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Ethynodiol/Ethinyl Estradiol

    Brands

    DEA Class; Rx

    Common Brand Names; Kelnor, Zovia

    • Estrogens/Progestins; 
    • Contraceptives, Oral

    Combined oral contraceptive (COC) containing a synthetic estrogen and ethynodiol diacetate, a progestin with moderate androgenic and slight estrogenic activity
    Used for routine contraception in adolescent and adult premenopausal females
    All COCs contain a boxed warning regarding the increased risk for thromboembolism in women who smoke

    Indicated for routine contraception.

    For the treatment of severe acne vulgaris related to sebum overproduction in females who have no known contraindications to oral contraceptives, desire contraception, have achieved menarche, and are unresponsive to topical anti-acne medications.
    For the treatment or adjuvant treatment of amenorrhea, abnormal uterine bleeding (dysfunctional uterine bleeding), hirsutism, hypermenorrhea†, or polycystic ovary syndrome related to hypoestrogenic or hyperandrogenic conditions in females who have no known contraindications to oral contraceptives, desire contraception, have achieved menarche, and have been evaluated for causes of the condition.
    For the treatment of endometriosis to induce endometrial involution to a ‘resting’ phase and reduce the size and growth of endometrial tissue in females with no contraindications to hormonal contraceptives, have achieved menarche and who desire contraception.

    Documented hypersensitivity

    Active or history of breast cancer

    Arterial thromboembolic disease (stroke, MI), thrombophlebitis, DVT/PE, thrombogenic valvular disease

    Estrogen-dependent neoplasia, liver disease, liver tumors

    Undiagnosed abnormal vaginal bleeding

    Uncontrolled hypertension

    Diabetes mellitus with vascular involvement

    Jaundice with prior oral contraceptive use

    • Headache
    • Emotional lability
    • Breast symptoms
    • Menstrual cramps
    • Abdominal painsNausea
    • Application site reaction
    • Arterial/venous thromboembolism
    • Hypertension
    • MI
    • Cerebral hemorrhage
    • Gallbladder disease
    • Hepatic adenomas

    Family history of breast cancer and or DVT/PE, current/history of depression, endometriosis, DM, HTN, bone mineral density changes, renal/hepatic impairment, bone metabolic disease, SLE; conditions exacerbated by fluid retention (eg, migraine, asthma, epilepsy)

    Discontinue if the following develop jaundice, visual problems (may cause contact lens intolerance), any signs of VTE, migraine with unusual severity, significang blood pressure increase, severe depression, increased risk of thromboembolic complications after surgery

    Discontinue 4 week before major surgery or prolonged immobilization

    Patients on warfarin, oral anticoagulants (increase in anticoagulant dose may be warranted)

    Some studies link OCP use with increased risk of breast cancer, whereas other studies have not shown a change in risk

    Woman’s risk depends on conditions where naturally high hormone levels persist for long periods of time including early onset menstruation before age 12, late onset menopause, after age 55, first child after age 30, nulliparity

    Increased risk of cervical cancer with OCP use, however HPV remains as main risk factor for this cancer; evidence suggests long-term use of OCPs, 5 or more years, may be associated with increased risk

    Increased risk of liver cancer with OCP use; risk increases with longer duration of OCP use

    Pregnancy Category: X

    Lactation: small amounts of steroids are excreted in breast milk; estrogens may reduce quality/quantity of milk; may be prudent to use other forms of birth control until full weaning (AAP Committee states compatible with nursing)

    Adults

    Dependent on product used and indication for therapy.

    Geriatric

    Not indicated.

    Adolescents

    Dependent on product used and indication for therapy.

    Children

    Not indicated in prepubescent females.

    Ethynodiol/ethinylestradiol

    tablet

    • 0.035mg/1mg
    • 0.05mg/1mg