Lo Loestrin Fe

(Ethinyl Estradiol/Norethindrone Acetate/Iron)

The active ingredients in this birth control are norethindrone acetate, ethinyl estradiol, and ferrous fumarate. Ethinyl estradiol is a synthetic version of natural estrogen found in the female body. Similarly, norethindrone acetate is also a synthetic version of another female hormone known as progesterone. These synthetic progesterones are more commonly known as progestins. Throughout the female menstrual cycle, the levels of these hormones will change to trigger ovulation and menstrual bleeding. As a combination oral contraceptive, this medication essentially alters these hormone levels to suppress ovulation. The ferrous fumarate tablets makes up the inactive pills that do not serve a therapeutic effect.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Lo Loestrin Fe. However, the following is a synopsis of the general guidelines for the use of Lo Loestrin Fe:

• Lo Loestrin Fe should be used exactly as prescribed.
• The tablets in the blister pack are arranged in a specific order to maintain the right hormone levels needed to prevent pregnancy and maintain your menstrual cycle. Take the pills as organized in the blister pack and do not follow your own order. Once you finish a pack, move on to the next one without taking a break.
• Typically, one pill is taken at the same time every day with or without food in the order it has been laid out. To begin, start with the blue tablet at the start of the pack on the day your period starts.
• Initially, breakthrough bleeding or spotting in between periods, as well as stomach upset, are common. If these worsen or do not improve after 3 months of use, follow up with your doctor. If you start on any other day than the first day of your menstrual cycle, an alternative method of contraception should be used for 7 days until the medication begins to work. This backup method should be hormone-free such as a condom or spermicide.
• If you are switching from another form of hormonal contraception to Lo Loestrin Fe (such as a progestin-only pill, implant, IUD, vaginal ring, or injection), discuss with your doctor how to start Lo Loestrin Fe. When switching from other birth control pills, you will typically start this medication on the first day you would have started your previous birth control pack.
• This medication will not work as well if you miss pills, especially the blue or white tablets. Depending on how many and which doses are missed, follow the following steps:

--- If one blue tablet is missed, take it as soon as you remember and resume your regular dosing schedule, even if it means taking 2 tablets the same day.

--- If two blue tablets are missed in a row during Weeks ONE or TWO of your pack, take 2 tablets the day you remember and 2 the following day. On the 3rd day, resume your regular dosing schedule. A hormone-free contraceptive should be used for 7 days as a back-up after restarting following the missed dose.

--- If two blue or white tablets are missed in a row during Weeks THREE or FOUR of your pack, discard the remainder of the pack and begin a new one that same day. A hormone-free birth control method must be used for 7 days when starting the new pack. For this month, you may not get a period. If, however, you go 2 months without a period, contact your doctor as you may be pregnant.

--- If three or more blue or white tablets are missed in a row at any point, discard the remainder of the pack and begin a new one that same day. A back-up contraception must be used for 7 days when starting the new pack. For this month, you may not get a period. If, however, you go 2 months without a period, contact your doctor as you may be pregnant.

--- If you forget a brown pill in Week 4, discard the pill you missed and start a new pack on the day you would begin a new pack. Back-up contraception is not required.

--- If you do not know what to do about your missed doses, contact your doctor or pharmacist.

The most common side effects of Lo Loestrin Fe seen in clinical trials as compared to placebo include:

• Nausea
• Vomiting
• Headache
• Irregular vaginal bleeding or spotting between menstrual periods
• Dysmenorrhea (difficult or painful periods)
• Weight changes (typically weight gain)
• Bloating
• Breast tenderness
• Acne
• Abdominal pain
• Anxiety
• Depression

Some individuals may experience serious side effects while using Lo Loestrin Fe. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Signs of a serious cardiovascular event (heart attack or stroke) such as shortness of breath, sudden vision changes, severe chest pain, sudden onset of a severe headache, any weakness or numbness in your limbs, or slurred speech.
• Increased risk of blood clots. These can occur anywhere in the body, including your legs (deep vein thrombosis) and lungs (pulmonary embolism).
• Signs of liver problems such as jaundice or yellowing of the eyes or skin, loss of appetite, pain in the upper right abdomen, clay-colored stools, or dark urine.
• Increased risk of breast and cervical cancer.

These are not all of the possible side effects of Lo Loestrin Fe. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Lo Loestrin Fe, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Uncontrolled hypertension (high blood pressure), heart disease, or other heart problems
• Plans for surgery
• Plans for blood work
• A resolved blood clot
• Recently given birth
• Liver disease
• Headaches
• Irregular or abnormal uterine bleeding or spotting
• Gallbladder disease
• Diabetes or pre-diabetes
• Depression
• A family history of angioedema
• Problems with contact lenses

Boxed Warning

• Women 35 years old or older who smoke should not use this medication. Cigarette smoking in this population is associated with a high risk of blood clots and serious cardiovascular events.
• Estrogens with or without progestins should not be used to prevent heart disease or dementia.

Do not use if you have:

• Been told that you have an increased risk of thrombotic diseases, otherwise known as clotting disorders. These include pulmonary embolisms (blood clots in the lungs), retinal thrombosis (blood clots in the eyes), and DVTs (deep vein thrombosis, otherwise known as blood clots in the legs).
• Heart problems or coronary artery disease
• Stroke
• Heart attack
• High blood pressure that cannot be controlled by medicine
• Diabetes and signs of nerve, eye, or blood vessel problems
• Migraine headaches with aura or changes in vision
• Breast cancer
• Liver tumors or other liver problems
• Undiagnosed abnormal uterine bleeding
• Are using ombitasvir/ritonavir/paritaprevir with or without dasabuvir for the treatment of Hepatitis C
• ≥35 years of age and smoke
• An allergy to any of the ingredients in Lo Loestrin Fe

If started on any other day than the first day of the menstrual cycle, it can take 7 days for the medication to reach appropriate levels to have contraceptive effects. During these 7 days, it is recommended to use an alternative form of contraception as a backup while you wait.

If started on the first day of the menstrual cycle, an alternative method of contraception is not required when starting.

When Lo Loestrin Fe is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• St. John’s Wort
• Bosentan
• Barbiturates
• Carbamazepine
• Oxcarbazepine
• Felbamate
• Griseofulvin
• Phenytoin
• Topiramate
• Rifampin
• If you use something that decreases the efficacy of Lo Loestrin Fe, you may be required to use a back-up method of contraception until the drug interaction is resolved.

Lo Loestrin Fe is available as an oral dosage form. The blister pack consists of 28 tablets, of which:

24 are blue tablets containing 1 mg norethindrone acetate and 10 mcg ethinyl estradiol

2 are white tablets containing 10 mcg ethinyl estradiol

2 are brown tablets containing 75 mg ferrous fumarate (these tablets do not serve any therapeutic purpose)

It should be stored at room temperature in its original packaging, away from light and heat, and out of reach of children.

It is manufactured by the pharmaceutical company Allergan.

Currently, there is no generic available for this brand-name.

Consult your doctor or pharmacist before starting, stopping, or changing medications while taking Lo Loestrin Fe.

Lo Loestrin Fe should not be used during pregnancy. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

Depending on how many weeks you are postpartum, this medication may not be the right choice for you while breastfeeding, as it could decrease the amount of breast milk you make. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.