Ena

Name: Ena

What are Ena (estradiol and norethindrone)?

Estradiol is a form of estrogen, a female sex hormone that regulates many processes in the body.

Norethindrone is a form of progesterone, a female hormone important for regulating ovulation and menstruation.

Estradiol and norethindrone is a combination medicine used to treat menopause symptoms such as hot flashes and vaginal changes (itching, burning, dryness), and to prevent osteoporosis (bone loss) in menopausal women.

Estradiol and norethindrone may also be used for purposes not listed in this medication guide.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What other drugs will affect Ena (estradiol and norethindrone)?

Other drugs may interact with estradiol and norethindrone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

For the Consumer

Applies to estradiol / norethindrone: oral tablet

Other dosage forms:

  • transdermal patch extended release

Along with its needed effects, estradiol / norethindrone 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 while taking estradiol / norethindrone:

More common
  • Body aches or pain
  • chills or fever
  • cold or flu-like symptoms
  • difficulty breathing
  • headache
  • itching of the vagina or genital area
  • nonmenstrual vaginal bleeding
  • pain during sexual intercourse
  • thick, white vaginal discharge with no odor or with a mild odor
  • unusual tiredness or weakness
Incidence not known
  • Abdominal or stomach pain
  • blistering, peeling, or loosening of the skin
  • change in vaginal discharge
  • chest pain, discomfort, or tightness in chest
  • clay-colored stools
  • clear or bloody discharge from the nipple
  • confusion
  • dark urine
  • difficulty speaking
  • difficulty swallowing
  • dizziness or lightheadedness
  • double vision
  • fainting
  • fast heartbeat
  • inability to move the arms, legs, or facial muscles
  • inability to speak
  • joint or muscle pain
  • loss of appetite
  • lump in the breast or under the arm
  • nausea and vomiting
  • noisy breathing
  • pain in the ankles or knees
  • pain or discomfort in the arms, jaw, back, or neck
  • pain or feeling of pressure in the pelvis
  • pain, redness, or swelling in the arm or leg
  • painful, red lumps under the skin, mostly on the legs
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • problems with memory or speech
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • red, irritated eyes
  • redness or swelling of the breast
  • skin rash, hives, or itching
  • sores, ulcers, or white spots in the mouth or on the lips
  • sudden shortness of breath or troubled breathing
  • sweating
  • trouble recognizing objects
  • trouble thinking and planning
  • trouble walking

Some side effects of estradiol / norethindrone 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
  • Back pain
  • breast pain
  • cramps
  • crying
  • euphoria
  • mental depression
  • paranoia
  • quick to react or overreact emotionally
  • rapidly changing moods
  • trouble sleeping
  • weakness
  • weight gain
Incidence not known
  • Changes in appetite
  • changes in sexual ability, desire, drive, or performance
  • excess air or gas in the stomach or intestines
  • increased hair growth, especially on the face
  • patchy brown or dark brown discoloration of the skin
  • trouble wearing contact lenses

Usual Adult Dose for Atrophic Vaginitis

One (1 mg estradiol/0.5 mg norethindrone or 0.5 estradiol/ 0.1 mg norethindrone) tablet orally once a day.

-or-

One (0.05 mg-0.14 mg) patch applied twice weekly. If a greater progestin dose is desired, a single (0.05 mg-0.25 mg) patch may be applied twice weekly.

Alternatively, either patch may be applied as a continuation to an initial 14-day application of an estradiol-only transdermal patch within a 28-day cycle.

The patch should not be applied to, or near, the breasts. The application site should be smooth, clean, dry, fold-free, without damage or irritation, and be rotated with an interval of at least one week allowed to pass between applications to the same site.

If a patch dislodges, it may be reapplied to another area of the lower abdomen, or a new patch may be applied, in which case, the original treatment schedule resumes. However, only one patch should be worn at any given time during the three to four day dosing interval.

Renal Dose Adjustments

Data not available

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