February 20, 2017
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Loestrin Fe

"Despite the potential for adverse maternal and fetal outcomes, contraceptive use in women with certain medical conditions is suboptimal, according to a new study.

Steven W. Champaloux, PhD, MPH, a scientist in the Division of Reproduc"...

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Loestrin 24 Fe

LOESTRIN ® 24 Fe
(norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets)




WARNING

CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS

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. For this reason, COCs should not be used by women who are over 35 years of age and smoke [see CONTRAINDICATIONS].

DRUG DESCRIPTION

LOESTRIN 24 Fe is a combination oral contraceptive for oral administration consisting of active tablets containing norethindrone acetate, a progestin, and ethinyl estradiol, an estrogen, and placebo tablets containing ferrous fumarate, which serve no therapeutic purpose.

  • Each active white tablet contains 1 mg norethindrone acetate and 20 mcg ethinyl estradiol. Inactive ingredients include acacia, lactose, magnesium stearate, starch, confectioner's sugar, and talc.
  • Each placebo brown tablet contains 75 mg ferrous fumarate, microcrystalline cellulose, magnesium stearate, povidone, sodium starch glycolate, and compressible sugar. The ferrous fumarate tablets do not serve any therapeutic purpose. Ferrous fumarate tablets are not USP for dissolution and assay.

The chemical name of ethinyl estradiol is 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17diol. The empirical formula of ethinyl estradiol is C20H24O2 and the structural formula is:

Ethinyl estradiol - Structural Formula Illustration

The chemical name of norethindrone acetate is 17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3one acetate. The empirical formula of norethindrone acetate is C22H28O3 and the structural formula is:

Norethindrone acetate - Structural Formula Illustration

What are the possible side effects of birth control pills?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using birth control pills and call your doctor at once if you have a serious side effect such as:

  • sudden numbness or weakness, especially on one side of the body;
  • sudden and severe headache, confusion, problems with vision, speech, or balance;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden cough, wheezing, rapid...

Read All Potential Side Effects and See Pictures of Loestrin 24 Fe »

What are the precautions when taking norethindrone acetate and ethinyl estradiol (Loestrin 24 Fe)?

See also Warning section.

Before using this medication, tell your doctor or pharmacist if you are allergic to ethinyl estradiol, norethindrone, or ferrous fumarate; or to other estrogens, progestins, or iron products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood clots (for example, in the legs, eyes, lungs), blood clotting disorders (such as protein C or protein S deficiency), high blood pressure, abnormal breast exam, cancer (especially endometrial or breast cancer), high cholesterol or triglyceride (blood fat) levels, depression,...

Read All Potential Precautions of Loestrin 24 Fe »

Last reviewed on RxList: 9/8/2016
This monograph has been modified to include the generic and brand name in many instances.

Loestrin 24 Fe - User Reviews

Loestrin 24 Fe User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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