Lutera (28) oral Warnings
Smoking cigarettes/using tobacco while using hormonal birth control (pill/patch/ring) increases your risk of heart problems and stroke. Do not smoke. The risk of heart problems increases with age (especially in women over 35) and with frequent smoking (15 or more cigarettes a day).
Lutera (28) oral Uses
This medication is a combination of 2 hormones (an estrogen and a progestin) and is used to prevent pregnancy. It works mainly by preventing the release of an egg (ovulation) during your menstrual cycle. It also can work by making vaginal fluid thicker to help prevent sperm from reaching an egg (fertilization) and by changing the lining of the uterus (womb) to prevent attachment of a fertilized egg. If a fertilized egg does not attach to the uterus, it passes out of the body.
Read the Patient Information Leaflet provided by your pharmacist before you start using this product and each time you get a refill. The leaflet contains very important information about when to take your pills and what to do if you miss a dose. If you have any questions, consult your doctor or pharmacist.
Take this medication by mouth once daily or as directed by your doctor. Pick a time of day that is easy for you to remember, and take your pill at the same time each day. Pregnancy is more likely if you miss a pill or take a pill late. Make sure you get a new pill pack before you finish your current pack. Also, make sure you have back-up birth control (e.g., condoms) available in case you miss a pill.
If you have been using another form of hormonal birth control (e.g., patch, another type of pill), ask your doctor or pharmacist how to switch to this product.
If you are using this medication for the first time, and you are not switching from another form of hormonal birth control (e.g., patch, ring, other birth control pills), take the first pill in the pack on the first day of your period. If your doctor directs you to start this medication on any other day, use an additional form of birth control for the first 7 days.
Continue taking 1 tablet every day. After taking the last tablet in your old pack, start a new pack the next day. There is no break between packs, and there are no "reminder" tablets (tablets without medication). Most women do not have regular periods while taking this medication. You may have some bleeding or spotting. If this happens, do not stop taking your pills.
If you vomit or have diarrhea within 4 hours after taking this medication, you may need to use a back-up method of birth control. Consult your Patient Information Leaflet for more information. (See also Missed Dose section.)
If you have any stomach upset or nausea with this medication, it may help to take it after your evening meal or at bedtime. You may choose to take this medication at another time of day that is easier for you to remember. No matter what time you choose, it is very important that you take this medication at the same time each day, 24 hours apart. Ask your doctor or pharmacist if you have any questions.
Lutera (28) oral Side Effects
Nausea, vomiting, headache, stomach cramping/bloating, dizziness, vaginal discomfort/irritation, increased vaginal fluids, or breast tenderness/enlargement may occur. Acne may improve or get worse. If any of these effects persist or worsen, tell your doctor promptly.
Many women will not have regular periods while taking this medication. This is normal. Vaginal bleeding/spotting is likely to occur, especially during the first few months of use. If bleeding is unusually heavy or lasts for more than 7 days in a row, contact your doctor promptly.
Tell your doctor immediately if any of these serious side effects occur: problem wearing contact lenses, dark patches on the skin (melasma), unwanted facial/body hair, swelling ankles/feet, unusual weight changes (gain or loss).
This medication may rarely cause serious (sometimes fatal) problems from blood clots (e.g., pulmonary embolism, stroke, heart attack). Seek immediate medical attention if you experience: sudden shortness of breath, chest/jaw/left arm pain, confusion, coughing up blood, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, tingling/weakness/numbness in the arms/legs, 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, sudden/very severe headaches), slurred speech, weakness on one side of the body, vision problems/changes.
Tell your doctor immediately if any of these rare but very serious side effects occur: lump in the breast, severe pain in the stomach/abdomen/pelvis, mental/mood changes (e.g., depression, rare thoughts of suicide), persistent trouble sleeping, unusual tiredness, dark urine, yellowing eyes/skin.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
In the US -
Lutera (28) oral Precautions
See also Warning section.
