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Nordette 28
Nordette 28 is an oral contraceptive. Oral contraceptives are commonly known as 'the Pill'. Nordette pills contain two active ingredients (levonorgestrel and ethinyloestradiol) that can stop you from becoming pregnant if taken correctly. They are similar to hormones your body normally produces.
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IMPORTANT
NOTE: The following information is intended
to supplement, not substitute for, the expertise
and judgment of your physician, pharmacist or
other healthcare professional. It should not
be construed to indicate that use of the drug
is safe, appropriate, or effective for you.
Consult your healthcare professional before
using Nordette 28.
ORAL CONTRACEPTIVES
COMMON BRAND NAME(S):
Brevicon, Demulen, Lo/Ovral, Loestrin, Modicon,
Nordette, Norinyl, Ortho-Novum, Ovcon, Ovral,
Tri-Phasil
WARNING:
Smoking cigarettes while using this medication
increases your chance of having heart problems.
Do not smoke while using this medication. The
risk of heart problems increases with age (in
women greater than 35 years of age) and with
frequent smoking (15 cigarettes per day or greater).
USES: This
medication is used to prevent pregnancy or to
regulate your menstrual cycle. Certain brands
of birth control pills may be used for treating
acne or as a "morning after" pill
for emergency contraception. Consult your doctor
or pharmacist. Use of this medication does not
protect you or your partner against sexually
transmitted diseases (e.g., HIV, gonorrhea).
HOW TO USE: Take
this medication with food or immediately after
a meal to prevent stomach upset. Try to take
this medication at the same time each day. This
may help you to remember to take it. Learn proper
use of your particular brand of medication.
Follow your dosing schedule carefully. Be sure
to ask your doctor or pharmacist if you have
any questions. Use a supplemental form of birth
control during the first week of taking this
medication since it takes a while to be effective.
Follow your doctor's directions exactly if this
drug is being used as a "morning after"
pill.
SIDE EFFECTS:
This medication may cause dizziness, headache,
lightheadedness, stomach upset, bloating, or
nausea. If these effects persist or worsen,
contact your doctor. Notify your doctor if you
experience: severe depression, groin or calf
pain, sudden severe headache, chest pain, shortness
of breath, lumps in the breast, weakness or
tingling in the arms or legs, yellowing of the
eyes or skin. If you notice other effects not
listed above, contact your doctor or pharmacist.
PRECAUTIONS :
Before you take this medication, tell your doctor
your entire medical history, including family
medical history, especially: asthma, high blood
pressure, kidney disease, liver heart disease,
stroke, history of jaundice (yellowing skin/eyes)
or high blood pressure during pregnancy, excessive
weight gain or fluid retention during menstrual
cycle, blood clots, heart attack, seizures,
migraine headaches, breast cancer, high blood
level of cholesterol or lipids (fats), diabetes,
depression. Depending on strength, Nordette 28
may cause a patchy, darkening of the skin on
the face (melasma). Higher strengths are more
likely to cause melasma. Sunlight may intensify
this darkening and you may need to avoid prolonged
sun exposure and sunlamps. Consult your doctor
regarding use of sunscreens and protective clothing.
It may take a long time for you to become pregnant
after you stop taking birth control pills. Consult
your doctor. Do not smoke cigarettes. Birth-control
pills slightly increase your risk of strokes,
blood clots, high blood pressure, heart attacks,
gallbladder disease, vision problems, and liver
tumors. Cigarette smoking (especially 15 or
more cigarettes daily) and age (women older
than 35/smokers or 40/nonsmokers years of age)
further increase the risk of stroke, blood clots,
high blood pressure and heart attacks. Ask your
pharmacist or doctor for a copy of the patient
labeling which explains these risks in more
detail. Consult your doctor for any questions,
including possible use in nonsmokers over 40
years of age. If you are near-sighted or wear
contact lenses, you may develop vision problems.
Also, your tolerance of the lenses may decrease.
Contact your eye doctor if these problems occur.
