Ethinyl Estradiol/Norgestrel

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  • U.S.:
    • Cryselle, Lo Ovral, Low Ogestrel, Norgestrel Ethinyl Estradiol PI (28 tablets: 21 tablets 0.03 mg Ethinyl Estradiol and Norgestrel 0.3 mg, plus 7 placebo tablets)
    • Ogestrel (28 tablets: 21 tablets 0.05 mg Ethinyl Estradiol and Norgestrel 0.5 mg, plus 7 placebo tablets)


Combination oral contraceptives, containing both estrogen and progestins, act by suppression of gonadotropins (FSH and LH). Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which reduce the likelihood of implantation).


Ethinyl Estradiol/Norgestrel combination is indicated for use by women to prevent pregnancy

[edit] DOSAGE

28-pill packages (21 active tablets + 7 placebo tablets): The possibility of ovulation and conception prior to initiation of medication should be considered.

The patient should be instructed to begin taking Ethinyl Estradiol/Norgestrel active tablets on either Day 1 of menstruation (Day 1 Start) or the first Sunday after the onset of menstruation (Sunday Start).

Patient should take one tablet in the order directed on the package at the same time every day, preferably after the evening meal or at bedtime with some liquid, for 28 days. The failure rate may increase when pills are missed or taken incorrectly.

During the first cycle of Ethinyl Estradiol/Norgestrel, when beginning on the first Sunday after the onset of menstrual period, Ethinyl Estradiol/Norgestrel should not be considered effective as a contraceptive until after the first 7 consecutive days of product administration. Patients should use a non-hormonal contraceptive as back-up during the first 7 days.

After 28 tablets have been taken, a new course should be started


Oral contraceptives should not be used in women who currently have the following conditions:

  • A history of heart attack or stroke
  • Blood clots in the legs (thrombophlebitis), lungs (pulmonary embolism), or eyes
  • A history of blood clots in the deep veins of your legs
  • Hereditary or acquired thrombophilias (a condition that makes blood clot more than normal)
  • Chest pain (angina pectoris)
  • Known or suspected breast cancer or cancer of the lining of the uterus, cervix, or vagina
  • Unexplained vaginal bleeding (until your doctor reaches a diagnosis)
  • Hepatitis or yellowing of the whites of your eyes or of the skin (jaundice) during pregnancy or during previous use of hormonal contraceptives
  • Benign or cancerous liver tumor (Hepatic adenomas or carcinomas)
  • Severe high blood pressure
  • Diabetes with complications of the kidneys, eyes, nerves, or blood vessels
  • Headaches with neurological symptoms
  • Disease of heart valves with complications
  • Major surgery with prolonged immobilization


  • Oral contraceptives do not protect against HIV infection (AIDS) and other sexually transmitted diseases such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.
  • Cigarette smoking increases the risk of serious cardiovascular (heart and blood vessel problems) from hormonal contraceptives, including death from heart attack, blood clots, or stroke. This risk increases with age and with heavy smoking (15  or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.
  • Vascular risks: Stop taking oral contraceptives if a thrombotic event occurs. Stop at least 4 weeks before and through 2 weeks after major surgery. Start no earlier than 4 weeks after delivery, in women who are not breastfeeding.
  • Liver disease: Discontinue if jaundice occurs.
  • High blood pressure: Women with significant hypertension or hypertensive with vascular disease, should not be started on hormonal contraception.
  • Carbohydrate and lipid metabolic effects: Monitor prediabetic and diabetic women taking oral contraceptives. Consider an alternate contraceptive method for women with uncontrolled dyslipidemia.
  • Headache: Evaluate significant change in headaches and discontinue oral contraceptives if indicated.
  • Uterine bleeding: Unscheduled (breakthrough) bleeding and spotting sometimes occur in women taking oral contraceptives. Consider non-hormonal causes and take adequate diagnostic measures to rule out malignancy, other pathology, or pregnancy in the event of unscheduled bleeding, as in the case of any abnormal vaginal bleeding. If pathology and pregnancy have been excluded, time or a change to another contraceptive product may resolve the bleeding. Some women may encounter post-pill amenorrhea or oligomenorrhea, especially when such a condition was pre-existent.


  • Anti-HIV Protease inhibitors: some protease inhibitors may decrease the plasma levels of the estrogen and progestin. The safety and efficacy of combination oral contraceptive products may be affected with coadministration of anti-HIV protease inhibitors. Refer to the label of the individual anti-HIV protease inhibitors for further drug-drug interaction information.
  • Herbal products: St. John’s Wort (hypericum perforatum) may induce hepatic enzymes (cytochrome P450) and p-glycoprotein transporter and may reduce the effectiveness of contraceptive steroids. This may also result in breakthrough bleeding.
  • Combined hormonal contraceptives have been shown to significantly decrease plasma concentrations of lamotrigine when co-administered due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary.
  • Increase in plasma levels of estradiol associated with co-administered drugs:


  • Pregnancy Category X (US)
  • Nursing mothers: Not recommended; can decrease milk production. Ethinyl Estradiol/Norgestrel can be started no earlier than 4 weeks after delivery, in women who are not breastfeeding.


Possible adverse reactions include: headache, vaginal candidiasis, nausea, menstrual cramps, breast tenderness, vaginitis (bacterial), abnormal cervical smear, urinary tract infection, mood swings including depression, weight gain, vomiting, and metrorrhagia (abnormal bleeding between periods). (See also WARNINGS AND PRECAUTIONS for serious possible adverse events)