Norelgestromin and Ethinyl Estradiol (Systemic)

Brand Names : Ortho Evra

Before Using This Medicine

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. If you are using the skin patch contraceptive for contraception you should understand how their benefits and risks compare to those of other birth control methods. This is a decision you, your sexual partner, and your doctor will make. For norelgestromin/ethinyl estradiol, the following should be considered:

Allergies - Tell your doctor if you have ever had any unusual or allergic reaction to estrogens or progestins. Tell your doctor if you have ever had any unusual or reaction to any other hormones. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy - Norelgestromin/ethinyl estradiol is not recommended during pregnancy and should be discontinued if you become pregnant or think you are pregnant. In rare cases when hormonal contraceptives have been taken by mistake early in pregnancy, problems to the fetus have not occurred. Be sure you have discussed this with your doctor.

Breast-feeding - It is not known whether norelgestromin/ethinyl estradiol passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

Children - Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of norelgestromin/ethinyl estradiol in children with use in other age groups. This medicine should not be used before the start of menstruation.

Adolescents - This medicine may be used for birth control in teenage females and has not been shown to cause different side effects or problems than it does in adults. Some teenagers may need extra information on the importance of taking norelgestromin/ethinyl estradiol exactly as prescribed.

Older adults - Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of norelgestromin/ethinyl estradiol in the elderly with use in other age groups.

Other 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 norelgestromin/ethinyl estradiol, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Cyclosporine (e.g., Sandimmune) or
• Prednisolone (e.g., Prelone) or
• Theophylline (e.g., Slo-Phyllin, Theolair-SR) - The amounts of these medicines in your blood may be too high when taken with norelgestromin/ethinyl estradiol.

• Ampicillin or
• Barbiturates (e.g., Amytal, Nembutal) or
• Carbamazepine (e.g., Tegretol) or
• Felbamate (e.g., Felbatol) or
• Griseofulvin (e.g., Fulvicin-P/G) or
• HIV medicines (e.g., Agnerase, Crixivan, Norvir) or
• Oxcarbazepine (e.g., Trileptal) or
• Phenylbutazone (e.g., Butazolidin) or
• Phenytoin (e.g., Dilantin) or
• Rifampin (Rifadin) or
• Topiramate (e.g., Topamax) - Use of these medicines with norelgestromin/ethinyl estradiol may cause your contraceptive to be less effective.

• Hypericum perforatum (e.g., St. John's Wort) - Use of this herbal medicine with norelgestromin/ethinyl estradiol may cause your contraceptive to be less effective or cause vaginal bleeding during your cycle.

• Smoking, tobacco - Smoking may increase the chance of causing serious blood clots, vein, or heart problems.

Other medical problems - The presence of other medical problems may affect the use of norelgestromin/ethinyl estradiol. Make sure you tell your doctor if you have any other medical problems, especially:

• Breast cancer - current or suspected diagnosis or
• Breast cancer - personal history or
• Cancer of the uterus or cervix - Use of hormonal contraceptives may make these conditions worse.

• Jaundice during pregnancy or from using hormonal therapy in the past or
• Liver cancer, disease or tumors - Use of hormonal contraceptives may increase the chance of liver problems or make liver conditions worse.

• Diabetes mellitus (sugar diabetes) - Use of hormonal contraceptives may cause an increase, usually only a small increase, in your blood sugar and usually does not affect the amount of diabetes medicine that you take. You or your doctor will want to test for any changes in your blood sugar.

• Depression or
• Gallbladder disease or
• Heart attack or
• Heart disease, now or in the past or
• High blood pressure or
• Stroke, now or in the past - Use of hormonal contraceptives may cause or worsen these conditions.
• Abnormal or unusual vaginal bleeding - This condition may sometimes be treated with hormone contraceptives, but may make this condition worse.
• Migraine headache, new or worse or a new kind of headache - Use of hormonal contraceptives may cause headaches to be worse.
• Obesity - Use of the transdermal patch may be less effective in women with body weight greater than or equal to 198 pounds (90 kilograms).
• Problems with circulation or blood clots, now or in the past or
• Problems with heart valves or
• Surgery with a long period of inactivity - Use of hormonal contraceptives may increase the chance of blood clots and worsen these conditions.