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ORTHO TRI-CYCLEN
ORTHO TRI-CYCLEN ONLINE
Before Using This Medicine
In deciding to use a medicine, the risks of taking the medicine
must be weighed against the good it will do. If you are using oral
contraceptives for contraception you should understand how their
benefits and risks compare to those of other birth control
methods. This is a decision you, your sexual partner, and your
doctor will make. For oral contraceptives, the following should be
considered:
Allergies—Tell your doctor if you have ever
had any unusual or allergic reaction to estrogens or progestins.
Also tell your health care professional if you are allergic to any
other substances, such as foods, preservatives, or dyes.
Diet—Make certain your health care
professional knows if you are on any special diet, such as a
low-sodium or low-sugar diet.
Pregnancy—Oral contraceptives are not
recommended for use during pregnancy and should be discontinued if
you become pregnant or think you are pregnant. When oral
contraceptives were accidently taken early in pregnancy, problems
in the fetus did not occur. Women who are not breast-feeding may
begin to take oral contraceptives two weeks after having a baby.
Breast-feeding—Oral contraceptives pass into
the breast milk and can change the content or lower the amount of
breast milk. Also, they may shorten a woman's ability to
breast-feed by about 1 month, especially when the mother is only
partially breast-feeding. Because the amount of hormones is so
small in low-dose contraceptives, your doctor may allow you to
begin using an oral contraceptive after you have been
breast-feeding for a while. However, it may be necessary for you
to use another method of birth control or to stop breast-feeding
while taking oral contraceptives.
Teenagers—This medicine is frequently used for
birth control in teenage females and has not been shown to cause
different side effects or problems than it does in adults. Some
teenagers may need extra information on the importance of taking
this medication exactly as prescribed.
Other medicines—Although certain medicines
should not be used together at all, in other cases two different
medicines may be used together even if an interaction might occur.
In these cases, your doctor may want to change the dose, or other
precautions may be necessary. When you are taking oral
contraceptives, it is especially important that your health care
professional know if you are taking any of the following:
 | Amiodarone (e.g., Cordarone) or
| Anabolic steroids (nandrolone [e.g., Anabolin], oxandrolone
[e.g., Anavar], oxymetholone [e.g., Anadrol], stanozolol
[e.g., Winstrol]) or
| Androgens (male hormones) or
| Anti-infectives by mouth or by injection (medicine for
infection) or
| Barbiturates or
| Carbamazepine (e.g., Tegretol) or
| Carmustine (e.g., BiCNU) or
| Dantrolene (e.g., Dantrium) or
| Daunorubicin (e.g., Cerubidine) or
| Disulfiram (e.g., Antabuse) or
| Divalproex (e.g., Depakote) or
| Estrogens (female hormones) or
| Etretinate (e.g., Tegison) or
| Gold salts (medicine for arthritis) or
| Griseofulvin (e.g., Fulvicin) or
| Hydroxychloroquine (e.g., Plaquenil) or
| Mercaptopurine (e.g., Purinethol) or
| Methotrexate (e.g., Mexate) or
| Methyldopa (e.g., Aldomet) or
| Naltrexone (e.g., Trexan) (with long-term, high-dose use) or
| Phenothiazines (acetophenazine [e.g., Tindal],
chlorpromazine [e.g., Thorazine], fluphenazine [e.g., Prolixin],
mesoridazine [e.g., Serentil], perphenazine [e.g., Trilafon],
prochlorperazine [e.g., Compazine], promazine [e.g., Sparine],
promethazine [e.g., Phenergan], thioridazine [e.g., Mellaril],
trifluoperazine [e.g., Stelazine], triflupromazine [e.g.,
Vesprin], trimeprazine [e.g., Temaril]) or
| Phenylbutazone (e.g., Butazolidin) or
| Phenytoin (e.g., Dilantin) or
| Plicamycin (e.g., Mithracin) or
| Primidone (e.g., Mysoline) or
| Rifabutin (e.g., Mycobutin) or
| Rifampin (e.g., Rifadin) or
| Troleandomycin (e.g., TAO)—These medicines may increase
the chance of liver problems if taken with oral
contraceptives; also, these medicines may decrease the effect
of oral contraceptives and increase your chance of pregnancy.
