What is Estrostep Fe?Estrostep Fe is an oral contraceptive used to prevent pregnancy.
Estrostep Fe is also used to treat moderate acne in women ≥15 years who h ave a need for oral contraception in addition to having acne. Estrostep Fe is only for use once a women has begun menstruation, has failed therapy with topical acne treatments, and is able to stay on therapy with Estrostep Fe for at least 6 months.
What is the most important information I should know about Estrostep Fe?Cigarette smoking increases the risk of serious cardiovascular side effects (such as blood clots, heart attacks, and stroke) when combined with oral contraceptives such as Estrostep Fe. This risk increases with age and with heavy smoking (≥15 cigarettes per day) and is significantly increased in women >35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.
Estrostep Fe does not protect against transmission of HIV (AIDS) and other sexually transmitted diseases.
You may need to use back-up birth control, such as condoms or a spermicide when you first start using this medication. Follow your doctor's instructions.
If you experience vomiting or diarrhea for any reason, or if you are taking medication (such as an antibiotic), make sure to use a back-up birth control method (such as condoms or spermicide) until you check with your doctor.
You may have breakthrough bleeding, especially during the first 3 months. Do not stop taking Estrostep Fe if you experience spotting, light bleeding, or you feel sick; the problem will usually go away. Tell your doctor if this bleeding continues or is heavy.
If you wear contact lenses and notice a change in vision or an inability to wear your lenses, tell your doctor.
Oral contraceptives may cause edema (fluid retention), with swelling of the fingers or ankles, and may raise your blood pressure. If you experience fluid retention, contact your doctor.
Estrostep Fe may cause dark skin patches on your face (melasma). Exposure to the sun may make these patches darker; you may need to avoid prolonged exposure to the sun, sunlamps, and tanning beds. Consult your doctor regarding the use of sunscreens and protective clothing.
If you need to have any type of medical tests or surgery, or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.
Contact your doctor if you notice any unusual symptoms.
Who should not take Estrostep Fe?Estrostep Fe should not be used if you have any of the following conditions: a history of heart attack or stroke; blood clots in the legs (thrombophlebitis), lungs (pulmonary embolism), or eyes; a history of blood clots in the deep veins of your legs; chest pain (angina pectoris); known or suspected breast cancer or cancer of the lining of the uterus, cervix, or vagina; unexplained vaginal bleeding (until a diagnosis is reached by your doctor); yellowing of the whites of the eyes or of the skin (jaundice) during pregnancy or during previous use of the pill; or liver tumors (benign or cancerous).
Estrostep Fe should not be used by women who are pregnant or think they may be pregnant. Also, do not use Estrostep Fe if you have an allergy to it or any of its ingredients.
What should I tell my doctor before I take the first dose of Estrostep Fe?Tell your doctor about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Estrostep Fe. Also, talk to your doctor about your complete medical history, especially if you have breast nodules, fibrocystic disease of the breast, an abnormal breast x-ray or mammogram; diabetes; elevated cholesterol or triglycerides; high blood pressure; migraine or other headaches or epilepsy; mental depression; gallbladder, heart, or kidney disease; history of scanty or irregular menstrual periods.
Also, be sure to inform your doctor or healthcare provider if you smoke.
What is the usual dosage?The information below is based on the dosage guidelines your doctor uses. Depending on your condition and medical history, your doctor may prescribe a different regimen. Do not change the dosage or stop taking your medication without your doctor's approval.
Adults: Each white tablet (1 milligram [mg] norethindrone and 20-35 micrograms [mcg] ethinyl estradiol) dispenser has been preprinted with the days of the week, starting with Sunday. Take the appropriate tablet once daily. The "reminder" brown tablets (75 mg ferrous fumarate) should be taken the same way after all 21 white tablets have been used.
For acne treatment, follow the same guidelines for use of Estrostep Fe as an oral contraceptive.
How should I take Estrostep Fe?Take as directed based on the regimen of your choice. Consult with your doctor to decide upon a proper regimen and make sure you make all follow-up appointments. You have a choice of which day to start taking your first pack of pills. Decide with your doctor or clinic which is the best day for you. Pick a time of day which will be easy to remember. During the first week of initiating therapy, an additional method of contraception is recommended.
Tablets should be taken regularly at the same time each day and can be taken without regard to meals. The chewable tablet may be chewed or swallowed whole. If chewed, drink a full glass of water just after you swallow the pill.
Day 1 start: Pick the day label strip that starts with the first day of your period. (This is the day you start bleeding or spotting, even if it is almost midnight when the bleeding begins.) Place this day label strip on the tablet dispenser over the area that has the days of the week (starting with Sunday) printed on the plastic. Take the first "active" white pill during the first 24 hours of your period. You will not need to use a back-up method of birth control, since you are starting the pill at the beginning of your period.
