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Ethinyl Estradiol and Norethindrone (HRT)

Generic name: ethinyl estradiol and norethindrone (HRT) [ETH-in-ill-ESS-tra-DYE-ole-and-nor-ETH-in-drone]

Brand names: Fyavolv, Jinteli, Jevantique Lo HRT
Dosage form:oral tablet (2.5 micrograms-0.5 milligrams; 5 micrograms-1 mg).
Drug classes: contraceptives, sex hormone combinations

What are Ethinyl Estradiol and Norethindrone ?

Ethinyl estradiol is an estrogen. Estrogen, a female hormone essential for many bodily processes, is necessary to maintain sexual function.Norethindrone is a type of progesterone. The female hormone progesterone plays a role in the regulation of menstruation and ovulation.It is used for treating symptoms such as hot flashes or vaginal dryness. This medicine is used for osteoporosis.This medication guide does not list all possible uses for ethinyl estradiol or norethindrone.

Side effects of Ethinyl Estradiol and Norethindrone

If you experience any of the following symptoms of an allergy reaction, seek immediate medical attention: difficulty breathing, hives, swelling in your lips, face, throat, or tongue.

Ethinyl estradiol and norethindrone can cause severe side effects. If you experience:

  • Heart attack symptoms: chest pain, pressure or pain in your shoulder or jaw, nausea, and sweating.
  • Increased blood pressure; severe headache; blurred vision; or pounding of the neck and ears anxiety. Nosebleed.
  • Signs of a stroke: sudden numbness, weakness, or headache (especially on one side), slurred or mumbled speech, or problems with balance or vision;
  • Signs of blood clots: sudden vision loss, chest pain that stabs, shortness of breath, blood in the cough, or pain or heat in both legs.
  • You may experience swelling in the stomach or tenderness.
  • Jaundice
  • Unusual vaginal bleeding and pelvic pain
  • Breast lumps;
  • Memory problems, confusion, or unusual behaviors;
  • High levels of calcium are accompanied by nausea, vomiting, and constipation. Other symptoms include muscle weakness, pain in the bones, fatigue, or increased thirst.

Some of the common side effects associated with ethinyl estradiol or norethindrone include:

  • Stomach pain;
  • Bloating, swelling, and weight gain
  • Breast pain
  • Light vaginal bleeding;
  • Hair loss on the scalp

There may be other side effects. For medical advice on side effects, call your doctor. Please contact the FDA by dialing their phone number: 1-800-FDA-1088 to report side effects.

Warnings

This medicine should be avoided if: you are pregnant, have undiagnosed vaginal bleeds, have liver disease or bleeding disorders, will undergo major surgery, or have had heart attacks, strokes, blood clots, cancer of the breast, uterus/cervix, or vagina.Avoid using it if pregnant.This medication may increase the risk that you will develop a condition that may result in uterine carcinoma. Do not ignore any abnormal vaginal bleeding.This medicine should not be taken to treat strokes or dementia.

Before you take this drug

If you're allergic to either ethinyl estradiol or have any of the following:

  • Unusual vaginal bleeding not checked by your doctor
  • Liver disease
  • A bleeding disorder;
  • Anxiety about heart attacks, strokes or blood clots;
  • A history of cancers of the breast, uterus, cervix, or vagina

Avoid using it if pregnant. Inform your doctor immediately if you are pregnant while on treatment.This medicine increases your risk of blood clots and strokes. This medicine can increase your risk of blood clots, strokes, and heart attacks.This medicine can actually increase the risk of heart disease, stroke, or dementia.

If you've ever:

  • Heart disease
  • If you have liver disease or jaundice due to pregnancy, taking hormones, or being pregnant,
  • Kidney disease
  • Hereditary Angioedema
  • Asthma;
  • Epilepsy
  • Migraines;
  • Porphyria
  • A thyroid disease;
  • Calcium levels in the blood can be high or low.

Use of ethinyl estradiol or norethindrone can increase the risk of breast cancer, uterine cancer, and ovarian carcinoma. Speak to your doctor regarding this potential risk.This medication can reduce the production of breast milk. Inform your doctor that you are breastfeeding.

How to take Ethinyl Estradiol and Norethindrone ?

Read all the instructions or guides that come with your medication and follow all the directions. Follow the directions on your prescription label.Take this medication at the same time each day.Norethindrone and ethinyl estradiol may raise your chances of getting uterine carcinoma. Your doctor might also recommend that you take progesterone to help reduce this risk. Any unusual bleeding in the vaginal area should be reported immediately.You should have your doctor check on you regularly (every three to six months) in order to decide whether or not to continue the treatment. You should self-examine for lumps in your breasts every month and get regular mammograms.You may have to temporarily stop taking this medication if you are going through major surgery or if you will need long-term rest. You should let any doctor who treats you know that you use ethinyl estradiol or norethindrone.Keep away from heat and moisture at room temperature.

Details on dosage

Adult dose for contraception:

Take 1 tablet once daily, orally.
Comment: Take the medication at the same time each day.

Adult dosage for postmenopausal symptoms:

Take 1 tablet once daily, orally.
Comment: Some preparations may not be indicated to treat vasomotor symptoms due to the menopause. The manufacturer's product information is the best source of guidance.
Menopause symptoms: moderate to severe vasomotor symptoms

Adult dose for acne:

Take 1 tablet once daily, orally.
Comment: Some preparations may not be indicated to treat acne. Please consult the product information provided by the manufacturer.
Use: To treat moderate acne vulgaris among females who are menstruating and have not responded to anti-acne topical medications.

Adult dose for prevention of osteoporosis:

Take 1 tablet once daily, orally.
Comments:
Not all products are recommended for osteoporosis prevention after menopause. Please consult the product information provided by the manufacturer.
When prescribing only for the prevention of postmenopausal osteoporosis, the therapy should only be considered by women who are at high risk for osteoporosis. Non-estrogen medications should also be carefully considered.
Preventive osteoporosis after menopause

The usual pediatric dose for contraception is:

Take 1 tablet once daily, orally.
Comment: Take the medication at the same time each day.

The usual pediatric dose for acne is:

If you are 15 or older, take 1 tablet once daily.
Comments:
Not all products are suitable for treating acne. Please consult the product information provided by the manufacturer.
Use should only be for acne treatment if the patient wants to use an oral contraceptive for birth control and intends to continue using it for at least 6 months.
Use: To treat moderate acne vulgaris among females aged 15 or older who are not contraindicated to oral contraceptive treatment, have reached menarche, and do not respond to anti-acne topical medications.

What happens if you miss the dose?

If you are almost due for the next dose, skip the missed one. Never take more than one dose at a time.

What happens if I overdose?

Call the Poison Help Line at 1-800-222-1222 or seek emergency medical care. Overdose symptoms include nausea, vomiting, or vaginal blood.

What should be avoided?

Smoking is harmful. You can increase your chances of heart attacks, blood clots, and strokes when you use ethinyl estradiol or norethindrone.

Grapefruit can cause unwanted side effects when combined with norethindrone or ethinyl estradiol. Use grapefruit-based products sparingly.

Interaction with other drug

It is sometimes not safe to take certain drugs at the same time. Some medications can cause side effects that increase or decrease the effectiveness of another drug you are taking.Also, other drugs, such as vitamins and herbal remedies, may interact with ethinyl estradiol or norethindrone. Inform your doctor of all the medicines you are currently taking and those that you have started or stopped using.

DRUG STATUS

Availability

Prescription only

Pregnancy & Lactation

CSA Schedule*
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