Uses
What is norgestimate/ethinyl estradiol used for?
Norgestimate/ethinyl estradiol is a combination birth control pill (oral contraceptive) used to prevent pregnancy in women. Norgestimate/ethinyl estradiol contains 2 types of hormones: norgestimate (a progestin) and ethinyl estradiol (an estrogen).
Norgestimate/ethinyl estradiol (Tri-Mili) is used to prevent pregnancy and to treat acne vulgaris on your skin in women 15 years of age or older who have had their first menstrual period (menarche) and have decided that they want to be on birth control for pregnancy prevention.
Norgestimate/ethinyl estradiol may also be used for other conditions as determined by your healthcare provider.
How does norgestimate/ethinyl estradiol work (mechanism of action)?
Norgestimate/ethinyl estradiol works for pregnancy prevention in a few ways. Norgestimate/ethinyl estradiol stops ovulation, changes your cervical mucus which prevents sperm cells from entering your uterus, and causes changes in the tissue that lines the uterus (endometrium) which reduces the chances of a fertilized egg implanting in your uterus.
Norgestimate/ethinyl estradiol (Tri-Mili) works for acne by increasing a protein called sex-hormone binding globulin (SHBG) and lowering testosterone levels.
How is norgestimate/ethinyl estradiol supplied (dosage forms)?
Norgestimate/ethinyl estradiol is available as Estarylla, Mili, Mono-linyah, Previfem, Sprintec, Tri-Estarylla, Tri-Linyah, Tri-Lo-Estarylla, Tri-Lo-Linyah, Tri-Lo-Mili, Tri-Lo-Sprintec, Tri-Mili, Tri-Sprintec, and generic norgestimate/ethinyl estradiol in the following dosage forms that are taken by mouth.
- norgestimate and ethinyl estradiol oral tablets (0.25 mg/0.035 mg)
- norgestimate and ethinyl estradiol oral tablets (0.25 mg/0.035 mg; 0.215 mg/0.035 mg; 0.18 mg/0.035 mg)
- norgestimate and ethinyl estradiol oral tablets (0.25 mg/0.025 mg; 0.215 mg/0.025 mg; 0.18 mg/0.025 mg)
How should I store norgestimate/ethinyl estradiol?
Norgestimate/ethinyl estradiol should be stored at room temperature, between 68 F to 77 F (20 C to 25). Store in a cool, dry place. Protect from light.
Side Effects
What are the most common side effects of norgestimate/ethinyl estradiol?
The most common side effects of norgestimate/ethinyl estradiol are listed below. Tell your healthcare provider if you have any of these side effects that bother you.
- Headache/migraine (see below)
- Stomach pain, nausea, or vomiting
- Breast issues (breast discomfort, breast tenderness, breast pain, nipple pain, breasts becoming bigger, breast discharge)
- Unusual changes in mood or depression (see below)
- Weight changes or bloating
- Painful or irregular periods
- Acne
- Vaginal yeast infection or vaginal discharge
- Tiredness
There may be other side effects of norgestimate/ethinyl estradiol that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What are the serious side effects of norgestimate/ethinyl estradiol?
While less common, the most serious side effects of norgestimate/ethinyl estradiol are described below, along with what to do if they happen.
Severe Allergic Reactions. Norgestimate/ethinyl estradiol may cause allergic reactions, which can be serious. Stop using norgestimate/ethinyl estradiol and get help right away if you have any of the following symptoms of a serious allergic reaction.
- Breathing problems or wheezing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching, skin rash, or pale red bumps on the skin called hives
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
Blood Clots. Norgestimate/ethinyl estradiol may cause blood clots in your veins or arteries and could cause venous thromboembolism (VTE), stroke, heart attack, or a blood clot in the lungs (pulmonary embolism). Stop using norgestimate/ethinyl estradiol and get emergency help right away if you have any of the following signs of blood clots.