Before having surgery, including dental surgery,
tell the doctor that you take birth control
pills. Nordette 28 must not be used during pregnancy.
If you become pregnant or think you may be pregnant,
inform your doctor immediately. This medication
passes into breast milk. This may affect milk
production and may have harmful effects on a
nursing infant. Consult your doctor before breast-feeding.
DRUG INTERACTIONS:
Tell your doctor what prescription and
nonprescription drugs you are taking. Drugs
that may decrease the effectiveness of the pill
include: griseofulvin, many antibiotics (e.g.,
penicillins, macrolides, tetracyclines, sulfas,
cephalosporins), chloramphenicol, many seizure
medications (e.g., phenytoin, barbiturates,
primidone, carbamazepine), dapsone, rifamycins
(e.g., rifampin), modafinil, nevirapine, nelfinavir,
ritonavir, St John's wort, troglitazone. Ask
your doctor if you should use additional birth
control methods while taking any of the drugs
mentioned above while taking birth control pills.
Also tell your doctor if you use: thyroid hormone
drugs, certain benzodiazepines (e.g., diazepam,
chlordiazepoxide), prednisone-like drugs, certain
antidepressants (e.g., tricyclics), beta-blockers
(e.g., metoprolol), "blood thinners"
(anticoagulants such as warfarin), insulin.
This product can affect the results of certain
lab tests (e.g., thyroid). Inform all laboratory
personnel that you use Nordette 28. Birth control
pills may significantly intensify the effects
of alcohol. Consult your doctor or pharmacist
about this. Do not start or stop any medicine
without doctor or pharmacist approval.
OVERDOSE: If OVERDOSEis suspected, contact your local poison
control center or emergency room immediately.
Symptoms If OVERDOSEmay include nausea and
vomiting. Females may experience vaginal bleeding.
NOTES : Do not
allow anyone else to take this medication. Keep
all appointments with your doctor and the laboratory.
You should have a complete physical examination,
including blood pressure measurements, breast
and pelvic examinations, and a PAP test (for
vaginal cancer), at least once a year. Follow
your doctor's instructions for examining your
own breasts, and report any lumps immediately.
A manufacturer's fact sheet about Nordette 28
should be dispensed with each prescription.
Read the information carefully. Ask your doctor
or pharmacist any questions you may have.
MISSED DOSE :
MISSED DOSE advice differs and depends on the
brand used, and the number of doses missed.
Refer to the product package information for
advice on MISSED DOSE s. Ask your doctor or pharmacist
if you have any questions.
STORAGE : Store
at room temperature between 59 and 86 degrees
F (between 15 and 30 degrees C) away from moisture
and sunlight. Do not store in the bathroom.
Drug Information: Estrogens and Progestins Oral Contraceptives
(Systemic)
Description
Oral contraceptives are known also as the Pill, OCs, BCs, BC tablets, or
birth control pills. This medicine usually contains two types of hormones,
estrogens (ES-troh-jenz ) and progestins ( proh-JES-tins) and, when taken
properly, prevents pregnancy. It works by stopping a woman's egg from fully
developing each month. The egg can no longer accept a sperm and fertilization
is prevented. Although oral contraceptives have other effects that help
prevent a pregnancy from occurring, this is the main action.
Sometimes a woman's egg can still develop even though the medication is
taken once each day, especially when more than 24 hours pass between two
doses. In almost all cases when the medicine was taken properly and an egg
develops, fertilization can still be stopped by oral contraceptives. This is
because oral contraceptives also thicken cervical mucus at the opening of the
uterus. This makes it hard for the partner's sperm to reach the egg. In
addition, oral contraceptives change the uterus lining just enough so that an
egg will not stop in the uterus to develop. All of these effects make it
difficult to become pregnant when properly taking an oral contraceptive.
No contraceptive method is 100 percent effective. Studies show that
fewer than one of each one hundred women correctly using oral contraceptives
becomes pregnant during the first year of use. Birth control methods such
as having surgery to become sterile or not having sex are more effective.