Before using this medication, tell your doctor or pharmacist if you are allergic to ethinyl estradiol or levonorgestrel; 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 product, consult your doctor or pharmacist if you have: history of stroke or other blood clots (e.g., in the legs, eyes, lungs), blood clotting disorders (such as protein C or protein S deficiency), severe high blood pressure, abnormal breast exam, cancer (especially endometrial and breast cancer), diabetes that has caused kidney/eye/nerve/blood vessel disease, severe headaches, history of heart disease (e.g., heart attack, chest pain, irregular heartbeat), heart valve disease, liver problems (e.g., liver tumor, current liver disease), current or suspected pregnancy, 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 product, tell your doctor your medical history, especially of: high blood pressure, high cholesterol or triglyceride (blood fat) levels, depression, diabetes, swelling (edema), gallbladder problems, kidney disease, migraine, obesity, irregular/missed/very light periods, recent pregnancy, thyroid problems.
Do not smoke cigarettes or use tobacco. Doing so while using hormonal birth control (e.g., pills, injections, devices) greatly increases 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.
If you have diabetes, this medication may make it harder to control your blood sugar levels. Monitor your blood sugar regularly as directed by your doctor. Tell your doctor the results and any symptoms such as increased thirst/urination. Your anti-diabetic medication or diet may need to be adjusted.
Tell 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.
This medication may cause blotchy, dark areas on your skin (melasma). Sunlight may worsen this effect. Avoid prolonged sun exposure, sunlamps, and tanning booths. Use a sunscreen, and wear protective clothing when outdoors.
If you are nearsighted or wear contact lenses, you may develop vision problems or trouble wearing your contact lenses. Tell your eye doctor if these problems occur.
It may take longer for you to become pregnant after you stop taking birth control pills. Consult your doctor for more information.
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.
This medication passes into breast milk. This may affect how much milk you make and may also have undesirable effects on the nursing infant. Consult your doctor before breast-feeding.
Lutera (28) oral Interactions
The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.
To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.
Some products that may interact with this drug include: aromatase inhibitors (e.g., anastrazole, exemestane), ospemifene, raloxifene, sodium tetradecyl sulfate, tamoxifen, medication for underactive thyroid (hypothyroidism), drugs that may increase blood levels of this drug (such as acetaminophen, vitamin C, atorvastatin, indinavir, azole antifungals such as itraconazole/ketoconazole/vaginal miconazole).
Some drugs may cause hormonal birth control to work less well by decreasing the amount of birth control hormones in your body. This effect can result in pregnancy. Examples include griseofulvin, modafinil, rifamycins (such as rifampin, rifabutin), St. John's wort, drugs used to treat seizures (such as barbiturates, carbamazepine, felbamate, phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir, nevirapine, ritonavir), among others.
Tell your doctor when you start any new drug, and discuss if you should use additional reliable birth control. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.
This drug can speed up or slow down the removal of other drugs from your body by affecting certain liver enzymes. These affected drugs include acetaminophen, certain beta blockers (e.g., metoprolol), clofibrate, cyclosporine, morphine, corticosteroids such as prednisolone, certain benzodiazepines such as lorazepam/temazepam, theophylline, and tizanidine, among others. If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting this medication.
This medication can affect the results of certain lab tests (e.g., blood tests for clotting factors, thyroid). Make sure laboratory personnel and all your doctors know you use this medication.
This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.
Lutera (28) oral Overdose
If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe nausea/vomiting. Females may experience sudden/unusual vaginal bleeding.NOTES:
Do not share this medication with others.
Keep all appointments with your doctor and the laboratory. You should have regular complete physical exams including blood pressure, breast exam, pelvic exam, and screening for cervical cancer (Pap smear). Follow your doctor's instructions for examining your own breasts, and report any lumps immediately. Consult your doctor for more details.MISSED DOSE:
Read the package information for advice on what to do if you miss a dose or take it late. You may need to use back-up birth control (e.g., condoms or spermicide) to prevent pregnancy. Ask your doctor or pharmacist if you have any questions.
If you often forget to take the pill as directed, contact your doctor to discuss switching to another form of birth control.STORAGE:
Store at room temperature at or below 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.
Information last revised May 2013. Copyright(c) 2013 First Databank, Inc.