- Chest pain or pressure
- Fast or abnormal heartbeat
- Trouble breathing
- Pain in your back, jaw, throat, or arm
- Sweating, upset stomach, vomiting, or dizziness
- Sudden weakness on one side of your body
- Sudden and severe headache
- Slurred speech or trouble understanding speech
- Pain, swelling, or tenderness in your arm or leg
- Vision loss
- Bulging eyes
- Double vision
Increased Blood Pressure (Hypertension). Norgestimate/ethinyl estradiol may increase your blood pressure or make it worse if you have a history of high blood pressure. Stop using norgestimate/ethinyl estradiol and call your healthcare provider if your blood pressure increases significantly while taking this medicine.
If you measure your blood pressure and the top number (systolic) is 180 mm Hg or higher or the bottom number (diastolic) is 120 mm Hg or higher, stop taking norgestimate/ethinyl estradiol and get medical attention right away. Increases in blood pressure may not be noticeable but look out for any of the following symptoms of severely high blood pressure.
- Sudden severe headache
- Chest pain
- Dizziness or confusion
- Trouble breathing
- Nausea/vomiting
- Blurry or other changes to vision
- Anxiety
- Buzzing in the ears
- Nosebleed
- Feeling of skipped heart beats
Jaundice. Norgestimate/ethinyl estradiol may cause changes to your liver function, which could cause jaundice. Stop taking norgestimate/ethinyl estradiol and call your healthcare provider right away if your skin or the whites of your eyes turn yellowish in color, as this may be a symptom of jaundice.
Headache/Migraine. Stop taking norgestimate/ethinyl estradiol and call your healthcare provider right away if you develop new headaches/migraines that keep coming back or cause you a lot of pain.
Depression. Norgestimate/ethinyl estradiol may cause changes in mood, including depression. Stop taking norgestimate/ethinyl estradiol and call your healthcare provider right away if you have new or increased feelings of anxiety, depression, or other unusual changes in mood or behavior.
Warnings & Precautions
Who should not use norgestimate/ethinyl estradiol?
Allergies to Ingredients. People who are allergic to any of the following should not use norgestimate/ethinyl estradiol.
- Norgestimate
- Ethinyl estradiol
- Tri-Mili
- Mili
- Tri-Lo-Mili
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in the specific norgestimate/ethinyl estradiol products they stock.
Drug Interactions. Norgestimate/ethinyl estradiol should not be taken while you are using certain other medicines. Before taking norgestimate/ethinyl estradiol, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.
Pregnancy. Do not take norgestimate/ethinyl estradiol if you are pregnant. If you become pregnant, contact your healthcare professional right away. See the Pregnancy section for more details.
Smoking. Norgestimate/ethinyl estradiol should not be taken if you are 35 years of age or older and if you smoke, as this can increase your chances of having blood clots.
History of Blood Clots. Norgestimate/ethinyl estradiol should not be taken if you currently have or have had a history of deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, heart attack, or have blood clots/blood vessel damage from diabetes.
Blood and Blood Vessel Problems. Norgestimate/ethinyl estradiol should not be taken if you have a condition that makes your blood more prone to getting blood clots (hypercoagulation). Norgestimate/ethinyl estradiol should not be taken if you have plaque buildup in your blood vessels (coronary artery disease) or if you have a condition that affects the blood flow to your brain (cerebrovascular disease).
Diabetes. Norgestimate/ethinyl estradiol should not be taken if you have diabetes with kidney, eye, nerve, or blood vessel damage.
Heart Problems. Norgestimate/ethinyl estradiol should not be taken if you currently have or have had a history of heart rhythm problems (such as atrial fibrillation) or heart valve problems, as this may increase your chances of having a blood clot.
Increased Blood Pressure (Hypertension). Norgestimate/ethinyl estradiol should not be taken if you have high blood pressure that is not controlled or high blood pressure with a condition that affects your blood vessels (vascular disease).
