Estradiol and dienogest

Generic name: Estradiol And Dienogest
Drug class: Contraceptives

Usage of Estradiol and dienogest

Estradiol valerate and dienogest combination is used to prevent pregnancy. It is a birth control pill that contains two types of hormones, estrogens and progestins and, when taken properly, prevents pregnancy. It works by stopping a woman's egg from fully developing each month. The egg can no longer accept a sperm and fertilization is prevented.

Estradiol valerate and dienogest combination is also used to treat heavy menstrual bleeding that is not caused by any diagnosed conditions of the uterus (womb) in women who choose to use birth control pills.

No contraceptive method is 100 percent effective. Birth control methods such as having surgery to become sterile or not having sex are more effective. Discuss with your doctor your options for birth control.

Estradiol valerate and dienogest combination does not prevent AIDS or other sexually transmitted diseases. It will not help as emergency contraception, such as after unprotected sexual contact.

This medicine is available only with your doctor's prescription.

Estradiol and dienogest side effects

Along with its needed effects, a medicine 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:

More common

Breast pain, discomfort, or tenderness

headache, severe and throbbing

irregular menstrual periods

nausea

normal menstrual bleeding occurring earlier, possibly lasting longer than expected

vomiting

Rare

Abdominal or stomach pain

chills

clay-colored stools

dark urine

difficulty with breathing

dizziness

fever

headache

itching

loss of appetite

pain in the chest, groin, or legs, especially the calves

rash

slurred speech

sudden loss of coordination

sudden, severe weakness or numbness in the arm or leg

sudden, unexplained shortness of breath

unpleasant breath odor

unusual tiredness or weakness

vision changes

vomiting of blood

yellow eyes or skin

Incidence not known

Abdominal or stomach bloating

anxiety

blood in the stool

chest pain or discomfort

decrease in the amount of urine

fainting

hives

irritation

itching of the vagina or genitals

joint pain, stiffness, or swelling

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

noisy, rattling breathing

pain in the ankles or knees

pain or discomfort in the arms, jaw, back, or neck

pain, redness, or swelling in the arm or leg

painful, red lumps under the skin, mostly on the legs

pelvic pain

pounding in the ears

redness of the skin

shortness of breath

slow or fast heartbeat

stomach or pelvic discomfort, aching, or heaviness

sweating

swelling of the eyelids, face, lips, hands, lower legs, or feet

thick, white vaginal discharge with mild or no odor

tightness in the chest

troubled breathing at rest

troubled breathing or swallowing

upper right abdominal or stomach pain

weight gain

wheezing

Some side effects 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:

Less common

Blemishes on the skin

increased weight

pimples

Incidence not known

Patchy brown or dark brown discoloration of the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before taking Estradiol and dienogest

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies on the relationship of age to the effects of estradiol valerate and dienogest combination have not been performed in the pediatric population. However, pediatric-specific problems that would limit the usefulness of this medication in teenagers are not expected. This medicine may be used for birth control in teenage females but is not indicated before the start of menstruation.

Geriatric

Appropriate studies on the relationship of age to the effects of estradiol valerate and dienogest combination have not been performed in the geriatric population. This medicine is not indicated for use in elderly women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Tranexamic Acid

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abametapir

Amifampridine

Amoxicillin

Ampicillin

Amprenavir

Apalutamide

Aprepitant

Armodafinil

Artemether

Bacampicillin

Belzutifan

Betamethasone

Bexarotene

Bosentan

Bupropion

Carbamazepine

Carbenicillin

Cefaclor

Cefadroxil

Cefdinir

Cefditoren

Cefixime

Cefpodoxime

Cefprozil

Ceftazidime

Ceftibuten

Cefuroxime

Cenobamate

Ceritinib

Clobazam

Cloxacillin

Colesevelam

Conivaptan

Cyclacillin

Cyclosporine

Dabrafenib

Darunavir

Dexamethasone

Dicloxacillin

Donepezil

Doxycycline

Efavirenz

Elagolix

Elvitegravir

Encorafenib

Enzalutamide

Eslicarbazepine Acetate

Etravirine

Fedratinib

Fexinidazole

Fosamprenavir

Fosaprepitant

Fosnetupitant

Fosphenytoin

Griseofulvin

Guar Gum

Isotretinoin

Itraconazole

Ivosidenib

Lesinurad

Lixisenatide

Lorlatinib

Lumacaftor

Mavacamten

Meropenem

Minocycline

Mitapivat

Mitotane

Mobocertinib

Modafinil

Mycophenolate Mofetil

Mycophenolic Acid

Nafcillin

Nelfinavir

Netupitant

Nevirapine

Octreotide

Oxacillin

Oxcarbazepine

Oxytetracycline

Penicillin G

Penicillin G Procaine

Penicillin V

Phenobarbital

Phenylbutazone

Phenytoin

Pitolisant

Pixantrone

Prednisolone

Prednisone

Primidone

Red Clover

Rifabutin

Rifampin

Rifapentine

Ritonavir

Rufinamide

Secobarbital

Somatrogon-ghla

St John's Wort

Sugammadex

Sultamicillin

Tazemetostat

Telaprevir

Tetracycline

Theophylline

Ticarcillin

Tigecycline

Tirzepatide

Tizanidine

Topiramate

Ulipristal

Valproic Acid

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Amitriptyline

Atazanavir

Clomipramine

Diazepam

Doxepin

Ginseng

Imipramine

Lamotrigine

Levothyroxine

Licorice

Lorazepam

Selegiline

Tacrine

Temazepam

Tipranavir

Triazolam

Troleandomycin

Voriconazole

Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Caffeine

Relate drugs

How to use Estradiol and dienogest

To make using hormonal contraceptives as safe and reliable as possible, you should understand how and when to use them and what effects may be expected.

