Azurette Drug Information

    Generic name: DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL

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    Uses of Azurette

    Combined 0.1

    IUD Progesterone T 2.0 1.5 81 Copper T 380A 0.8 0.6 78 LNg 20 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 Adapted from Hatcher et al., 1998, Ref#1. 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 and 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.

    Dosage & Administration of Azurette

    To achieve maximum contraceptive effectiveness, Azurette (Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP) must be taken exactly as directed and at intervals not exceeding 24 hours. Azurette may be initiated using either a Sunday start or a Day 1 start. NOTE: Each cycle pack dispenser is preprinted with the days of the week, starting with Sunday, to facilitate a Sunday start regimen.

    Six different "day label stickers" are provided with each cycle pack dispenser in order to accommodate a Day 1 start regimen. In this case, the patient should place the self-adhesive "day label sticker" that corresponds to her starting day over the preprinted days. IMPORTANT: The possibility of ovulation and conception prior to initiation of use of Azurette should be considered.

    The use of Azurette for contraception may be initiated 4 weeks postpartum in women who elect not to breast feed. 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 for Nursing Mothers ). If the patient starts on Azurette postpartum, and has not yet had a period, she should be instructed to use another method of contraception until a dark blue tablet has been taken daily for 7 days.

    SUNDAY START When initiating a Sunday start regimen, another method of contraception should be used until after the first 7 consecutive days of administration. Using a Sunday start, tablets are taken daily without interruption as follows: The first dark blue tablet should be taken on the first Sunday after menstruation begins (if menstruation begins on Sunday, the first dark blue tablet is taken on that day). One dark blue tablet is taken daily for 21 days, followed by 1 white (inert) tablet daily for 2 days and 1 green (active) tablet daily for 5 days. For all subsequent cycles, the patient then begins a new 28-tablet regimen on the next day (Sunday) after taking the last green tablet.

    If a patient misses 1 dark blue tablet, she should take the missed tablet as soon as she remembers. If the patient misses 2 consecutive dark blue tablets in Week 1 or Week 2, the patient should take 2 tablets the day she remembers and 2 tablets the next day; thereafter, the patient should resume taking 1 tablet daily until she finishes the cycle pack. The patient should be instructed to use a back-up method of birth control if she has intercourse in the 7 days after missing pills.

    If the patient misses 2 consecutive dark blue tablets in the third week or misses 3 or more dark blue tablets in a row at any time during the cycle, the patient should keep taking 1 dark blue tablet daily until the next Sunday. On Sunday the patient should throw out the rest of that cycle pack and start a new cycle pack that same day. The patient should be instructed to use a back-up method of birth control if she has intercourse in the 7 days after missing pills.

    DAY 1 START Counting the first day of menstruation as "Day 1", tablets are taken without interruption as follows: One dark blue tablet daily for 21 days, one white (inert) tablet daily for 2 days followed by 1 green (ethinyl estradiol) tablet daily for 5 days. For all subsequent cycles, the patient then begins a new 28-tablet regimen on the next day after taking the last green tablet. If a patient misses 1 dark blue tablet, she should take the missed tablet as soon as she remembers.

    If the patient misses 2 consecutive dark blue tablets in Week 1 or Week 2, the patient should take 2 tablets the day she remembers and 2 tablets the next day; thereafter, the patient should resume taking 1 tablet daily until she finishes the cycle pack. The patient should be instructed to use a back-up method of birth control if she has intercourse in the 7 days after missing pills. If the patient misses 2 consecutive dark blue tablets in the third week or if the patient misses 3 or more dark blue tablets in a row at any time during the cycle, the patient should throw out the rest of that cycle pack and start a new cycle pack that same day.

    The patient should be instructed to use a back-up method of birth control if she has intercourse in the 7 days after missing pills. ALL ORAL CONTRACEPTIVES 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, non-functional 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 both pregnancy and pathology have been excluded, time or a change to another preparation 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 until pregnancy is ruled out. 2. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out before continuing oral contraceptive use.