Use of an additional form of birth control is recommended
unless directed otherwise by your health care professional |
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| Corticosteroids (cortisone-like medicine) or
| Theophylline—Oral contraceptives may increase the effects
of these medicines and increase the chance of problems
occurring |
|
| Cyclosporine—Oral contraceptives increase the effect of
cyclosporine and increase the chance of problems occurring |
| Ritonavir (e.g., Norvir) or
| Troglitazone (e.g., Rezulin)—These medicines may decrease
the effect of oral contraceptives and increase your chance of
pregnancy. Use of an additional form of birth control is
recommended unless directed otherwise by your health care
professional |
|
| Smoking, tobacco—Smoking may decrease the effect of oral
contraceptives and increase the chance of causing serious
blood clot, vein, or heart problems |
Other medical problems—The presence of other
medical problems may affect the use of oral contraceptives. Make
sure you tell your doctor if you have any other medical problems,
especially:
| Abnormal changes in menstrual or uterine bleeding or
| Endometriosis or
| Fibroid tumors of the uterus—Oral contraceptives usually
improve these female conditions but sometimes they can make
them worse or make the diagnosis of these problems more
difficult |
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| Blood clots (or history of) or
| Heart or circulation disease or
| Stroke (or history of)—If these conditions are already
present, oral contraceptives may have a greater chance of
causing blood clots or circulation problems, especially in
women who smoke tobacco. Otherwise, oral contraceptives may
help prevent circulation and heart disease if you are healthy
and do not smoke |
| |
| Breast disease (not involving cancer)—Oral contraceptives
usually protect against certain breast diseases, such as
breast cysts or breast lumps; however, your doctor may want to
follow your condition more closely |
| Cancer, including breast cancer (or history of or family
history of)—Oral contraceptives may worsen some cancers,
especially when breast, cervical, or uterine cancers already
exist. Use of oral contraceptives is not recommended if you
have any of these conditions. If you have a family history of
breast disease, oral contraceptives may still be a good choice
but you may need to be tested more often |
| Chorea gravidarum or
| Gallbladder disease or gallstones (or history of) or
| High blood cholesterol or
| Liver disease (or history of, including jaundice during
pregnancy or oral contraceptive use) or
| Mental depression (or history of)—Oral contraceptives may
make these conditions worse or, rarely, cause them to occur
again. Oral contraceptives may still be a good choice but you
may need to be tested more often |
| | | |
| Diabetes mellitus (sugar diabetes)—Use of oral
contraceptives may cause an increase, usually only a small
increase, in your blood sugar and usually does not affect the
amount of diabetes medicine that you take. You or your doctor
will want to test for any changes in your blood sugar for 12
to 24 months after starting to take oral contraceptives in
case the dose of your diabetes medicine needs to be changed |
| Epilepsy (seizures) (or history of) or
| Heart or circulation problems or
| High blood pressure (hypertension) or
| Migraine headaches—Oral contraceptives may cause fluid
build-up and may cause these conditions to become worse;
however, some people have fewer migraine headaches when they
use oral contraceptives |
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Proper Use of This Medicine
To make using oral contraceptives as safe and reliable as
possible, you should understand how and when to take them and what
effects may be expected.
A paper with information for the patient will be given to
you with your filled prescription, and will provide many details
concerning the use of oral contraceptives. Read this paper
carefully and ask your health care professional if you need
additional information or explanation.
Take this medicine with food to help prevent nausea that might
occur during the first few weeks. Nausea usually disappears with
continued use or if the medicine is taken at bedtime.
When you begin to use oral contraceptives, your body
will require at least 7 days to adjust before a pregnancy will be
prevented. You will need to use an additional birth control method
for at least 7 days. Some doctors recommend using an additional
method of birth control for the first cycle (or 3 weeks) to ensure
full protection. Follow the advice of your doctor or other health
care professional.
Try to take the doses no more than 24 hours apart to reduce
the possibility of side effects and to prevent pregnancy.
Since one of the most important factors in the proper use of oral
contraceptives is taking every dose exactly on schedule, you
should never let your tablet supply run out. When possible, try to
keep an extra month's supply of tablets on hand and replace it
monthly.
It is very important that you keep the tablets in their
original container and take the tablets in the same order that
they appear in the container. The containers help you keep track
of which tablets to take next. Different colored tablets in the
same package contain different amounts of hormones or are placebos
(tablets that do not contain hormones). The effectiveness of
the medicine is reduced if the tablets are taken out of order.
| Monophasic (one-phase) cycle dosing schedule: Most
available dosing schedules are monophasic. If you are taking
tablets of one strength (color) for 21 days, you are using a
monophasic schedule. For the 28-day monophasic cycle you will
also take an additional 7 inactive tablets, which are another
color. If you are taking the brand name Mircette, the
last seven tablets of the 28-day cycle contains two inactive
tablets (for Days 22 and 23) and five tablets (for Days 24
through 28) that contain a low dose of estrogen. Taking the
last 7 tablets is not required for full protection against
pregnancy but they do help to replace estrogen.
