Emoquette

Name: Emoquette

Emoquette Drug Class

Emoquette is part of the drug class:

  • Progesterone and Estrogen Contraceptives Used in Sequence

What is the most important information I should know about birth control pills?

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: uncontrolled high blood pressure, heart disease, a blood-clotting disorder, circulation problems, diabetic problems with your eyes or kidneys, unusual vaginal bleeding, liver disease, liver cancer, severe migraine headaches, if you smoke and are over 35, or if you have ever had breast or uterine cancer, jaundice caused by 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.

How should I take birth control pills?

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 medicine 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 at room temperature away from moisture and heat.

What do I need to tell my doctor BEFORE I take Emoquette?

  • If you have an allergy to ethinyl estradiol, desogestrel, or any other part of Emoquette.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have had any of these health problems: Blood clots, blood clotting problem, breast cancer, diseased arteries in the brain, disease of a heart valve with problems, heart disease, chest pain caused by angina, heart attack, stroke, high blood pressure, high cholesterol, a pancreas problem (pancreatitis) due to high blood triglycerides, liver disease, liver tumor, very bad headache or migraine, diabetes that affects blood flow, or tumor where estrogen makes it grow.
  • If you have had any of these health problems: Endometrial cancer, cancer of the cervix or vagina, or vaginal bleeding where the cause is not known.
  • If you have ever had a cancer where hormones make it grow.
  • If you have eyesight problems like loss of eyesight from blood vessel problems in the eye.
  • If you have surgery and need bedrest.
  • If you turned yellow during pregnancy or with estrogen-based or hormone contraceptive use.
  • If you are pregnant or may be pregnant. Do not take this medicine if you are pregnant.
  • If you are breast-feeding or plan to breast-feed.
  • If you are taking ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir).

This is not a list of all drugs or health problems that interact with Emoquette.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

How is this medicine (Emoquette) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Follow how to use as you have been told by the doctor or read the package insert.
  • Take Emoquette at the same time of day.
  • Take with or without food. Take with food if it causes an upset stomach.
  • If you also take colesevelam, take it at least 4 hours before or after you take this medicine.
  • Do not skip doses, even if you do not have sex very often.
  • If you throw up or have diarrhea, Emoquette (ethinyl estradiol and desogestrel) may not work as well to prevent pregnancy. Use an extra form of birth control, like condoms, until you check with your doctor.
  • If you miss 2 periods in a row, take a pregnancy test before starting a new cycle.

What do I do if I miss a dose?

  • If a dose is missed, check the package insert or call the doctor to find out what to do. If using this medicine to prevent pregnancy, another form of birth control may need to be used for some time to prevent pregnancy.

Indications and Usage for Emoquette

Emoquette®  (desogestrel and ethinyl estradiol tablets USP) tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.

Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates.

In a clinical trial with Emoquette®, 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents an overall user-efficacy (typical user-efficacy) pregnancy rate of 1.12 per 100 women-years. This rate includes patients who did not take the drug correctly.

TABLE 1: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF TYPICAL USE AND THE FIRST YEAR OF PERFECT USE OF CONTRACEPTION AND THE PERCENTAGE CONTINUING USE AT THE END OF THE FIRST YEAR. UNITED STATES.
Method
(1)

% of Women Experiencing an
Unintended Pregnancy
Within the First Year of Use

% of Women
Continuing Use
at One Year3

Typical Use1
(2)

 Perfect Use2
(3)

(4)
  Chance4  85  85  
  Spermicides5  26  6  40
  Periodic abstinence  25    63
     Calendar    9  
     Ovulation Method    3  
     Sympto-Thermal6    2  
     Post-Ovulation    1  
  Withdrawal  19  4  
  Cap7      
     Parous Women  40  26  42
     Nulliparous Women  20  9  56
  Sponge      
     Parous Women 40  20  42
     Nulliparous Women  20  9  56
  Diaphragm7  20  6  56
  Condom8      
     Female (Reality®)  21  5  56
     Male  14  3  61
  Pill  5    71
     Progestin Only    0.5  
     Combined    0.1  
  IUD      
     Progesterone T  2.0  1.5  81
     Copper T380A  0.8  0.6  78
     LNg20  0.1  0.1  81
  Depo-Provera®  0.3  0.3  70
  Norplant and Norplant-2  0.05  0.05  88
  Female Sterilization  0.5  0.5  100
  Male Sterilization  0.15  0.10  100

Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9

Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception.10

Source: Trussell J. Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowel D, Guest F. Contraceptive Technology: Seventeenth Revised Edition. New York, NY; Irvington Publishers, 1998.

1 Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. 
2 Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. 
4 The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether.
5 Foams, creams, gels, vaginal suppositories, and vaginal film.
6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.
7 With spermicidal cream or jelly.
8 Without spermicides. 
9 The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 4 yellow pills). 
10 However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency of duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age. 

Emoquette® has not been studied for and is not indicated for use in emergency contraception.

Emoquette Dosage and Administration

To achieve maximum contraceptive effectiveness, Emoquette® must be taken exactly as directed and at intervals not exceeding 24 hours. Emoquette® is available in the blister pack which is preset for a Sunday Start. Day 1 Start is also provided.

