a serious degree.<br/>7. CONTACT LENSES: Contact lens wearers who develop visual changes or changes
in lens tolerance should be assessed by an ophthalmologist.<br/>8. DRUG INTERACTIONS: Changes in contraceptive effectiveness
associated with co-administration of other products: Contraceptive
effectiveness may be reduced when hormonal contraceptives are co-administered
with antibiotics, anticonvulsants, and other drugs that increase the metabolism
of contraceptive steroids. This could result in unintended pregnancy or breakthrough
bleeding. Examples include rifampin, barbiturates, phenylbutazone, phenytoin,
carbamazepine, felbamate, oxcarbazepine, topiramate, griseofulvin and bosentan.
Several cases of contraceptive failure and breakthrough bleeding have been
reported in the literature with concomitant administration of antibiotics
such as ampicillin and tetracyclines. However, clinical pharmacology studies
investigating drug interaction between combined oral contraceptives and these
antibiotics have reported inconsistent results. Several
of the anti-HIV protease inhibitors have been studied with co-administration
of oral combination hormonal contraceptives; significant changes (increase
and decrease) in the plasma levels of the estrogen and progestin have been
noted in some cases. The safety and efficacy of oral contraceptive products
may be affected with co-administration of anti-HIV protease inhibitors. Healthcare
professionals should refer to the label of the individual anti-HIV protease
inhibitors for further drug-drug interaction information. Herbal
products containing St. John's Wort (hypericum perforatum) may induce hepatic
enzymes (cytochrome P450) and p-glycoprotein transporter and may reduce the
effectiveness of contraceptive steroids. This may also result in breakthrough
bleeding. Concurrent use of bosentan and norethisterone/ethinyl
estradiol may result in decreased concentrations of these contraceptive hormones
thereby increasing the risk of unintended pregnancy and unscheduled bleeding. Increase in plasma levels associated with co-administered
drugs: Co-administration of atorvastatin and
certain oral contraceptives containing ethinyl estradiol increase AUC values
for ethinyl estradiol by approximately 20%. Ascorbic acid and acetaminophen
may increase plasma ethinyl estradiol levels, possibly by inhibition of conjugation.
CYP 3A4 inhibitors such as itraconazole or ketoconazole may increase plasma
hormone levels. Changes in
plasma levels of co-administered drugs: Combination
hormonal contraceptives containing some synthetic estrogens (e.g., ethinyl
estradiol) may inhibit the metabolism of other compounds. Increased plasma
concentrations of cyclosporin, prednisolone, and theophylline have been reported
with concomitant administration of oral contraceptives. Decreased plasma
concentrations of acetaminophen and increased clearance of temazepam, salicylic
acid, morphine and clofibric acid, due to induction of conjugation, have been
noted when these drugs were administered with oral contraceptives. Combined
hormonal contraceptives have been shown to significantly decrease plasma concentrations
of lamotrigine when co-administered due to induction of lamotrigine glucuronidation.
This may reduce seizure control; therefore, dosage adjustments of lamotrigine
may be necessary. Healthcare professionals
are advised to also refer to prescribing information of co administered drugs
for recommendations regarding management of concomitant therapy.<br/>9. INTERACTIONS WITH LABORATORY TESTS: Certain endocrine and liver function tests and blood components
may be affected by oral contraceptives:<br/>10. CARCINOGENESIS: See WARNINGS Section.<br/>11. PREGNANCY: Pregnancy Category X. See CONTRAINDICATIONS and WARNINGS Sections.<br/>12. NURSING MOTHERS: Small amounts of oral contraceptive steroids have been identified
in the milk of nursing mothers and a few adverse effects on the child have
been reported, including jaundice and breast enlargement. In addition, combination
oral contraceptives given in the postpartum period may interfere with lactation
by decreasing the quantity and quality of breast milk. If possible, the nursing
mother should be advised not to use combination oral contraceptives but to
use other forms of contraception until she has completely weaned her child.<br/>13. PEDIATRIC USE: Safety and efficacy of ORTHO-NOVUM Tablets and MODICON Tablets
has been established in women of reproductive age. Safety and efficacy are
expected to be the same for postpubertal adolescents under the age of 16 and
for users 16 years and older. Use of this product before menarche is not indicated.<br/>14. GERIATRIC USE: This product has not been studied in women over 65 years
of age and is not indicated in this population.
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Serious ill effects have not been reported following acute
ingestion of large doses of oral contraceptives by young children. Overdosage
may cause nausea, and withdrawal bleeding may occur in females.
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norethindrone and ethinyl estradiol
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ORTHO-NOVUM 7/7/7 (Kit)
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An increased risk of the following serious adverse reactions
has been associated with the use of oral contraceptives . There is evidence of an association between the following
conditions and the use of oral contraceptives: The following adverse reactions have been reported in patients
receiving oral contraceptives and are believed to be drug-related: The following adverse reactions have been reported in users
of oral contraceptives and a causal association has been neither confirmed
nor refuted:
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ORTHO-NOVUM 7/7/7, ORTHO-NOVUM
1/35, and MODICON Tablets are
indicated for the prevention of pregnancy in women who elect to use this product
as a method of contraception. 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, the IUD,
and the NORPLANT' System depends upon the reliability with which they
are used. Correct and consistent use of methods can result in lower failure
rates. ORTHO-NOVUM 7/7/7, ORTHO-NOVUM
1/35 and MODICON have not been studied for and are not indicated for use in
emergency contraception.
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ORTHO-NOVUM 7/7/7
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