Information on Seasonale

Pronounced: SEE-zun-ahl
Brand names: Alesse, Brevicon, Demulen, Desogen, Genora, Levlen, Levlite, Loestrin, Lo/Ovral, Low-Ogestrel, Micronor, Modicon, Necon, Nordette, Norethin, Norinyl, Ogestrel, Ortho-Cept, Ortho-Cyclen, Ortho-Novum, Ortho Tri-Cyclen, Ovcon, Ovral, Triphasil, Trivora, Zovia

Why is Seasonale prescribed?

Oral contraceptives (also known as "The Pill") are highly effective means of preventing pregnancy. Oral contraceptives consist of synthetic forms of two hormones produced naturally in the body: either progestin alone or estrogen and progestin. Estrogen and progestin regulate a woman's menstrual cycle, and the fluctuating levels of these hormones play an essential role in fertility.

To reduce side effects, oral contraceptives are available in a wide range of estrogen and progestin concentrations. Progestin-only products (such as Micronor) are usually prescribed for women who should avoid estrogens; however, they may not be as effective as estrogen/progestin contraceptives.

One variety of the Pill--the Ortho Tri-Cyclen 28-day Dial pak--is also used in the treatment of moderate acne in women aged 15 and older. It is taken just as it would be for contraception.

Most important fact about Seasonale

Cigarette smoking increases the risk of serious heart-related side effects (stroke, heart attack, blood clots, etc.) in women who use oral contraceptives. This risk increases with heavy smoking (15 or more cigarettes per day) and with age. There is an especially significant increase in heart disease risk in women over 35 years old who smoke and use oral contraceptives.

How should you take Seasonale?

Oral contraceptives should be taken daily, no more than 24 hours apart, for the duration of the prescribed cycle of 21 or 28 days. Start the cycle according to package directions. Ideally, you should take your pill at the same time every day to reduce the chance of forgetting a dose; with progestin-only contraceptives, taking the pill at the same time each day is essential.

--If you miss a dose...

If you neglect to take only one estrogen/progestin pill, take it as soon as you remember, take the next pill at your regular time, and continue taking the rest of the medication cycle. The risk of pregnancy is small if you miss only one combination pill per cycle. If you miss more than one tablet, check your product's patient information for instructions.

Missing a single progestin-only tablet increases the chance of pregnancy. Consult your doctor immediately if you miss a single dose or if you take it 3 or more hours late, and use another method of birth control until your next period begins or pregnancy is ruled out.

--Storage instructions...

To help keep track of your doses, use the original container. Store at room temperature.

What are the possible side effects of Seasonale?

Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking an oral contraceptive.

Side effects may include:

• abdominal cramps
• acne
• appetite changes
• bladder infection
• bleeding in spots during a menstrual period
• bloating
• blood clots
• breast tenderness or enlargement
• cataracts
• chest pain
• contact lens discomfort
• decreased flow of milk when given immediately after birth
• depression
• difficulty breathing
• dizziness
• fluid retention
• gallbladder disease
• growth of face, back, chest, or stomach hair
• hair loss
• headache
• heart attack
• high blood pressure
• inflammation of the large intestine
• kidney trouble
• lack of menstrual periods
• liver tumors
• lumps in the breast
• menstrual pattern changes
• migraine
• muscle, joint, or leg pain
• nausea
• nervousness
• premenstrual syndrome (PMS)
• secretion of milk
• sex drive changes
• skin infection
• skin rash or discoloration
• stomach cramps
• stroke
• swelling
• temporary infertility
• unexplained bleeding in the vagina
• vaginal discharge
• vaginal infections (and/or burning and itching)
• visual disturbances
• vomiting
• weight gain or loss
• yellow skin or whites of eyes

Why should Seasonale not be prescribed?

You should not take oral contraceptives if you have had an allergic reaction to them or if you are pregnant (or think you might be).

If you have ever had breast cancer or cancer in the reproductive organs or liver tumors, you should not take oral contraceptives.

If you have or have ever had a stroke, heart disease, liver disease, angina (severe chest pain), or blood clots, you should not take oral contraceptives. Women who have had pregnancy-related jaundice or jaundice stemming from previous use of oral contraceptives should not take them.

If you have undiagnosed and/or unexplained abnormal vaginal bleeding, do not take oral contraceptives.

Special warnings about Seasonale

Oral contraceptives should be used with caution if you are over 40 years old; smoke tobacco; have liver, heart, gallbladder, kidney, or thyroid disease; have high blood pressure, high cholesterol, diabetes, epilepsy, asthma, or porphyria (a blood disorder); or tend to be seriously overweight. Caution is also advised if you have blood circulation problems or have had a heart attack or stroke in the past. Be cautious, too, if you have problems with depression, migraine or other headaches, irregular menstrual periods, or visual disturbances.

If you have a family history of breast cancer or other cancers, you might want to consider using a progestin-only product. The estrogen in combination oral contraceptives has been linked with a slight increase in the risk of breast cancer. If you do use a combination, chose one with a relatively low amount of estrogen. Take high-estrogen pills (0.05 milligrams of estrogen) only if your doctor feels it's necessary.