This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

This medicine is available in blister packs. Each blister pack contains 28 tablets with different colors that need to be taken in the same order as directed on the blister pack.

When you begin using this medicine, your body will require at least 9 days to adjust before a pregnancy will be prevented. Use a second form of contraception, such as a condom, spermicide, or diaphragm, for the first 9 days of your first cycle of pills.

Take this medicine at the same time each day, such as after the evening meal or at bedtime. Do not skip or delay taking your pill by more than 12 hours. If you miss a dose, you could get pregnant. Ask your doctor for ways to help you remember to take your pills, or about using another method of birth control.

You may have light bleeding or spotting when you first take the pill.

You may feel sick or nauseous, especially during the first few months that you take this medicine. If your nausea is continuous and does not go away, call your doctor.

If you vomit or have diarrhea within 3 to 4 hours of taking this medicine, follow the instructions in the patient leaflet or call your doctor.

If you are switching from a combination hormonal method (e.g., another pill, patch, vaginal ring) to using Natazia®, take the first dark yellow pill on the first day of your period. If you do not start your period, see your doctor for a pregnancy test. If you have used a vaginal ring or patch, take the pill on the day the ring or patch is removed. You must also use a second method of birth control (e.g., condom, diaphragm, spermicide) for the first 9 days you take this medicine.

If you are switching from a progestin-only method (e.g., progestin-only pill, implant, injection, intrauterine system) to using Natazia®, take the first dark yellow pill on the day you would have taken your next progestin-only pill, or on the day your implant or IUD is removed, or on the day you would have your next injection. You must also use a second method of birth control (e.g., condom, diaphragm, spermicide) for the first 9 days you take this medicine.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Your doctor may ask you to begin your dose on the first day of your menstrual period (called Day 1). When you begin on a certain day it is important that you follow that schedule, even if you miss a dose. Do not change your schedule on your own. If the schedule that you use is not convenient, check with your doctor about changing it.

For oral dosage form (tablets):

For contraception (to prevent pregnancy) and to treat heavy menstrual bleeding:

Adults and teenagers—One tablet taken at the same time each day for 28 days.

Children—Use and dose must be determined by your doctor.

Missed Dose

Call your doctor or pharmacist for instructions.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Warnings

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and does not cause unwanted effects. These visits will usually be every 12 months, but some doctors require them more often.

Although you are using this medicine to prevent pregnancy, you should know that using this medicine while you are pregnant could harm the unborn baby. If you suspect that you may be pregnant, stop using this medicine immediately and check with your doctor.

Vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is sometimes called spotting when slight, or breakthrough bleeding when heavier.

If this should occur, continue with your regular dosing schedule.

The bleeding usually stops within 1 week. Check with your doctor if the bleeding continues for more than 1 week.

If bleeding continues after you have been taking hormonal contraceptives on schedule and for more than 3 months, check with your doctor.

Check with your doctor right away if you miss a menstrual period. Missed periods may occur if you skip one or more tablets and have not taken your pills exactly as directed. If you miss two periods in a row, talk to your doctor. You might need a pregnancy test.

Do not use this medicine if you smoke cigarettes or if you are over 35 years old. If you smoke while using birth control pills, you increase your risk of having a heart attack, stroke, or blood clot. Your risk is even higher if you are over age 35, if you have diabetes, high blood pressure, high cholesterol, or if you are overweight. Talk with your doctor about ways to stop smoking. Keep your diabetes under control. Ask your doctor about diet and exercise to control your weight and blood cholesterol level.

Stop using this medicine and check with your doctor right away if you have pain in the chest, groin, or legs, especially the calves, difficulty with breathing, a sudden, severe headache, slurred speech, a sudden, unexplained shortness of breath, a sudden loss of coordination, or vision changes while using this medicine.

Check with your doctor immediately if you have problems wearing contact lenses or if blurred vision, difficulty with reading, or any other change in vision occurs during or after treatment. Your eyes need to be checked by an ophthalmologist (eye doctor).

Stop using this medicine and check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may not work as well in women who are overweight. If you gain a lot of weight after you start taking this medicine, ask your doctor if you should change to another type of birth control pill.

Check with your doctor before refilling an old prescription, especially after a pregnancy. You will need another physical examination and your doctor may change your prescription.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or certain medical tests.

This medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's wort) or vitamin supplements.

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.