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Drugs (Loestrin 1.5/30)*
Description
Oral contraceptives are known also as the Pill, OC's, BC's, BC tablets, or birth control
pills. They usually contain two types of female hormones, estrogens (ESS-troe-jenz) and
progestins (proe-JESS-tins). When taken by mouth on a regular schedule, they change the
hormone balance of the body, which prevents pregnancy.
Sometimes these preparations can be used in the treatment of conditions that are helped by
added hormones. Oral contraceptives do not prevent or cure venereal diseases (VD),
however.
Before you take an oral contraceptive, you and your doctor should discuss the benefits and
risks of using these medicines. Besides surgery or not having intercourse, these medicines
are the most effective method of preventing pregnancy. However, oral contraceptives
sometimes have side effects that could be very serious.
To make the use of 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 doctor, nurse, or pharmacist if you need additional information or
explanation.
Oral contraceptives are available only with your doctor's prescription, in the following
dosage forms:
Oral
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)
Norgestrel and Ethinyl Estradiol
Tablets (U.S. and Canada)
It is very important that you read and understand the following information. If any of it
causes you special concern, check with your doctor. Also, if you have any questions or if
you want more information about this medicine or your medical problem, ask your doctor,
nurse, or pharmacist.
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. This is a decision you and your doctor will make. For estrogen and
progestin birth control pills, 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 doctor and pharmacist if you are allergic to any
other substances, such as foods, preservatives, or dyes.
Pregnancy -- Oral contraceptives are not recommended for use during pregnancy.
Breast-feeding -- The estrogens in oral contraceptives pass into the breast milk. It is
not known what effect oral contraceptives may have on the infant. Studies have shown oral
contraceptives to cause tumors in humans and animals. Use of "high-dose" birth
control medicines is not recommended during breast-feeding. It may be necessary for you to
use another method of birth control or to stop breast-feeding while taking oral
contraceptives. However, your doctor may allow you to begin using one of the
"low-dose" oral contraceptives after you have been breast-feeding for a while.
Age Groups
In deciding to use a medicine, the risks of taking the medicine must be weighed against
the good it will do. This is a decision you and your doctor will make. For estrogen and
progestin birth control pills, the following should be considered:
Children -- 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.
However, some teenagers may need extra information on the importance of taking this
medication exactly as prescribed in order for it to work.
Other Therapy
In deciding to use a medicine, the risks of taking the medicine must be weighed against
the good it will do. This is a decision you and your doctor will make. For estrogen and
progestin birth control pills, the following should be considered:
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 estrogen and progestin birth control pills, it is
especially important that your doctor and pharmacist know if you are taking any of the
following:
Acetaminophen (e.g., Tylenol) (with long-term, high-dose use)
Adrenocorticoids (cortisone-like medicine)
Amiodarone (e.g., Cordarone)
Anabolic steroids (nandrolone [e.g., Anabolin], oxandrolone [e.g.,
Anavar],
oxymetholone [e.g., Anadrol], stanozolol [e.g., Winstrol])
Androgens (male hormones)
Anticoagulants (blood thinners)
Anti-infectives by mouth or by injection (medicine for infection)
Antithyroid agents (medicine for overactive thyroid)
Barbiturates
Bromocriptine (e.g., Parlodel)
Carbamazepine (e.g., Tegretol)
Carmustine (e.g., BiCNU)
Chloroquine (e.g., Aralen)
Dantrolene (e.g., Dantrium)
Daunorubicin (e.g., Cerubidine)
Disulfiram (e.g., Antabuse)
Divalproex (e.g., Depakote)
Estrogens (female hormones)
Etretinate (e.g., Tegison)
Gold salts (medicine for arthritis)
Griseofulvin (e.g., Fulvicin)
Hydroxychloroquine (e.g., Plaquenil)
Mercaptopurine (e.g., Purinethol)
Methotrexate (e.g., Mexate)
Methyldopa (e.g., Aldomet)
Naltrexone (e.g., Trexan) (with long-term, high-dose use)
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])
Phenylbutazone (e.g., Butazolidin)
Phenytoin (e.g., Dilantin)
Plicamycin (e.g., Mithracin)
Primidone (e.g., Mysoline)
Rifampin (e.g., Rifadin)
Tricyclic antidepressants (amitriptyline [e.g., Elavil], amoxapine [e.g.,
Asendin],
clomipramine [e.g., Anafranil], desipramine [e.g., Pertofrane], doxepin [e.g.,
Sinequan],
imipramine [e.g., Tofranil], nortriptyline [e.g., Aventyl], protriptyline [e.g.,
Vivactil], trimipramine [e.g., Surmontil])
Valproic acid (e.g., Depakene)
Other medical problems -- The presence of other medical problems may affect the use of
estrogen and progestin birth control pills. Make sure you tell your doctor if you have any
other medical problems, especially:
Angina pectoris (chest pains on exertion)
Asthma
Blood clots (or history of)
Bone disease
Breast disease (not cancerous, such as fibrocystic disease [breast cysts], breast
lumps, or abnormal mammograms [x-ray pictures of the breast])
Cancer (or history of or family history of breast cancer)
Changes in vaginal bleeding
Diabetes mellitus (sugar diabetes)
Endometriosis
Epilepsy
Fibroid tumors of the uterus
Gallbladder disease or gallstones (or history of)
Heart or circulation disease
High blood cholesterol
High blood pressure (hypertension)
Jaundice (or history of, including jaundice during pregnancy)
Kidney disease
Liver disease (such as jaundice or porphyria)
Lumps in breasts
Mental depression (or history of)
Migraine headaches
Scanty or irregular menstrual periods
Stroke (history of)
Too much calcium in the blood
Tuberculosis
Varicose veins
Before you begin using any new medicine (prescription or nonprescription) or if you
develop any new medical problem while you are using this medicine, check with your doctor,
nurse, or pharmacist.
