Brevicon

(Ethinyl Estradiol/Norethindrone)

The active ingredients in Brevicon are ethinyl estradiol (an estrogen) and norethindrone (a progestin). These hormones prevent ovulation, which is the release of an egg from the ovary. It also thickens cervical mucus to make it harder for sperm to reach an egg and changes the lining of the uterus to reduce the chance of pregnancy.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Brevicon. However, the following is a synopsis of the general guidelines for the use of Brevicon:

• Brevicon is taken by mouth once daily, at the same time each day.
• Tablets are taken in a specific order from a pill pack. For a 21-day pack, pills containing hormones are taken for 21 days, followed by a 7-day pill-free interval. For a 28-day pack, take 1 pill every day without a pill-free interval. The last 7 pills of the 28-day pack do not contain hormones. A withdrawal bleed should occur during these 7 days.
• Your healthcare provider will tell you when to start, often on the first day of your menstrual period or the first Sunday after it begins.
• If you miss pills, follow the instructions provided with your pack and use a back-up method, such as condoms or spermicide, if advised by your healthcare provider.
• Starting a new pack late or missing pills may increase the risk of pregnancy.

Some mild or common side effects of Brevicon include:

• Nausea, vomiting, or stomach upset
• Bloating or fluid retention
• Breast tenderness
• Headache
• Breakthrough bleeding or spotting between menstrual periods, or other changes in the menstrual cycle, including amenorrhea (loss of menstrual periods)
• Problems with contact lenses
• Mild weight changes
• Mood changes

Some individuals may experience serious side effects while using Brevicon. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Signs of blood clots, blood clots in the legs (thrombophlebitis), brain (stroke), lungs (pulmonary embolism), or other thromboembolic disorders
• Chest pain, shortness of breath, or symptoms of a heart attack
• Sudden severe headache, vision problems, or weakness on one side of the body, which could be the signs of a stroke
• High blood pressure that is new or worsening
• Signs of liver problems, including yellowing of the skin or eyes
• Unusual vaginal bleeding or heavy bleeding

These are not all of the possible side effects of Brevicon. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Brevicon, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• A history of blood clots, heart disease, or coronary artery disease
• High blood pressure, high cholesterol, or high triglycerides
• Diabetes or glucose control issues
• Liver disease or gallbladder problem
• Breast cancer, endometrial cancer, or other hormone-sensitive cancers
• Obesity or other cardiovascular risk factors
• Migraine headaches with aura
• A history of ovarian cysts
• Plans for long-term use or upcoming surgery
• A mood disorder
• Eye conditions

Boxed Warning

• Cigarette smoking can cause an increased risk of serious cardiovascular side effects like heart attack and stroke if you are taking combination oral contraceptives. This risk increases with age, especially in people over 35 years old, and with heavy smoking. Brevicon should not be used by individuals who smoke and are over 35 years of age.

Brevicon should not be used in the following:

• Allergic reactions to any ingredient in the formulation
• Current or history of deep vein thrombosis (DVT), pulmonary embolism (PE), or other blood-clotting problems
• Stroke, heart attack, or valvular heart disease
• Severe uncontrolled hypertension (high blood pressure)
• Diabetes with vascular complications
• Certain cancers
• Liver disease
• Migraines with aura
• Unexplained vaginal bleeding

Brevicon is also not indicated for use during pregnancy, after menopause, or in people who are over 35 years old and smoke.

When started on the first day of your menstrual period, Brevicon is effective right away. If it is started at another time in your cycle, a back-up method of birth control may be needed for the first 7 days.

When Brevicon is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the risk of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid negative drug interactions, including:

• Certain antibiotics, such as ampicillin and rifampin
• Certain seizure medications, such as phenytoin
• Ritonavir and other antivirals used to treat the hepatitis C virus
• St. John’s Wort and herbal supplements
• Some prescription drugs that affect liver enzymes

Brevicon tablets are available in 0.5mg/35 mcg or 1mg/35 mcg norethindrone/ethinyl estradiol combinations in a fixed-dose pill pack.

Store Brevicon at room temperature, away from excess heat and moisture. Keep the pill pack in its original dispenser and out of reach of children.

Brevicon is manufactured by Pfizer Inc.

Yes, Brevicon is available as a generic. Several brand and generic name versions include Cyonanz, Dasetta, Modicon, Necon, and Norinyl.

You can stop taking Brevicon at any time, but you should talk with your healthcare provider before stopping if you are using it for reasons other than birth control. If you stop, ovulation may return quickly, and another form of contraception should be used if pregnancy is not desired.

Brevicon should not be used during pregnancy. While it should not cause any birth defects if you accidentally take it during early pregnancy, you will no longer need to take it if you become pregnant.

Small amounts of hormones may pass into breast milk. Brevicon may reduce milk production. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.