Ortho Evra

DRUG DESCRIPTION

ORTHO EVRA® is a combination transdermal contraceptive patch with a contact surface area of 20 cm?. It contains 6.00 mg norelgestromin (NGMN) and 0.75 mg ethinyl estradiol (EE). Systemic exposures (as measured by area under the curve [AUC] and steady state concentration [Css]) of NGMN and EE during use of ORTHO EVRA® are higher and peak concentrations (Cmax) are lower than those produced by an oral contraceptive containing norgestimate 250 mcg / EE 35 mcg. (See BOLDED WARNING; CLINICAL PHARMACOLOGY, Transdermal versus Oral Contraceptives).

ORTHO EVRA® is a thin, matrix-type transdermal contraceptive patch consisting of three layers. The backing layer is composed of a beige flexible film consisting of a low-density pigmented polyethylene outer layer and a polyester inner layer. It provides structural support and protects the middle adhesive layer from the environment. The middle layer contains polyisobutylene/polybutene adhesive, crospovidone, non-woven polyester fabric and lauryl lactate as inactive components. The active components in this layer are the hormones, norelgestromin and ethinyl estradiol. The third layer is the release liner, which protects the adhesive layer during storage and is removed just prior to application. It is a transparent polyethylene terephthalate (PET) film with a polydimethylsiloxane coating on the side that is in contact with the middle adhesive layer.

The outside of the backing layer is heat-stamped “ORTHO EVRA®.”

The structural formulas of the components are:

Norelgestromin Structural Formula Illustration

Molecular weight, norelgestromin: 327.47
Molecular weight, ethinyl estradiol: 296.41

Chemical name for norelgestromin: 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-,3-oxime,(17?)

Chemical name for ethinyl estradiol: 19-Norpregna-1,3,5(10)-trien-20-yne-3,17diol,(17?)

What are the possible side effects of ethinyl estradiol and norelgestromin (Ortho Evra)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using the patches and call your doctor at once if you have any of these serious side effects:

  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, pain behind the eyes, problems with vision, speech, or balance;
  • chest pain or heavy feeling, pain spreading to the arm or...

Read All Potential Side Effects and See Pictures of Ortho Evra »

What are the precautions when taking norelgestromin, ethinyl estradiol (Ortho Evra)?

See also Warning section.

Before using this medication patch, tell your doctor or pharmacist if you are allergic to any of its ingredients; or to other estrogens or progestins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: history of stroke or other blood clots (e.g., in the legs, eyes, lungs), severe high blood pressure, abnormal breast exam, breathing problems (e.g., asthma), cancer (especially endometrial or breast cancer), diabetes that has caused kidney/eye/nerve/blood vessel disease,...

Read All Potential Precautions of Ortho Evra »


Ortho Evra Consumer (continued)

SIDE EFFECTS: Vaginal bleeding between periods (spotting) may commonly occur during the first few months of use. If this bleeding is persistent or unusually heavy, contact your doctor. Nausea, vomiting, headache, redness/irritation at the application site, dizziness, breast tenderness/enlargement, vaginal discomfort/irritation, increased vaginal discharge, missed/irregular periods, acne, or stomach cramping/bloating may occur. If you miss 2 periods in a row (or 1 period if the patch has not been used properly), talk to your doctor about a pregnancy test. If any of these effects persist or worsen, notify your doctor.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: changes in vaginal bleeding (e.g., continuous spotting, sudden heavy bleeding, missed periods), unwanted facial/body hair (hirsutism), dark patches on the skin (melasma), mental/mood changes (e.g., depression, suicidal thoughts, persistent trouble sleeping), swelling of the ankles/feet, weight changes (gain or loss), problem wearing contact lenses.

This medication may rarely cause serious (sometimes fatal) blood clot problems (e.g., thrombosis, pulmonary embolism, stroke, heart attack). The risk for blood clots may be higher for the birth control patch than for the pill. Seek immediate medical attention if you experience: tingling/weakness/numbness in the arms/legs, pain/swelling/warmth in the groin/calf, chest/jaw/left arm pain, confusion, coughing up blood, sudden shortness of breath, sudden dizziness/fainting, weakness on one side of the body, vision problems/changes, slurred speech, sudden severe headaches, headaches that are different from those you may have experienced in the past (e.g., headaches with other symptoms such as vision changes/lack of coordination, existing migraines becoming worse).

Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: lumps in the breast, severe stomach/abdominal/pelvic pain, yellowing eyes/skin, unusual tiredness, dark urine.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: See also Warning section.

