Drospirenone & Ethinyl Estradiol

Drospirenone/ethinyl estradiol is a prescription birth control medication used to prevent pregnancy and to treat premenstrual dysphoric disorder (a mood disorder related to the menstrual cycle). It is a single product containing two hormones, drospirenone and ethinyl estradiol, which belong to a group of drugs called hormonal contraceptives. These hormones prevent pregnancy by stopping ovulation and by altering cervical mucus and the lining of the uterus.

This medication comes in tablet form and is taken once daily, with or without food.

Common side effects include nausea, breast tenderness, and vaginal bleeding between menstrual periods. 

Drospirenone/ethinyl estradiol is a prescription birth control medicine used:

• to prevent pregnancy
• to treat premenstrual dysphoric disorder (PMDD, a mood disorder related to the menstrual cycle)
• to treat acne in women at least 14 years of age who have started having menstrual periods

This medication may be prescribed for other uses.  Ask your doctor or pharmacist for more information.

Drospirenone & Ethinyl Estradiol may be found in some form under the following brand names:

• Gianvi

• Loryna

• Nikki

• Ocella

• Syeda

• Vestura

• Yasmin

• Yaz

• Zarah

Like pregnancy, birth control pills increase the risk of serious blood clots, especially in women who have other risk factors, such as smoking, obesity, or age greater than 35. This increased risk is highest when you first start taking birth control pills and when you restart the same or different birth control pills after not using them for a month or more.

It is possible to die from a problem caused by a blood clot, such as a heart attack or a stroke. Some examples of serious clots are blood clots in the:

• Legs (thrombophlebitis)
• Lungs (pulmonary embolus)
• Eyes (loss of eyesight)
• Heart (heart attack)
• Brain (stroke)

A few women who take birth control pills may get:

• High blood pressure
• Gallbladder problems
• Rare cancerous or noncancerous liver tumors
• All of these events are uncommon in healthy women.

Call your healthcare provider right away if you have:

• Persistent leg pain
• Sudden shortness of breath
• Sudden blindness, partial or complete Severe pain in your chest
• Sudden, severe headache unlike your usual headaches
• Weakness or numbness in an arm or leg, or trouble speaking
• Yellowing of the skin or eyeballs

The most common side effects of birth control pills are:

• Spotting or bleeding between menstrual periods
• Nausea
• Breast tenderness
• Headache
• These side effects are usually mild and usually disappear with time.

Less common side effects are:

• Acne
• Less sexual desire
• Bloating or fluid retention
• Blotchy darkening of the skin, especially on the face
• High blood sugar, especially in women who already have diabetes
• High fat (cholesterol; triglyceride) levels in the blood
• Depression, especially if you have had depression in the past. Call your healthcare provider immediately if you have any thoughts of harming yourself. 
• Problems tolerating contact lenses
• Weight changes

Do Birth Control Pills Cause Cancer?

• Birth control pills do not seem to cause breast cancer. However, if you have breast cancer now, or have had it in the past, do not use birth control pills because some breast cancers are sensitive to hormones.
• Women who use birth control pills may have a slightly higher chance of getting cervical cancer. However, this may be due to other reasons such as having more sexual partners.

If you are currently on daily, long-term treatment for a chronic condition with any of the following medications, you should consult your healthcare provider before taking drospirenone/ethinyl estradiol :

• NSAIDs (ibuprofen, naproxen and others)
• Potassium-sparing diuretics (spironolactone and others)
• Potassium supplementation
• ACE inhibitors (captopril, enalapril, lisinopril and others)
• Angiotensin-II receptor antagonists (Cozaar, Diovan, Avapro and others)
• Heparin
• Aldosterone antagonists

Tell your healthcare provider about all medicines and herbal products that you take. Some other medicines and herbal products may make birth control pills less effective, including:

• Barbiturates
• Bosentan
• Carbamazepine
• Felbamate
• Griseofulvin
• Oxcarbazepine
• Phenytoin
• Rifampin
• St. John’s wort
• Topiramate

Consider using another birth control method when you take medicines that may make birth control pills less effective.

Birth control pills may interact with lamotrigine, an anticonvulsant used for epilepsy. This may increase the risk of seizures, so your healthcare provider may need to adjust the dose of lamotrigine.

WARNING TO WOMEN WHO SMOKE

Do not use drospirenone/ethinyl estradiol  if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects (heart and blood vessel problems) from birth control pills, including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke.

