Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1899
| Predicate | Object |
|---|---|
| rdf:type | |
| rdfs:label |
Ortho-Cept (Kit)
|
| dailymed-instance:supplemen... |
DETAILED PATIENT LABELING: This product (like all oral contraceptives)
is intended to prevent pregnancy. It does not protect against HIV infection
(AIDS) and other sexually transmitted diseases. PLEASE NOTE: This
labeling is revised from time to time as important new medical information
becomes available. Therefore, please review this labeling carefully. The
following oral contraceptive product contains a combination of a progestogen
and estrogen, the two kinds of female hormones: ORTHO-CEPT (desogestrel and ethinyl estradiol)
Tablets Each light orange tablet contains
0.15 mg desogestrel and 0.03 mg ethinyl estradiol. Each green tablet contains
inert ingredients. INTRODUCTION Any woman who considers using oral contraceptives
(the birth control pill or the pill) should understand the benefits and risks
of using this form of birth control. This patient labeling will give you much
of the information you will need to make this decision and will also help
you determine if you are at risk of developing any of the serious side effects
of the pill. It will tell you how to use the pill properly so that it will
be aseffective as possible. However, this labeling is not a replacement for
a careful discussion between you and your healthcare professional. You should
discuss the information provided in this labeling with him or her, both when
you first start taking the pill and during your revisits. You should also
follow your healthcare professional's advice with regard to regular check-ups
while you are on the pill. EFFECTIVENESS
OF ORAL CONTRACEPTIVES Oral contraceptives
or "birth control pills" or "the pill" are used to prevent pregnancy and are
more effective than most other non-surgical methods of birth control. When
they are taken correctly without missing any pills, the chance of becoming
pregnant is approximately 1% (1 pregnancy per 100 women per year of use).
Typical failure rates, including women who do not always take the pills exactly
as directed, are approximately 5% per year. The chance of becoming pregnant
increases with each missed pill during a menstrual cycle. WHO SHOULD NOT TAKE ORAL CONTRACEPTIVES 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 are strongly advised not to smoke. Some women should not use the pill. For example, you should
not take the pill if you have any of the following conditions: Tell your healthcare professional if you have ever had any
of these conditions. Your healthcare professional can recommend another method
of birth control. OTHER
CONSIDERATIONS BEFORE TAKING ORAL CONTRACEPTIVES Tell
your healthcare professional if you have or have had: Women with any of these conditions should be checked often
by their healthcare professional if they choose to use oral contraceptives. Also,
be sure to inform your healthcare professional if you smoke or are on any
medications. RISKS OF
TAKING ORAL CONTRACEPTIVES 1.
Risk of Developing Blood Clots Blood clots
and blockage of blood vessels are one of the most serious side effects of
taking oral contraceptives and can cause death or serious disability. In particular,
a clot in the legs can cause thrombophlebitis and a clot that travels to the
lungs can cause a sudden blocking of the vessel carrying blood to the lungs.
The risks of these side effects may be greater with desogestrel-containing
oral contraceptives, such as ORTHO-CEPT, than with certain other low-dose
pills. Rarely, clots occur in the blood vessels of the eye and may cause blindness,
double vision, or impaired vision. If you take oral
contraceptives and need elective surgery, need to stay in bed for a prolonged
illness or injury or have recently delivered a baby, you may be at risk of
developing blood clots. You should consult your healthcare professional about
stopping oral contraceptives three to four weeks before surgery and not taking
oral contraceptives for two weeks after surgery or during bed rest. You should
also not take oral contraceptives soon after delivery of a baby. It is advisable
to wait for at least four weeks after delivery if you are not breast feeding.
