Estradiol and Norethindrone (Oral)

Estradiol and norethindrone are also known under US brand names, Mimvey, Activella, and Lopreeza. It is used in the treatment of moderate or severe hot flushes and other symptoms of the menopause.

Overview

Estradiol and norethindrone is a combination drug that is used in the treatment of moderate or severe hot flashes or other symptoms of the menopause. It's also used in the treatment of changes in and around the vagina, such as vaginal itching, dryness, and burning that is caused by menopause or low estrogen levels. This medication is also used to treat some conditions in women before and after the menopause if their ovaries do not produce enough estrogen naturally. This drug can help prevent osteoporosis after menopause. This medication is a combination of 2 different hormones, a progestin hormone (norethindrone) and an estrogen hormone (estradiol). It works by preventing such symptoms as feelings of warmth in the neck, face, chest or strong feelings of sweating and heat (known as hot flashes) in women during the menopause. This medication is only available via prescription from your doctor and is available in the dosage form of a tablet.

Condition(s) treated?

  • Wasting of Tissues of the Vulva

Type of medicine?

  • Oral tablet

Side Effects

Along with the intended effects of this drug, it can produce some unwanted side effects. Not all of these side effects may occur, but if they do, they may require medical attention.

Inform your doctor urgently if you suffer from any of the following side effects whilst taking estradiol/norethindrone:

More common side effects

  • Nonmenstrual vaginal bleeding

Incidence not known

  • Confusion

Some side effects that occur with this drug do not usually require medical attention. You find that these side effects begin to disappear once your body begins adjusting to the medication. If they are bothering you, you should contact your local pharmacist or healthcare professional for ways to limit the severity of these side effects. Check with your doctor or health care professional if you suffer from any of the following side effects or if you have any questions.

More common side effects

  • Paranoia

Incidence not known

  • Patchy brown or dark brown discoloration of the skin

If you wish you to, you can report any side effects you experience to the FDA on 1-800-FDA-1088.

Dosage

Your final dosage of this medication will be based on a variety of different factors. These include your age, weight, and height. What other medication you are currently taking, your past medical history and your reaction to the first dose will also affect your final dose. Do not alter or stop taking your medication without speaking to your doctor first. The following dose requirements are only a guide and your final dose may be different depending on an individual basis.

Typical adult dose for hot flashes and other symptoms caused by menopause

One tablet is taken orally once daily. One tablet contains one milligram (mg) of estradiol and 0.5 mg of norethindrone or 0.1 mg of norethindrone and 0.5 mg of estradiol.

Typical adult dose for treatment of changes in and around the vagina (such as vaginal itching, dryness, and burning)

One tablet is taken once daily. One tablet contains 0.5 mg of norethindrone and 1 milligram (mg) of estradiol.

Typical adult dose for prevention of osteoporosis after menopause

One tablet is taken once daily. One tablet contains 0.5 mg of norethindrone or 1 milligram (mg) of estradiol or 0.1 mg of norethindrone or 0.5 mg of estradiol

The use of this medication in children is not recommended for any of the above dose requirements.

Missed Dose

If you miss a dose of this medication, you should take it as soon as you realise you have forgotten. However, if it is close to the next time of your scheduled dose, you should skip the dose you have missed and return to the original dosing schedule that has been advised. Under no circumstances should you double dose.

Interactions

Drug interactions can cause severe side effects and reduce the effectiveness of either drug you are taking. To limit the risk of these side effects, you should give your doctor or healthcare professional a full list of all the medications you are taking or haven taken previously. This list should include all prescription and nonprescription drugs, all vitamins and herbal products. You should also let your doctor know of any other medical conditions you may suffer from as this could increase your risk of interactions. Also, let them know of any medical conditions that run in your family history.

The use of this medication alongside any of the following medications is not recommended. Your doctor may avoid treating you with this drug or alter some of the other drugs you are taking.

  • Tranexamic Acid

The use of this medication alongside these medications it not usually recommend, but in some circumstances, it may be necessary. If you are given both medications at the same time, your doctor may alter the dose or frequency in which you use one or both medications.

  • Conivaptan

The use of this medication with any of the following medications can increase your risk of some side effects, but in some cases, you may need to use both drugs. If you are given both medications at once, your doctor may alter the dose or frequency in which you use one or both of the medications.

  • Ketoconazole

There are over 300 drugs that can interact with this drug, some of them are listed below. It's important to let your doctor know if you are taking any of the drugs listed below.

