Norelgestromin-Ethinyl Estradiol

Norelgestromin-Ethinyl Estradiol is a transdermal contraceptive patch used for the prevention of pregnancy.

• Norelgestromin-Ethinyl Estradiol is available under the following different brand names: Xulane, Ortho Evra (DSC)

Common side effects of Norelgestromin-Ethinyl Estradiol include:

• Breast tenderness,
• Darkening of facial skin,
• Nausea,
• Vomiting,
• Breakthrough bleeding,
• Skin irritation, redness, itching, or swelling where the patch was worn,
• Headache,
• Menstrual cramps,
• Anxiety, and   
• Mood changes

Serious side effects of Norelgestromin-Ethinyl Estradiol include:

• Hives,
• Difficulty breathing,
• Swelling of the face, lips, tongue, or throat,
• Sudden numbness or weakness (especially on one side of the body),
• Sudden severe headache,
• Slurred speech,
• Problems with vision or balance,
• Sudden vision loss,
• Stabbing chest pain,
• Shortness of breath,
• Coughing up blood,
• Pain or warmth in one or both legs,
• Chest pain or pressure,
• Pain spreading to the jaw or shoulder,
• Nausea,
• Sweating,
• Loss of appetite,
• Upper stomach pain,
• Tiredness,
• Dark urine,
• Clay-colored stools,
• Yellowing of the skin or eyes (jaundice),
• Severe headache,
• Pounding in the neck or ears,
• Change in the pattern or severity of migraine headaches,
• Swelling in the hands, ankles, or feet,
• Breast lump,
• Sleep problems,
• Weakness,
• Tired feeling, and
• Mood change

Rare side effects of Norelgestromin-Ethinyl Estradiol include:

• None 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Transdermal patch

Delivers (150 mcg/35 mcg)/24 hours.

Contraception

• Adult dosage
• One patch applied to the skin each week for 3 weeks (days 1, 8, & 15), then off for 1 week (days 22-28); repeat the cycle.
• Initial treatment: Apply patch on 1st day of menstruation (day 1); if applied after 1st day, use an additional form of contraception for 7 days
• Switching from OC: Apply on 1st day of withdrawal bleeding; if applied after 1st day, use an additional form of contraception for 7 days
• After 1st trimester abortion: Begin treatment immediately; if not started within 5 days, use an additional form of contraception for 7 days
• If the Patient Forgets to Change the Patch
  • At the start of the patch cycle: Apply a new patch immediately, count it as "day 1" of the cycle, and use an additional form of contraception for 7 days.
  • In the middle of the patch cycle
  • Below 48 hours: Apply a new patch immediately, then the next patch on the usual "Patch Change Day."
  • Above 48 hours: Apply new patch immediately, count as "day 1" of the cycle, and use an additional form of contraception for 7 days
• If Patch Partially or Completely Detached
  • Below 24 hours: Reapply to the same place, or replace with a new patch immediately.
  • Above 24 hours: Apply new patch immediately, count as "day 1" of the cycle.
  • Above 1 week: Rule out pregnancy before restarting treatment; use an additional form of contraception for 7 days

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Norelgestromin-Ethinyl Estradiol has severe interactions with the following drugs.
  • ombitasvir/paritaprevir/ritonavir & dasabuvir (DSC)
  • tranexamic acid oral
• Norelgestromin-Ethinyl Estradiol has serious interactions with at least 62 other drugs.
• Norelgestromin-Ethinyl Estradiol has moderate interactions with at least 151 other drugs.
• Norelgestromin-Ethinyl Estradiol has minor interactions with at least 31 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Documented hypersensitivity
• Active or history of breast cancer
• Arterial thromboembolic disease (stroke, MI), thrombophlebitis, DVT/PE, thrombogenic valvular disease
• Estrogen-dependent neoplasia
• Liver disease, liver tumors
• Undiagnosed abnormal vaginal bleeding
• Uncontrolled hypertension
• Diabetes mellitus with vascular involvement
• Jaundice with prior oral contraceptive use

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Norelgestromin-Ethinyl Estradiol?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Norelgestromin-Ethinyl Estradiol?”

Cautions

• Family history of breast cancer and or DVT/PE, current/history of depression, endometriosis, DM, HTN, bone mineral density changes, renal/hepatic impairment, bone metabolic disease, SLE; conditions exacerbated by fluid retention (. g, migraine, asthma, epilepsy)
• Discontinue if the following develop jaundice, visual problems (may cause contact lens intolerance), any signs of VTE, migraine with unusual severity, significant blood pressure increase, severe depression, and increased risk of thromboembolic complications after surgery.
• Discontinue 4 weeks before major surgery or prolonged immobilization.
• Patients on warfarin, oral anticoagulants (increase in anticoagulant dose may be warranted)
• Some studies link OCP use with an increased risk of breast cancer, whereas other studies have not shown a change in risk; a woman's risk depends on conditions where naturally high hormone levels persist for long periods including early onset menstruation before age 12, late onset menopause, after age 55, first child after age 30, nulliparity.
• Increased risk of cervical cancer with OCP use, however, HPV remains a main risk factor for this cancer; evidence suggests long-term use of OCPs, 5 or more years, may be associated with increased risk.
• Increased risk of liver cancer with OCP use; risk increases with longer duration of OCP use
• Risk of venous thromboembolism (VTE) is highest in the first year of use; the risk may increase when combined hormonal contraceptives are re-started after a break in the use of 4 weeks or longer.
• CDC guidelines recommend waiting at least 3 weeks following vaginal birth or 6 weeks after cesarean section to decrease the risk for venous thromboembolism before initiating combined hormonal contraceptives; women with additional risk factors for VTE (besides postpartum) should not use combined hormonal contraceptives (MMWR July 7, 2011)

Pregnancy and Lactation

• Do not use it during pregnancy.
• Lactation
  • Small amounts of steroids are excreted in breast milk; estrogens may reduce the quality/quantity of milk; may be prudent to use other forms of birth control until full weaning (AAP Committee states compatible with nursing)