Ethinyl estradiol and Norgestimate

Ethinyl estradiol and norgestimate are prescription medications, a combination of birth control pills containing female hormones that prevent ovulation (the release of an egg from an ovary).

• Ethinyl estradiol and Norgestimate are available under various brand names: Estarylla, Femynor, Mili, Mono-Linyah, Mononessa, Ortho Tri-Cyclen, Ortho Tri-Cyclen Lo, Ortho-Cyclen, Previfem, Sprintec, Tri Femynor, Tri-Estarylla, Tri-Linyah, Tri-Lo-Estarylla, Tri-Lo-Marzia, Tri-Lo-Mili, Tri-Lo-Sprintec, Tri-Mili, TriNessa, TriNessa Lo, Tri-Previfem, Tri-Sprintec, Tri-VyLibra, Tri-VyLibra Lo, VyLibra

Common side effects of Ethinyl estradiol and Norgestimate include:

• stomach pain, gas, nausea, vomiting.
• breast tenderness.
• acne, and darkening of facial skin.
• headache, nervousness, and mood changes.
• problems with contact lenses.
• Weight change.
• breakthrough bleeding.
• vaginal itching or discharge; or
• rash.

Serious side effects of Ethinyl estradiol and Norgestimate include:

• hives.
• difficult breathing.
• swelling of your face, lips, tongue, or throat.
• signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance.
• signs of a blood clot--sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs.
• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating.
• liver problems--loss of appetite, upper stomach pain, tiredness, fever, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
• severe headache, pounding in your neck or ears.
• swelling in your hands, ankles, or feet.
• changes in the pattern or severity of migraine headaches.
• a breast lump; or
• symptoms of depression--sleep problems, weakness, tired feeling, mood changes.

Rare side effects of Ethinyl estradiol and Norgestimate 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, Monophasic (Estarylla, Femynor, Mili, MonoNessa, Previfem, Sprintec)

• Days 1-21: 0.25mg/35mcg
• Days 22-28: Inert tablets

Tablet, Triphasic (Ortho Tri-Cyclen, Tri-Estarylla, TriFemynor, Tri-Mili, Trinessa, Tri-Sprintec, Tri-Previfem)

• Days 1-7: 0.18mg/35mcg
• Days 8-14: 0.215mg/35mcg
• Days 15-21: 0.25mg/35mcg
• Days 22-28: Inert tablets

Tablet, Triphasic (Ortho Tri-Cyclen Lo, Tri-Lo-Estarylla, Tri-Lo-Marzia, Tri-Lo-Mili)

• Days 1-7: 0.18mg/25mcg
• Days 8-14: 0.215mg/25mcg
• Days 15-21: 0.25mg/25mcg
• Days 22-28: Inert tablets

Contraception

• Sunday starter: 1 hormonally active tablet daily for 21 days, then 1 inert tablet daily for 7 days; cycle repeated; start Sunday after the onset of menstruation; if menstrual period occurs on Sunday, start that very same day; take additional method of contraception until after first 7 days of consecutive administration
• Day 1 starter: Take the first dose on the day of the menstrual cycle and continue to take 1 tablet daily
• 21-tablet package: Take 1 tablet for 21 days followed by 7 days off the medication
• 28-tablet package: Take 1 tablet daily without interruption

Missed dose monophasic

• One dose missed: Take a dose as soon as remembered or take 2 tablets the next day
• Two consecutive doses missed: Take 2 tablets as soon as remembered or 2 tablets next two days; use an additional method of contraception for 7 days after the missed dose
• Two consecutive doses missed in week three or three doses missed at any time: Use an additional method of contraception for 7 days after the missed dose
• Start a new pack of two doses is missed in the third week or three doses are missed at any time as follows
• Sunday starter: Continue daily dose until Sunday, then discard the rest of the pack and start a new pack that same day
• Day 1 starter: Discard the current pack and start a new pack that same day
• Missed dose biphasic/triphasic formulations
• One dose missed: Take a dose as soon as remembered or take 2 tablets the next day
• Two consecutive doses missed in week 1 or 2 of the pack: Take 2 tablets as soon as remembered and 2 tablets the next day; continue taking 1 tablet daily until the pack is empty; use an additional method of contraception for 7 days after the missed dose
• Two consecutive doses missed in week three of the pack: Use an additional method of contraception for 7 days after the missed dose
• Start a new pack of two doses missed in week 3 of the pack
• Sunday starter: Continue daily dose until Sunday, then discard the rest of the pack and start a new pack that same day
• Day 1 starter: Discard the current pack and start a new pack that same day

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.

