Previfem

Previfem is a prescription birth control medication used to prevent pregnancy. Previfem contains two hormones, norgestimate and ethinyl estradiol, which belong to a group of drugs called hormonal contraceptives. These hormones prevent pregnancy by stopping ovulation and by altering cervical mucus and the lining of the uterus to prevent sperm from entering.

This medication comes in tablet form and is taken once daily, with or without food.

Common side effects of Previfem include nausea, breast tenderness, and vaginal bleeding between menstrual periods. 

Do not use birth control pills if you are pregnant or if you have recently had a baby.

You should not take birth control pills if you have any of the following conditions: unusual vaginal bleeding, chest pain, uncontrolled high blood pressure, an uncontrolled heart valve disorder, diabetic problems with your eyes or kidneys, liver cancer, severe migraine headaches, or if you have ever had breast or uterine cancer, jaundice caused by pregnancy or birth control pills, a heart attack, a stroke, or a blood clot.

Taking birth control pills can increase your risk of blood clots, stroke, or heart attack, especially if you have certain other conditions, or if you are overweight.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. You should not take birth control pills if you smoke and are over 35 years old.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You will take your first pill on the first day of your period or on the first Sunday after your period begins. You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medicine. Follow your doctor's instructions.

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 take one pill daily. Get your prescription refilled before you run out of pills completely.

The 28 day birth control pack contains seven "reminder" pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

Use a back-up birth control if you are sick with severe vomiting or diarrhea.

If you need surgery or medical tests 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.

While taking birth control pills, you will need to visit your doctor regularly.

Store this medication at room temperature away from moisture and heat.

Some drugs can make birth control pills less effective, which may result in pregnancy. Other drugs may interact with ethinyl estradiol and desogestrel, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

This section provides information on the proper use of a number of products that contain ethinyl estradiol and norgestimate. It may not be specific to Previfem. Please read with care.

To make using oral contraceptives as safe and reliable as possible, you should understand how and when to take them and what effects may be expected.

This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

This medicine is available in blister packs with a Dialpak® tablet dispenser or a Veridate® tablet dispenser. Each blister pack contains 28 tablets with different colors that need to be taken in the same order as directed on the blister pack.

When you begin using this medicine, your body will require at least 7 days to adjust before a pregnancy will be prevented. Use a second form of contraception, such as a condom, spermicide, or diaphragm, for the first 7 days of your first cycle of pills.

Take this medicine at the same time each day. Birth control pills work best when no more than 24 hours pass between doses.

Do not skip or delay taking your pill by more than 24 hours. If you miss a dose, you could get pregnant. Ask your doctor for ways to help you remember to take your pills or about using another method of birth control.

You may feel sick or nauseated, especially during the first few months that you take this medicine. If your nausea is continuous and does not go away, call your doctor.

Follow the instructions in the patient leaflet or call your doctor if you vomit or have diarrhea within 3 to 4 hours of taking this medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Your doctor may ask you to begin your dose on the first day of your menstrual period (called Day 1 start) or on the first Sunday after your menstrual period starts (called Sunday start). When you begin on a certain day it is important that you follow that schedule, even if you miss a dose. Do not change your schedule on your own. If the schedule that you use is not convenient, check with your doctor about changing it. For a Sunday start, you need to use another form of birth control (eg, condom, diaphragm, spermicide) for the first 7 days.

You should begin your next and all subsequent 28-day regimens of therapy on the same day of the week as the first regimen began and follow the same schedule.

• For oral dosage form (tablets):
  • For contraception (to prevent pregnancy):
    • Adults and teenagers—
      • Ortho-Cyclen®: One blue tablet (active) taken at the same time each day for 21 consecutive days followed by one dark green (inert) tablet daily for 7 days per menstrual cycle.
      • Ortho Tri-Cyclen®: One white, light blue, or blue tablet (active) taken at the same time each day for 21 consecutive days followed by one dark green (inert) tablet daily for 7 days per menstrual cycle.
    • Children—Use and dose must be determined by your doctor.
  • For acne:
    • Adults and teenagers 15 years of age and older—One white, light blue, or blue tablet (active) taken at the same time each day for 21 consecutive days followed by one dark green (inert) tablet daily for 7 days per menstrual cycle.
    • Teenagers and children younger than 15 years of age—Use and dose must be determined by your doctor.

Missed Dose

Call your doctor or pharmacist for instructions.

This medicine has specific patient instructions on what to do if you miss a dose. Read and follow these instructions carefully and call your doctor if you have any questions.

