Introvale (Levonorgestrel/Ethinyl Estradiol) Drug Information
What is Introvale (Levonorgestrel/Ethinyl Estradiol)?
Introvale (Levonorgestrel/Ethinyl Estradiol) contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.
Introvale (Levonorgestrel/Ethinyl Estradiol) are used as contraception to prevent pregnancy.
Introvale (Levonorgestrel/Ethinyl Estradiol) may also be used for other purposes not listed in this medication guide.
What is the most important information I should know about Introvale (Levonorgestrel/Ethinyl Estradiol)?
Do not use Introvale (Levonorgestrel/Ethinyl Estradiol) if you are pregnant or recently had a baby. Do not use this medication if you have: a history of stroke or blood clot, circulation problems, breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, severe high blood pressure, migraine headaches, a heart valve disorder, or a history of jaundice caused by birth control pills.
You may need to use back-up birth control when you first start using this medication.
Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.
Some drugs can make birth control pills less effective, which may result in pregnancy. Tell your doctor about all the prescription and over-the-counter medications you use.
What should I discuss with my healthcare provider before taking Introvale (Levonorgestrel/Ethinyl Estradiol)?
This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills (6 weeks if you are breast-feeding). Do not use this medication if you have:
- a history of a stroke or blood clot;
- circulation problems (especially if caused by diabetes);
- a hormone-related cancer such as breast or uterine cancer;
- abnormal vaginal bleeding;
- liver disease or liver cancer;
- severe high blood pressure;
- severe migraine headaches;
- a heart valve disorder; or
- a history of jaundice caused by birth control pills.
Before using this medication, tell your doctor if you have any of the following conditions.
- high blood pressure, heart disease, congestive heart failure, angina (chest pain), or a history of heart attack;
- high cholesterol or if you are overweight;
- a history of depression;
- gallbladder disease;
- seizures or epilepsy;
- a history of irregular menstrual cycles; or
- a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram.
The hormones in birth control pills can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby.
How should I take Introvale (Levonorgestrel/Ethinyl Estradiol)?
Take this medication exactly as it was prescribed for you. Do not take larger amounts, or take it for longer than recommended by your doctor. You will take your first pill on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).
You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.
You will not have a menstrual period every month while you are taking an extended-cycle birth control pill. Instead, your period should occur every 12 weeks.
The 91-day birth control pack contains three trays with cards that hold 84 "active" pills and seven "reminder" pills. You must use the pills in a certain order to keep you on a regular cycle. Trays 1 and 2 each hold 28 pills. Tray 3 holds 35 pills, including the 7 reminder pills. Your period should begin while you are using these reminder pills.
Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not use this medication regularly. Get your prescription refilled before you run out of pills completely.
You may have breakthrough bleeding while taking birth control pills. Tell your doctor if this bleeding continues or is very heavy.
If you need to have any type of medical tests or surgery, or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.
Your doctor will need to see you on a regular basis while you are using this medication. Do not miss any appointments.
Store this medication at room temperature away from moisture and heat.
What happens if I miss a dose?
Missing a pill increases your risk of becoming pregnant.
If you miss one "active" pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.
If you miss two "active" pills in a row, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.
If you miss three "active" pills in a row, do not take the missed pills. Continue taking 1 pill per day on schedule according to the pill package and leave the missed pills in the package. You may have some bleeding or spotting if you miss three pills in a row. Use back-up birth control for at least the next 7 days.
If you miss any reminder pills, throw them away and keep taking one pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill. If your period does not start while you are taking the reminder pills, call your doctor because you might be pregnant.
What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.
What should I avoid while taking Introvale (Levonorgestrel/Ethinyl Estradiol)?
Do not smoke while using birth control pills, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills.
Birth control pills will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.
Introvale (Levonorgestrel/Ethinyl Estradiol) side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:
- sudden numbness or weakness, especially on one side of the body;
- sudden headache, confusion, pain behind the eyes, problems with vision, speech, or balance;
- chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
- a change in the pattern or severity of migraine headaches;
- nausea, stomach pain, low fever, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);
- swelling in your hands, ankles, or feet; or
- symptoms of depression (sleep problems, weakness, mood changes).
Less serious side effects may include:
- mild nausea, vomiting, bloating, stomach cramps;
- breast pain, tenderness, or swelling;
- freckles or darkening of facial skin;
- increased hair growth, loss of scalp hair;
- changes in weight or appetite;
- problems with contact lenses;
- vaginal itching or discharge;
- changes in your menstrual periods, decreased sex drive; or
- headache, nervousness, dizziness, tired feeling.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Introvale (Levonorgestrel/Ethinyl Estradiol) Dosing Information
Usual Adult Dose for Contraception:
Introvale (Levonorgestrel/Ethinyl Estradiol) products are packaged in 21, 28 and 91 day dosage preparations.
