ORTHO TRI-CYCLEN DRUG INFO
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 this
drug.
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,
this drug 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. This drug
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 this drug. 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 overdose
is suspected, contact your local
poison control center or emergency
room immediately. Symptoms of
overdose may 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 this drug 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 doses.
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.
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