BOXED WARNING Cigarette smoking and serious cardiovascular events: risk rises with age (esp. >35 y) and cigarettes smoked; contraindicated in women over 35 who smoke
FDA dosing
Population
Start
Target
Max
Prevention of pregnancy - Loestrin 21 (1/20 or 1.5/30; 21 active tablets)
Women of reproductive age (incl. postpubertal adolescents)
1 tablet QD x21 days, then 7 days no tablets (Sunday-Start or Day-1 Start)
21 days on - 7 days off; start new 21-tablet pack on the eighth day
1 tablet QD
Renal Undefined
Hepatic Discontinue if jaundice develops; steroid hormones may be poorly metabolized in impaired liver function; hepatic adenomas/carcinomas contraindicated
Interval between tablets must not exceed 24 hours
Instructions
Take exactly as directed at intervals not exceeding 24 hours; regularly with a meal or at bedtime
Sunday-Start: use an additional method until after the first week of the initial cycle
1 tablet missed: take as soon as remembered, next tablet at the regular time
2 consecutive missed (week 1 or 2): take 2 tablets as soon as remembered and 2 the next day; backup method x7 days
2 missed in week 3 or 3+ consecutive missed: Sunday-Start - 1 tablet daily until Sunday, discard pack, start new pack that Sunday; Day-1 Start - discard and start new pack same day; backup method x7 days
Spotting on regimen: continue without interruption; bleeding resembling menstruation: stop and restart from a new dispenser next Sunday or Day 1
Postpartum (not breastfeeding): start no earlier than 4-6 weeks after delivery
Missed 2 consecutive periods (or first missed period if non-adherent): rule out pregnancy before continuing
HCV ombitasvir/paritaprevir/ritonavir: stop before starting; may restart about 2 weeks after completing
Available strengths
tab 1/0.02, 1.5/0.03 mg
Contraindications
Women over 35 years who smoke (boxed warning)
Thrombophlebitis or thromboembolic disorders, current or past history (incl. deep vein thrombophlebitis)
Cerebral vascular or coronary artery disease
Current or past breast cancer (may be hormone sensitive)
Endometrial carcinoma or other known/suspected estrogen-dependent neoplasia
Undiagnosed abnormal genital bleeding
Cholestatic jaundice of pregnancy or jaundice with prior pill use
Hepatic adenomas or carcinomas
Hepatitis C regimens containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (ALT elevations)
Cautions
Thromboembolic and vascular problems: MI, thromboembolism, cerebrovascular disease; stop >=4 weeks before and 2 weeks after high-risk elective surgery and during prolonged immobilization
Malignant neoplasms (breast, cervical)
Hepatic neoplasia (benign adenomas; hepatocellular carcinoma with long-term use)
Liver enzyme elevations with HCV ombitasvir/paritaprevir/ritonavir regimens
Ocular lesions: discontinue for unexplained vision loss, proptosis, diplopia, papilledema or retinal vascular lesions
Use before/during early pregnancy: not a pregnancy test; discontinue if pregnancy confirmed
Gallbladder disease
Carbohydrate and lipid effects: glucose intolerance, hypertriglyceridemia - observe prediabetic/diabetic women
Elevated blood pressure: monitor; discontinue if significant elevation
Headache: new/worsening migraine or new-pattern severe headache requires discontinuation
Bleeding irregularities, esp. first three months; post-pill amenorrhea
No protection against HIV/STIs; fluid retention; hereditary angioedema; depression
Corneal steepening, contact lens intolerance; diminished lactation if given immediately postpartum
Pregnancy Discontinue if pregnancy occurs (no reason to use COCs in pregnancy); epidemiologic studies show no increased risk of birth defects with use before or inadvertently during early pregnancy
Lactation Small amounts of steroids in milk (infant jaundice, breast enlargement reported); may decrease quantity and quality of milk postpartum - if possible use another method until completely weaned