Sunday start: Take the first "active" white pill on the Sunday after your period starts, even if you are still bleeding. If your period begins on Sunday, start the pack that same day. Use another method of birth control as a back-up method if you have sex anytime from the Sunday you start your first pack until the next Sunday (7 days). Condoms or spermicide are good back-up methods of birth control.
WHEN YOU FINISH A PACK OR SWITCH YOUR BRAND OF PILLS:
21 pills: Wait 7 days to start the next pack. You will probably have your period during that week. Be sure that no more than 7 days pass between 21-day packs.
28 pills: Start the next pack on the day after your last "reminder" pill. Do not wait any days between packs.
Menstruation usually begins in 2 or 3 days, but may begin as late as the fourth or fifth day after the brown tablets have been started. In any event, the next course of tablets should be started without interruption. If spotting occurs while you are taking white tablets, continue the medication without interruption.
At times there may be no menstrual period after a cycle of pills. Therefore, if you miss one menstrual period but have taken the pills exactly as you were supposed to, continue as usual into the next cycle. If you have not taken the pills correctly and miss a menstrual period, you may be pregnant and should stop taking oral contraceptives until your doctor or healthcare provider determines whether or not you are pregnant. Until you can get to your doctor or healthcare provider, use another form of contraception. If two consecutive menstrual periods are missed, you should stop taking pills until it is determined whether or not you are pregnant.
What should I avoid while taking Estrostep Fe?Do not smoke while using birth control pills, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills.
Avoid having unprotected sex because birth control pills will not protect you from sexually transmitted diseases including HIV and AIDS.
Avoid prolonged exposure to sun, sunlamps, and tanning beds because Estrostep Fe may cause dark skin patches on your face (melasma); exposure to the sun may make these patches darker.
What are possible food and drug interactions associated with Estrostep Fe?If Estrostep Fe is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Estrostep Fe with the following: acetaminophen, antibiotics (ampicillin, griseofulvin, tetracycline), anticonvulsants (eg, carbamazepine), ascorbic acid,, atorvastatin, barbiturates (eg, phenobarbital, pentobarbital), carbamazepine, clofibric acid, cyclosporine, morphine, phenytoin, phenylbutazone, prednisolone, rifampin, salicylic acid, St John's Wort, temazepam, and theophylline.
What are the possible side effects of Estrostep Fe?Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking this drug.
Side effects may include: breakthrough bleeding, breast pain or tenderness, change in weight or appetite, edema, decreased sex drive, depression, freckles or darkening of facial skin, headache, increased hair growth, loss of hair, migraine, nausea, problems with contact lenses, nervousness, dizziness, loss of menstrual period, stomach cramps/bloating, vaginal itching, vomiting
Can I receive Estrostep Fe if I am pregnant or breastfeeding?You should not use Estrostep Fe if you are pregnant or plan on becoming pregnant. If you are breastfeeding, consult your doctor before starting oral contraceptives.
What should I do if I miss a dose of Estrostep Fe?If you miss 1 white pill, take it as soon as you remember. Take the next pill at your regular time. This means you may take 2 pills in 1 day.
If you miss 2 white pills (week 1 or week 2), take 2 pills on the day you remember and 2 pills the next day. Then resume to 1 pill a day until you finish the pack.
If you miss 2 white pills (week 3): Day-1 starter: Throw out the rest of the pill pack and start a new pack that same day. Sunday starter: Continue with 1 pill every day until Sunday. On Sunday, throw out the pack and start a new pack. You may not have your period this month, but this is expected. However, if you miss your period 2 months in a row, call your doctor or clinic because you might be pregnant. You MUST use another birth control method (such as condoms or spermicide) as a back-up method of birth control until you have taken a white "active" pill every day for 7 days.
If you miss 3 or more white pills (during the first 3 weeks): Day-1 starter: Throw out the rest of the pill pack and start a new pack that same day. Sunday starter: Keep taking 1 pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack of pills that same day. You MUST use another birth control method (such as condoms or spermicide) as a back-up method of birth control until you have taken a white "active" pill every day for 7 days.
If you forget any of the 7 brown "reminder" pills in week 4, throw away the pills you missed. Keep taking 1 pill each day until the pack is empty. You do not need a back-up method.
If you are unsure what to do about the pills you have missed, use a back-up method anytime you have sex until the next time you see your doctor. Keep taking the white pills each day until your next doctor's appointment.
How should I store Estrostep Fe?Store Estrostep Fe at room temperature and away from children. Protect from moisture, heat, light, and humidity. Store tablets inside the pouch when not in use.
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