LOESTRIN 24 FE DRUG INFO

IMPORTANT NOTE: Loestrin 24 Fe is not yet available for purchase online. The information below is provided for information purposes only.



What is the most important information I should know about Loestrin 24 Fe?
• Do not use Loestrin 24 Fe if you are pregnant, if you need major surgery or will be on bed rest for a period of time, or if you have any of the following: severe high blood pressure, circulation problems, a bleeding disorder, abnormal vaginal bleeding, liver disease, a history of stroke or blood clot, or a hormone-related cancer such as breast or uterine cancer. Tell your doctor about all of your medical conditions, past or present.
• Take your pill at the same time every day. Each dose should come no more than 24 hours after the last dose.
• You may need to use a backup birth control method, such as condoms or a spermicide, during the first week when you start a new pack of Loestrin 24 Fe. You may also need to avoid getting pregnant during the first few months after you stop using Loestrin 24 Fe. Follow your doctor's instructions.
• Do not smoke while you are using Loestrin 24 Fe, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills.
• Missing a pill increases your risk of becoming pregnant. Loestrin 24 Fe will come with patient instructions for what to do if you miss a dose. Follow these directions carefully. If you do not have the patient instruction sheet, call your doctor or pharmacist and ask what to do if you miss a dose.
• Some drugs can make Loestrin 24 Fe less effective, which may result in pregnancy. You may need to use a back-up birth control method if you are using certain drugs. 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.

What is Loestrin 24 Fe?
• Loestrin 24 Fe contain a combination of the female hormones estrogen and progesterone. These hormones prevent ovulation (the release of an egg from an ovary).
• Loestrin 24 Fe also have other effects that help prevent pregnancy. They cause the cervical mucous to thicken, making it harder for sperm to reach the uterus, and they keep the egg from attaching itself to the uterus.
• Loestrin 24 Fe is used as contraception to prevent pregnancy.
• Loestrin 24 Fe may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking Loestrin 24 Fe?
• Do not use Loestrin 24 Fe if you are pregnant, or if you have:

· a history of a stroke or blood clot;
· a heart valve disorder;
· severe or uncontrolled high blood pressure;
· diabetes with circulation problems;
· migraine headaches;
· breast, uterine, or other hormone-related cancer;
· a bleeding or blood-clotting disorder;
· undiagnosed or abnormal vaginal bleeding;
· liver disease or a history of jaundice (yellowing of the skin and eyes) from taking Loestrin 24 Fe; or
· if you need major surgery or will be on bed rest for a period of time.

• Do not smoke while you are using Loestrin 24 Fe, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills.

• Before taking Loestrin 24 Fe, tell your doctor if you have:
· high blood pressure, angina (chest pain), or heart disease;
· high cholesterol;
· gallbladder disease;
· diabetes; or
· seizures or epilepsy.

• If you have any of these conditions, you may not be able to use Loestrin 24 Fe, or you may need a dosage adjustment or special tests during treatment.

• FDA pregnancy category X. This medication can cause birth defects. Do not use Loestrin 24 Fe if you are pregnant. Tell your doctor right away if you become pregnant while using Loestrin 24 Fe, or if you miss two menstrual periods in a row.

• Your doctor may instruct you to avoid getting pregnant during the first few months after you stop using Loestrin 24 Fe. Follow your doctor's instructions.

• The hormones in Loestrin 24 Fe can pass into breast milk and may harm a nursing baby. Loestrin 24 Fe may also slow breast milk production. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take my Loestrin 24 Fe?
• Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor.
• When you start a new birth control pack, take the first pill on the first Sunday after your period begins (unless your doctor tells you otherwise).
• Take one pill every day, no more than 24 hours after your last dose. Try to take the pills at the same time every day--for example, just before bed, with a meal, or first thing in the morning.
• Taking your pill at night may help to reduce any nausea or headache the hormones may cause.
• The 28-day birth control pack contains seven pills that are either iron tablets or placebos (also called sugar pills). The 24-day pack contains four iron pills. These are "reminder" pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.
• If you are using a 28-day or 24-day birth control pack, take one pill every day. When the pack runs out, throw it away. Begin a new pack the following day.
• The 21-day birth control pack contains no reminder pills. Take one pill every day for 21 days, then do not take any pills for 7 days. You should have your period during the 7 days with no pills. Start a new pack of pills at the end of the 7 days.
• You may need to use a backup birth control method, such as condoms or a spermicide, during the first week when you start a new pack of Loestrin 24 Fe. Follow your doctor's instructions.
• Your doctor will need to see you on a regular basis while you are using Loestrin 24 Fe. It is important that you not miss any scheduled visits to your doctor.
• Store Loestrin 24 Fe at room temperature away from moisture and heat.