Proper Use of This Medicine
Take this medicine only as directed by your doctor. This medicine must be taken exactly on
schedule to prevent pregnancy. Try to take the medicine at the same time each day, not
more than 24 hours apart, to reduce the possibility of side effects and to provide the
best protection.
Nausea may occur during the first few weeks after you start taking this medicine. This
effect usually disappears with continued use. If the nausea is bothersome, it can usually
be prevented or reduced by taking each dose with food or immediately after food.
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. Always
keep 1 extra month's supply of tablets on hand. To keep the extra month's supply from
becoming too old, use it next, after the pills now being used, and replace the extra
supply each month on a regular schedule. The tablets will keep well when kept dry and at
room temperature (light will fade some tablet colors but will not change the medicine's
effect).
Keep the tablets in the container in which you received them. Most containers aid you in
keeping track of your dosage schedule.
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.
Dosing
Dosing --
Monophasic cycle dosing schedule: Most available dosing schedules are of the
monophasic type. If you are taking tablets of one strength (color) for 20 or 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 of another color.
Biphasic cycle dosing schedule:
-- If you are using a biphasic 21-day schedule, you are taking tablets of one strength
(color) for 10 days (the 1st phase). You then take tablets of a second strength (color)
for the next 11 days (the 2nd phase). For the 28-day biphasic cycle you will also take an
additional 7 inactive tablets, which are of a third color.
-- If you are using a biphasic 24-day schedule, you are taking tablets of one strength
(color) for 17 days (the 1st phase). You then take tablets of a second strength (color)
for the next 7 days (the 2nd phase).
Triphasic cycle dosing schedule: If you are using a triphasic 21-day schedule, you
are taking tablets of one strength (color) for 6 or 7 days depending on the medicine
prescribed (the 1st phase). You then take tablets of a second strength (color) for the
next 5 to 9 days depending on the medicine prescribed (the 2nd phase). After that, you
take tablets of a third strength (color) for the next 5 to 10 days depending on the
medicine prescribed (the 3rd phase). At this point, you will have taken a total of 21
tablets. For the 28-day triphasic cycle you will also take an additional 7 inactive
tablets, which are of a fourth color.
It is very important that you take the tablets in the same order that they appear in the
container. Tablets of different colors in the same package are also different in strength.
Taking the tablets out of order may reduce the effectiveness of the medicine.
Missed dose -- If you miss a dose of this medicine:
For monophasic or biphasic cycles:
-- If you are using a 20-, 21-, or a 24-day schedule and you miss a dose of this medicine
for one day, take the missed tablet as soon as you remember. If it is not remembered until
the next day, take the missed tablet plus the tablet that is regularly scheduled for that
day. This means that you will take 2 tablets on the same day. Then continue on your
regular dosing schedule.
-- If you are using a 20-, 21-, or a 24-day schedule and you miss a dose for 2 days in a
row, take 2 tablets a day for each of the next 2 days, then continue on your regular
dosing schedule. In addition, you should use a second method of birth control to make sure
that you are fully protected for the rest of the cycle. Report to your doctor.
-- If you are using a 20-, 21-, or a 24-day schedule and you miss a dose for 3 days or
more in a row, stop taking the medicine completely and use another method of birth control
until your period begins or until your doctor determines that you are not pregnant. Then
restart protection with a new cycle of tablets.
-- If you are using a 28-day schedule and you miss any of the first 21 (active) tablets,
follow the instructions for the 21-day schedule depending on how many doses you have
missed. If you miss any of the last 7 (inactive) tablets, 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.
For triphasic cycles:
-- If you are using a 21-day schedule and you miss a dose of this medicine for one day,
take the missed tablet as soon as you remember. If it is not remembered until the next
day, take the missed tablet plus the tablet that is regularly scheduled for that day. This
means that you will take 2 tablets on the same day. Then continue on your regular dosing
schedule. In addition, you should use a second method of birth control to make sure that
you are fully protected for the rest of the cycle. Report to your doctor.