Regardless of the number of tablets in a package, the cycle length for oral contraceptives is generally considered to be 28 days, except for the 91 day dosage preparation which considers the cycle to be 91 days. (The first day of menstrual bleeding is counted as day 1.) One product (marketed as Lybrel) is supplied in a 28 day package in which all the tablets contain the same active ingredients (no placebo tablets). The tablets are given continuously and gradually reduce or stop menstruation in most women. Thus there is no cycle length with this product.
Initiation of Oral Contraceptive Therapy
This product can be administered in two ways.
When initiating a Sunday start regimen, the first tablet may be taken on the first Sunday after menstruation begins. If a period begins on a Sunday, the first tablet may be taken on that day. When initiating a Sunday start regimen, another contraceptive method should be used until after the first 7 consecutive days of administration. For a 28 day package, one tablet is taken daily for 28 days and a new package begun on the following day. For a 21 day package, one tablet is taken daily for 21 days followed by 7 days with no medication. A new package of contraceptives is begun on the following day. For a 91 day package, one tablet is taken daily for 91 days and a new package begun on the following day. The manufacturer of the 91-day preparation recommends only the Sunday start regimen.
When initiating a Day 1 start regimen, the first tablet is taken on the first day on menstruation. Such initiation may increase the risk of spotting and breakthrough bleeding but decrease the risk of early ovulation and pregnancy. For a 28 day package, one tablet is taken daily for 28 days and a new package begun on the following day. For a 21 day package, one tablet is taken daily for 21 days followed by 7 days with no medication. A new package of contraceptives is begun on the following day.
Many clinicians recommend that additional contraceptive methods be used during the first cycle of hormonal therapy in order to reduce the risk of unintended pregnancy.
If a woman misses one dose of active tablets, the missed dose should be taken as soon as it is remembered and the normal schedule should be resumed.
If a woman misses two doses in week 1 or week 2 of the cycle, 2 tablets may be taken as soon as they are remembered and 2 tablets taken the next day and the normal schedule may be resumed. (Additional contraceptive methods should be used for 7 days.)
If a woman misses two doses in week 3 or three doses at any time in the cycle, Day 1 starters should discard the current package and begin a new package that same day. Sunday starters should take 1 tablet daily from the current package until Sunday, when the current package is discarded and a new package begun. (Additional contraceptive methods should be used until the woman has taken at least 7 days of hormonal therapy from the new package.)
Usual Adult Dose for Postcoital Contraception:
Ethinyl estradiol-levonorgestrel 30 mcg-150 mcg (Levlen or Nordette), 4 tablets no later than 72 hours after having unprotected sex followed by 4 more tablets exactly 12 hours after the first dose.
Ethinyl estradiol-levonorgestrel 30 mcg-125 mcg (Tri-Levlen or Triphasil), 4 tablets no later than 72 hours after having unprotected sex followed by 4 more tablets exactly 12 hours after the first dose. Note that only the phase 3 cycle of these triphasic contraceptives contain sufficient hormone to act as a postcoital contraceptive.
Ethinyl estradiol-levonorgestrel 50 mcg-250 mcg (Preven), 2 tablets no later than 72 hours after having unprotected sex followed by 2 more tablets exactly 12 hours after the first dose.
Patients should be advised to begin therapy at a time that it will make it convenient to take the second dose 12 hours later. Pretreatment with a long acting antinauseant such as meclizine will lessen the incidence of nausea.
What other drugs will affect ethinyl estradiol and levonorgestrel extended-cycle?
The following drugs can make birth control pills less effective, which may result in pregnancy:
- acetaminophen (Tylenol) or ascorbic acid (vitamin C);
- phenylbutazone (Azolid, Butazolidin);
- prednisolone (Orapred);
- theophylline (Respbid, Theo-Dur);
- cyclosporine (Neoral, Sandimmune, Gengraf);
- St. John's wort;
- antibiotics such as amoxicillin (Augmentin), ampicillin (Omnipen), doxycycline (Doryx, Vibramycin), griseofulvin (Grisactin, Grifulvin, Fulvicin), minocycline (Minocin), penicillin (Veetids, Pen Vee K, Bicillin), rifampin (Rifadin), rifabutin (Mycobutin), tetracycline, and others;
- seizure medicines such as phenytoin (Dilantin), carbamazepine (Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), topiramate (Topamax), or primidone (Mysoline);
- a barbiturate such as butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or
- HIV medicines such as indinavir (Crixivan), saquinavir (Invirase), lopinavir/ritonavir (Kaletra), fosamprenavir (Lexiva), ritonavir (Norvir), or nelfinavir (Viracept), and others.
This list is not complete and there may be other drugs that can interact with birth control pills. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.