    Side Effects of Azurette

    • To report SUSPECTED ADVERSE REACTIONS, contact Mayne Pharma Toll-Free at 1-844-825-8500 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see WARNINGS section):
    • Thrombophlebitis and venous thrombosis with or without embolism
    • Arterial thromboembolism
    • Pulmonary embolism
    • Myocardial infarction
    • Cerebral hemorrhage
    • Cerebral thrombosis
    • Hypertension
    • Gallbladder disease
    • Hepatic adenomas or benign liver tumors There is evidence of an association between the following conditions and the use of oral contraceptives:
    • Mesenteric thrombosis
    • Retinal thrombosis The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related:
    • Nausea
    • Vomiting
    • Gastrointestinal symptoms (such as abdominal cramps and bloating)
    • Breakthrough bleeding
    • Spotting
    • Change in menstrual flow
    • Amenorrhea
    • Temporary infertility after discontinuation of treatment
    • Edema
    • Melasma which may persist
    • Breast changes: tenderness, enlargement, secretion
    • Change in weight (increase or decrease)
    • Change in cervical erosion and secretion
    • Diminution in lactation when given immediately postpartum
    • Cholestatic jaundice
    • Migraine
    • Rash (allergic)
    • Mental depression
    • Reduced tolerance to carbohydrates
    • Vaginal candidiasis
    • Change in corneal curvature (steepening)
    • Intolerance to contact lenses The following adverse reactions have been reported in users of oral contraceptives and the association has been neither confirmed nor refuted:
    • Pre-menstrual syndrome
    • Cataracts
    • Changes in appetite
    • Cystitis-like syndrome
    • Headache
    • Nervousness
    • Dizziness
    • Hirsutism
    • Loss of scalp hair
    • Erythema multiforme
    • Erythema nodosum
    • Hemorrhagic eruption
    • Vaginitis
    • Porphyria
    • Impaired renal function
    • Hemolytic uremic syndrome
    • Acne
    • Changes in libido
    • Colitis
    • Budd-Chiari Syndrome

    Warnings & Cautions for Azurette

    Oral contraceptives non-smoker** 0.3 0.5 0.9 1.9 13.8 31.6 Oral contraceptives smoker**

    2.2 3.4 6.6 13.5 51.1

    IUD** 0.8 0.8 1.0 1.0 1.4 1.4 Condom* 1.1 1.6 0.7 0.2

    0.3

    Diaphragm/spermicide* 1.9 1.2 1.2 1.3 2.2 2.8 Periodic abstinence* 2.5 1.6 1.6

    1.7 2.9 3.6 *Deaths are birth related **Deaths are method related Adapted from H.W. Ory, ref. #35. 3. CARCINOMA OF THE REPRODUCTIVE ORGANS AND BREASTS Numerous epidemiologic studies have been performed on the incidence of breast, endometrial, ovarian, and cervical cancer in women using oral contraceptives. While there are conflicting reports, most studies suggest that the use of oral contraceptives is not associated with an overall increase in the risk of developing breast cancer. Some studies have reported an increased relative risk of developing breast cancer, particularly at a younger age.

    This increased relative risk appears to be related to duration of use. 36–43, 79–89 Some studies suggest that oral contraceptive use has been associated with an increase in the risk of cervical intra-epithelial neoplasia in some populations of women. 45–48 However, there continues to be controversy about the extent to which such findings may be due to differences in sexual behavior and other factors. 4. HEPATIC NEOPLASIA Benign hepatic adenomas are associated with oral contraceptive use, although the incidence of benign tumors is rare in the United States. Indirect calculations have estimated the attributable risk to be in the range of 3.3 cases/100,000 for users, a risk that increases after four or more years of use especially with oral contraceptives of higher dose. 49 Rupture of rare, benign, hepatic adenomas may cause death through intra-abdominal hemorrhage. 50,51 Studies from Britain have shown an increased risk of developing hepatocellular carcinoma 52–54 in long-term (>8 years) oral contraceptive users. However, these cancers are extremely rare in the US and the attributable risk (the excess incidence) of liver cancers in oral contraceptive users approaches less than one per million users. 5.RISK OF LIVER ENZYME ELEVATIONS WITH CONCOMITANT HEPATITIS C TREATMENT During clinical trials with the Hepatitis C combination drug regimen that contains ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, ALT elevations greater than 5 times the upper limit of normal (ULN), including some cases greater than 20 times the ULN, were significantly more frequent in women using ethinyl estradiol-containing medications such as COCs.

    Discontinue AZURETTE prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir . Azurette can be restarted approximately 2 weeks following completion of treatment with the combination drug regimen. 6. OCULAR LESIONS There have been clinical case reports of retinal thrombosis associated with the use of oral contraceptives. Oral contraceptives should be discontinued if there is unexplained partial or complete loss of vision; onset of proptosis or diplopia; papilledema; or retinal vascular lesions. Appropriate diagnostic and therapeutic measures should be undertaken immediately. 7. ORAL CONTRACEPTIVE USE BEFORE OR DURING EARLY PREGNANCY Extensive epidemiologic studies have revealed no increased risk of birth defects in women who have used oral contraceptives prior to pregnancy. 55–57 Studies also do not suggest a teratogenic effect, particularly in so far as cardiac anomalies and limb reduction defects are concerned, 55,56,58,59 when oral contraceptives are taken inadvertently during early pregnancy.

    The administration of oral contraceptives to induce withdrawal bleeding should not be used as a test for pregnancy. Oral contraceptives should not be used during pregnancy to treat threatened or habitual abortion. It is recommended that for any patient who has missed two consecutive periods, pregnancy should be ruled out before continuing oral contraceptive use.