Since the blood's clotting ability may be affected by oral contraceptives, your doctor may take you off them prior to surgery. If bleeding lasts more than 8 days while you are on a progestin-only oral contraceptive, or if you have no period at all, be sure to let your doctor know. The risk of blood clots is greater with oral contraceptives that contain desogestrel, such as Ortho-Cept.

Oral contraceptives do not protect against HIV infection (AIDS) or any other sexually transmitted disease. If there is a danger of infection, use a latex condom and spermicide in addition to the pill.

If you develop a migraine or severe headache that does not let up or keeps recurring while you are taking a progestin-only oral contraceptive, check with your doctor. You may need to switch to a different type of pill.

If you miss a menstrual period but have taken your pills regularly, contact your doctor but do not stop taking your pills. If you miss a period and have not taken your pills regularly, or if you miss two consecutive periods, you may be pregnant; stop taking your pills and check with your doctor immediately to see if you are pregnant. Use another form of birth control while you are not taking your pills.

If you are taking a progestin-only oral contraceptive and you have sudden or severe abdominal pain, call your doctor immediately. There is a higher risk of ectopic (outside the womb) pregnancy or ovarian cysts with this type of contraceptive.

You should also be aware that oral contraceptives have been know to cause rare cases of noncancerous--but dangerous--liver tumors.

Possible food and drug interactions when taking Seasonale

If oral contraceptives are taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining oral contraceptives with the following:

• Acetaminophen (Tylenol)
• Amitriptyline (Elavil, Endep)
• Ampicillin (Principen, Totacillin)
• Aspirin
• Atorvastatin (Lipitor)
• Barbiturates (phenobarbital, Seconal)
• Carbamazepine (Tegretol)
• Chloramphenicol (Chloromycetin)
• Clofibrate (Questran)
• Clomipramine (Anafranil)
• Cyclosporine (Neoral, Sandimmune)
• Diazepam (Valium)
• Doxepin (Sinequan)
• Glipizide (Glucotrol)
• Griseofulvin (Fulvicin, Grisactin)
• Imipramine (Tofranil)
• Lorazepam (Ativan)
• Metoprolol (Lopressor)
• Morphine (MS Contin)
• Oxazepam (Serax)
• Penicillin (Veetids, Pen-Vee K)
• Phenylbutazone (Butazolidin)
• Phenytoin (Dilantin)
• Prednisolone (Prelone, Pediapred)
• Prednisone (Deltasone)
• Primidone (Mysoline)
• Propranolol (Inderal)
• Rifampin (Rifadin, Rimactane)
• Sulfonamides (Bactrim, Septra)
• Temazepam (Restoril)
• Tetracycline (Achromycin V, Sumycin)
• Theophylline (Theo-Dur, Slo-bid)
• Vitamin C
• Warfarin (Coumadin, Panwarfin)

In addition, oral contraceptives may affect tests for blood sugar levels and thyroid function and may cause an increase in blood cholesterol levels.

Special information if you are pregnant or breast feeding

If you are pregnant (or think you might be), you should not use oral contraceptives, since they are not safe during pregnancy. In addition, wait at least 4 weeks after delivery before starting an oral contraceptive.

Nursing mothers should not use most oral contraceptives, since these drugs can appear in breast milk and may cause jaundice and enlarged breasts in nursing infants. In this situation, your doctor may advise you to use a different form of contraception while you are nursing your baby. However, progestin-only oral contraceptives should not affect your milk or your baby's health.

Recommended dosage

If you have any questions about how you should take oral contraceptives, consult your doctor or the patient instructions that come in the drug package. The following is a partial list of instructions for taking oral contraceptives; it should not be used as a substitute for consultation with your doctor.

Some brands can be started on the first day of your menstrual cycle or on the first Sunday afterwards. Others must be started on the fifth day of the cycle or the first Sunday afterwards. The instructions below are for the first-Sunday schedule.

Oral contraceptives are supplied in 21-day and 28-day packages.

FOR A 21-DAY SCHEDULE

Oral contraceptives are taken every day for a 3-week period, followed by 1 week of no oral contraceptives; this cycle is repeated each month.

1) Starting on the first Sunday after the beginning of your menstrual period, take one tablet daily (at the same time each day) for the next 21 days. Note: If your period begins on Sunday, take the first tablet that day.

2) Wait 1 week before taking any tablets. Your menstrual period should occur during this time.

3) Following this 1-week waiting time, begin taking a daily tablet again for the next 21 days.

FOR A 28-DAY SCHEDULE

Starting on the first Sunday after the beginning of your menstrual period, take one tablet daily (at the same time each day) for the next 28 days. Continue taking the oral contraceptives according to your physician's instructions. Note: If your period begins on Sunday, take the first tablet that day.

FOR BOTH 21- AND 28-DAY REGIMENS

When following a regimen with a Sunday or Day 5 start, use an additional method of birth control for the first 7 days of the cycle.

Progestin-only tablets should be taken at the same time of day every day of the year.

Overdosage

While any medication taken in excess can cause overdose, the risk associated with oral contraceptives is minimal. Even young children who have taken large amounts of oral contraceptives have not experienced serious adverse effects. However, if you suspect an overdose, seek medical help immediately.

Symptoms of overdose may include:

• Nausea
• Withdrawal bleeding in females