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ETHINYL ESTRADIOL/NORGESTIMATE (Ortho-Cyclen®, Ortho Tri-Cyclen®, Ortho Tri-Cyclen Lo®, Previfem™, Sprintec™) products are effective as oral contraceptives (birth control pills or 'the pill'). These products combine natural or synthetic estrogens and progestins, similar to the natural sex hormones (estrogen and progesterone) produced in a woman's body. Ethinyl estradiol is an estrogen and norgestimate is a progestin. These products can prevent ovulation and pregnancy. In general, a combination of estrogen and progestin works better than a single-ingredient product. Ethinyl estradiol/norgestimate (Ortho-Cyclen®, Ortho Tri-Cyclen®, Ortho Tri-Cyclen Lo®, Previfem™, Sprintec™) tablets can also help regulate menstrual flow, treat acne, or may be used for other hormone related problems in females. The type and amount of estrogen and/or progestin may be different from one product to another.
What should my health care professional know before I use ethinyl estradiol; norgestimate (Ortho-Cyclen®, Ortho Tri-Cyclen®, Ortho Tri-Cyclen Lo®, Previfem™, Sprintec™)?
They need to know if you have or ever had any of these conditions:
•blood clots
•blood sugar problems, like diabetes
•cancer of the breast, cervix, ovary, uterus, vagina, or unusual vaginal bleeding that has not been evaluated by a health care professional
•depression
•fibroids
•gallbladder disease
•heart or circulation problems
•high blood pressure
•jaundice
•liver disease
•menstrual problems
•migraine headaches
•tobacco smoker
•stroke
•an unusual or allergic reaction to estrogen/progestin, other hormones, medicines, foods, dyes, or preservatives
•pregnant or trying to get pregnant
•breast-feeding
How should I use this medicine (Ortho-Cyclen®, Ortho Tri-Cyclen®, Ortho Tri-Cyclen Lo®, Previfem™, Sprintec™)?
Take ethinyl estradiol/norgestimate (Ortho-Cyclen®, Ortho Tri-Cyclen®, Ortho Tri-Cyclen Lo®, Previfem™, Sprintec™) pills by mouth. Before you start taking these pills decide what is a suitable time of day and always take them at the same time of day and in the order directed. Swallow the pills with a drink of water. Take with food to reduce stomach upset. Do not take more often than directed.
Most products contain a 21-day supply of pills containing the active ingredients. Some products contain an additional 7 pills containing iron or inactive ingredients to be taken during the week of menstruation; this reduces the chance of missing the first day of the next cycle. Most products are to be started on the first Sunday after you start your period or on the first day of your period. You may need to ask your health care provider which day you should start your packet.
Before starting this medication, read the paper on your prescription provided by your pharmacist. This paper will tell you about the specific product you are taking. Make certain you understand the instructions. Keep an extra month's supply of your pills available to ensure that you will not miss the first day of the next cycle. Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.
What
if I miss a dose (Ortho-Cyclen®, Ortho Tri-Cyclen®, Ortho
Tri-Cyclen Lo®, Previfem™, Sprintec™)?
Try not to miss a dose. If you do, it may be necessary to consult your doctor or
health care professional. The following information describes only some of the
ways that missed doses can be handled.
For monophasic, biphasic or triphasic cycles: 21-day schedule:
If you miss one dose, take it as soon as you remember and then take the next
pill at the regular time as usual. You may take 2 tablets in one day. If you
miss two doses (days) in a row, take 2 tablets for the next 2 days, then,
continue with your regular schedule. Whenever 1 or 2 doses are missed, you
should use a second method of contraception for the next 7 days in addition to
taking the pills. If you miss three doses in a row, you should notify your
physician or other health care professional for instructions. You will probably
need to throw away the rest of the tablets in that cycle pack and start over.
Another method of contraception should be used until at least 7 doses have been
taken in the new cycle. Missing a pill can cause spotting or light bleeding.
Make sure that no more than 7 days pass at the end of the 21 day cycle, before
you start your next pack of pills.
28-day schedule:
Follow the same directions as above for the first 21 days of the schedule. If
you miss 1 of the last 7 pills, you can either double the dose or skip it, but
it is important to start the next month's cycle on the scheduled day.
What
drug(s) may interact with ethinyl estradiol; norgestimate ?(Ortho-Cyclen®,
Ortho Tri-Cyclen®, Ortho Tri-Cyclen Lo®, Previfem™, Sprintec™)
•antibiotics or medicines for infections, especially rifampin
•aprepitant
•barbiturate medicines for producing sleep or treating seizures (convulsions)
•bosentan
•carbamazepine
•caffeine
•clofibrate
•cyclosporine
•dantrolene
•doxercalciferol
•grapefruit juice
•hydrocortisone
•medicines for anxiety or sleeping problems, such as diazepam or temazepam
•medicines for mental depression
•medicines for diabetes, including troglitazone and pioglitazone
•mineral oil
•modafinil
•mycophenolate
•nefazodone
•oxcarbazepine
•phenytoin
•prednisolone
•ritonavir or other medicines for the treatment of the HIV virus or AIDS
•selegiline
•soy isoflavones supplements
•St. John's wort
•tamoxifen or raloxifene
•theophylline
•topiramate
•warfarin
Tell your doctor or health care professional about all other medicines you are
taking, including non-prescription medicines, nutritional supplements, or herbal
products. Also tell your doctor or health care professional if you are a
frequent user of drinks with caffeine or alcohol, if you smoke, or if you use
illegal drugs. These may affect the way your medicine works. Check before
stopping or starting any of your medicines.
