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.

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.

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.

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).

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.

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.