Norgestrel-Ethinyl Estradiol

Norgestrel-Ethinyl Estradiol is a combination birth control pill containing female hormones that prevent ovulation. 

• Norgestrel-Ethinyl Estradiol is available under the following different brand names: Cryselle, Low-Ogestrel, Elinest, Ogestrel

Common side effects of Norgestrel-Ethinyl Estradiol include:

• nausea (especially while taking for the first time Lo/Ovral-28),
• vomiting,
• headache,
• stomach cramping,
• bloating,
• dizziness,
• vaginal discomfort/irritation/itching,
• increased vaginal fluids/discharge,
• breast tenderness or enlargement,
• nipple discharge,
• freckles or darkening of facial skin,
• increased hair growth,
• loss of scalp hair,
• changes in weight or appetite,
• problems with contact lenses, or
• decreased sex drive.

Serious side effects of Norgestrel-Ethinyl Estradiol include:

• sudden numbness or weakness, especially on one side of the body.
• sudden and severe headache, confusion, problems with vision, speech, or balance.
• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling.
• sudden cough, wheezing, rapid breathing, coughing up blood.
• pain, swelling, warmth, or redness in one or both legs.
• a change in the pattern or severity of migraine headaches.
• upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• swelling in your hands, ankles, or feet.
• a breast lump.
• or symptoms of depression (sleep problems, weakness, tired feeling, mood changes).

Rare side effects of Norgestrel-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 such as fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheartedness, 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

Tablet

• 0.3 mg/ 30 mcg (Cryselle, Elinest, Lo-Ogestrel, Lo/Ovral)
• 0.5 mg/ 50 mcg (Ogestrel)

Contraception

Adult dosage

• Start on day 1 of the menstrual cycle or Sunday following the start of the cycle
• 1 hormonally active tablet orally for 21 days, then 7 tablet-free days (or inert tablets as supplied); repeat the cycle

Initiating after Pregnancy

Adult dosage

• Initiating after vaginal birth: Wait at least 3 weeks
• Initiating after cesarean section birth: Wait at least 6 weeks
• Women with other risk factors for VTE in addition to postpartum: Do not use combined hormonal contraceptives

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.

• Norgestrel-Ethinyl Estradiol has severe interactions with the following drugs
  • ombitasvir/paritaprevir/ritonavir & dasabuvir (DSC)
  • tranexamic acid oral
• Norgestrel-Ethinyl Estradiol has serious interactions with at least 70 other drugs.
• Norgestrel-Ethinyl Estradiol has moderate interactions with at least 127 other drugs.
• Norgestrel-Ethinyl Estradiol has minor interactions with at least 24 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 health care 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
• Carcinoma of the endometrium
• Liver disease, liver tumors
• Undiagnosed abnormal vaginal bleeding
• Uncontrolled hypertension
• Cerebral vascular or coronary artery disease
• Diabetes mellitus with vascular involvement, jaundice with prior oral contraceptive use
• Receiving hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir

Effects of drug abuse

• None

Short-Term Effects

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

Long-Term Effects

• See “What Are Side Effects Associated with Using Norgestrel-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, 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)
• Increased risk of cervical cancer with OCP use, however, HPV remains the 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
• 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)
• May experience spotting, amenorrhea, and unscheduled bleeding, especially during the first 3 months of therapy; evaluate unscheduled or breakthrough bleeding that persists or occurs after regular cycles to rule out malignancy or pregnancy; after discontinuing OCP, may experience oligomenorrhea or amenorrhea
• Sun exposure, a combination of hormonal contraceptives, and pregnancy may trigger chloasma; patients should avoid sun exposure or ultraviolet radiation if susceptible to chloasma or at risk
• Increased risk of cholestasis associated with the history of cholestasis with prior OCP use or prior cholestasis of pregnancy
• Discontinue use and evaluate for retinal thrombosis if unexplained loss of vision, papilledema, proptosis, or diplopia occurs
• Combination hormonal therapy may adversely affect lipid levels, including serum triglycerides; the risk of pancreatitis may increase in patients with hypertriglyceridemia or a family history of hypertriglyceridemia; in uncontrolled hyperlipidemia, consider alternative contraception
• Use of combination hormonal contraceptives is associated with hepatic adenomas; fatal intra-abdominal hemorrhage may occur with rupture; rare hepatocellular carcinoma associated with long-term use of OCP
• Therapy is not recommended in patients with acute viral hepatitis or during a flare; the severity of cirrhotic fibrosis or hepatocellular carcinoma has not been shown to increase with continued use of hormonal combination therapy or to trigger liver failure or hepatic dysfunction
• Risk of cardiovascular disease may increase in patients at risk, including high LDL, low HDL, high triglycerides, patients who smoke, or with diabetes; use caution
• Use caution in patients with diabetes; therapy may impair glucose tolerance; therapy may have limited effect on long-term effects on diabetes control and insulin needs in patients with nonvascular disease
• Based on the severity of the condition, evaluate patients for contraceptive use, if there is concomitant neuropathy, nephropathy, retinopathy, diabetes above 20 years, or another vascular disease
• Combination hormonal contraceptive has been associated with an increased risk of gallbladder disease and may also worsen existing disease
• Hereditary angioedema may become exacerbated in patients with hereditary angioedema
• Hormonal combination therapy is not recommended in patients with complicated organ transplants; limited data suggest serious medical complications, including rejection, graft failure, cardiac allograft vasculopathy, requiring discontinuation of hormonal combination therapy
• Therapy may increase the risk of heart disease, VTE, and stroke in patients with systemic lupus erythematosus (SLE); should not be used in patients with SLE who have positive antiphospholipid antibodies as it may increase the risk of arterial and venous thrombosis
• Discontinue hormonal therapy before starting therapy with a combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; may restart approximately 2 weeks following completion of treatment with a combination drug regimen
• Breast cancer
  • Epidemiology studies have not found a consistent association between the use of combined oral contraceptives (COCs) and breast cancer risk; studies do not show an association between ever (current or past) use of COCs and risk of breast cancer
  • Some studies report a small increase in the risk of breast cancer among current or recent users (below 6 months since last use) and current users with a longer duration of COC use
  • 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

Pregnancy and Lactation

• There is little or no increased risk of birth defects in children of females who inadvertently use COCs during early pregnancy
• Discontinue use if pregnancy is confirmed
• Do not administer COCs to induce withdrawal bleeding as a test for pregnancy; do not use COCs during pregnancy to treat threatened or habitual abortion
• Lactation
  • Contraceptive hormones and/or metabolites are present in human milk in small amounts; effects of therapy on a breastfed child are unknown; COCs can reduce milk production in lactating women
  • Advise the nursing mother to use non-COC contraception, when possible until she has weaned her child; this is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women
  • The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on the breastfed child from the drug or underlying maternal condition