Lunelle

Generic Name: estradiol and medroxyprogesterone (ess tra DY ol and med ROX ee pro JESS te role)Brand Names: Lunelle

What is Lunelle (estradiol and medroxyprogesterone)?

Estradiol and medroxyprogesterone 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.

Estradiol and medroxyprogesterone is used as contraception to prevent pregnancy.

Estradiol and medroxyprogesterone may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Lunelle (estradiol and medroxyprogesterone)?Do not use birth control injections if you are pregnant or if you have recently had a baby. Do not use this medication if you have any of the following conditions: a history of 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, 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, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

Using 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 injections less effective, which may result in pregnancy. Tell your doctor about all the prescription and over-the-counter medications you use, including vitamins, minerals and herbal products. Do not start using a new medication without telling your doctor.

What should I discuss with my healthcare provider before using Lunelle (estradiol and medroxyprogesterone)?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 using birth control injections (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. You may need a dose adjustment or special tests to safely take birth control hormones.

• high blood pressure, heart disease, congestive heart failure, angina (chest pain), or a history of heart attack;

• high cholesterol or if you are overweight;

• kidney disease;

• a history of depression;

• gallbladder disease;

• diabetes;

• 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 this medication 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 is estradiol and medroxyprogesterone used?

This medication is given as an injection into a muscle in your upper arm, thigh, or buttocks. You will receive this injection in your doctor's office or other clinic setting. Before receiving your first injection, tell your doctor about all other forms of birth control you have used within the past 7 days.

The first injection of this medication is given during the first 5 days of a normal menstrual period, or within 5 days after undergoing a complete first-trimester abortion.

After your first injection, you will need to receive monthly injections every 28 to 30 days to assure prevention of pregnancy. Do not allow more than 33 days to pass between injections, even if your menstrual period has started later than expected.

Tell your doctor if your period has not started by the time you are due for your monthly injection.

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 injections.

Your doctor will need to see you on a regular basis while you are using this medication. Do not miss any appointments.

What happens if I miss a dose?

Missing a monthly injection increases your risk of becoming pregnant. Call your doctor for instructions if you miss an appointment for your injection.

What happens if I overdose?

Seek emergency medical attention if you think you have received too much of this medicine. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

What should I avoid while using Lunelle (estradiol and medroxyprogesterone)?

Do not smoke while using birth control injections, 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 injections 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.

Lunelle (estradiol and medroxyprogesterone) 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, clay-colored stools, jaundice (yellowing of the skin or eyes);

• swelling in your hands, ankles, or feet;

• a breast lump;

• symptoms of depression (sleep problems, weakness, mood changes); or

• ongoing pain, bleeding, or other drainage where the shot was given.

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. Tell your doctor about any unusual or bothersome side effect.

What other drugs will affect Lunelle (estradiol and medroxyprogesterone)?

Some drugs can make birth control hormones less effective, which may result in pregnancy. Before using birth control pills, tell your doctor if you are using any of the following drugs:

• phenylbutazone (Azolid, Butazolidin);

• prednisolone (Orapred);

• theophylline (Respbid, Theo-Dur);

• aminoglutethamide (Cytadren);

• cyclosporine (Neoral, Sandimmune, Gengraf);

• St. John's wort;

• antibiotics such as amoxicillin (Augmentin), ampicillin (Omnipen), doxycycline (Doryx, Vibramycin), griseofulvin (Grisactin, Grifulvin V, Fulvicin PG), minocycline (Minocin), penicillin (Veetids, Pen Vee K, Bicillin), rifampin (Rifadin), rifabutin (Mycobutin), tetracycline (Sumycin, Achromycin, Robitet), and others;

• seizure medicines such as phenytoin (Dilantin), carbamazepine (Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), topiramate (Topamax), or primidone (Mysoline);

• a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or

• HIV medicines such as amprenavir (Agenerase), atazanavir (Reyataz), tipranavir (Aptivus), indinavir (Crixivan), saquinavir (Invirase), lopinavir/ritonavir (Kaletra), fosamprenavir (Lexiva), ritonavir (Norvir), or nelfinavir (Viracept).

This list is not complete and there may be other drugs that can interact with estradiol and medroxyprogesterone. 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.

Where can I get more information?

• Your pharmacist can provide more information about estradiol and medroxyprogesterone.

• 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.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 2.02. Revision Date: 10/15/2007 3:47:02 PM.