• If you miss one active tablet in weeks 1, 2, or 3: Take the tablet as soon as possible and take the next tablet at your regular schedule. Continue taking one tablet a day until you finish the pack.
• If you miss two active tablets in week 1 or 2: Take the two tablets as soon as possible and the next two tablets the next day. Continue taking one tablet a day until you finish the pack. Use a second form of birth control (such as a condom, spermicide) for 7 days after you miss a dose.
• If you miss two active tablets in week 3, or you miss three or more active tablets in a row in weeks 1, 2, or 3:
  • Day 1 start: Throw out the rest of the pack and start a new pack that same day. Use a second form of birth control (such as a condom, spermicide) for 7 days after you miss a dose.
  • Sunday start: Continue taking one tablet a day until Sunday, then throw out the rest of the pack and start a new pack that same day. Use a second form of birth control (such as a condom, spermicide) for 7 days after you miss a dose, to prevent pregnancy.

Make sure your doctor knows if you miss your period 2 months in a row, because this could mean that you are pregnant.

You may not have a period for that month if you miss more than one dose or change your schedule.

You could have light bleeding or spotting if you do not take a pill on time. The more pills you miss, the more likely you are to have bleeding.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Abdominal or stomach pain
• absent, missed, or irregular menstrual periods
• anxiety
• change in vision
• changes in skin color
• chest pain or discomfort
• chills
• clay-colored stools
• constipation
• cough
• dark urine
• diarrhea
• dizziness or lightheadedness
• fainting
• fever
• headache
• hives or welts
• itching skin
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of appetite
• medium to heavy, irregular vaginal bleeding between regular monthly periods, which may require the use of a pad or a tampon
• nausea and vomiting
• pain or discomfort in the arms, jaw, back, or neck
• pain, tenderness, or swelling of the foot or leg
• pains in the chest, groin, or legs, especially in the calves of the legs
• pounding in the ears
• rash
• redness of the skin
• severe headaches of sudden onset
• slow or fast heartbeat
• sudden loss of coordination or slurred speech
• sudden onset of shortness of breath for no apparent reason
• sudden shortness of breath or troubled breathing
• sweating
• unusual tiredness or weakness
• vomiting of blood

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Abdominal or stomach cramps
• bloating
• blotchy spots on the exposed skin
• breast enlargement or tenderness
• discouragement
• feeling sad or empty
• irritability
• itching of the vagina or outside the genitals
• loss of interest or pleasure
• pain during sexual intercourse
• thick, white curd-like vaginal discharge without odor or with mild odor
• tiredness
• trouble concentrating
• trouble sleeping
• trouble wearing contact lenses

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Coughing up blood.
• Shortness of breath.
• Chest pain or pressure.
• Very bad dizziness or passing out.
• Very upset stomach or throwing up.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Swelling, warmth, numbness, change of color, or pain in a leg or arm.
• Very bad headache.
• Low mood (depression).
• Mood changes.
• Feeling very tired or weak.
• Very bad belly pain.
• Swelling.
• Not able to pass urine or change in how much urine is passed.
• A lump in the breast, breast soreness, or nipple discharge.
• Vaginal itching or discharge.
• Spotting or vaginal bleeding that is very bad or does not go away.
• Bulging eyes.
• Change in eyesight.
• Change in how contact lenses feel in the eyes.

• Store at room temperature.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

How to Start Previfem® (norgestimate/ethinyl estradiol tablets) or Tri-Previfem® (norgestimate/ethinyl estradiol tablets)

Previfem® (norgestimate/ethinyl estradiol tablets USP) and Tri-Previfem® (norgestimate/ethinyl estradiol tablets USP) are dispensed in a blister pack tablet dispenser [see How Supplied/Storage and Handling (16)].

Previfem® (norgestimate/ethinyl estradiol tablets USP) and Tri-Previfem® (norgestimate/ethinyl estradiol tablets USP) may be started using either a Day 1 start or a Sunday start (see Table 1). For the first cycle of a Sunday Start regimen, an additional method of contraception should be used until after the first 7 consecutive days of administration.

How to Take Previfem® or Tri-Previfem®

Starting Previfem® and Tri-Previfem® after Abortion or Miscarriage

First-trimester

• After a first-trimester abortion or miscarriage, Previfem® or Tri-Previfem® may be started immediately. An additional method of contraception is not needed if Previfem® or Tri-Previfem® is started immediately.
• If Previfem® or Tri-Previfem® is not started within 5 days after termination of the pregnancy, the patient should use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of her first cycle pack of Previfem® or Tri-Previfem®.

