Brand Names

DEMULEN 1/35-21
DEMULEN 1/35-28
DEMULEN 1/50-21
DEMULEN 1/50-28
ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL
KELNOR
KELNOR 1/50
LO-MALMOREDE
MALMOREDE
OVULEN
OVULEN-21
OVULEN-28
ZOVIA 1/35E-21
ZOVIA 1/35E-28
ZOVIA 1/50E-21

Boxed Warning

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. 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.

Indications and Usage

Ethynodiol diacetate and ethinyl estradiol tablets USP, 1 mg/35 mcg 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 combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and progestogen implants and injections, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. 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. Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.The treatment schedule is one dose within 72 hours after unprotected intercourse and a second dose 12 hours after the first dose. The Food and Drug Administration 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 2 light-orange pills), Lo/Ovral (1 dose is 4 white pills), Triphasil or Tri-Levlen (1 dose is 4 yellow pills). Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception.However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches six months of age. Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: I

Dosage and Administration

To achieve maximum contraceptive effectiveness, oral contraceptives must be taken exactly as directed and at intervals of 24 hours. IMPORTANT: If the Sunday start schedule is selected, the patient should be instructed to use an additional method of protection until after the first week of administration in the initial cycle. The possibility of ovulation and conception prior to initiation of use should be considered. Dosage Schedules Each ethynodiol diacetate and ethinyl estradiol tablet dispenser contains 21 light orange colored active tablets arranged in three numbered rows of 7 tablets each, followed by a fourth row of 7 green placebo tablets. Days of the week are printed above the tablets, starting with Sunday on the left. 28-Day Schedule: For a DAY 1 START, count the first day of menstrual flow as Day 1 and the first tablet (light orange) is then taken on Day 1. For a SUNDAY START when menstrual flow begins on or before Sunday, the first tablet (light orange) is taken on that day. With either a DAY 1 START or SUNDAY START, 1 tablet (light orange) is taken each day at the same time for 21 days. Then the green tablets are taken for 7 days, whether bleeding has stopped or not. After all 28 tablets have been taken, whether bleeding has stopped or not, the same dosage schedule is repeated beginning on the following day. Special notes Spotting, breakthrough bleeding, or nausea. If spotting (bleeding insufficient to require a pad), breakthrough bleeding (heavier bleeding similar to a menstrual flow), or nausea occurs the patient should continue taking her tablets as directed. The incidence of spotting, breakthrough bleeding or nausea is minimal, most frequently occurring in the first cycle. Ordinarily spotting or breakthrough bleeding will stop within a week. Usually the patient will begin to cycle regularly within two or three courses of tablet-taking. In the event of spotting or breakthrough bleeding organic causes should be borne in mind. (See WARNING No. 11.) Misse

Contraindications

Ethynodiol diacetate and ethinyl estradiol tablets are contraindicated in females who are known to have or develop the following conditions: •Thrombophlebitis or thromboembolic disorders •A past history of deep vein thrombophlebitis or thromboembolic disorders •Cerebral vascular disease, myocardial infarction, or coronary artery disease, or a past history of these conditions •Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive •Known or suspected carcinoma of the female reproductive organs or suspected estrogen-dependent neoplasia, or a history of these conditions •Undiagnosed abnormal genital bleeding •History of cholestatic jaundice of pregnancy or jaundice with prior oral contraceptive use •Past or present, benign or malignant liver tumors •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).

Adverse Reactions

An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see WARNINGS ): •Thrombophlebitis and thrombosis •Arterial thromboembolism •Pulmonary embolism •Myocardial infarction and coronary thrombosis •Cerebral hemorrhage •Cerebral thrombosis •Hypertension •Gallbladder disease •Benign and malignant liver tumors, and other hepatic lesions There is evidence of an association between the following conditions and the use of oral contraceptives, although additional confirmatory studies are needed: •Mesenteric thrombosis •Neuro-ocular lesions (e.g., retinal thrombosis and optic neuritis) 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 during or after use •Temporary infertility after discontinuation of use •Edema •Chloasma or melasma, which may persist •Breast changes: tenderness, enlargement, secretion •Change in weight (increase or decrease) •Change in cervical erosion or 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 or conditions have been reported in users of oral contraceptives and the association has been neither confirmed nor refuted: •Premenstrual 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 •Endocervical hyperplasia or ectropion Post Marketing Experience

Overdosage

Serious ill effects have not been reported following acute ingestion n of large doses of oral contraceptives by young children.180, 181 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 epidemiological studies that largely utilized oral contraceptive formulations containing estrogen doses exceeding 35 mcg of ethinyl estradiol or 50 mcg of mestranol.148,149 Effects on menses: •Increased menstrual cycle regularity •Decreased blood loss and decreased risk of iron-deficiency anemia •Decreased frequency of dysmenorrhea Effects related to inhibition of ovulation: •Decreased risk of functional ovarian cysts •Decreased risk of ectopic pregnancies Effects from long-term use: •Decreased risk of fibroadenomas and fibrocystic disease of the breast •Decreased risk of acute pelvic inflammatory disease •Decreased risk of endometrial cancer •Decreased risk of ovarian cancer •Decreased risk of uterine fibroids

⚠ Caution

Medical Disclaimer: This information is for educational purposes only. Always consult a healthcare professional before taking any medication.