ORTHO TRI-CYCLEN DRUG INFO
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.
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
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.