Norethindrone, Ethinyl Estradiol, and Ferrous Fumarate (Oral)

Overview

Norethindrone, Ethinyl Estradiol, and Ferrous Fumarate are used in combination as a birth control pill, preventing pregnancy. It contains two specific types of hormone: Norethindrone and Ethinyl Estradiol. When taken regularly and according to a physician's instructions, it works to prevent pregnancy by stopping an egg from developing fully each month. As the egg is then unable to accept a sperm, fertilization is halted. Ferrous Fumarate is also included to supplement a female patient's iron intake.

Patients should be aware that no birth control method is completely effective. Abstaining from sex altogether, or having surgery to become sterile are likely to be more effective than contraceptive medications. Patients should always fully discuss contraceptive methods with their physician and assess all the options.

Norethindrone, Ethinyl Estradiol, and Ferrous Fumarate works to prevent pregnancy, but it cannot offer protection against sexually transmitted diseases, including HIV. It also should not be used as a form of emergency contraception after unprotected sex.

Norethindrone, Ethinyl Estradiol, and Ferrous Fumarate is only available on prescription from a qualified physician. It is available in tablets and chewable tablets, and may be more familiar under the US brand names Lo Loestrin Fe and Lo Minastrin Fe.

Patients should always read the patient information leaflet included by their pharmacist before they start taking Norethindrone, Ethinyl Estradiol, and Ferrous Fumarate, even if they are using a refill. The leaflet includes plenty of information on when to take the medication and what to do if a patient misses a dose. If a patient then has any questions, they should ask their pharmacist or physician.

Norethindrone, Ethinyl Estradiol, and Ferrous Fumarate should be taken with or without food, as directed by a physician, typically once per day only. Patients will need to pick a time of day which they should find easy to remember, and they will have to take every dose at the same time.

Norethindrone, Ethinyl Estradiol, and Ferrous Fumarate is available in chewable tablets. Most formulations are designed to be swallowed whole. Some brands will direct patients to swallow whole with water, and some will direct patients to take without water. Patients should always carefully follow the directions given on the label and in the corresponding patient information leaflet.

Patients should continue to take Norethindrone, Ethinyl Estradiol, and Ferrous Fumarate as directed by their physician. They should follow the directions in the pack to find their first dose and then follow the designated order. Patients should not skip doses, as this raises their risk of becoming pregnant. Their risk of becoming pregnant also rises if they change the time they take their doses, or start a new pack late.

Patients who experience nausea or upset stomach after taking Norethindrone, Ethinyl Estradiol, and Ferrous Fumarate may find it helps to take it after their evening meal or before bed. Patients should choose a time which is easy for them to remember. Whatever the time they choose, they should always take their dose at the same time every day, leaving 24 hours between each dose. Patients should ask their physician or pharmacist for further advice on dosing times.

Patients who have diarrhea or vomiting within four hours after their dose should read their patient information leaflet carefully for instruction on what to do if a dose is missed. Vomiting and diarrhea can stop a pill from working, so it is important that patients follow the instructions for skipped doses.

Norethindrone, Ethinyl Estradiol, and Ferrous Fumarate is supplied in packs of 28 pills, where 24 tablets are filled with the active hormones, and four pills have a small amount of iron supplement. Patients should take one active pill once a day for the first 24 days in a row. They should then take the inactive pills once a day for four days in a row, as directed by their physician. This should correspond with when a patient receives their menstrual period. After they have finished the pack, they should immediately continue with the next pack even if they are still on their period, or have not yet had their period.

Some medicines can interact with iron supplements (including levothyroxine, tetracyclines, quinolones, levodopa and penicillamine). Patients who are taking any of these medicines should seek advice from their physician before taking the final four inactive pills in their pack.

Patients who are switching over from other types of hormonal contraceptives (including other birth control pills and patches) should ask their physician or pharmacist for advice.

Conditions Treated

  • Pregnancy (preventative)

Type Of Medicine

  • Oral contraceptive (birth control pill)

Side Effects

Along with its desired functions, all medicines carry the risk of causing undesired side effects. Not all of the following side effects may appear, but some may require medical attention if they do.

If a patient notices any of the following side effects, they should consult their physician immediately:

  • Dark urine

Other side effects may appear that do not typically require medical assistance. These side effects may retreat during treatment as the patient's body adjusts to the medicine. Patients who are concerned about the duration or type of side effects should talk to their physician or pharmacist, who will be happy to answer any questions. They may be able to provide advice on how to prevent or minimize side effects.