If you are breast feeding, you should wait until you have weaned your child
before using the pill. (See also the section on Breast Feeding in General Precautions.) The
risk of circulatory disease in oral contraceptive users may be higher in users
of high dose pills. The risk of venous thromboembolic disease associated with
oral contraceptives does not increase with length of use and disappears after
pill use is stopped. The risk of abnormal blood clotting increases with age
in both users and nonusers of oral contraceptives, but the increased risk
from the oral contraceptive appears to be present at all ages. For women aged
20 to 44 it is estimated that about 1 in 2,000 using oral contraceptives will
be hospitalized each year because of abnormal clotting. Among nonusers in
the same age group, about 1 in 20,000 would be hospitalized each year. For
oral contraceptive users in general, it has been estimated that in women between
the ages of 15 and 34 the risk of death due to a circulatory disorder is about
1 in 12,000 per year, whereas for nonusers the rate is about 1 in 50,000 per
year. In the age group 35 to 44, the risk is estimated to be about 1 in 2,500
per year for oral contraceptive users and about 1 in 10,000 per year for nonusers. 2. Heart Attacks and Strokes Oral
contraceptives may increase the tendency to develop strokes (stoppage or rupture
of blood vessels in the brain) and angina pectoris and heart attacks (blockage
of blood vessels in the heart). Any of these conditions can cause death or
serious disability. Smoking greatly increases the possibility
of suffering heart attacks and strokes. Furthermore, smoking and the use of
oral contraceptives greatly increase the chances of developing and dying of
heart disease. 3. Gallbladder
Disease Oral contraceptive users probably
have a greater risk than nonusers of having gallbladder disease, although
this risk may be related to pills containing high doses of estrogens. 4. Liver Tumors In rare cases,
oral contraceptives can cause benign but dangerous liver tumors. These benign
liver tumors can rupture and cause fatal internal bleeding. In addition, some
studies report an increased risk of developing liver cancer. However, liver
cancers are rare. 5. Cancer
of the Reproductive Organs and Breasts Various
studies give conflicting reports on the relationship between breast cancer
and oral contraceptive use. Oral contraceptive use may slightly increase your
chance of having breast cancer diagnosed, particularly after using hormonal
contraceptives at a younger age. After you stop using hormonal contraceptives,
the chances of having breast cancer diagnosed begin to go back down. You should
have regular breast examinations by a healthcare professional and examine
your own breasts monthly. Tell your healthcare professional if you have a
family history of breast cancer or if you have had breast nodules or an abnormal
mammogram. Womenwho currently have or have had breast cancer should not use
oral contraceptives because breast cancer is usually a hormone-sensitive tumor. Some
studies have found an increase in the incidence of cancer of the cervix in
women who use oral contraceptives. However, this finding may be related to
factors other than the use of oral contraceptives. There is insufficient evidence
to rule out the possibility that pills may cause such cancers. ESTIMATED RISK OF DEATH FROM A BIRTH CONTROL METHOD OR PREGNANCY All methods of birth control and pregnancy
are associated with a risk of developing certain diseases which may lead to
disability or death. An estimate of the number of deaths associated with different
methods of birth control and pregnancy has been calculated and is shown in
the following In the above table, the risk of death from any birth control
method is less than the risk of childbirth, except for oral contraceptive
users over the age of 35 who smoke and pill users over the age of 40 even
if they do not smoke. It can be seen in the table that for women aged 15 to
39, the risk of death was highest with pregnancy (7-26 deaths per 100,000
women, depending on age). Among pill users who do not smoke, the risk of death
is always lower than that associated with pregnancy for any age group, although
over the age of 40, the risk increases to 32deaths per 100,000 women, compared
to 28 associated with pregnancy at that age. However, for pill users who smoke
and are over the age of 35, the estimated number of deaths exceeds those for
other methods of birth control. If a woman is over the age of 40 and smokes,
her estimated risk of death is four times higher (117/100,000 women) than
the estimated risk associated with pregnancy (28/100,000 women) in that age
group. The suggestion that women over 40 who do not
smoke should not take oral contraceptives is based on information from older,
higher-dose pills. An Advisory Committee of the FDA discussed this issue in
1989 and recommended that the benefits of low-dose oral contraceptive use
by healthy, non-smoking women over 40 years of age may outweigh the possible
risks. Older women, as all women, who take oral contraceptives, should take
an oral contraceptive which contains the least amount of estrogen and progestogen
that is compatible with the individual patient needs. WARNING SIGNALS If any of
these adverse effects occur while you are taking oral contraceptives, call
your healthcare professional immediately: SIDE EFFECTS OF ORAL CONTRACEPTIVES 1. Vaginal Bleeding Irregular vaginal bleeding or spotting may
occur while you are taking the pills. Irregular bleeding may vary from slight
staining between menstrual periods to breakthrough bleeding which is a flow
much like a regular period. Irregular bleeding occurs most often during the
first few months of oral contraceptive use, but may also occur after you have
been taking the pill for some time. Such bleeding may be temporary and usually
does not indicate any serious problems. It is important to continue taking
your pills on schedule. If the bleeding occurs in more than one cycle or lasts
for more than a few days, talk to your healthcare professional. 2. Contact Lenses If you
wear contact lenses and notice a change in vision or an inability to wear
your lenses, contact your healthcare professional. 3. Fluid Retention Oral contraceptives
may cause edema (fluid retention) with swelling of the fingers or ankles and
may raise your blood pressure. If you experience fluid retention, contact
your healthcare professional. 4.