Before using this medication patch, tell your doctor or pharmacist if you are allergic to any of its ingredients; or to other estrogens or progestins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: history of stroke or other blood clots (e.g., in the legs, eyes, lungs), severe high blood pressure, abnormal breast exam, breathing problems (e.g., asthma), cancer (especially endometrial or breast cancer), diabetes that has caused kidney/eye/nerve/blood vessel disease, severe headaches, history of heart disease (e.g., heart attack, chest pain), heart valve disease, kidney problems, liver problems (e.g., liver tumor), current or suspected pregnancy, seizure, recent major surgery, long periods of sitting or lying down (e.g., immobility such as being bedridden), history of yellowing eyes/skin (jaundice) during pregnancy or while using birth control pills, unexplained vaginal bleeding, heavy tobacco use (especially if 35 or over).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: high cholesterol or triglyceride (blood fat) levels, depression, diabetes, high blood pressure, fluid retention (edema), gallbladder problems, migraine, obesity, irregular/missed/very light periods, recent pregnancy, thyroid problems.

Do not smoke cigarettes. Hormonal birth control (e.g., pills, injections, devices) products combined with smoking cigarettes significantly increase your risk for stroke, blood clots, high blood pressure, and heart attacks, especially in women older than 35. For more details, ask your doctor or pharmacist or consult the Patient Information Leaflet that comes with this product.

Notify your doctor beforehand if you will be having surgery or will be confined to a chair/bed for a long time (e.g., a long plane flight). You may need to stop the medication for a time or take special precautions in these circumstances while you are using this drug.

The drugs in this patch may cause blotchy, dark areas on your skin (melasma). Sunlight may intensify this effect. If this occurs, avoid prolonged sun exposure, use a sunscreen, and wear protective clothing when outdoors.

If you are nearsighted 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.

This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor immediately. If you have just given birth or had a pregnancy loss/abortion after the first 3 months, talk with your doctor about reliable forms of birth control, and find out when it is safe to start using birth control that contains a form of estrogen, such as this medication.

The medication from this patch passes into breast milk and may have undesirable effects on the nursing infant. Consult your doctor before breast-feeding.


Ortho Evra Patient Information Including Side Effects

Brand Names: Ortho Evra

Generic Name: ethinyl estradiol and norelgestromin (Pronunciation: EH thi nil ESS tra DYE ol and nor ell JESS tro min)

  • What is ethinyl estradiol and norelgestromin (Ortho Evra)?
  • What are the possible side effects of ethinyl estradiol and norelgestromin (Ortho Evra)?
  • What is the most important information I should know about ethinyl estradiol and norelgestromin (Ortho Evra)?
  • What should I discuss with my healthcare provider before using ethinyl estradiol and norelgestromin (Ortho Evra)?
  • How should I use ethinyl estradiol and norelgestromin (Ortho Evra)?
  • What happens if I miss a dose (Ortho Evra)?
  • What happens if I overdose (Ortho Evra)?
  • What should I avoid while using ethinyl estradiol and norelgestromin (Ortho Evra)?
  • What other drugs will affect ethinyl estradiol and norelgestromin (Ortho Evra)?
  • Where can I get more information?

What is ethinyl estradiol and norelgestromin (Ortho Evra)?

Ethinyl estradiol and norelgestromin contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Ethinyl estradiol and norelgestromin are used as contraception to prevent pregnancy.

Ethinyl estradiol and norelgestromin may also be used for other purposes not listed in this medication guide.

What are the possible side effects of ethinyl estradiol and norelgestromin (Ortho Evra)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using the patches and call your doctor at once if you have any of these serious side effects:

  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, pain behind the eyes, problems with vision, speech, or balance;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • a change in the pattern or severity of migraine headaches;
  • stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);
  • swelling in your hands, ankles, or feet;
  • a breast lump; or
  • symptoms of depression (sleep problems, weakness, mood changes).

Less serious side effects:

  • mild nausea, vomiting, bloating, stomach cramps;
  • breast pain, tenderness, or swelling;
  • freckles or darkening of facial skin;
  • increased hair growth, loss of scalp hair;
  • changes in weight or appetite;
  • problems with contact lenses;
  • vaginal itching or discharge;
  • changes in your menstrual periods, decreased sex drive; or
  • headache, nervousness, dizziness, tired feeling.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about ethinyl estradiol and norelgestromin (Ortho Evra)?

Do not use this medication if you are pregnant or if you have recently had a baby.

Do not use this medication if you have a history of stroke or blood clot, circulation problems (especially if caused by diabetes), a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, severe high blood pressure, migraine headaches, a heart valve disorder, or a history of jaundice caused by birth control pills.

Using hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.

Many drugs can interact with birth control medication, and some can make it less effective. Tell your doctor about all other medications you are using.

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