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Ortho Evra instructions


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Ortho Evra instructions

Generic Name: Ethinyl Estradiol and Norelgestromin

Brand Name: Ortho Evra

The following product information is not intended to replace the physician's or manufacturer's instructions.

Warning:
Smoking cigarettes while using this medication increases your chance of having heart problems. Do not smoke while using this medication. The risk of heart problems increases with age (women greater than 35 years of age) and with frequent smoking (15 cigarettes per day or greater).

Ortho Evra common medical uses:
Ortho Evra is a skin patch that is effective as a contraceptive (birth control). This product combines natural or synthetic estrogens and progestins, similar to the natural sex hormones (estrogen and progesterone) produced in a woman's body. Ethinyl estradiol is an estrogen and norelgestromin is a progestin. This patch keeps you from becoming pregnant by delivering continuous levels of these hormones through the skin and into the bloodstream. This patch can also help regulate menstrual flow, treat acne or may be used for other hormone-related problems in females. Using this medication patch does not protect you or your partner against sexually transmitted diseases (STDs).

How to use Ortho Evra:
Follow carefully the directions that come with the patches. Ortho Evra patches are for use on the skin. Do not try to cut or trim the patch. Apply the patch to a clean, dry, intact healthy skin area on the buttock, abdomen, upper outer arm or upper torso, in a place where it won't be rubbed by tight clothing. Only one patch should be worn at a time. Do not place on skin that is red, irritated or cut, and do not place on the breasts. To prevent problems with the stickiness of the patch, no makeup, creams, lotions, oils, powders or other topical products should be applied to the skin area where the patch is or will be placed. Using your palm, press the patch firmly in place for 10 seconds to make sure that there is good contact with your skin. The patch is worn for 7 days. Change the patch every 7 days on the proper 'patch change day', keeping to a regular schedule. When you apply a new patch, use a new area of skin. To avoid skin irritation, apply each new patch to a different place on the skin. Repeat this weekly cycle for 3 weeks (3 patches equal 1 cycle). After your third patch is removed, you will have one week without using the patch. Your menstrual cycle (period) usually should start during the week when you do not use the patch. If your menstrual cycle (period) does not begin during this week, consult your doctor. After your 4th week, begin a new patch cycle, even if you still are experiencing some bleeding (still having your period). Do not go longer than 7 days without a patch. If the medication patch accidentally comes off, is removed, or if it becomes detached, apply a new patch. If it is detached or comes off for longer than 24 hours, or if you are not sure how long the patch has been detached or removed, use additional forms of birth control for at least 7 days and continue with the same cycle.

Ortho Evra side effects:
Cigarette smoking increases the risk of serious cardiovascular side effects, especially if you are over 35. Women who use hormonal contraceptives are strongly advised not to smoke.

Along with its needed effects, a medicine may cause some unwanted effects. Severe side effects are relatively rare in women who are healthy and do not smoke while they are taking hormone-containing contraceptives. Many of the minor side effects may go away as your body adjusts to the medicine. However, the potential for severe side effects does exist. If you experience any of the following serious side effects, stop using Ortho Evra and seek emergency medical attention or contact your doctor immediately:

  • allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face)
  • sharp chest pain, coughing blood or sudden shortness of breath (possible blood clot in the lung)
  • pain in the calf (possible blood clot in the leg)
  • crushing chest pain or heaviness in the chest (possible heart attack)
  • sudden severe headache or vomiting, dizziness, faintness or problems with vision or speech, weakness or numbness in an arm or leg (possible stroke)
  • sudden partial or complete loss of vision (possible clot in the eye)
  • changes in blood sugar
  • yellowing of the skin or whites of the eyes (jaundice), especially with fever, tiredness, loss of appetite, dark colored urine, or light colored bowel movements (possible liver problems)
  • severe pain, swelling, or tenderness in the abdomen (gallbladder or liver problems)
  • irregular vaginal bleeding or spotting that happens in more than 1 menstrual cycle or lasts for more than a few days
  • swelling (edema) of the fingers or ankles
  • new or changing breast lumps.