| Biphasic (two-phase) cycle dosing schedule: If you
are using a biphasic twenty-one–day schedule, you are taking
tablets of one strength (color) for either seven or ten days,
depending on the medication prescribed (the first phase). You
then take tablets of a second strength (color) for the next
eleven or fourteen days, depending on the medication
prescribed (the second phase). At this point, you will have
taken a total of twenty-one tablets. For the
twenty-eight–day biphasic cycle you will also take an
additional seven inactive tablets, which are a third color.
| Triphasic (three-phase) cycle dosing schedule: If you
are using a triphasic twenty-one–day schedule, you are
taking tablets of one strength (color) for five, six or seven
days, depending on the medicine prescribed (the first phase).
You then take tablets of a second strength (color) for the
next five, seven, or nine days, depending on the medicine
prescribed (the second phase). After that, you take tablets of
a third strength (color) for the next five, seven, nine, or
ten days, depending on the medicine prescribed (the third
phase). At this point, you will have taken a total of
twenty-one tablets. For the twenty-eight–day triphasic cycle
you will also take an additional seven inactive tablets, which
are a fourth color. |
| |
If you are taking one of the brand name products Estrostep
Fe or Loestrin Fe each of the last seven tablets
that you will take on Days 21 through 28 of your cycle contains
iron. These tablets are also a different color from the other
tablets in your package. They help to replace some of the iron you
lose when you have a menstrual period.
Dosing—
Your health care professional may begin your dose on the first
day of your menstrual period (called Day-1 start) or on Sunday
(called Sunday start). When you begin on a certain day it is
important that you follow that schedule, even when you miss a dose
. Do not change your schedule on your own. If the
schedule that you have been put on is not convenient, check with
your health care professional about changing schedules.
| For oral dosage forms (monophasic, biphasic, or
triphasic tablets):
| For contraception:
| Adults and teenagers:
| For the twenty-one–day cycle: Take 1 tablet a
day for twenty-one days. Skip seven days. Then
repeat the cycle.
| For the twenty-eight–day cycle: Take 1 tablet
a day for twenty-eight days. Then repeat the
cycle. |
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| For oral dosage forms (norethindrone acetate and
ethinyl estradiol triphasic tablets and norgestimate and
ethinyl estradiol triphasic tablets :
| To treat acne:
| Adults and teenagers 15 years of age and over:
| For the twenty-one–day cycle: Take 1 tablet a
day for twenty-one days. Skip seven days. Then
repeat the cycle.
| For the twenty-eight–day cycle: Take 1 tablet
a day for twenty-eight days. Then repeat the
cycle. |
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| Teenagers up to 15 years of age—Use and dose must
be determined by your doctor. |
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Missed dose—
Follow your doctor's orders or the directions on the label
if you miss a dose of this medicine. The following information
includes only some of the ways to handle missed doses. Your health
care professional may want you to stop taking the medicine and use
other birth control methods for the rest of the month until you
have your menstrual period. Then your health care professional can
tell you how to begin taking your medicine again.
For monophasic, biphasic, or triphasic cycles:
| If you miss the first tablet of a new cycle—Take the
missed tablet as soon as you remember and take the next tablet
at the usual time. You may take 2 tablets in one day. Then
continue your regular dosing schedule. Also, use another birth
control method until you have taken seven days of your tablets
after the last missed dose.
| If you miss 1 tablet during the cycle—Take the missed
tablet as soon as you remember. Take the next tablet at the
usual time. You may take 2 tablets in one day. Then continue
your regular dosing schedule.
| If you miss 2 tablets in a row in the first or second
week—Take 2 tablets on the day that you remember and 2
tablets the next day. Then continue taking 1 tablet a day.
Also use another birth control method until you begin a new
cycle.
| If you miss 2 tablets in a row in the third week; or
| If you miss 3 or more tablets in a row at any time during
the cycle—
| Using a Day-1 start: Throw out your current cycle and
begin taking a new cycle. Also, use another birth control
method until you have taken seven days of your tablets
after the last missed dose. You may not have a menstrual
period this month. But if you miss two menstrual periods
in a row, call your health care professional.
| Using a Sunday start: Keep taking one tablet a day from
your current pack until Sunday. Then, on Sunday, throw out
your old pack and begin a new pack. Also use another birth
control method until you have taken seven days of your
tablets after the last missed dose. You may not have a
menstrual period this month. But if you miss two menstrual
periods in a row, call your health care professional. |
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If you miss any of the last seven (inactive) tablets of a
twenty-eight–day cycle, there is no danger of pregnancy.
