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norethindrone, ethinyl estradiol, and ferrous fumarate (Oral route)

ETH-i-nil es-tra-DYE-ol, nor-ETH-in-drone AS-e-tate, ETH-i-nil es-tra-DYE-ol, FER-us FUE-ma-rate

Oral route(Tablet)

Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. COCs should not be used by women who are over 35 years of age and who also smoke .

Commonly used brand name(s)

In the U.S.

  • Lo Loestrin Fe
  • Lo Minastrin Fe

Available Dosage Forms:

  • Tablet
  • Tablet, Chewable

Uses For norethindrone, ethinyl estradiol, and ferrous fumarate

Norethindrone, ethinyl estradiol, and ferrous fumarate combination is used to prevent pregnancy. It is a birth control pill that contains two types of hormones, ethinyl estradiol and norethindrone, and when taken properly, prevents pregnancy. It works by stopping a woman's egg from fully developing each month. The egg can no longer accept a sperm and fertilization is prevented.

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norethindrone, ethinyl estradiol, and ferrous fumarate also contains ferrous fumarate. Ferrous fumarate is an iron supplement.

No contraceptive method is 100 percent effective. Birth control methods such as having surgery to become sterile or not having sex are more effective than birth control pills. Discuss your options for birth control with your doctor.

norethindrone, ethinyl estradiol, and ferrous fumarate does not prevent AIDS or other sexually transmitted diseases. It will not help as emergency contraception, such as after unprotected sexual contact.

norethindrone, ethinyl estradiol, and ferrous fumarate is available only with your doctor's prescription.

Before Using norethindrone, ethinyl estradiol, and ferrous fumarate

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For norethindrone, ethinyl estradiol, and ferrous fumarate, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to norethindrone, ethinyl estradiol, and ferrous fumarate or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies on the relationship of age to the effects of norethindrone, ethinyl estradiol, and ferrous fumarate combination have not been performed in the pediatric population. However, pediatric-specific problems that would limit the usefulness of this medication in teenagers are not expected. norethindrone, ethinyl estradiol, and ferrous fumarate may be used for birth control in teenage females but should not be used before the start of menstruation.

Geriatric

Appropriate studies on the relationship of age to the effects of norethindrone, ethinyl estradiol, and ferrous fumarate combination have not been performed in the geriatric population. norethindrone, ethinyl estradiol, and ferrous fumarate should not be used in elderly women.

Pregnancy

Pregnancy Category Explanation
All Trimesters X Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

Ethinyl Estradiol

Studies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake.

Ethinyl EstradiolNorethindrone AcetateIron

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking norethindrone, ethinyl estradiol, and ferrous fumarate, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using norethindrone, ethinyl estradiol, and ferrous fumarate with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Tranexamic Acid

Using norethindrone, ethinyl estradiol, and ferrous fumarate with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Boceprevir
  • Carbamazepine
  • Ceritinib
  • Clozapine
  • Crizotinib
  • Dabrafenib
  • Eltrombopag
  • Felbamate
  • Fentanyl
  • Isotretinoin
  • Mitotane
  • Paclitaxel
  • Paclitaxel Protein-Bound
  • Piperaquine
  • Siltuximab
  • Theophylline
  • Tizanidine

Using norethindrone, ethinyl estradiol, and ferrous fumarate with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Alprazolam
  • Amprenavir
  • Aprepitant
  • Atazanavir
  • Bacampicillin
  • Betamethasone
  • Bexarotene
  • Bosentan
  • Carbidopa
  • Cefdinir
  • Clarithromycin
  • Colesevelam
  • Cyclosporine
  • Darunavir
  • Delavirdine
  • Demeclocycline
  • Dolutegravir
  • Doxycycline
  • Efavirenz
  • Eslicarbazepine Acetate
  • Etoricoxib
  • Etravirine
  • Fosamprenavir
  • Fosaprepitant
  • Fosphenytoin
  • Gatifloxacin
  • Ginseng
  • Grepafloxacin
  • Griseofulvin
  • Lamotrigine
  • Levodopa
  • Levofloxacin
  • Levothyroxine
  • Licorice
  • Lomefloxacin
  • Methyldopa
  • Minocycline
  • Modafinil
  • Moxifloxacin
  • Mycophenolate Mofetil
  • Mycophenolic Acid
  • Nelfinavir
  • Norfloxacin
  • Ofloxacin
  • Omeprazole
  • Oxcarbazepine
  • Penicillamine
  • Phenobarbital
  • Phenytoin
  • Pioglitazone
  • Prednisolone
  • Primidone
  • Rifabutin
  • Rifampin
  • Rifapentine
  • Ritonavir
  • Roflumilast
  • Rosuvastatin
  • Rufinamide
  • Selegiline
  • St John's Wort
  • Telaprevir
  • Temafloxacin
  • Tetracycline
  • Tipranavir
  • Topiramate
  • Troglitazone
  • Troleandomycin
  • Trovafloxacin Mesylate
  • Valdecoxib
  • Voriconazole
  • Warfarin
  • Zinc

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using norethindrone, ethinyl estradiol, and ferrous fumarate with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use norethindrone, ethinyl estradiol, and ferrous fumarate, or give you special instructions about the use of food, alcohol, or tobacco.

