Drospirenone and estetrol

Generic name: Drospirenone And Estetrol
Brand names: Nextstellis
Dosage form: oral tablet (3 mg-14.2 mg)
Drug class: Contraceptives

Usage of Drospirenone and estetrol

Drospirenone and estetrol is a combination hormonal birth control that is used to prevent pregnancy.

Drospirenone and estetrol may also be used for purposes not listed in this medication guide.

Drospirenone and estetrol side effects

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

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg pain or swelling, feeling short of breath.

Drospirenone and estetrol may cause serious side effects. Call your doctor at once if you have:

unusual vaginal bleeding, irregular or missed periods;

jaundice (yellowing of the skin or eyes);

a change in the pattern or severity of migraine headaches;

a breast lump;

symptoms of depression--sleep problems, weakness, tired feeling, mood changes;

high blood potassium--nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement; or

low blood potassium--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common side effects of drospirenone and estetrol may include:

irregular or painful periods;

breast pain or tenderness;

mood changes;

headache;

acne;

weight gain; or

decreased interest in sex.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking Drospirenone and estetrol

Using hormonal birth control can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, or if you are overweight. Your risk of stroke or blood clot is highest during your first year of using birth control. Your risk is also high when you restart this medicine after not using for 4 weeks or longer.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. Your risk increases the older you are and the more you smoke. You should not use this medicine if you smoke and are over 35 years old.

You should not use hormonal birth control if you have:

untreated or uncontrolled high blood pressure;

high blood pressure with blood vessel problems;

heart problems (heart valve disorder or heart rhythm disorder);

a history of heart attack, stroke, or blood clot;

an increased risk of having blood clots due to a hereditary blood disorder;

diabetes (and you've had diabetes longer than 20 years, or if diabetes has caused damage to your kidneys, eyes, nerves, or blood vessels);

a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina;

unusual vaginal bleeding that has not been checked by a doctor;

adrenal gland problems;

liver disease or liver cancer;

kidney disease or kidney failure;

severe migraine headaches with aura;

if you are overweight and have a BMI (body mass index) of 35 or higher; or

if you take any hepatitis C medication containing ombitasvir/paritaprevir/ritonavir (Viekira), with or without dasabuvir.

Tell your doctor if you have ever had:

diabetes;

high cholesterol or triglycerides;

depression; or

jaundice caused by pregnancy.

Do not use if you are pregnant and stop taking drospirenone and estetrol if you become pregnant.

Drospirenone and estetrol can slow breast milk production. Ask a doctor if it is safe to breastfeed while using this medicine.

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How to use Drospirenone and estetrol

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Read and follow all Instructions for Use. Ask your doctor or pharmacist if you need help.

drospirenone and estetrol comes in pills of 2 different colors. Take a pink (active) pill every day for 24 days in a row, and then take a white (inactive) pill for the next 4 days in a row. Then start a new pack and repeat this daily cycle.

Take the medicine at the same time each day.

When you first start using drospirenone and estetrol, you may need to use back-up birth control such as a condom, diaphragm, cervical cap, or contraceptive sponge.

You may have breakthrough bleeding, especially during the first 4 months. Tell your doctor if this bleeding continues or is very heavy.

Your blood pressure will need to be checked often.

Tell your doctor if you have a planned surgery.

Store at room temperature away from moisture and heat. Remove a pill from the pack only when you are ready to take your daily dose.

Warnings

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. You should not use drospirenone and estetrol if you smoke and are older than 35 years of age.

What other drugs will affect Drospirenone and estetrol

Tell your doctor about all your current medicines. Many drugs can affect drospirenone and estetrol, especially:

aprepitant;

bosentan;

phenobarbital or other barbiturates;

lamotrigine;

St. John's wort;

an antibiotic--clarithromycin, rifabutin, rifampin, rifapentine, telithromycin;

antifungal medicine--fluconazole, griseofulvin, itraconazole, ketoconazole, voriconazole;

antiviral medicine for HIV or hepatitis C--boceprevir, boceprevir, efavirenz, etravirine, indinavir, nelfinavir, nevirapine, ritonavir, telaprevir;

cancer medicine--apalutamide, enzalutamide, mitotane;

a diuretic or "water pill"--amiloride, eplerenone, Spironolactone;

seizure medicine--Carbamazepine, felbamate, oxcarbazepine, phenytoin, topiramate; or

steroid medicine--dexamethasone, prednisone.

This list is not complete and many other drugs may affect drospirenone and estetrol. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Disclaimer

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