-- If you are using a 21-day schedule and you miss a dose for 2 days in a row, take 2
tablets a day for each of the next 2 days, then continue on your regular dosing schedule.
In addition, you should use a second method of birth control to make sure that you are
fully protected for the rest of the cycle. Report to your doctor.
-- If you are using a 21-day schedule and you miss a dose for 3 days or more in a row,
stop taking the medicine completely and use another method of birth control until your
period begins or until your doctor determines that you are not pregnant. Then restart
protection with a new cycle of tablets.
-- If you are using a 28-day schedule and you miss any of the first 21 (active) tablets,
follow the instructions for the 21-day schedule depending on how many doses you have
missed. If you miss any of the last 7 (inactive) tablets, 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.
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.
When you begin to use oral contraceptives, your body will require at least 7 days to
adjust before pregnancy will be prevented; therefore, you should use a second method of
birth control for the first cycle (or 3 weeks) to ensure full protection.
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, since this medicine may
cause serious blood clots, heart attack, or stroke.
The following medicines may reduce the effectiveness of oral contraceptives. You should
use a second method of birth control during each cycle in which any of the following
medicines are used:
Ampicillin
Adrenocorticoids (cortisone-like medicine)
Bacampicillin
Barbiturates
Carbamazepine (e.g., Tegretol)
Chloramphenicol (e.g., Chloromycetin)
Dihydroergotamine (e.g., D.H.E. 45)
Griseofulvin (e.g., Fulvicin)
Mineral oil
Neomycin, oral
Penicillin V
Phenylbutazone (e.g., Butazolidin)
Phenytoin (e.g., Dilantin)
Primidone (e.g., Mysoline)
Rifampin (e.g., Rifadin)
Sulfonamides (sulfa medicine)
Tetracyclines (medicine for infection)
Tranquilizers
Valproic acid (e.g., Depakene)
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, check with your doctor.
Missed menstrual periods may occur:
if you have not taken the medicine exactly as scheduled. Pregnancy must be
considered a possibility.
if the medicine is not properly adjusted for your needs.
if you have taken oral contraceptives for a long time, usually 2 or more years, and
stop their use.
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 wear contact lenses and notice a change in vision or are not able to wear them,
check with your doctor.
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.
Do not give this medicine to anyone else. Your doctor has prescribed it only for you after
studying your health record and the results of your physical examination. Oral
contraceptives may be dangerous for other people because of differences in their health
and body make-up.
Check with your doctor before taking any leftover oral contraceptives from an old
prescription, especially after a pregnancy. Your old prescription may be dangerous to you
now or may allow you to become pregnant if your health has changed since your last
physical examination.
Side Effects of This Medicine
Discuss these possible effects with your doctor:
Along with their needed effects, birth control tablets sometimes cause some
unwanted effects such as benign (not cancerous) liver tumors, liver cancer, blood clots,
heart attack, and stroke, and problems of the gallbladder, liver, and uterus. Although
these effects are rare, they can be very serious and may cause death.
Cigarette smoking during the use of oral contraceptives has been found to increase
the risk of serious side effects affecting the heart and/or blood circulation, such as
dangerous blood clots, heart attack, or stroke. The risk increases as the age of the
patient and the amount of smoking increase. This risk is greater in women age 35 and over.
To reduce the risk of serious side effects, do not smoke cigarettes while using oral
contraceptives.
The following side effects may be caused by blood clots, which could lead to stroke, heart
attack, or death. Although these side effects rarely occur, they require immediate medical
attention. Get emergency help immediately if any of the following side effects occur:
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:
Less common or rare
Bulging eyes; changes in vaginal bleeding (spotting, breakthrough bleeding, prolonged
bleeding, or complete stoppage of bleeding); double vision; fainting; frequent urge to
urinate or painful urination; increased blood pressure; loss of vision (gradual, partial,
or complete); lumps in, or discharge from, breast; mental depression; pains in stomach,
side, or abdomen; skin rash, redness, or other skin irritation; swelling, pain, or
tenderness in upper abdomen (stomach) area; unusual or dark-colored mole; vaginal
discharge (thick, white, or curd-like); vaginal itching or irritation; yellow eyes or skin
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
Acne (usually less common after first 3 months); bloating of stomach; cramps of lower
stomach; increase or decrease in appetite; nausea; swelling of ankles and feet; swelling
and increased tenderness of breasts; unusual tiredness or weakness; unusual weight gain
Less common or rare
Brown, blotchy spots on exposed skin; diarrhea (mild); dizziness; headaches or migraine
headaches; increased body and facial hair; increased sensitivity to contact lenses;
increased skin sensitivity to sun; irritability; some loss of scalp hair; unusual decrease
or increase in sexual desire; vomiting; weight loss
Other side effects not listed above may also occur in some patients. If you notice any
other effects, check with your doctor.
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