  • Caffeine
  • Dairy Food
  • Grapefruit Juice
  • Phytic Acid Containing Food

Other Medical Problems

The presence of other medical problems may affect the use of norethindrone, ethinyl estradiol, and ferrous fumarate. Make sure you tell your doctor if you have any other medical problems, especially:

  • Abnormal or unusual vaginal bleeding or
  • Blood clots, or history of or
  • Breast cancer, active or history of or
  • Diabetes with kidney, eye, nerve, or blood vessel damage or
  • Heart attack, history of or
  • Heart or blood vessel disease or
  • Heart rhythm problems or
  • Hypertension (high blood pressure), uncontrolled or
  • Liver disease, including tumors or cancer or
  • Migraine headache, new or worse or a new kind of headache or
  • Problems with circulation or blood clots, now or in the past or
  • Problems with heart valves or
  • Stroke, history of—Should not be used in patients with these conditions.
  • Angioedema (swelling of the face, tongue, or throat), inherited or
  • Cervical cancer or intraepithelial neoplasia or
  • Chloasma gravidarum (skin disorder during pregnancy), history of or
  • Cholestasis (bile problem) during pregnancy, history of or
  • Depression, history of or
  • Diabetes or
  • Dyslipidemia (high cholesterol or fats in the blood), uncontrolled or
  • Gallbladder disease or
  • Hypertension (high blood pressure), controlled—Use with caution. May make these conditions worse.

Proper Use of norethindrone, ethinyl estradiol, and ferrous fumarate

To make using hormonal contraceptives as safe and reliable as possible, you should understand how and when to use them and what effects may be expected.

norethindrone, ethinyl estradiol, and ferrous fumarate comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

norethindrone, ethinyl estradiol, and ferrous fumarate is available in blister packs. Each blister pack contains 28 tablets with different colors that need to be taken in the same order as directed on the blister pack.

When you begin using norethindrone, ethinyl estradiol, and ferrous fumarate, your body will require at least 7 days to adjust before a pregnancy will be prevented. Use a second form of contraception, such as a condom, spermicide, or diaphragm, for the first 7 days of your first cycle of pills.

Take norethindrone, ethinyl estradiol, and ferrous fumarate at the same time each day. You may take norethindrone, ethinyl estradiol, and ferrous fumarate with or without food.

Do not skip or delay taking your pill by more than 24 hours. If you miss a dose, you could get pregnant. Ask your doctor for ways to help you remember to take your pills or about using another method of birth control.

You may have light bleeding or spotting when you first take the pill.

You may feel sick or nauseous, especially during the first few months that you take norethindrone, ethinyl estradiol, and ferrous fumarate. If your nausea is continuous and does not go away, call your doctor.

If you vomit or have diarrhea within 3 to 4 hours of taking norethindrone, ethinyl estradiol, and ferrous fumarate, follow the instructions in the patient leaflet or call your doctor.

If you are switching from a combination hormonal method (e.g., another pill, patch, vaginal ring) to using Lo Loestrin Fe®, take the medicine on the day you would have taken your next pill. If you do not start your period, see your doctor for a pregnancy test. If you have used a vaginal ring or patch, finish the 21 days of use, and wait 7 days after the ring or patch is removed before you start taking norethindrone, ethinyl estradiol, and ferrous fumarate. You must also use a second method of birth control (e.g., condom, diaphragm, spermicide) for the first 7 days you take norethindrone, ethinyl estradiol, and ferrous fumarate.

If you are switching from a progestin-only method (e.g., progestin-only pill, implant, injection, intrauterine system) to using Lo Loestrin Fe®, take the medicine on the day you would have taken your next progestin-only pill, or on the day your implant is removed, or on the day you would have your next injection. If you switch from an IUD, talk to your doctor when to start taking norethindrone, ethinyl estradiol, and ferrous fumarate. You must also use a second method of birth control (e.g., condom, diaphragm, spermicide) for the first 7 days you take norethindrone, ethinyl estradiol, and ferrous fumarate.