Melasma A spotty darkening of the skin is
possible, particularly of the face, which may persist. 5. Other Side Effects Other
side effects may include nausea and vomiting, change in appetite, headache,
nervousness, depression, dizziness, loss of scalp hair, rash, vaginal infections
and allergic reactions. If any of these side effects
bother you, call your healthcare professional. GENERAL PRECAUTIONS 1. Missed Periods and Use of Oral Contraceptives Before or
During Early Pregnancy There may be times
when you may not menstruate regularly after you have completed taking a cycle
of pills. If you have taken your pills regularly and miss one menstrual period,
continue taking your pills for the next cycle but be sure to inform your healthcare
professional before doing so. If you have not taken the pills daily as instructed
and missed a menstrual period, you may be pregnant. If you missed two consecutive
menstrual periods, you may be pregnant. Check with your healthcare professional
immediately to determine whether you are pregnant. Stop taking oral contraceptives
if pregnancy is confirmed. There is no conclusive evidence
that oral contraceptive use is associated with an increase in birth defects,
when taken inadvertently during early pregnancy. Previously, a few studies
had reported that oral contraceptives might be associated with birth defects,
but these findings have not been seen in more recent studies. Nevertheless,
oral contraceptives should not be used during pregnancy. You should check
with your healthcare professional about risks to your unborn child of any
medication taken during pregnancy. 2. While Breast Feeding If
you are breast feeding, consult your healthcare professional before starting
oral contraceptives. Some of the drug will be passed on to the child in the
milk. A few adverse effects on the child have been reported, including yellowing
of the skin (jaundice) and breast enlargement. In addition, oral contraceptives
may decrease the amount and quality of your milk. If possible, do not use
oral contraceptives while breast feeding. You should use another method of
contraception since breast feeding provides only partial protection from becoming
pregnant and this partial protection decreases significantlyas you breast
feed for longer periods of time. You should consider starting oral contraceptives
only after you have weaned your child completely. 3. Laboratory Tests If you
are scheduled for any laboratory tests, tell your healthcare professional
you are taking birth control pills. Certain blood tests may be affected by
birth control pills. 4. Drug
Interactions Certain drugs may interact with
birth control pills to make them less effective in preventing pregnancy or
cause an increase in breakthrough bleeding. Such drugs include rifampin; drugs
used for epilepsy such as barbiturates (for example, phenobarbital); topiramate
(TOPAMAX), carbamazepine (Tegretol is one
brand of this drug), phenytoin (Dilantin is one brand of
this drug); phenylbutazone (Butazolidin is one brand); certain
drugs used in the treatment of HIV or AIDS; and possibly certain antibiotics.
Medicine for pulmonary hypertension, such as bosentan (Tracleer).Pregnancies and breakthrough bleeding have been reported by women who used
some form of the herbal supplement St. John's Wort while using combined hormonal
contraceptives. Hormonal contraceptives may interact with lamotrigine (LAMICTAL),
an anticonvulsant used for epilepsy. This may increase the risk of seizures
so your healthcare professional may need to adjust the dose of lamotrigine.
You may need to use additional contraception when you take other products
which can make oral contraceptives less effective. Be sure to tell your healthcare
professional if you are taking or start taking any medications while taking
birth control pills. 5. Sexually
transmitted diseases This
product (like all oral contraceptives) is intended to prevent pregnancy. It
does not protect against transmission of HIV (AIDS) and other sexually transmitted
diseases such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis
B, and syphilis. HOW
TO TAKE THE PILL BEFORE YOU
START TAKING YOUR PILLS: BEFORE
YOU START TAKING YOUR PILLS You have a choice of which day to start taking your first
pack of pills. ORTHO-CEPT is available in the DIALPAK Tablet
Dispenser which is preset for a Sunday Start. Day 1 Start is also provided.