Second-trimester

• Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start Previfem® or Tri-Previfem®, following the instructions in Table 1 for Day 1 or Sunday start, as desired. If using Sunday start, use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of the patient’s first cycle pack of Previfem® or Tri-Previfem® [see Contraindications (4), Warnings and Precautions (5.1), and FDA-Approved Patient Labeling].

Starting Previfem® or Tri-Previfem® after Childbirth

• Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with Previfem® or Tri-Previfem® following the instructions in Table 1 for women not currently using hormonal contraception.
• Previfem® or Tri-Previfem® are not recommended for use in lactating women [see Use in Specific Populations (8.3)].
• If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of Previfem® or Tri-Previfem® [see Contraindications (4), Warnings and Precautions (5.1), Use in Specific Populations (8.1 and 8.3), and FDA-Approved Patient Labeling].

Previfem® and Tri-Previfem® come in a blister pack pill dispenser. Read the instructions below for using the blister pack pill dispenser.

The blister package consists of three parts, the calendar label, the sleeve and the blister pack containing 28 individually sealed pills. Note that the pills are arranged in four numbered rows of 7 pills, with the pre-printed days of the week printed above them.  Refer to the sample of the blister pack below:

Previfem® consists of 21 blue “active” birth control pills and 7 light green “reminder” pills.

Tri-Previfem® consists of 7 white “active” pills, 7 light-blue “active” pills, 7 blue “active” pills and 7 light green “reminder” pills.

There are two ways to start taking birth-control pills, Sunday Start or Day 1 Start.

How to use Blister Cards for the 28 tablets
1. If Sunday Start, the patient discards the stickers and takes the first active pill on the first Sunday after their menstrual period begins. Due to the potential risk of becoming pregnant, use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of the patient’s first cycle pack of Previfem® or Tri-Previfem®.

2. If Day 1 Start, the patient picks the Days of the Week Sticker that starts the first day of their period. When the patient has picked the right sticker, they need to throw away the others and place the sticker on the blister card over the preprinted days of the week and make sure it lines up with the pills.

3. The patient removes the first pill by pushing down on the pill and waits 24 hours to take their next pill. The patient continues to take one pill each day until all the pills have been taken.

4. The pill should be taken at the same time each day. 

5. After taking the last pill, the patient starts a new blister pack the very next day, no matter when their next period starts.

6. The patient should take the pills in each new package as before and start with the pill on the first row and take one pill each day, left to right, until the last pill has been taken.

Missed Tablets

Advice in Case of Gastrointestinal Disturbances

In case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken. If vomiting or diarrhea occurs within 3 to 4 hours after taking an active tablet, handle this as a missed tablet [see FDA-Approved Patient Labeling].

Tri-Previfem® Use for Acne

The timing of initiation of dosing with Tri-Previfem® for acne should follow the guidelines for use of Tri-Previfem® as an oral contraceptive. Consult the DOSAGE AND ADMINISTRATION section (2.1) for instructions.

Previfem®:

Previfem® (norgestimate and ethinyl estradiol tablets USP) is packaged in cartons of 6 blister pack tablet dispensers containing 28 tablets as follows:

21 blue tablets containing 0.25 mg of norgestimate and 0.035 mg of ethinyl estradiol which are round, unscored, film-coated tablets debossed with “93” and “748” on each side.

7 light-green, round, film-coated tablets debossed with “93” and “743” containing inert ingredients.

Tri-Previfem®:

Tri-Previfem® (norgestimate and ethinyl estradiol tablets USP) is packaged in cartons of 6 blister pack tablet dispensers, each blister pack tablet dispenser contains 28 tablets as follows:

Each white tablet contains 0.18 mg norgestimate and 0.035 mg of ethinyl estradiol.

Each light-blue tablet contains 0.215 mg of norgestimate and 0.035 mg ethinyl estradiol.

Each blue tablet contains 0.25 mg of, norgestimate and 0.035 mg of ethinyl estradiol.

Each light-green tablet contains inert ingredients.

The white tablets are round, unscored film-coated, imprinted with “93” on one side and “746” on the other side; the light-blue tablets are round, unscored film-coated, imprinted with “93” on one side and “747” on the other side; the blue tablets are round, unscored film-coated, imprinted with “93” on one side and “748” on the other side; the light-green tablets are round, film-coated, imprinted with “93” on one side and “743” on the other side.