Day 1 Start

The dosage of Emoquette® for the initial cycle of therapy is one white “active” tablet administered daily from the 1st day through the 21st day of the menstrual cycle, counting the first day of menstrual flow as “Day 1”. Tablets are taken without interruption as follows: One white “active” tablet daily for 21 days, then one light-green “reminder” tablet daily for 7 days. After 28 tablets have been taken, a new course is started and a white “active” tablet is taken the next day.

The use of Emoquette® for contraception may be initiated 4 weeks postpartum in women who elect not to breastfeed. When the tablets are administered during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered (see CONTRAINDICATIONS and WARNINGS concerning thromboembolic disease. See also PRECAUTIONS, Nursing Mothers). If the patient starts on Emoquette® postpartum, and has not yet had a period, she should be instructed to use another method of contraception until a white “active” tablet has been taken daily for 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered. If the patient misses one (1) white “active” tablet in Weeks 1, 2, or 3, the white “active” tablet should be taken as soon as she remembers. If the patient misses two (2) white “active” tablets in Week 1 or Week 2, the patient should take two (2) white “active” tablets the day she remembers and two (2) white “active” tablets the next day; and then continue taking one (1) white “active” tablet a day until she finishes the pack. The patient should be instructed to use a back-up method of birth control such as a condom or spermicide if she has sex in the seven (7) days after missing pills. If the patient misses two (2) white “active” tablets in the third week or misses three (3) or more white “active” tablets in a row, the patient should throw out the rest of the pack and start a new pack that same day. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills.

Sunday Start

When taking Emoquette®, the first white “active” tablet should be taken on the first Sunday after menstruation begins. If the period begins on Sunday, the first white “active” tablet is taken on that day. If switching directly from another oral contraceptive, the first white “active” tablet should be taken on the first Sunday after the last ACTIVE tablet of the previous product. Tablets are taken without interruption as follows: One white “active” tablet daily for 21 days, then one light-green “reminder” tablet daily for 7 days. After 28 tablets have been taken, a new course is started and a white “active” tablet is taken the next day (Sunday). When initiating a Sunday start regimen, another method of contraception should be used until after the first 7 consecutive days of administration.

The use of Emoquette® for contraception may be initiated 4 weeks postpartum. When the tablets are administered during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered (see CONTRAINDICATIONS and WARNINGS concerning thromboembolic disease. See also PRECAUTIONS, Nursing Mothers). If the patient starts on Emoquette® postpartum, and has not yet had a period, she should be instructed to use another method of contraception until a white “active” tablet has been taken daily for 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered. If the patient misses one (1) white “active” tablet in Weeks 1, 2, or 3, the white “active” tablet should be taken as soon as she remembers. If the patient misses two (2) white “active” tablets in Week 1 or Week 2, the patient should take two (2) white “active” tablets the day she remembers and two (2) white “active” tablets the next day; and then continue taking one (1) white “active” tablet a day until she finishes the pack. The patient should be instructed to use a back-up method of birth control such as a condom or spermicide if she has sex in the seven (7) days after missing pills. If the patient misses two (2) white “active” tablets in the third week or misses three (3) or more white “active” tablets in a row, the patient should continue taking one white “active” tablet every day until Sunday. On Sunday the patient should throw out the rest of the pack and start a new pack that same day. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills.

Additional instructions for all dosing regimens

Breakthrough bleeding, spotting, and amenorrhea are frequent reasons for patients discontinuing oral contraceptives. In breakthrough bleeding, as in all cases of irregular bleeding from the vagina, nonfunctional causes should be borne in mind. In undiagnosed persistent or recurrent abnormal bleeding from the vagina, adequate diagnostic measures are indicated to rule out pregnancy or malignancy. If pathology has been excluded, time or a change to another formulation may solve the problem. Changing to an oral contraceptive with a higher estrogen content, while potentially useful in minimizing menstrual irregularity, should be done only if necessary since this may increase the risk of thromboembolic disease.

Use of oral contraceptives in the event of a missed menstrual period:

  1. If the patient has not adhered to the prescribed schedule, the possibility of pregnancy should be considered at the time of the first missed period and oral contraceptive use should be discontinued if pregnancy is confirmed.
  2. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out.

How is Emoquette Supplied

Emoquette® (desogestrel and ethinyl estradiol tablets USP) is packaged in cartons of 3 and 6 blister pack tablet dispensers; each blister pack tablet dispenser contains 28 tablets. Each white tablet contains 0.15 mg desogestrel and 0.03 mg ethinyl estradiol. Each light-green tablet contains inert ingredients.

The white tablets are round, film-coated, imprinted with “93” on one side and “876” on the other side; the light-green tablets are round, film-coated imprinted with “93” on one side, and “743” on the other side.

Blister pack tablet dispenser NDC 0603-7540-01
Boxes of 3 blister pack tablet dispensers NDC 0603-7540-49
Boxes of 6 blister pack tablet dispensers NDC 0603-7540-17

STORAGE: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

For the Consumer

Applies to desogestrel / ethinyl estradiol: oral tablet

Along with its needed effects, desogestrel / ethinyl estradiol 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 while taking desogestrel / ethinyl estradiol:

Incidence not known
  • 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, lightheadedness, fainting
  • fever
  • hives or welts
  • itching skin or rash
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • 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
  • 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 of desogestrel / ethinyl estradiol 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:

Incidence not known
  • Bloating
  • blotchy spots on the exposed skin
  • breast enlargement or tenderness
  • 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
  • trouble wearing contact lenses

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