Decide with your healthcare professional which is the best day for you. Pick
a time of day which will be easy to remember. DAY 1 START: SUNDAY START: If you MISS 1 light
orange "active" pill: If you MISS 2 light
orange "active" pills in a row in WEEK 1 OR WEEK
2 of your pack: If you MISS 2 light
orange "active" pills in a row in THE 3RD WEEK: If you MISS 3 OR MORE light
orange "active" pills in a row (during the first 3 weeks): A REMINDER: If
you forget any of the 7 green "reminder" pills in Week 4: THROW
AWAY the pills you missed.Keep taking 1 pill each day until the pack
is empty.You do not need a back-up method. FINALLY, IF YOU ARE STILL NOT SURE WHAT TO DO ABOUT THE PILLS
YOU HAVE MISSED: Use a BACK-UP METHOD anytime
you have sex.KEEP TAKING ONE LIGHT ORANGE "ACTIVE"
PILL EACH DAY until you can reach your healthcare professional PREGNANCY DUE TO PILL FAILURE When
taken correctly without missing any pills, oral contraceptives are highly
effective; however the typical failure rate of large numbers of pill users
is 5% per year when women who miss pills are included. If failure does occur,
the risk to the fetus is minimal. PREGNANCY
AFTER STOPPING THE PILL There may be some
delay in becoming pregnant after you stop using oral contraceptives, especially
if you had irregular menstrual cycles before you used oral contraceptives.
It may be advisable to postpone conception until you begin menstruating regularly
once you have stopped taking the pill and desire pregnancy. There
does not appear to be any increase in birth defects in newborn babies when
pregnancy occurs soon after stopping the pill. OVERDOSAGE Serious ill effects
have not been reported following ingestion of large doses of oral contraceptives
by young children. Overdosage may cause nausea and withdrawal bleeding in
females. In case of overdosage, contact your healthcare professional. OTHER INFORMATION Your healthcare
professional will take a medical and family history before prescribing oral
contraceptives and will examine you. The physical examination may be delayed
to another time if you request it and the healthcare professional believes
that it is a good medical practice to postpone it. You should be reexamined
at least once a year. Be sure to inform your healthcare professional if there
is a family history of any of the conditions listed previously in this leaflet.
Be sure to keep all appointments with your healthcare professional because
this is a time to determine if there are early signs of side effects of oral
contraceptive use. Do not use the drug for any condition
other than the one for which it was prescribed. This drug has been prescribed
specifically for you; do not give it to others who may want birth control
pills. HEALTH BENEFITS
FROM ORAL CONTRACEPTIVES In addition to preventing
pregnancy, use of combination oral contraceptives may provide certain benefits.
They are: If you want more information about birth control pills,
ask your healthcare professional or pharmacist. They have a more technical
leaflet called the Professional Labeling, which you may wish to read. The
professional labeling is also published in a book entitled Physicians'
Desk Reference, available in many book stores and public libraries. STORAGE:
Store at 25��C (77��F); excursions permitted to 15��- 30��C
(59��- 86��F).
|
| dailymed-instance:dosage |
To achieve maximum contraceptive effectiveness, ORTHO-CEPT
must be taken exactly as directed and at intervals not exceeding 24 hours.
ORTHO-CEPT is available in the DIALPAK Tablet Dispenser which
is preset for a Sunday Start. Day 1 Start is also provided.<br/>Day 1 Start: The dosage of ORTHO-CEPT for the initial cycle of therapy
is one light orange "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". Tablets are taken without interruption as follows: One light orange
"active" tablet daily for 21 days, then one green "reminder" tablet daily
for 7 days. After 28 tablets have been taken, a new course is started and
a light orange "active" tablet is taken the next day. The
use of ORTHO-CEPT 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".)
If the patient starts on ORTHO-CEPT postpartum, and has not yet had a period,
she should be instructed to use another method of contraception until a light
orange "active" tablet has been taken daily for 7 days. The possibility of
ovulation and conception prior to initiation of medication should be considered.
If the patient misses one (1) light orange "active" tablet in Weeks 1, 2,
or 3, the light orange "active" tablet should be taken as soon as she remembers.