• Norgestimate/Ethinyl Estradiol has severe interactions with the following drugs:
  • ombitasvir/paritaprevir/ritonavir & dasabuvir (DSC)
  • tranexamic acid oral
• Norgestimate/Ethinyl Estradiol has serious interactions with the following drugs:
  • abametapir
  • amobarbital
  • anastrozole
  • apalutamide
  • armodafinil
  • atazanavir
  • belzutifan
  • bosentan
  • brigantineib
  • butabarbital
  • Calasparrase pegol
  • carbamazepine
  • conivaptan
  • darunavir
  • dexamethasone
• Norgestimate/Ethinyl Estradiol has moderate interactions with at least 131 other drugs.
• Norgestimate/Ethinyl Estradiol has minor interactions with at least 27 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 the products you use. 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, myocardial infarction [MI]), thrombophlebitis, DVT/pulmonary embolism (PE), thrombogenic valvular disease
• Estrogen-dependent neoplasia
• Liver disease, liver tumors
• Undiagnosed abnormal uterine bleeding
• Uncontrolled hypertension (.g, persistent BP values above160 mm Hg systolic or below100 mg Hg diastolic)
• Diabetes mellitus with vascular involvement
• Jaundice with previous oral contraceptive use
• Receiving hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir
• Women above 35 years who smoke
• Cerebrovascular and/or coronary artery disease, disease, headaches with focal neurological symptoms, migraine headaches with aura, or migraine headaches if above 35 years of age

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Norgestimate/Ethinyl Estradiol?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Norgestimate/Ethinyl Estradiol?”

Cautions

• Use caution in the family history of breast cancer and or DVT/PE, current or previous depression, endometriosis, diabetes mellitus, hypertension, bone mineral density changes, renal or hepatic impairment, bone metabolic disease, systemic lupus erythematosus (SLE), conditions exacerbated by fluid retention (.g, migraine, asthma, epilepsy)
• Monitor prediabetic and diabetic women on therapy; consider an alternate contraceptive method for women with uncontrolled dyslipidemia
• Headache: Evaluate significant change in headaches and discontinue therapy if indicated
• Women with a history of hypertension or hypertension-related diseases or renal disease should be encouraged to use another method of contraception
• Discontinue if any of the following develop: Jaundice, visual problems (may cause contact lens intolerance), signs of venous thromboembolism, 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 or oral anticoagulants: Increase in anticoagulant dosage may be warranted
• Some studies link oral contraceptive use with increased risk of breast cancer, whereas others do not; risk depends on conditions where naturally high hormone levels persist for long periods, including early-onset menstruation (Children below12 years), late-onset menopause (Adults above 55 years), first child after age 30 years, nulliparity
• Increased risk of cervical cancer with oral contraceptive use, however, human papillomavirus (HPV) remains the primary risk factor for this cancer
• Long-term (above5years) use of oral contraceptives may be associated with increased risk
• Increased risk of liver cancer with oral contraceptive use; risk increases with duration of use
• 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
• Chloasma is associated with combination hormonal contraceptives, as well as pregnancy and sun exposure; avoid sun exposure or ultraviolet radiation during therapy
• The risk of cholestasis increased with prior history of cholestasis with prior contraceptive use or previous cholestasis of pregnancy
• Combination hormonal contraceptives may adversely affect lipid levels; consider alternative contraception for women with uncontrolled dyslipidemia
• Retinal vascular thrombosis reported in patients receiving estrogens; discontinue medication pending examination if there is a sudden partial or complete loss of vision, or a sudden onset of proptosis, diplopia, or migraine; if examination reveals papilledema or retinal vascular lesions, estrogens should be discontinued
• Breakthrough or tetracyclic bleeding and spotting may occur, especially during the first 3 months of therapy; missed periods may also occur occasionally; evaluate and rule out malignancy if irregular or unresolving vaginal bleeding occurs
• There are, possible risks that may be associated with the use of progestins with estrogens compared to estrogen-alone regimens, including a possible increased risk of breast cancer, adverse effects on lipoprotein metabolism (.g., lowering HDL, raising LDL), and impairment of glucose tolerance
• The risk of ovarian or endometrial cancer decreased in women using combination hormonal contraceptives
• May increase the risk of gallbladder disease or may worsen gallbladder disease
• Use of combination hormonal contraceptives associated with hepatic adenomas; rupture may cause fatal intra-abdominal hemorrhage; long-term use may be associated with increased risk of hepatocellular carcinoma
• Estrogens may induce or exacerbate symptoms in women with hereditary angioedema
• The risk of hypertension may be increased with age, dose, and duration of use; not for use in women with hypertension and vascular disease
• The use of combination hormonal contraceptives is not recommended in women with complicated organ transplants; medical complications reported

Pregnancy and Lactation

• Do not use it in pregnancy. The risks involved outweigh the potential benefits. Safer alternatives exist.

Lactation: 

• Small amounts of steroids are excreted in breast milk; estrogens may reduce the quality or quantity of milk; may be prudent to use other forms of birth control until full weaning (American Academy of Pediatrics committee states that agent is compatible with nursing); not recommended.
• Do not use this product without medical advice if you are breastfeeding.