However, the first tablet (active) of the next month's cycle must
be taken on the regularly scheduled day, in spite of any missed
doses, if pregnancy is to be avoided. The active and inactive
tablets are colored differently for your convenience.
Storage—
To store this medicine:
| Keep out of the reach of children.
| Store away from heat and direct light.
| Do not store in the bathroom, near the kitchen sink, or in
other damp places. Heat and moisture may cause the medicine to
break down.
| Do not keep outdated medicine or medicine no longer needed.
Be sure that any discarded medicine is out of the reach of
children. |
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Precautions While Using This Medicine
It is very important that your doctor check your progress
at regular visits to make sure this medicine does not cause
unwanted effects. These visits will usually be every 6 to 12
months, but some doctors require them more often.
Tell the medical doctor or dentist in charge that you are
taking this medicine before any kind of surgery (including dental
surgery) or emergency treatment. Your doctor will decide
whether you should continue taking this medicine.
The following medicines may reduce the effectiveness of oral
contraceptives. You should use an additional method of birth
control during each cycle in which any of the following medicines
are used:
| Ampicillin
| Barbiturates
| Carbamazepine (e.g., Tegretol)
| Griseofulvin (e.g., Fulvicin)
| Penicillin V
| Phenytoin (e.g., Dilantin)
| Primidone (e.g., Mysoline)
| Rifampin (e.g., Rifadin)
| Ritonavir (e.g., Norvir)
| Tetracyclines (medicine for infection)
| Troglitazone (e.g., Rezulin) |
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Check with your doctor if you have any questions about this.
Vaginal bleeding of various amounts may occur between your
regular menstrual periods during the first 3 months of use. This
is sometimes called spotting when slight, or breakthrough bleeding
when heavier. If this should occur:
| Continue on your regular dosing schedule.
| The bleeding usually stops within 1 week.
| Check with your doctor if the bleeding continues for more
than 1 week.
| After you have been taking oral contraceptives on schedule
and for more than 3 months and bleeding continues, check with
your doctor. |
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Missed menstrual periods may occur:
| If you have not taken the medicine exactly as scheduled.
Pregnancy must be considered as a possibility.
| If the medicine is not the right strength or type for your
needs.
| If you stop taking oral contraceptives, especially if you
have taken oral contraceptives for 2 or more years. |
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Check with your doctor if you miss any menstrual periods so
that the cause may be determined.
In some patients using estrogen-containing oral contraceptives,
tenderness, swelling, or bleeding of the gums may occur. Brushing
and flossing your teeth carefully and regularly and massaging your
gums may help prevent this. See your dentist regularly to have
your teeth cleaned. Check with your medical doctor or dentist if
you have any questions about how to take care of your teeth and
gums, or if you notice any tenderness, swelling, or bleeding of
your gums. Also, it has been shown that estrogen-containing oral
contraceptives may cause a healing problem called dry socket after
a tooth has been removed. If you are going to have a tooth
removed, tell your dentist or oral surgeon that you are taking
oral contraceptives.
Some people who take oral contraceptives may become more
sensitive to sunlight than they are normally. When you begin
taking this medicine, avoid too much sun and do not use a sunlamp
until you see how you react to the sun, especially if you tend to
burn easily. If you have a severe reaction, check with your
doctor. Some people may develop brown, blotchy spots on exposed
areas. These spots usually disappear gradually when the medicine
is stopped.
If you suspect that you may have become pregnant, stop
taking this medicine immediately and check with your doctor.
If you are scheduled for any laboratory tests, tell your doctor
that you are taking birth control pills.
Check with your doctor before refilling an old prescription,
especially after a pregnancy. You will need another physical
examination and your doctor may change your prescription.
Side Effects of This Medicine
Side Effects of This Medicine
Healthy women who do not smoke cigarettes have almost no chance
of having a severe side effect from taking oral contraceptives.
For most women, more problems occur because of pregnancy than will
occur from taking oral contraceptives. But for some women who have
special health problems, oral contraceptives can cause some
unwanted effects. Some of these unwanted effects include benign
(not cancerous) liver tumors, liver cancer, or blood clots or
related problems, such as a stroke. Although these effects are
very rare, they can be serious enough to cause death. You may want
to discuss these effects with your doctor.
Smoking cigarettes during the use of oral contraceptives
has been found to greatly increase the chances of these serious
side effects occurring. To reduce the risk of serious side
effects, do not smoke cigarettes while you are taking oral
contraceptives. Cigarette smoking increases the risk of
serious cardiovascular side effects from oral contraceptive use.