Report to your doctor if any of the following less serious side effects continue or are bothersome: headache or dizziness; changes in menstrual cycle or breast tenderness; changes in weight or appetite; water retention; intolerance to contact lenses; changes in skin color. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

Ortho Evra precautions:
Tell your doctor if you have the following medical conditions: blood clots; blood sugar problems, like diabetes; ; cancer of the breast, cervix, ovary, uterus, vagina, or unusual vaginal bleeding that has not been evaluated by a health care professional; depression; fibroids; gallbladder disease; heart disease or circulation problems; high blood pressure; jaundice; liver disease; menstrual problems; migraine headaches; stroke; an unusual or allergic reaction to estrogens, progestins, other hormones, medicines, foods, or preservatives; pregnant or trying to get pregnant; breast-feeding. If you have any unusual vaginal bleeding contact your health care professional for advice. If you miss a period, the possibility of pregnancy must be considered. See your doctor as soon as you can. To ensure adequate protection, use an additional method of contraception (like condoms, diaphragm or spermicide) during the first cycle that you use this patch. If you stop using this patch and want to get pregnant, a return to normal ovulation can take some time. You may not return to normal ovulation and fertility for 3 to 6 months. Discuss your pregnancy plans with your doctor. If you are taking hormone-based contraceptives for the treatment of acne, hirsutism (male-like hair growth), endometriosis or other hormone related problems, it may take several months of continued treatment to notice improvement in your symptoms or condition. Tobacco smoking increases the risk of getting a blood clot or having a stroke while you are taking this medicine, especially if you are more than 35 years old. You are strongly advised not to smoke. This contraceptive can increase your sensitivity to the sun and you may burn more easily. Use sunscreen and protective clothing during long periods outdoors. Tanning booths should be used with caution.If you are near-sighted or wear contact lenses, you may develop vision problems or may have problems wearing your contact lenses. Contact your eye doctor if these problems occur. You may get a vaginal yeast infection. If you have never had a yeast infection before, see your prescriber or other health care provider to confirm the problem. If you have had yeast infections in the past and are comfortable with self-medicating the problem, get and use a nonprescription medication to treat the yeast infection. If you are going to have elective surgery, you may need to stop using this contraceptive patch one month beforehand. Consult your health care professional for advice prior to scheduling the surgery.

Drug Interactions:
Many drugs can interact with Ortho Evra, resulting in side effects or decreased effectiveness of the medicine. Tell your doctor of all prescription and nonprescription medication you may use, especially:

  • anti-seizure medicine (carbamazepine, felbamate, phenobarbital, phenytoin, topiramate)
  • certain antibiotics (ampicillin, erythromycin)
  • HIV protease inhibitors (indinavir, ritonavir)
  • phenylbutazone
  • griseofulvin
  • atorvastatin
  • azole antifungals (itraconazole, ketoconazole)
  • rifampin
  • St John's wort
  • cyclosporine
  • temazepam
  • prednisolone
  • morphine
  • theophylline
  • ascorbic acid (vitamin C)
  • acetaminophen
  • aspirin
  • clofibric acid
  • modafinil
  • troglitazone

This product can affect the results of certain lab tests (blood tests such as glucose, clotting factors, or thyroid). Make sure laboratory personnel and your doctors know you use this product. Do not start or stop any medicine without doctor or pharmacist approval.

Overdose:
Overdose with this product is highly unlikely. If overdose is suspected, remove the patch (or patches) and contact your local poison control center or emergency room immediately. This medicine device may be harmful if swallowed. Symptoms of overdose may include: severe nausea, vomiting, unusual vaginal bleeding or irregular menstrual periods.

Missed dose:
If you forget to apply a patch at the start of any cycle, week one (Day 1), you could become pregnant. You must use back-up contraception, (condom, spermicide, diaphragm) for one week. Apply the first patch of a new cycle as soon as you remember. You now have a new 'Patch Change Day' and a new Day 1. If you forget to change a patch for one or two days in Week two or Week three, apply a new patch as soon as you remember. Apply the next patch on your normal 'Patch Change Day'. No back-up contraception is needed. If you forget to change a patch for more than two days in Week two or Week three, you could become pregnant. Start a new four week cycle as soon as you remember by putting on a new patch. You now have a new 'Patch Change Day' and a new Day 1. You must use back-up contraception for the first 7 days of your new cycle. If you forget to remove a patch at the end of Week four, take it off as soon as you remember. Start your next cycle on your normal 'Patch Change Day'. No back-up contraception is needed.

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