If the patient misses two (2) light orange "active" tablets in Week 1 or Week
2, the patient should take two (2) light orange "active" tablets the day she
remembers and two (2) light orange "active" tablets the next day; and then
continue taking one (1) light orange "active" 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
aftermissing pills. If the patient misses two (2) light orange "active" tablets
in the third week or misses three (3) or more light orange "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.<br/>Sunday Start: When taking ORTHO-CEPT, the first light orange "active" tablet
should be taken on the first Sunday after menstruation begins. If period begins
on Sunday, the first light orange "active" tablet is taken on that day. If
switching directly from another oral contraceptive, the first light orange
"active" tablet should betaken on the first Sunday after the last ACTIVE
tablet of the previous product. Tablets are taken without interruption as
follows: One light orange "active" tablet daily for 21 days, then one green
"reminder" tablet daily for 7 days. After 28 tablets have been taken, a new
course is started and a light orange "active" tablet is taken the next day
(Sunday). When initiating a Sunday start regimen, another method of contraception
should be used until after the first 7 consecutive days of administration. The
use of ORTHO-CEPT for contraception may be initiated 4 weeks postpartum. 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".)
If the patient starts on ORTHO-CEPT postpartum, and has not yet had a period,
she should be instructed to use another method of contraception until a light
orange "active" tablet has been taken daily for 7 days. The possibility of
ovulation and conception prior to initiation of medication should be considered.
If the patient misses one (1) light orange active tablet in Weeks 1, 2, or
3, the light orange "active" tablet should be taken as soon as she remembers.
If the patient misses two (2) light orange "active" tablets in Week 1 or Week
2, the patient should take two (2) light orange "active" tablets the day she
remembers and two (2) lightorange "active" tablets the next day; and then
continue taking one (1) light orange "active" 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) light orange "active" tablets
in the third week or misses three (3) or more light orange "active" tablets
in a row, the patient should continue taking one light orange "active" tabletevery 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.
|
| dailymed-instance:descripti... |
ORTHO-CEPT Tablets provide an oral contraceptive regimen
of 21 light orange round tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17
alpha-pregn-4-en- 20-yn-17-ol) and 0.03 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5
(10)-trien-20-yne-3,17,diol). Inactive ingredients include colloidal silicone
dioxide, corn starch, ferric oxide, lactose, hypromellose, lactose, polyethylene
glycol, povidone, stearic acid, talc, titanium dioxide, and vitamin E. Each
green tablet contains the following inactive ingredients: FD&C Blue No.1
Aluminum Lake, ferric oxide, hypromellose, lactose, magnesium stearate, polyethylene
glycol, pregelatinized starch, talc and titanium dioxide.
|
| dailymed-instance:clinicalP... |
Pharmacodynamics: 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 changes in the endometrium
which reduce the likelihood of implantation. Receptor
binding studies, as well as studies in animals, have shown that 3-keto-desogestrel,
the biologically active metabolite of desogestrel, combines high progestational
activity with minimal intrinsic androgenicity.The relevance
of this latter finding in humans is unknown.<br/>Pharmacokinetics: Desogestrel is rapidly and almost completely absorbed and
converted into 3-keto-desogestrel, its biologically active metabolite. Following
oral administration, the relative bioavailability of desogestrel, as measured
by serum levels of 3-keto-desogestrel, is approximately 84%. In
the third cycle of use after a single dose of ORTHO-CEPT, maximum concentrations
of 3-keto-desogestrel of 2,805��1,203 pg/mL (mean��SD) are reached
at 1.4��0.8 hours. The area under the curve (AUC)
is 33,858��11,043 pg/mL���hr after a single dose. At steady state,
attained from at least day 19 onwards, maximum concentrations of 5,840��1,667 pg/mL are reached at 1.4��0.9 hours. The minimum plasma levels
of 3-keto-desogestrel at steady state are 1,400��560 pg/mL. The AUCat
steady state is 52,299��17,878 pg/mL���hr. The mean AUCfor
3-keto-desogestrel at single dose is significantly lower than the mean AUCat
steady state. This indicates that the kinetics of 3-keto-desogestrel are non-linear
due to an increase in binding of 3-keto-desogestrel to sex hormone-binding
globulin in the cycle, attributed to increased sex hormone-binding globulin
levels which are induced by the daily administration of ethinyl estradiol.
Sex hormone-binding globulin levels increased significantly in the third treatment
cycle from day 1 (150��64 nmol/L) to day 21 (230��59 nmol/L). The
elimination half-life for 3-keto-desogestrel is approximately 38��20
hours at steady state. In addition to 3-keto-desogestrel, other phase I metabolites
are 3��-OH-desogestrel, 3��-OH-desogestrel, and 3��-OH-5��-H-desogestrel.