  • Guaifenesin / oxtriphylline
  • Dapagliflozin / saxagliptin

Other Medical Problems

The presence of other medical conditions can affect the use of this medication. Make sure you let your doctor know if you are suffering from any of the following medical conditions:

  • Abnormal or unusual vaginal bleeding

Proper use

It's extremely important that you use this medication exactly the way you have been directed by your healthcare professional or your doctor. Do not use the medication more often, for a longer period of time or take more of it. If you do so, you can increase your risk of severe and unwanted side effects.

This medication comes with a patient information leaflet. Ensure that you read the instructions carefully and follow them exactly. If you have any questions you seek advice from a medical professional or your own doctor.

To use:

To use the dispenser, begin by turning the inner disc so the current day of the week is in line with the plastic tab. Pull the plastic tab upwards and break it off. Slowly tip the first tablet out.

On the next day, to get the next tablet out, simply turn the outer transparent dial one space clockwise which will be indicated by the arrow. This transparent dial can only be turned after the tablet in the opening has been removed. This technique will help you remember to take one tablet every single day.

Warnings

Allergies

Let your doctor or healthcare professional know if you suffer from any allergic or unusual reactions to this medication or any other medications. You should also let them know of any other allergic reactions you suffer from including animals, food, preservatives or dyes etc.

Use in paediatric population

The use of this drug is not indicated in young children. Therefore safety and efficacy have not yet been established.

Use in geriatric population

Although appropriate studies have not been performed on the relationship of age to the effects of this drug, there has been no indication of a geriatric-specific problem so far. However, elderly patients are more likely to have strokes, breast cancer or suffer from dementia, which may require a degree of caution to be exercised in those older patients who receive this medication.

Use in pregnancy and breastfeeding

This drug is under FDA pregnancy category X. Under no circumstances should you use estradiol and norethindrone if you are pregnant. Inform your doctor immediately if you fall pregnant during treatment.

With regards to breastfeeding, this drug can pass into breast milk during feeding. This medicine can slow breast milk production. Do not use if you are breastfeeding an infant.

It's extremely important that your doctor monitors your progress at regular visits to make sure this medication is working properly and does not produce unwanted effects. Breast exam, pelvic exam, and mammogram (breast x-ray) may be required to check for unwanted side effects unless your doctor has told you otherwise. Make sure you keep all appointments.

It's very unlikely that a postmenopausal woman may fall pregnant. However, you should be aware that the use of this medication whilst you are pregnant, could harm an unborn infant. If you believe you have fallen pregnant while using the medication, let your doctor know immediately.

The use of this medication can increase your risk of stroke, forming blood clots or even heart attacks. This risk can continue even once you have finished using this medication. Your risk is even higher if you suffer from high blood pressure, type 2 diabetes, suffer from high cholesterol or smoke. Inform your doctor or healthcare professional immediately if you experience confusion, chest pain, difficulty speaking, headaches, double vision, an inability to move arms, facial or legs muscle, or an inability to talk.

The use of this medication can increase your risk of a variety of cancers including, uterine cancer, endometrial cancer, and breast cancer. Speak with your doctor or healthcare professional about this risk. Consult with your doctor or healthcare professional right away if you experience abnormal vaginal bleeding.

Don't use this medication if you have had your womb (uterus) removed (hysterectomy).

The use of this medication can increase your risk of dementia. This is particularly true of women who are aged sixty-five years or older.

Check with your doctor or healthcare professional right away if a change in your vision occurs whilst taking this medication such as a severe headache or sudden loss of vision. Your doctor may require you to have your eyes checked by an eye doctor to check for problems and monitor the situation.

Ensure any dentist or doctor knows that you are using this medication. You may be required to stop using this medication before you have surgery or if you need to stay in bed for an extended period of time. This medication could affect the results of some medical tests.

You should avoid drinking or eating grapefruit whilst taking this medication. This is because it can affect the amount of medication that is absorbed into the body. You should also avoid consuming too much caffeine as this can also affect the use of this medication.

Don't take other medicines unless they have been discussed with your doctor.

Storage

This medication should be stored in a closed container away from the heat at room temperature. It should also be kept from moisture and direct light. Don't let this medication freeze. Ensure children have no access to this medication. Do not keep any drugs that you no longer need or have expired. Consult your local pharmacist or healthcare professional for advice on the best way to dispose of medication once you are finished with it.

Summary

When used correctly, drug combination, Estradiol, and Norethindrone are successful in the treatment of a variety of menopause symptoms. This drug is not recommended for the use in children. You should under no circumstances use this drug whilst pregnant or whilst breastfeeding. You should let your doctor know if you fall pregnant whilst taking this drug. Due to a large number of interactions possible with this drug combination, you should let your doctor know of all the different medications you are currently taking and have done in the past. There are a number of other medical conditions that can affect the effectiveness of this medication, so you should let your doctor know if you suffer from any other conditions.