Your healthcare provider will not give you drospirenone/ethinyl estradiol  if you:

Also, do not take birth control pills if you:
• Smoke and are over 35 years old
• Are or suspect you are pregnant

Birth control pills may not be a good choice for you if you have ever had jaundice (yellowing of the skin or eyes) caused by pregnancy (also called cholestasis of pregnancy).
Tell your healthcare provider if you have ever had any of the above conditions (your healthcare provider can recommend another method of birth control).

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of drospirenone/ethinyl estradiol there are no specific foods that you must exclude from your diet when receiving drospirenone/ethinyl estradiol.

Tell your doctor if you:

• ever had blood clots in your legs (deep vein thrombosis), lungs (pulmonary embolism), or eyes (retinal thrombosis)
• ever had a stroke
• ever had a heart attack
• have certain heart valve problems or heart rhythm abnormalities that can cause blood clots to form in the heart
• have an inherited problem with your blood that makes it clot more than normal
• have high blood pressure that medicine can’t control
• have diabetes with kidney, eye, nerve, or blood vessel damage
• ever had certain kinds of severe migraine headaches with aura, numbness, weakness or changes in vision
• ever had breast cancer or any cancer that is sensitive to female hormones
• have liver disease, including liver tumors
• have kidney disease
• have adrenal disease
• smoke and are over 35 years old
• are or suspect you are pregnant
• have ever had jaundice (yellowing of the skin or eyes) caused by pregnancy (also called cholestasis of pregnancy)

Tell your healthcare provider if you have ever had any of the above conditions (your healthcare provider can recommend another method of birth control).

Birth control pills should not be taken during pregnancy. Tell your doctor if you become pregnant while taking drospirenone/ethinyl estradiol.

If you are breastfeeding, consider another birth control method until you are ready to stop breastfeeding. Birth control pills that contain estrogen, like drospirenone/ethinyl estradiol, may decrease the amount of milk you make. A small amount of the pill's hormones pass into breast milk.

• Your chance of getting pregnant depends on how well you follow the directions for taking your birth control pills. The better you follow the directions, the less chance you have of getting pregnant.
• Based on the results of one clinical study, 1 to 2 women out of 100 women, may get pregnant during the first year they use drospirenone/ethinyl estradiol .

How to take drospirenone/ethinyl estradiol:

1. Be sure to read these directions before you start taking your pills or anytime you are not sure what to do.
2. The right way to take the pill is to take one pill every day at the same time in the order directed on the package. Preferably, take the pill after the evening meal or at bedtime, with some liquid, as needed. Drospirenone/ethinyl estradiol can be taken without regard to meals. If you miss pills you could get pregnant. This includes starting the pack late. The more pills you miss, the more likely you are to get pregnant.
3. Many women have spotting or light bleeding at unexpected times, or may feel sick to their stomach during the first 1-3 packs of pills. If you do have spotting or light bleeding or feel sick to your stomach, do not stop taking the pill. The problem will usually go away. If it does not go away, check with your healthcare provider.
4. Missing pills can also cause spotting or light bleeding, even when you make up these missed pills. On the days you take two pills, to make up for missed pills, you could also feel a little sick to your stomach.
5. If you have vomiting (within 3 to 4 hours after you take your pill), you should follow the instructions for "WHAT TO DO IF YOU MISS PILLS." If you have diarrhea or if you take certain medicines, including some antibiotics and some herbal products such as St. John's Wort, your pills may not work as well. Use a back-up method (such as condoms and spermicides) until you check with your healthcare provider.
6. If you have trouble remembering to take the pill, talk to your healthcare provider about how to make pill-taking easier or about using another method of birth control.

Before You Start Taking Your Pills:

1. Decide What Time of Day You Want to Take Your Pill. It is important to take drospirenone/ethinyl estradiol in the order directed on the package at the same time every day, preferably after the evening meal or at bedtime, with some liquid, as needed. Drospirenone/ethinyl estradiol can be taken without regard to meals.

2. Look at Your Pill Pack - It has 28 Pills. The drospirenone/ethinyl estradiol-pill pack has 24 light pink pills (with hormones) to be taken for 24 days, followed by 4 white pills (without hormones) to be taken for the next four days.
3. Also look for:v a) Where on the pack to start taking pills, b) In what order to take the pills (follow the arrows)
4. Be sure you have ready at all times (a) another kind of birth control (such as condoms and spermicides) to use as a back-up in case you miss pills, and (b) an extra, full pill pack.

When To Start the First Pack of Pills:

You have a choice for which day to start taking your first pack of pills. Decide with your healthcare provider which is the best day for you.
Pick a time of day which will be easy to remember.