Dosing

The dose of norethindrone, ethinyl estradiol, and ferrous fumarate will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of norethindrone, ethinyl estradiol, and ferrous fumarate. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Your doctor may ask you to begin your dose on the first day of your menstrual period (called Day 1 Start) or on the first Sunday after your menstrual period starts (called Sunday Start). When you begin on a certain day it is important that you follow that schedule, even if you miss a dose. Do not change your schedule on your own. If the schedule that you use is not convenient, check with your doctor about changing it. For a Sunday start, you need to use another form of birth control (e.g., condom, diaphragm, spermicide) for the first 7 days.

  • For oral dosage form (tablets):
    • For contraception (to prevent pregnancy):
      • Adults and teenagers—One tablet taken at the same time each day for 28 days.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

Call your doctor or pharmacist for instructions.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using norethindrone, ethinyl estradiol, and ferrous fumarate

It is very important that your doctor check your progress at regular visits to make sure norethindrone, ethinyl estradiol, and ferrous fumarate is working properly and does not cause unwanted effects. These visits will usually be every 6 to 12 months, but some doctors require them more often.

Although you are using norethindrone, ethinyl estradiol, and ferrous fumarate to prevent pregnancy, you should know that using norethindrone, ethinyl estradiol, and ferrous fumarate while you are pregnant could harm the unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

Vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is sometimes called spotting when slight, or breakthrough bleeding when heavier.

  • If this should occur, continue with your regular dosing schedule.
  • The bleeding usually stops within 1 week. Check with your doctor if the bleeding continues for more than 1 week.
  • If bleeding continues after you have been taking hormonal contraceptives on schedule and for more than 3 months, check with your doctor.

Check with your doctor right away if you miss a menstrual period. Missed periods may occur if you skip one or more blue tablets and have not taken your pills exactly as directed. If you miss two periods in a row, talk to your doctor. You might need a pregnancy test.

If you suspect that you may be pregnant, stop using norethindrone, ethinyl estradiol, and ferrous fumarate immediately and check with your doctor.

Do not use norethindrone, ethinyl estradiol, and ferrous fumarate if you smoke cigarettes or if you are over 35 years old. If you smoke while using birth control pills, you increase your risk of having a heart attack, stroke, or blood clot. Your risk is even higher if you are over age 35, if you have diabetes, high blood pressure, high cholesterol, or if you are overweight. Talk with your doctor about ways to stop smoking. Keep your diabetes under control. Ask your doctor about diet and exercise to control your weight and blood cholesterol level.

Stop using norethindrone, ethinyl estradiol, and ferrous fumarate and check with your doctor right away if you have pain in the chest, groin, or legs, especially the calves; difficulty with breathing; a sudden, severe headache; slurred speech; a sudden, unexplained shortness of breath; a sudden loss of coordination; or vision changes while using norethindrone, ethinyl estradiol, and ferrous fumarate.

Check with your doctor immediately if you have trouble wearing contact lenses or if blurred vision, difficulty with reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Stop using norethindrone, ethinyl estradiol, and ferrous fumarate and check with your doctor right away if you have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.

Check with your doctor before refilling an old prescription, especially after a pregnancy. You will need another physical examination and your doctor may change your prescription.

Make sure any doctor or dentist who treats you knows that you are using norethindrone, ethinyl estradiol, and ferrous fumarate. You may need to stop using norethindrone, ethinyl estradiol, and ferrous fumarate several days before having surgery or certain medical tests.

norethindrone, ethinyl estradiol, and ferrous fumarate may cause skin discoloration. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's wort) or vitamin supplements.

norethindrone, ethinyl estradiol, and ferrous fumarate Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common
  • Breast tenderness
  • heavy non-menstrual vaginal bleeding
  • irregular menstrual periods
  • longer or heavier menstrual periods
  • normal menstrual bleeding occurring earlier, possibly lasting longer than expected
Incidence not known
  • Chest pain
  • chills
  • clay-colored stools
  • confusion
  • dark urine
  • diarrhea
  • difficulty with speaking
  • dizziness
  • double vision
  • fast or irregular heartbeat
  • fever
  • headache
  • inability to move the arms, legs, or facial muscles
  • inability to speak
  • indigestion
  • itching
  • loss of appetite
  • nausea
  • pain, redness, or swelling in the arm or leg
  • pains in the chest, groin, or legs, especially in the calves of the legs
  • rash
  • severe headaches of sudden onset
  • severe nausea or vomiting
  • slurred speech
  • stomach pain
  • sudden loss of coordination
  • sudden onset of shortness of breath for no apparent reason
  • sudden onset of slurred speech
  • sudden vision changes
  • tightness in the chest
  • unpleasant breath odor
  • unusual tiredness or weakness
  • unusual warmth or flushing of the skin
  • unusually heavy or unexpected menstrual bleeding
  • vaginal bleeding or spotting
  • vomiting of blood
  • yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Vomiting
Less common
  • Anxiety
  • blemishes on the skin
  • cramps
  • depression
  • heavy bleeding
  • pain
  • pimples
  • weight changes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

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