  • Cramps

Some patients may also experience side effects that are not listed in this guide. If a patient notices another side effect from using Norethindrone, Ethinyl Estradiol, and Ferrous Fumarate, they should consult their physician for advice. New side effects can also be reported to the FDA by dialling 1-800-FDA-1088.

Dosage

Different patients will require different doses of Norethindrone, Ethinyl Estradiol, and Ferrous Fumarate. Patients should always follow their physician's directions or the instructions on the label. The below information covers typical dosage instructions, but should not be considered all-inclusive. Actual doses will vary depending on the severity of the patient's condition, their medical history, and the other medicines they are taking. If a patient's dose does not appear below, they should not make any changes without first checking with their physician.

The exact dose prescribed will also depend on the strength of the specific formulation used. The time allocated between doses, the number of doses per day, and the total length of treatment will also vary depending on the type of medical problem it is being used to treat.

A physician may ask a patient to start taking Norethindrone, Ethinyl Estradiol, and Ferrous Fumarate on the first day of their menstrual cycle (known as Day 1 Start) or on the first Sunday following the start of their menstrual period (known as Sunday Start). It is important that, once a patient starts on a specific day, they continue to follow the schedule, even if they forget a dose. Patients should not change their schedule without first consulting with a healthcare professional. For those with a Sunday Start, they should make sure they have another form of birth control (such as a diaphragm, condom and spermicide) to cover the first seven days.

To prevent pregnancy (contraception), adults and teenagers should take one tablet for 28 days at the same time every day. Any use and dosage in children should only be determined by a qualified physician. If patients miss a dose, they should call their physician or pharmacist for further instruction.

Major drug interactions:

Some medicines should never be used together as they carry the risk of causing serious complications for the patient by interacting with one another. Other medicines may carry a risk of interactions, but may still be prescribed, depending on the judgement of a qualified physician. They may therefore choose to alter the dosage instructions, including the timing and frequency of one or both medicines to reduce the risks. Patients should fully inform their physician about all medicines they are taking - including over the counter medications, vitamins and herbal remedies. Patients should particularly make their physician aware of the following medicines, which are known to interact with Norethindrone, Ethinyl Estradiol, and Ferrous Fumarate.

The following list of medicines are not recommended for use alongside Norethindrone, Ethinyl Estradiol, and Ferrous Fumarate. A physician may choose to not prescribe one of the medicines, or may choose some of a patient's other medicines to reduce the risk.

  • Tranexamic Acid

The following list of medications are not usually recommended for use alongside Norethindrone, Ethinyl Estradiol, and Ferrous Fumarate, but a physician may, in some cases, decide that it is appropriate to prescribe them together. In that case, they may adjust the dosage instructions to reduce the risk of interactions.

  • Isotretinoin

The following list of medicines have an increased risk of causing side effects when used alongside Norethindrone, Ethinyl Estradiol, and Ferrous Fumarate. In some cases, using both drugs may be the best course of treatment, in which case a physician may take steps to reduce the risk by changing the doses, the frequency, or the timing of doses for one or both of the medicines.

  • Aprepitant

Some medicines should also not be used around the time of eating, or with certain types of food and drink, as they may cause interactions. Drinking alcohol or using tobacco products can also have an effect. The following list of lifestyle-based interactions have been chosen by their known significance, and should be taken as all-inclusive.

The following substances may increase a patient's risk of specific side effects, but using them may be unavoidable in some circumstances. Patients who are concerned about any of them should consult their physician for advice on how to prevent or reduce the risk of interactions.

  • Dairy foods

Patients who have other medical issues may also experience difficulties when using Norethindrone, Ethinyl Estradiol, and Ferrous Fumarate. Patients who have (or have a history of) any of the following conditions should ensure their physician is made fully aware:

  • Breast cancer

Warnings

A patient's physician should regularly review their condition through regular appointments while the patient is taking Norethindrone, Ethinyl Estradiol, and Ferrous Fumarate. They will assess whether the medicine is still working as desired, and whether continued treatment is necessary. Review appointments should be made around every six to 12 months, but some physicians may schedule them more regularly.

Patients should be made aware that, although using Norethindrone, Ethinyl Estradiol, and Ferrous Fumarate should prevent pregnancy, using it while pregnant could harm the unborn baby. If a patient believes they may have become pregnant during treatment, they should consult their physician immediately.

