Classes
DEA Class; Rx
Common Brand Names; Necon 1/50, Norinyl 1+50
- Progestins
Description
Combined oral contraceptive (COC); mestranol is an estrogen that is metabolized to ethinyl estradiol for activity; norethindrone is a first-generation 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
Indications
Contraindications
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
Adverse Effects
Common
Emotional lability
Headache
Breast symptoms
Menstrual cramps
Abdominal pains
Nausea
Serious
Arterial/venous thromboembolism
Hypertension
MI
Cerebral hemorrhage
Gallbladder disease
Hepatic adenoma
Warnings
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 and Lactation
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 w/ nursing)
Maximum Dosage
Dependent on product used and indication for therapy.
Dependent on product used and indication for therapy.
Dependent on product used and indication for therapy.
Not indicated in prepubescent females.
How supplied
Mestranol/norethindrone
tablet
- 50mcg/1mg