Headaches/Migraines. Norgestimate/ethinyl estradiol should not be taken if you have migraines with vision or hearing changes, muscle weakness, tingling, or speaking problems (aura) or certain types of headaches. Norgestimate/ethinyl estradiol should not be taken if you are 35 or older with migraine headaches (with or without aura).
Liver Tumors or Problems. Norgestimate/ethinyl estradiol should not be used if you have hepatic adenoma (a non-cancerous tumor on your liver), hepatocellular carcinoma (cancerous tumor on the liver), acute hepatitis (inflammation of the liver), or decompensated cirrhosis (scar tissue on your liver).
Spotting. Norgestimate/ethinyl estradiol should not be taken if you are bleeding between your monthly periods without any specific causes. Tell your healthcare provider if you are bleeding between your monthly periods while on norgestimate/ethinyl estradiol. Your healthcare provider will find out why this is happening and may do tests to determine if you are able to take this medicine.
Breast Cancer. Norgestimate/ethinyl estradiol should not be taken if you have or have had breast cancer.
What should I know about norgestimate/ethinyl estradiol before using it?
Read the Instructions for Use when taking norgestimate/ethinyl estradiol for the first time and for instructions on how to take norgestimate/ethinyl estradiol if you’ve missed a dose.
Norgestimate/ethinyl estradiol does not protect against human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), or other sexually transmitted infections (STIs).
Do not take norgestimate/ethinyl estradiol if you smoke and are 35 years of age or older. Smoking while taking norgestimate/ethinyl estradiol can increase your chances of having heart and blood vessel problems, which can include blood clots, heart attack, or stroke. Your risk increases as you get older and the number of cigarettes you smoke.
Norgestimate/ethinyl estradiol comes in a blister pack with 28 tablets that are separated into different colors. Take tablets in order (from left to right) at the same time every day until the pack is finished. After taking the last tablet in the blister pack, start with the first tablet in a new blister pack. Talk to your healthcare provider about backup contraception options (condoms, spermicide).
Your periods may be irregular, lighter and/or shorter than usual while you are on norgestimate/ethinyl estradiol. If you miss your period and have not taken norgestimate/ethinyl estradiol as directed, call your healthcare provider right away.
Do not take norgestimate/ethinyl estradiol unless it has been prescribed to you by a healthcare provider. Take it as prescribed.
Do not share norgestimate/ethinyl estradiol with other people, even if they have the same condition as you. It may harm them.
Keep norgestimate/ethinyl estradiol out of the reach of children.
What should I tell my healthcare provider before using norgestimate/ethinyl estradiol?
Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if norgestimate/ethinyl estradiol is right for you.
In particular, make sure that you discuss any of the following.
Major Surgeries. Talk to your healthcare provider about any upcoming surgeries. Taking norgestimate/ethinyl estradiol may increase your risk of blood clots after surgery. Your healthcare provider may stop norgestimate/ethinyl estradiol if you are about to have major surgery and may not start you on it right away after your surgery. If your healthcare provider decides to stop norgestimate/ethinyl estradiol because of an upcoming surgery, your healthcare provider will talk to you about other forms of contraception to use during that time.
Gallbladder Problems. Talk to your healthcare provider if you have gallbladder problems, as this may worsen while taking norgestimate/ethinyl estradiol. Tell your healthcare provider if you previously had a condition called cholestasis (slowed flow of bile from the liver) while you were pregnant, as this may increase your chances of having cholestasis again when taking norgestimate/ethinyl estradiol. Cholestasis can cause your skin or the whites of your eyes to turn yellowish (jaundice).
Angioedema. Talk to your healthcare provider if you have a condition called hereditary angioedema that leads to swelling in different parts of your body including your lips, face, tongue, or throat. Taking norgestimate/ethinyl estradiol may increase your chances of having angioedema or make your angioedema symptoms worse if you have a history of angioedema.
Skin Issues. Talk to your healthcare provider if you have had a condition that led to dark patches of skin around your forehead, nose, cheeks, and around your mouth, especially during pregnancy (chloasma), as this may increase your chances of having chloasma while taking norgestimate/ethinyl estradiol.
