Ortho Tri-Cyclen Information:
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 Ortho Tri-Cyclen 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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