    If the patient has not adhered to the prescribed schedule, the possibility of pregnancy should be considered at the first missed period. Oral contraceptive use should be discontinued until pregnancy is ruled out. 8.GALLBLADDER DISEASE Earlier studies have reported an increased lifetime relative risk of gallbladder surgery in users of oral contraceptives and estrogens. 60,61 More recent studies, however, have shown that the relative risk of developing gallbladder disease among oral contraceptive users may be minimal. 62–64 The recent findings of minimal risk may be related to the use of oral contraceptive formulations containing lower hormonal doses of estrogens and progestogens. 9. CARBOHYDRATE AND LIPID METABOLIC EFFECTS Oral contraceptives have been shown to cause a decrease in glucose tolerance in a significant percentage of users. 17 Oral contraceptives containing greater than 75 micrograms of estrogens cause hyperinsulinism, while lower doses of estrogen cause less glucose intolerance. 65 Progestogens increase insulin secretion and create insulin resistance, this effect varying with different progestational agents. 17,66 However, in the non-diabetic woman, oral contraceptives appear to have no effect on fasting blood glucose. 67 Because of these demonstrated effects, prediabetic and diabetic women should be carefully monitored while taking oral contraceptives. A small proportion of women will have persistent hypertriglyceridemia while on the pill.

    As discussed earlier (see WARNINGS 1.a. and 1.d. ), changes in serum triglycerides and lipoprotein levels have been reported in oral contraceptive users. 10. ELEVATED BLOOD PRESSURE An increase in blood pressure has been reported in women taking oral contraceptives 68 and this increase is more likely in older oral contraceptive users 69 and with continued use. 61 Data from the Royal College of General Practitioners 12 and subsequent randomized trials have shown that the incidence of hypertension increases with increasing quantities of progestogens. Women with a history of hypertension or hypertension-related diseases, or renal disease 70 should be encouraged to use another method of contraception. If women elect to use oral contraceptives, they should be monitored closely and if significant elevation of blood pressure occurs, oral contraceptives should be discontinued.

    For most women, elevated blood pressure will return to normal after stopping oral contraceptives, 69 and there is no difference in the occurrence of hypertension between ever- and never-users. 68,70,71 11. HEADACHE The onset or exacerbation of migraine or development of headache with a new pattern which is recurrent, persistent, or severe requires discontinuation of oral contraceptives and evaluation of the cause. 12. BLEEDING IRREGULARITIES Breakthrough bleeding and spotting are sometimes encountered in patients on oral contraceptives, especially during the first three months of use. Non-hormonal causes should be considered and adequate diagnostic measures taken to rule out malignancy or pregnancy in the event of breakthrough bleeding, as in the case of any abnormal vaginal bleeding. If pathology has been excluded, time or a change to another formulation may solve the problem.

    In the event of amenorrhea, pregnancy should be ruled out. Some women may encounter post-pill amenorrhea or oligomenorrhea, especially when such a condition was pre-existent. 13. ECTOPIC PREGNANCY Ectopic as well as intrauterine pregnancy may occur in contraceptive failures. image-02 image-03

    Contraindications for Azurette

    • Oral contraceptives should not be used in women who currently have the following conditions:
    • Thrombophlebitis or thromboembolic disorders
    • A past history of deep vein thrombophlebitis or thromboembolic disorders
    • Cerebral vascular or coronary artery disease
    • Known or suspected carcinoma of the breast
    • Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
    • Undiagnosed abnormal genital bleeding
    • Cholestatic jaundice of pregnancy or jaundice with prior pill use
    • Hepatic adenomas or carcinomas
    • Known or suspected pregnancy
    • Are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations (see Warnings , RISK OF LIVER ENZYME ELEVATIONS WITH CONCOMITANT HEPATITIS C TREATMENT ).

    Overdosage Information for Azurette

    • Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children. Overdosage may cause nausea, and withdrawal bleeding may occur in females. NON-CONTRACEPTIVE HEALTH BENEFITS The following non-contraceptive health benefits related to the use of oral contraceptives are supported by epidemiologic studies which largely utilized oral contraceptive formulations containing estrogen doses exceeding 0.035 mg of ethinyl estradiol or 0.05 mg of mestranol. 73–78 Effects on menses:
    • increased menstrual cycle regularity
    • decreased blood loss and decreased incidence of iron deficiency anemia
    • decreased incidence of dysmenorrhea Effects related to inhibition of ovulation:
    • decreased incidence of functional ovarian cysts
    • decreased incidence of ectopic pregnancies Effects from long-term use:
    • decreased incidence of fibroadenomas and fibrocystic disease of the breast
    • decreased incidence of acute pelvic inflammatory disease
    • decreased incidence of endometrial cancer
    • decreased incidence of ovarian cancer

    Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.

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