The 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.
The following side effects may be caused by blood clots. Get
emergency help immediately if any of the following side
effects occur:
| Rare
| Abdominal or stomach pain (sudden, severe, or
continuing); coughing up blood; headache
(severe or sudden); loss of coordination (sudden);
loss of vision or change in vision (sudden); pains
in chest, groin, or leg (especially in calf of leg);
shortness of breath (sudden or unexplained);
slurring of speech (sudden); weakness, numbness, or
pain in arm or leg (unexplained) |
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Check with your doctor as soon as possible if any of the
following side effects occur:
| More common—usually less common after the first 3
months of oral contraceptive use
| Changes in the uterine bleeding pattern at menses or
between menses, such as decreased bleeding at menses,
breakthrough bleeding or spotting between periods,
prolonged bleeding at menses, complete stopping of
menstrual bleeding that occurs over several months in a
row, or stopping of menstrual bleeding that only occurs
sometimes |
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| Less common
| Headaches or migraines (although headaches may lessen in
many users, in others, they may increase in number or
become worse); increased blood pressure;
vaginal infection with vaginal itching or irritation, or
thick, white, or curd-like discharge |
| For women with diabetes mellitus
| Mild increase of blood sugar—Faintness, nausea,
pale skin, or sweating |
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| Rare
| Mental depression; swelling, pain, or tenderness
in upper abdominal area |
| For women who smoke tobacco
| Pains in stomach, side, or abdomen; yellow
eyes or skin |
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| For women with a history of breast disease
| Lumps in breast |
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Other side effects may occur that usually do not need medical
attention. These side effects may go away during treatment as your
body adjusts to the medicine. However, check with your doctor if
any of the following side effects continue or are bothersome:
| More common
| Abdominal cramping or bloating; acne (usually less
common after first 3 months and may improve if acne
already exists); breast pain, tenderness, or
swelling; dizziness; nausea; swelling of
ankles and feet; unusual tiredness or weakness;
vomiting |
|
| Less common
| Brown, blotchy spots on exposed skin; gain or loss
of body or facial hair; increased or decreased
interest in sexual intercourse; increased
sensitivity of skin to sunlight; weight gain or loss
|
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Other side effects not listed above may also occur in some
patients. If you notice any other effects, check with your doctor.
Additional Information
Once a medicine has been approved for marketing for a certain
use, experience may show that it is also useful for other medical
problems. Although these uses are not included in product
labeling, oral contraceptives are used in certain patients with
the following medical conditions:
| Amenorrhea (stopping of menses for several consecutive
months)
| Dysfunctional uterine bleeding (abnormal uterine bleeding)
| Dysmenorrhea (painful menstrual bleeding)
| Hypermenorrhea (excessive menstrual bleeding)
| Emergency contraception within 72 hours of unprotected
intercourse
| Endometriosis (painful bleeding from uterine-like tissue
that can grow in different parts of the female body)
| Hirsutism in females (male-like hair growth)
| Hyperandrogenism, ovarian (excessive production of male
hormones)
| Polycystic ovary syndrome (many problems that include
amenorrhea, hirsutism, infertility, and many tiny cysts or
sacs usually in both ovaries) |
| | | | | | | |
For patients taking this medicine for emergency
contraception :
| Must be taken with food within 72 hours of unprotected
sexual intercourse. One single course (2 doses 12 hours apart)
is a one-time emergency protection. Using more than one course
in a month will reduce the effectiveness.
| Because the hormones are strong, watch for danger signs.
Call your doctor if you experience any severe pains in your
leg, stomach, or chest; any vision or breathing changes;
yellowing of skin; headaches; numbness; or trouble in
speaking.
| You may experience nausea so take it with food and call your
doctor if you vomit the medicine.
| Your menstrual period may start earlier than usual. If it
doesn't start, call your doctor. |
| | |
For patients taking this medicine for hirsutism:
| You may need to use oral contraceptives for 6 to 12 months
before you see less new hair growth. |
For patients taking this medicine for endometriosis :
| Sometimes instead of following the directions on the oral
contraceptive's package, your doctor may ask you to follow
different directions, such as taking the active tablets in the
package each day without stopping for 6 to 9 months. This
means that after 21 days you will start a new package of
pills. If you are not sure about how to take this medicine,
discuss any questions with your health care professional.
| Also, your symptoms of endometriosis may worsen at first but
with continued use of the oral contraceptives your symptoms
should lessen and your condition improve. |
|
Other than the above information, there is no additional
information relating to proper use, precautions, or side effects
for these uses.
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