Using condoms, diaphragms, progestin-only oral contraceptives, or spermicides
is not as effective as using oral contraceptives containing estrogens and
progestins. Discuss with your health care professional your options for birth
control.
The triphasic cycle product of norgestimate and ethinyl estradiol (the
brand name Ortho Tri-Cyclen) and norethindrone acetate and ethinyl
estradiol (the brand name Estrostep ) can be used for the treatment
of moderate acne only if the patient is at least 15 years old, has acne that
has not improved with topical anti-acne medicines, has gotten approval from
her doctor, has begun to have menstrual periods, desires an oral contraceptive
for birth control, and plans to stay on it for at least 6 months.
Sometimes these preparations can be used for other conditions as determined
by your doctor.
Oral contraceptives are available only with your doctor's prescription, in
the following dosage forms:
Oral
- Desogestrel and Ethinyl Estradiol
- Tablets (U.S. and Canada)
- Ethynodiol Diacetate and Ethinyl Estradiol
- Tablets (U.S. and Canada)
- Levonorgestrel and Ethinyl Estradiol
- Tablets (U.S. and Canada)
- Norethindrone Acetate and Ethinyl Estradiol
- Tablets (U.S. and Canada)
- Norethindrone and Ethinyl Estradiol
- Tablets (U.S. and Canada)
- Norethindrone and Mestranol
- Tablets (U.S. and Canada)
- Norgestimate and Ethinyl Estradiol
- Tablets (U.S. and Canada)
- Norgestrel and Ethinyl Estradiol
- Tablets (U.S. and Canada)
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
- 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
- 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
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.
- 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.
- Teenagers up to 15 years of age—Use and dose must be
determined by your doctor.
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.
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.
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)
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.
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.
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)
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
- 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
- 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
- For women with a history of breast disease
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
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.
^M
Some commonly used brand names are:
In the U.S.—
- Alesse3
- Brevicon5
- Cyclessa1
- Demulen 1/352
- Demulen 1/502
- Desogen1
- Estrostep4
- Estrostep Fe4
- Genora 0.5/355
- Genora 1/355
- Genora 1/506
- Intercon 0.5/355
- Intercon 1/355
- Intercon 1/506
- Jenest5
- Levlen3
- Levlite3
- Levora 0.15/303
- Loestrin 1/204
- Loestrin Fe 1/204
- Loestrin 1.5/304
- Loestrin Fe 1.5/304
- Lo/Ovral8
- Mircette1
- ModiCon5
- Necon 0.5/355
- Necon 1/355
- Necon 1/506
|
|
- Necon 10/115
- N.E.E. 1/355
- N.E.E. 1/505
- Nelova 0.5/35E5
- Nelova 1/35E5
- Nelova 1/50M6
- Nelova 10/115
- Nordette3
- Norethin 1/35E5
- Norethin 1/50M6
- Norinyl 1+355
- Norinyl 1+505
- Ortho-Cept1
- Ortho-Cyclen7
- Ortho-Novum 1/355
- Ortho-Novum 1/506
- Ortho-Novum 7/7/75
- Ortho-Novum 10/115
- Ortho Tri-Cyclen7
- Ovcon-355
- Ovcon-505
- Ovral8
- Tri-Levlen3
- Tri-Norinyl5
- Triphasil3
- Trivora3
- Zovia 1/35E2
- Zovia 1/50E2
|
|
In Canada—
- Brevicon 0.5/355
- Brevicon 1/355
- Cyclen7
- Demulen 302
- Demulen 502
- Loestrin 1.5/304
- Marvelon1
- Minestrin 1/204
- Min-Ovral3
- Norinyl 1/505
- Ortho 0.5/355
|
|
- Ortho 1/355
- Ortho 7/7/75
- Ortho 10/115
- Ortho-Cept1
- Ortho-Novum 1/506
- Ovral8
- Select 1/355
- Synphasic5
- Tri-Cyclen7
- Triphasil3
- Triquilar3
|
|
|
Note:
|
For quick reference, the following
estrogens and progestins are numbered to match the corresponding brand
names. |
Other commonly used names are: Ethinylestradiol[Ethinyl estradiol] Ethinyloestradiol [Ethinyl
estradiol] Ethynodiol[Ethynodiol diacetate] Etynodiol[Ethynodiol
diacetate] Etynodiol acetate[Ethynodiol diacetate] Norethindrone[Norethisterone]
| This information applies to the following
medicines |
| 1.