Day 1 Start:
1. Take the first light pink pill of the pack during the first 24 hours of your period.
2. You will not need to use a back-up method of birth control, since you are starting the Pill at the beginning of your period. However, if you start drospirenone/ethinyl estradiol later than the first day of your period, you should use another method of birth control (such as a condom and spermicide) as a back-up method until you have taken 7 light pink pills.

Sunday Start: 
1. Take the first light pink pill of the pack on the Sunday after your period starts, even if you are still bleeding. If your period begins on Sunday, start the pack that same day.
2. Use another method of birth control (such as a condom and spermicide) as a back-up method if you have sex anytime from the Sunday you start your first pack until the next Sunday (7 days). This also applies if you start drospirenone/ethinyl estradiol after having been pregnant, and you have not had a period since your pregnancy.

When You Switch From a Different Birth Control Pill:

• When switching from another birth control pill, drospirenone/ethinyl estradiol should be started on the same day that a new pack of the previous birth control pill would have been started.

When You Switch From Another Type of Birth Control Method:

• When switching from a transdermal patch or vaginal ring, drospirenone/ethinyl estradiol should be started when the next application would have been due.
• When switching from an injection, drospirenone/ethinyl estradiol should be started when the next dose would have been due.
• When switching from an intrauterine contraceptive or an implant, drospirenone/ethinyl estradiol should be started on the day of removal.

What to Do During the Month:

1. Take one pill at the same time every day until the pack is empty. Do not skip pills even if you are spotting or bleeding between monthly periods or feel sick to your stomach (nausea). Do not skip pills even if you do not have sex very often.
2. When you finish a pack of pills, start the next pack on the day after your last white pill. Do not wait any days between packs.

What to Do if You Miss Pills:

If you miss 1 light pink pill of your pack:
1. Take it as soon as you remember. Take the next pill at your regular time. This means you may take two pills in one day.
2. You do not need to use a back-up birth control method if you have sex. 

If you miss 2 light pink pills in a row in Week 1 or Week 2 of your pack:
1. Take two pills on the day you remember and two pills the next day.
2. Then take one pill a day until you finish the pack.
3. You could become pregnant if you have sex in the 7 days after you restart your pills. You must use another birth control method (such as a condom and spermicide) as a back-up for those 7 days.

If you miss 2 light pink pills in a row in Week 3 or Week 4 of your pack:
1. If you are a Day 1 Starter: Throw out the rest of the pill pack and start a new pack that same day. If you are a Sunday Starter:
Keep taking one pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack of pills that same day.
2. You could become pregnant if you have sex in the 7 days after you restart your pills. You must use another birth control method (such as a condom and spermicide) as a back-up for those 7 days.
3. You may not have your period this month but this is expected. However, if you miss your period two months in a row, call your healthcare provider because you might be pregnant.

If you miss 3 or more light pink pills in a row during any week:
1. If you are a Day 1 Starter: Throw out the rest of the pill pack and start a new pack that same day. If you are a Sunday Starter:
Keep taking 1 pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack of pills that same day.
2. You could become pregnant if you have sex in the 7 days after you restart your pills. You must use another birth control method (such as condoms and spermicides) as a back-up for those 7 days.
3. Call your healthcare provider if you miss your period, because you might be pregnant. If you miss any of the 4 white pills in Week 4:
Throw away the pills you missed. Keep taking one pill each day until the pack is empty. You do not need a back-up method. Finally, if you are still not sure what to do about the pills you have missed: Use a back-up method (such as condoms and spermicides) anytime you have sex.

Take one tablet by mouth at the same time every day. The failure rate may increase when pills are missed or taken incorrectly.

To achieve maximum contraceptive and PMDD effectiveness, drospirenone/ethinyl estradiol must be taken exactly as directed, in the order directed on the blister pack. Single missed pills should be taken as soon as remembered.

If you take too much drospirenone/ethinyl estradiol, call your local Poison Control Center or seek emergency medical attention right away.

• Birth control pills do not protect you against any sexually transmitted disease, including HIV, the virus that causes AIDS.
• Do not skip any pills, even if you do not have sex often.
• If you miss a period, you could be pregnant. However, some women miss periods or have light periods on birth control pills, even when they are not pregnant.

Contact your healthcare provider for advice if you:

• Think you are pregnant
• Miss one period and have not taken your birth control pills every day
• Miss two periods in a row
• You should stop drospirenone/ethinyl estradiol at least four weeks before you have major surgery and not restart it until at least two weeks after the surgery due to an increased risk of blood clots.

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS

Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke.