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Norethindrone Acetate, Ethinyl Estradiol Oral tablet, Iron Oral tablet

The products combine two types of female hormones, an estrogen and a progestin

Generic Name: ethinyl estradiol-norethindrone  |  Brand Name: femhrt 1 mg/5 mcg

There is an FDA Alert for this drug. Click here to view it.

Special Alerts:

ISSUE: FDA is aware of two newly published studies that evaluated the risk of venous thromboembolism (VTE) in women who use birth control pills that contain drospirenone. The two recently published studies looked at whether there is a higher risk of blood clots in women taking birth control pills containing the progestin drospirenone when compared to similar women taking birth control pills containing a different progestin called levonorgestrel. These two new studies reported that there is a greater risk of VTE associated with birth control pills that contain drospirenone. This risk is reported to be up to 2 to 3 times greater than the risk of VTE associated with using levonorgestrel-containing pills. Other studies have not reported an increase in risk. The FDA is currently evaluating the conflicting results from these studies and will look at all currently available information to fully assess the risks and benefits of drospirenone-containing birth control pills. FDA will continue to communicate any new safety information to the public as it becomes available. Read the drug safety communication for more information on these studies.

BACKGROUND: Drospirenone is a type of female sex hormone called a progestin. Most birth control pills contain two types of hormones--estrogen and progestin. Birth control pills work by preventing the release of eggs from the ovaries (ovulation) and changing the cervical mucus and the lining of the uterus to prevent pregnancy. Brand names of drospirenone-containing products include Yaz (generics Gianvi and Loryna), Yasmin (generics Ocella, Syeda, and Zarah), Beyaz, and Safyral.

RECOMMENDATION: If your birth control pill contains drospirenone, do not stop taking it without first talking to your healthcare professional. Contact your healthcare professional immediately if you develop any symptoms of blood clots, including persistent leg pain, severe chest pain, or sudden shortness of breath. If you smoke and are over 35 years of age, you should not take combination oral contraceptives because they increase the risk that you could experience serious cardiovascular events, including blood clots. For more information visit the FDA website at: [Web] and [Web].

What is this medicine?

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE (ETH in il es tra DYE ole; nor eth IN drone AS e tate) is an oral contraceptive. The products combine two types of female hormones, an estrogen and a progestin. They are used to prevent ovulation and pregnancy. Some products are also used to treat acne in females.

What should I tell my health care provider before I take this medicine?

They need to know if you have or ever had any of these conditions:
  • abnormal vaginal bleeding
  • blood vessel disease or blood clots
  • breast, cervical, endometrial, ovarian, liver, or uterine cancer
  • diabetes
  • gallbladder disease
  • heart disease or recent heart attack
  • high blood pressure
  • high cholesterol
  • kidney disease
  • liver disease
  • migraine headaches
  • stroke
  • systemic lupus erythematosus (SLE)
  • tobacco smoker
  • an unusual or allergic reaction to estrogens, progestins, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

Take this medicine by mouth. To reduce nausea, this medicine may be taken with food. Follow the directions on the prescription label. Take this medicine at the same time each day and in the order directed on the package. Do not take your medicine more often than directed.

Contact your pediatrician regarding the use of this medicine in children. Special care may be needed. This medicine has been used in female children who have started having menstrual periods.

A patient package insert for the product will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.

What if I miss a dose?

If you miss a dose, refer to the patient information sheet you received with your medicine for direction. If you miss more than one pill, this medicine may not be as effective and you may need to use another form of birth control.

What may interact with this medicine?

  • acetaminophen
  • antibiotics or medicines for infections, especially rifampin, rifabutin, rifapentine, and griseofulvin, and possibly penicillins or tetracyclines
  • aprepitant
  • ascorbic acid (vitamin C)
  • atorvastatin
  • barbiturate medicines, such as phenobarbital
  • bosentan
  • carbamazepine
  • caffeine
  • clofibrate
  • cyclosporine
  • dantrolene
  • doxercalciferol
  • felbamate
  • grapefruit juice
  • hydrocortisone
  • medicines for anxiety or sleeping problems, such as diazepam or temazepam
  • medicines for diabetes, including pioglitazone
  • mineral oil
  • modafinil
  • mycophenolate
  • nefazodone
  • oxcarbazepine
  • phenytoin
  • prednisolone
  • ritonavir or other medicines for HIV infection or AIDS
  • rosuvastatin
  • selegiline
  • soy isoflavones supplements
  • St. John's wort
  • tamoxifen or raloxifene
  • theophylline
  • thyroid hormones
  • topiramate
  • warfarin


Last Updated: December 03, 2009
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Ethinyl estradiol-norethindrone

 
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