What happens if I miss a dose?
• Missing a pill increases your risk of becoming pregnant.
• For most brands of birth control pill:

· If you miss one pill, take it as soon as you remember or take two pills at the time of your next regularly scheduled dose. It is unlikely that you will ovulate after missing only one pill. However, you may want to use a back-up birth control method for at least 7 days after the missed pill to keep from getting pregnant.
· If you miss two pills in a row, take the two missed pills as soon as you remember, or take two pills per day for the two days after your missed pills. You may ovulate after missing two pills in a row. You must use a back-up birth control method for at least 7 days following the missed pills. For best protection, continue using the back-up method until your next period.
· If you miss three pills in a row, throw away the package and start a new package on the 7th day after you last took a pill. Use a back-up birth control method for at least the first 7 days after starting the new package. Your period should start during the 7 days without pills. If you do not have a period, have a pregnancy test before you start a new package of pills.
• Loestrin 24 Fe will come with patient instructions for what to do if you miss a dose. Follow these directions carefully. If you do not have the patient instruction sheet, call your doctor or pharmacist and ask what to do if you miss a dose.

What happens if I overdose?
• Seek emergency medical attention if you think you have used too much of this medicine.
• Symptoms of an overdose may include nausea, vomiting, and vaginal bleeding.


What should I avoid while taking Loestrin 24 Fe?
• Avoid smoking. It greatly increases your risk of a heart attack, stroke or blood clot formation.
• Loestrin 24 Fe do not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

What are the possible side effects of Loestrin 24 Fe?
• 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.

• Stop using Loestrin 24 Fe and 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, problems with vision, speech, or balance;
· sudden shortness of breath or pain in the chest;
· pain, redness, swelling, or numbness in your arm or leg;
· sudden loss of vision; or
· nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

• Continue using your Loestrin 24 Fe and talk to your doctor if you have any of these less serious side effects:

· mild headache or dizziness;
· nausea, vomiting, or diarrhea;
· breakthrough bleeding; or
· breast tenderness.

• You may notice these side effects only during the first 3 to 6 months of birth control use.

• You may have other less serious side effects such as:

· depression;
· bloating, changes in weight or appetite;
· vaginal itching or discharge;
· changes in your menstrual periods;
· problems with contact lenses;
· acne or other skin changes;
· mood swings, decreased sex drive;
· tired feeling; or
· changes in your blood sugar.

• Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Loestrin 24 Fe?
• Some drugs can make Loestrin 24 Fe less effective, which may result in pregnancy. Use a back-up birth control method if you are using any of the following drugs:

· a penicillin antibiotic such as amoxicillin (Amoxil, Augmentin), ampicillin (Omnipen, Totacillin), bacampicillin (Spectrobid), carbenicillin (Geocillin), cloxacillin (Cloxapen, Tegopen), dicloxacillin (Dynapen, Pathocil), nafcillin (Nafcil, Unipen), oxacillin (Bactocill, Prostphlin), or penicillin (Veetids, Pen Vee K, Bicillin);
· a tetracycline antibiotic such as demeclocycline (Declomycin), doxycycline (Doryx, Vibramycin), minocycline (Minocin), or tetracycline (Sumycin, Achromycin, Robitet);
· a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton);
· HIV medicines such as amprenavir (Agenerase), tipranavir (Aptivus), indinavir (Crixivan), saquinavir (Invirase, Fortovase), lopinavir/ritonavir (Kaletra), fosamprenavir (Lexiva), ritonavir (Norvir), atazanavir (Reyataz), or nelfinavir (Viracept);
· St. John's wort;
· rifampin (Rifadin);
· phenytoin (Dilantin);
· carbamazepine (Tegretol); or
· griseofulvin (Grisactin, Grifulvin V, Fulvicin PG).

• There may be other drugs not listed that can affect Loestrin 24 Fe. 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.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.







* In a clinical trial, on average, women taking Loestrin 24 Fe had a period that lasted less than 3 days by cycle 6.
1 Of the 953 women who were currently using the Pill, patch or vaginal ring, or had in the past.
2 Harris Interactive® conducted an online survey, commissioned by Warner Chilcott, from March 9th-13th and March 15th-17th of 2006 among a nationwide sample of 1342 women aged 18-49. The data were weighted to be representative of the total US adult population on the basis of region, age within gender, education, household income, race/ethnicity, and propensity of the respondent to be online. In theory, for probability samples of this size, the 95% confidence interval would be ±4%.
3 In a clinical trial, women taking Loestrin 24 Fe had significantly lighter periods compared with women taking a leading brand (a 20 mcg, typical 21-day birth control pill) by cycle 6.