Desogestrel and Ethinyl Estradiol
(des-oh-JES-trel and ETH-in-il es-tra-DYE-ole) |
| 2.
Ethynodiol Diacetate and Ethinyl
Estradiol (e-thye-noe-DYE-ole dye-AS-e-tate and ETH-in-il
es-tra-DYE-ole) |
| 3.
Levonorgestrel and Ethinyl Estradiol
(LEE-voh-nor-jes-trel and ETH-in-il es-tra-DYE-ole) |
| 4.
Norethindrone Acetate and Ethinyl
Estradiol (nor-eth-IN-drone AS-e-tate and ETH-in-il
es-tra-DYE-ole) |
|
| 5.
Norethindrone and Ethinyl Estradiol
(nor-eth-IN-drone and ETH-in-il es-tra-DYE-ole) |
| 6.
Norethindrone and Mestranol
(nor-eth-IN-drone and MES-tra-nole) |
| 7.
Norgestimate and Ethinyl Estradiol
(nor-JES-ti-mate and ETH-in-il es-tra-DYE-ole) |
| 8.
Norgestrel and Ethinyl Estradiol
(nor-JES-trel and ETH-in-il es-tra-DYE-ole) |
|
| ‡
Generic name product may be available in the U.S. |
| §
Generic name product may be available in Canada |
| *
Not commercially available in the U.S. |
| †
Not commercially available in Canada |
Category
- Antiacne agent, systemic --Norgestimate and
Ethinyl Estradiol, triphasic formulation only; Norethindrone and Ethinyl
Estradiol, triphasic formulation only
- Antiendometriotic --Desogestrel and Ethinyl
Estradiol; Ethynodiol Diacetate and Ethinyl Estradiol; Levonorgestrel and
Ethinyl Estradiol; Norethindrone and Ethinyl Estradiol; Norethindrone and
Mestranol; Norethindrone Acetate and Ethinyl Estradiol; Norgestimate and
Ethinyl Estradiol; Norgestrel and Ethinyl Estradiol
- Contraceptive, postcoital, systemic --Levonorgestrel
and Ethinyl Estradiol; Norgestrel and Ethinyl Estradiol
- Contraceptive, systemic --Desogestrel and Ethinyl
Estradiol; Ethynodiol Diacetate and Ethinyl Estradiol; Levonorgestrel and
Ethinyl Estradiol ; Norethindrone and Ethinyl Estradiol; Norethindrone and
Mestranol; Norethindrone Acetate and Ethinyl Estradiol; Norgestimate and
Ethinyl Estradiol; Norgestrel and Ethinyl Estradiol
- Estrogen-progestin --Desogestrel and Ethinyl
Estradiol; Ethynodiol Diacetate and Ethinyl Estradiol; Levonorgestrel and
Ethinyl Estradiol; Norethindrone and Ethinyl Estradiol; Norethindrone and
Mestranol; Norethindrone Acetate and Ethinyl Estradiol; Norgestimate and
Ethinyl Estradiol; Norgestrel and Ethinyl Estradiol
- Gonadotropin inhibitor, female, noncontraceptive use --Desogestrel
and Ethinyl Estradiol; Ethynodiol Diacetate and Ethinyl Estradiol;
Levonorgestrel and Ethinyl Estradiol; Norethindrone and Ethinyl Estradiol;
Norethindrone and Mestranol; Norethindrone Acetate and Ethinyl Estradiol;
Norgestimate and Ethinyl Estradiol; Norgestrel and Ethinyl Estradiol
|