Depression. Talk to your healthcare provider if you have a history of depression. Taking norgestimate/ethinyl estradiol may worsen depression.
Pregnancy. Do not use norgestimate/ethinyl estradiol and tell your healthcare provider if you are or plan to become pregnant. If you become pregnant, stop taking norgestimate/ethinyl estradiol right away and contact your healthcare provider.
Breastfeeding. Norgestimate/ethinyl estradiol passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Norgestimate/ethinyl estradiol may decrease the amount of breastmilk you make. Your healthcare provider will advise you if you should take norgestimate/ethinyl estradiol while breastfeeding.
Interactions
Does norgestimate/ethinyl estradiol interact with foods or drinks?
Eating grapefruit or drinking grapefruit juice while taking norgestimate/ethinyl estradiol can increase the level of ethinyl estradiol in your body. Talk to your healthcare provider if you eat grapefruit or drink grapefruit juice. Your healthcare provider will advise you if you can eat grapefruit/drink grapefruit juice while taking norgestimate/ethinyl estradiol.
There are no known interactions between norgestimate/ethinyl estradiol and alcohol.
Does norgestimate/ethinyl estradiol interact with other medicines (drug interactions)?
Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
Some other medicines may alter the blood levels of norgestimate/ethinyl estradiol, and vice versa. This can cause norgestimate/ethinyl estradiol to not work as well, may cause bleeding between your monthly periods, or higher than normal levels of hormones in your body. Tell your healthcare provider about all medicines that you take or have recently taken.
In particular, make sure that you discuss if you are using any of the following before using norgestimate/ethinyl estradiol.
- A medicine for HIV, AIDS, or hepatitis C
- Phenytoin (Dilantin, Phenytek, and others), felbamate, oxcarbazepine, rufinamide, or lamotrigine which are medicines to control seizures
- A barbiturate, such as phenobarbital, butalbital, or primidone which is a medicine that may be used to treat insomnia, migraines, or seizures
- Carbamazepine (Tegretol, Carbatrol, and others), which is a medicine used to control seizures and treat nerve pain
- Bosentan, which is a medicine used to treat a condition called pulmonary arterial hypertension (PAH)
- Griseofulvin, itraconazole, voriconazole, fluconazole, ketoconazole, or voriconazole which are medicines used to treat certain types of fungal infections
- Topiramate, which is a medicine used to control seizures and to prevent migraine headaches
- Rifabutin, which is a medicine used to treat certain bacterial infections
- Aprepitant, which is a medicine used to prevent nausea and vomiting caused by chemotherapy
- St. John’s wort, which is a supplement that may be used to treat depression
- Atorvastatin, rosuvastatin, or colesevelam, which are medicines used for high cholesterol
- Vitamin C (ascorbic acid) which is a medicine used to treat/prevent low vitamin C levels
- Acetaminophen (Tylenol), which is used to treat pain and fever
- Cyclosporine (Gengraf, Neoral, Sandimmune, and others), which is a medicine to suppress your immune system
- Prednisolone, which is a medicine used for certain inflammatory conditions
- Theophylline, which is a medicine used to treat asthma and other lung problems
- Tizanidine (Zanaflex), which is a muscle relaxant
- Morphine, which is used to treat pain
- Temazepam, which is a medicine used for sleeping problems (insomnia)
- A thyroid medicine, such as levothyroxine, which is used to raise thyroid hormone levels
Overdose/Missed Dose
What should I do if I accidentally use too much norgestimate/ethinyl estradiol?
If you or someone else has used too much norgestimate/ethinyl estradiol, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.
What should I do if I miss a dose of norgestimate/ethinyl estradiol?
Norgestimate/ethinyl estradiol may not work as it should if you miss tablets. Follow the Instructions for Use on how to take norgestimate/ethinyl estradiol when you miss a dose, as this can change depending on how many tablets you have missed and which weeks they were missed on.
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