These other metabolites are not known to have any pharmacologic effects, and
are further converted in part by conjugation (phase II metabolism) into polar
metabolites, mainly sulfates and glucuronides. Ethinyl
estradiol is rapidly and almost completely absorbed. In the third cycle of
use after a single dose of ORTHO-CEPT, the relative bioavailability is approximately
83%. In the third cycle of use after a single dose of
ORTHO-CEPT, maximum concentrations of ethinyl estradiol of 95��34 pg/mL
are reached at 1.5��0.8 hours. The AUCis 1,471��268 pg/mL���hr after a single dose. At steady state, attained
from at least day 19 onwards, maximum ethinyl estradiol concentrations of
141��48 pg/mL are reached at about 1.4��0.7 hours. The minimum
serum levels of ethinyl estradiol at steady state are 24��8.3 pg/mL.
The AUC, at steady state is 1,117��302 pg/mL���hr.
The mean AUCfor ethinyl estradiol following a single
dose during treatment cycle 3 does not significantly differ from the mean
AUCat steady state. This finding indicates linear kinetics
for ethinyl estradiol. The elimination half-life is
26��6.8 hours at steady state. Ethinyl estradiol is subject to a significant
degree of presystemic conjugation (phase II metabolism). Ethinyl estradiol
escaping gut wall conjugation undergoes phase I metabolism and hepatic conjugation
(phase II metabolism). Major phase I metabolites are 2-OH-ethinyl estradiol
and 2-methoxy-ethinyl estradiol. Sulfate and glucuronide conjugates of both
ethinyl estradiol and phase I metabolites, which are excreted in bile, can
undergo enterohepatic circulation.
|
| dailymed-instance:activeIng... | |
| dailymed-instance:supply |
ORTHO-CEPT Tablets are available in a DIALPAK Tablet
Dispenser (NDC 0062-1796-15) containing 28 tablets, as follows: 21 light light
orange, round, convex, beveled edged, coated tablets imprinted "ORTHO" on
one side and "D 150" on the other side containing 0.15 mg desogestrel together
with 0.03 mg ethinyl estradiol, and 7 green, round, convex, beveled edged,
coated tablets imprinted "ORTHO P" on both sides containing inert ingredients. STORAGE:
Store at 25��C (77��F); excursions permitted to 15��- 30��C
(59��- 86��F).
|
| dailymed-instance:boxedWarn... |
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.
|
| dailymed-instance:activeMoi... | |
| dailymed-instance:inactiveI... |
dailymed-ingredient:colloidal_silicone_dioxide,
dailymed-ingredient:corn_starch,
dailymed-ingredient:ferric_acid,
dailymed-ingredient:hypromellose,
dailymed-ingredient:lactose,
dailymed-ingredient:polyethylene_glycol,
dailymed-ingredient:povidone,
dailymed-ingredient:stearic_acid,
dailymed-ingredient:talc,
dailymed-ingredient:titanium_dioxide,
dailymed-ingredient:vitamin_E
|
| dailymed-instance:precautio... |
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 oral contraceptives,
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:<br/>Changes in Contraceptive Effectiveness
Associated with Co-Administration of Other Products: Contraceptive effectiveness may be reduced when hormonal
contraceptives are coadministered 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 ethinyl estradiol
containing products may result in decreased concentrations of these contraceptive
hormones thereby increasing the risk of unintended pregnancy and unscheduled
bleeding.<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:<br/>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, 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 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-CEPT Tablets have 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.
|
| dailymed-instance:overdosag... |
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.
|
| dailymed-instance:genericMe... |
desogestrel and ethinyl estradiol
|
| dailymed-instance:fullName |
Ortho-Cept (Kit)
|
| dailymed-instance:adverseRe... |
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 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:
|
| dailymed-instance:indicatio... |
ORTHO-CEPT Tablets are indicated for the prevention of pregnancy
in women who elect to use oral contraceptives 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 these methods can result in lower
failure rates. In a clinical trial with ORTHO-CEPT,
1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were
reported. This represents an overall user-efficacy (typical user-efficacy)
pregnancy rate of 1.12 per 100 women-years. This rate includes patients who
did not take the drug correctly. ORTHO-CEPT has not been studied for and is not indicated
for use in emergency contraception.
|
| dailymed-instance:represent... | |
| dailymed-instance:routeOfAd... | |
| dailymed-instance:name |
Ortho-Cept
|