During the first three months of treatment, patients may experience irregular vaginal bleeding between their usual menstrual periods. This may be termed 'spotting' when slight, or 'breakthrough bleeding' when it appears heavier. Patients should continue with their dosing schedule. This initial bleeding typically stops after the first week of doses. Patients who experience unusual bleeding after the first week should check with their physician. If the bleeding continues for more than three months, a physician may wish to conduct some tests or change the patient's dose or medication.

Patients who miss a menstrual period should check with their physician urgently. If a patient skips one or more tablets, or does not keep to the dosing schedule, they may miss periods. Patients who miss more than two periods in a row should speak to their physician, as they may need a pregnancy test.

Patients who suspect they have become pregnant should stop using Norethindrone, Ethinyl Estradiol, and Ferrous Fumarate immediately, and call their physician.

Patients who smoke cigarettes or are over the age of 35 should not be prescribed Norethindrone, Ethinyl Estradiol, and Ferrous Fumarate. Smoking whilst on contraceptive pills can increase a patient's risk of developing stroke, heart attack or blood clots. The risks are elevated when the patient is over the age of 35, is overweight, or has high cholesterol, diabetes or high blood pressure. Patients who smoke should talk to their doctor about quitting. Diabetic patients should seek advice on ways to keep their diabetes controlled. Concerned patients should ask for advice on ways to control their weight and cholesterol levels.

Patients who notice chest pain, pain in the legs, groin or calves, breathing difficulties, slurred speech, a sudden, severe headache, new shortness of breath, a loss of coordination, or vision problems should seek medical attention immediately.

Patients who experience difficulty wearing contact lenses, or notice they have blurred vision, difficulties reading, or other vision problems, should contact their physician immediately. The physician may refer the patient to an ophthalmologist.

Patients who notice they have tenderness or pain in their upper abdomen, dark-colored urine, pale stools, a loss of appetite, unusual fatigue or weakness, nausea, or yellowing skin or eyes should seek urgent medical attention. These could be the signs of a problem with the liver.

Patients should always check with their physician before refilling old prescriptions, particularly after pregnancy. Patients should have regular physical exams. Patients should also always tell any doctor or dentist that they are taking Norethindrone, Ethinyl Estradiol, and Ferrous Fumarate before any surgery or other medical treatments. They may need to stop taking it just before certain medical procedures.

Norethindrone, Ethinyl Estradiol, and Ferrous Fumarate can cause skin discoloration, so patients are advised to always use sunscreen when outside and avoid tanning beds.

Patients are reminded to avoid taking any other medicines unless they have been checked and approved by their physician. These include over the counter medications, herbal remedies (including St John's wort) and vitamins.

Storage

Like many medicines, Norethindrone, Ethinyl Estradiol, and Ferrous Fumarate should always be stored in its original packaging with the lid firmly closed. It should be kept out of direct sunlight, and away from extremes of temperature and any moisture. Do not let it freeze.

All medicines should be safely stored out of the reach of children.

Patients should never keep medicines they no longer use, or outdated or surplus medications. Patients with leftover medicines should ask their physician or pharmacist for details of local take-back programs.

Summary

Norethindrone, Ethinyl Estradiol, and Ferrous Fumarate combines three separate medicines to prevent pregnancy in teenage and adult female patients. Delivered in tablets, it contains two types of hormones: a progestin and an estrogen. These hormones stop the body from releasing an egg during the menstrual cycle (ovulation), increase the thickness of vaginal fluid to prevent sperm from reaching the egg, and alter the lining of the uterus to prevent attachment of a fertilized egg. There is also a small dose of iron (ferrous fumarate) in each of the four inactive pills taken during the fourth week of dosage. These inactive pills are designed to help patients to stay in the habit of taking one pill every day at the same time throughout their monthly cycle, and do not contain any of the active hormones Norethindrone and Ethinyl Estradiol. The iron supplement is not included at enough strength to treat an active iron deficiency.

Alongside the benefit of preventing pregnancy, these contraceptive pills can also make a patient's menstrual periods more regular and decrease pain and blood loss, reduce the risk of developing ovarian cysts, and improve acne.

As a birth control pill, Norethindrone, Ethinyl Estradiol, and Ferrous Fumarate cannot provide any protection against sexually transmitted diseases (including HIV, gonorrhea and chlamydia).

Patients are reminded to always read the patient information leaflet included with their medicine from the pharmacist, even after a refill.