What
side effects may I notice from taking ethinyl estradiol; norgestimate
(Ortho-Cyclen®, Ortho Tri-Cyclen®, Ortho Tri-Cyclen Lo®,
Previfem™, Sprintec™)?
Severe side effects are relatively rare in women who are healthy and do not
smoke while they are taking oral contraceptives. On average, more women have
problems due to complications from getting pregnant than have problems with oral
contraceptives. Many of the minor side effects may go away as your body adjusts
to the medicine. However, the potential for severe side effects does exist and
you may want to discuss these with your health care provider.
The following symptoms or side effects may be related to blood clots and require
immediate medical or emergency help:
•chest pain
•coughing up blood
•dizziness or fainting spells
•leg, arm or groin pain
•severe or sudden headaches
•stomach pain (severe)
•sudden shortness of breath
•sudden loss of coordination, especially on one side of the body
•swelling of the hands, feet or ankles, or rapid weight gain
•vision or speech problems
•weakness or numbness in the arms or legs, especially on one side of the body
Other serious side effects are rare. Contact your health care provider as soon
as you can if the following side effects occur:
•breast tissue changes or discharge
•changes in vaginal bleeding during your period or between your periods
•headaches or migraines
•increases in blood sugar, especially if you have diabetes
•increases in blood pressure, especially if you are known to have high blood
pressure
•symptoms of vaginal infection (itching, irritation or unusual discharge)
•tenderness in the upper abdomen
•vomiting
•yellowing of the eyes or skin
Side effects that usually do not require medical attention (report to your
health care provider if they continue or are bothersome):
•breakthrough bleeding and spotting that continues beyond the 3 initial cycles
of pills
•breast tenderness
•mild stomach upset
•mood changes, anxiety, depression, frustration, anger, or emotional outbursts
•increased or decreased appetite
•increased sensitivity to sun or ultraviolet light
•nausea
•skin rash, acne, or brown spots on the skin
•tiredness
•weight gain
What should
I watch for while taking ethinyl estradiol; norgestimate
(Ortho-Cyclen®, Ortho Tri-Cyclen®, Ortho Tri-Cyclen Lo®, Previfem™,
Sprintec™)?
Visit your doctor or health care provider for regular checks on your progress.
You should have a complete check-up every 6 to 12 months. If you have any
unusual vaginal bleeding contact your doctor or health care provider for advice.
If you miss a period, the possibility of pregnancy must be considered. See your
doctor or health care professional as soon as you can.
Use an additional method of contraception during the first cycle that you take
these tablets. If you stop taking these tablets and want to get pregnant,
a return to normal ovulation can take some time. You may not return to normal
ovulation and fertility for 3 to 6 months. Discuss your pregnancy plans with
your health care provider.
If you are taking oral contraceptives for the treatment of acne, hirsutism
(male-like hair growth), endometriosis or other hormone related problems, it may
take several months of continued treatment to notice improvement in your
symptoms or condition. Tobacco smoking increases the risk of getting a
blood clot or having a stroke while you are taking oral contraceptives,
especially if you are more than 35 years old. You are strongly advised not to
smoke.
Oral contraceptives can increase your sensitivity to the sun and you may burn
more easily. Use sunscreen and protective clothing during long periods outdoors.
Tanning booths should be used with caution. If you wear contact lenses and
notice visual changes, or if the lenses begin to feel uncomfortable, consult
your eye care specialist. In some women, tenderness, swelling, or minor
bleeding of the gums may occur. Notify your dentist if this happens. Brushing
and flossing your teeth regularly may help limit this. See your dentist
regularly and inform your dentist of the medicines you are taking.
You may get a vaginal yeast infection. If you have never had a yeast infection
before, see your doctor or other health care provider to confirm the problem. If
you have had yeast infections in the past and are comfortable with
self-medicating the problem, get and use a nonprescription medication to treat
the yeast infection. If you are going to have elective surgery, you may
need to stop taking your contraceptive pills one month beforehand. Consult your
health care professional for advice prior to scheduling the surgery.
Taking contraceptive pills does not protect you against HIV infection (AIDS) or
any other sexually transmitted diseases.
Where
can I keep my medicine (Ortho-Cyclen®, Ortho Tri-Cyclen®,
Ortho Tri-Cyclen Lo®, Previfem™, Sprintec™)?
Keep out of the reach of children. Store at room temperature between 15
and 30 degrees C (59 and 86 degrees F). Keep container tightly closed. Throw
away any unused medicine after the expiration date.
Last Updated:08/30/2005
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