Combined Oral contraceptives
Action
Inhibits ovulation by suppressing gonadotropins, follicle-stimulating hormone and luteinizing hormone.
Indications Prevention of pregnancy.
Unlabeled use(s):
Postcoital contraceptive.
Contraindications Thrombophlebitis; thromboembolic disorders; history of deep vein thrombophlebitis; cerebral vascular disease; MI; coronary artery disease; known or suspected breast carcinoma or estrogen-dependent neoplasia; past or present benign or malignant liver tumors that developed during use of estrogen-containing products; past or present angina pectoris; undiagnosed abnormal genital bleeding; known or suspected pregnancy; cholestatic jaundice of pregnancy or jaundice with prior pill use.
Route/Dosage
ADULTS: PO 1 tablet daily beginning on first Sunday after menstruation begins. If menstruation begins on Sunday, take first tablet on that day.
21-DAY REGIMEN
ADULTS: PO 1 tablet daily for 21 days, beginning on day 5 of cycle. Take no tablets for 7 days; then start new course of 21-day regimen.
28-DAY REGIMEN
ADULTS: PO 1 tablet daily.
Interactions
Barbiturates, hydantoins, rifampin, griseofulvin, penicillin, tetracyclines:
Lab Test Interferences May cause increases in sulfobromophthalein retention; factors II, VII, VIII, IX, X; plasminogen, fibrinogen; norepinephrine-induced platelet aggregation; thyroid-binding globulin, leading to increased total thyroid hormone measurements; transcortin; corticosteroid levels; triglycerides and phospholipids; ceruloplasmin; aldosterone; amylase; gamma-glutamyl transpeptidase; iron-binding capacity; transferrin; prolactin; renin activity; vitamin A. May cause decreases in anti-thrombin III; free T3 resin uptake; pregnanediol excretion; response to metyrapone test; folate; glucose tolerance; albumin; cholinesterase; haptoglobin; zinc; vitamin B12.
Adverse Reactions
CV:
Precautions
Pregnancy:
PATIENT CARE CONSIDERATIONS
Administration/Storage
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May be given with or without food. Give at same time each day. Efficacy depends on strict adherence to dosage schedule.
Assessment/Interventions
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Do not administer oral contraceptives to induce withdrawal bleeding as test for pregnancy. If spotting or breakthrough bleeding continues past second month, notify physician. Monitor blood glucose levels in patients with diabetes. Obtain patient medical history, including drug history and any known allergies.
Patient/Family Education
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Warn patient that side effects such as nausea and breakthrough bleeding are common at firstTeach patient routine breast self-examination technique. Instruct patient to report symptoms of blood clots (eg, pain, numbness, shortness of breath, visual disturbances). Caution patient that antibiotics may decrease effectiveness of oral contraceptives and to use a nonhormonal form of contraception while taking antibiotics and for 7 days after stopping antibiotics. Advise patient to wait ³ 3 mo after discontinuing oral contraceptives to try to become pregnant. Caution patient to avoid prolonged exposure to sunlight, and to use sunscreen or wear protective clothing to avoid photosensitivity reaction. Advise patient that oral contraceptives may change the fit of rigid contact lenses. Encourage patient who smokes to stop. Cardiovascular dysfunction and thromboembolic disease have been associated with use of oral contraceptives in patients who smoke. Advise patient to take multiple daily vitamin. Advise patient what to do if dose is missed: (1) if missed 1, take when remember or take 2 the next day; (2) if missed 2, take 2 on 2 consecutive days; (3) if missed ³ 3, stop pills; (4) use alternative form of birth control in all cases. Advise patient to use additional method of birth control until after first week of administration in initial cycle.
Category X.
Lactation: Excreted in breast milk. Defer use until infant weaned.
Acute intermittent porphyria: May be precipitated by estrogen therapy in susceptible individuals.
Carbohydrate and lipid metabolism: Glucose tolerance may decrease; triglycerides and total phospholipids may increase. Progestins may elevate LDL levels.
Depression: Use drug with caution in patients with history of depression.
Fibroids: Oral contraceptives may cause an increase in size of preexisting uterine leiomyomata (fibroids).
Fluid retention: Use drug with caution in patients with hypertension, convulsive disorders, migraines, asthma, cardiac, hepatic or renal dysfunction.
Liver dysfunction: May impair metabolism of oral contraceptives.
Pyridoxine deficiency: May occur due to disturbance in normal tryptophan metabolism.
Serum folate: May be depressed by oral contraceptive therapy.
Tartrazine sensitivity: Some products may contain tartrazine, which may cause allergic-type reaction in susceptible individuals.
Coronary thrombosis; MI; hypertension.
CNS: Cerebral thrombosis; cerebral hemorrhage; migraine; mental depression.
DERM: Melasma; rash; photosensitivity.
EENT: Steepening of corneal curvature; contact lens intolerance.
GI: Nausea and vomiting; abdominal cramps; bloating; mesenteric thrombosis.
GU: Renal artery thrombosis; break-through bleeding; spotting; change in menstrual flow; dysmenorrhea; amenorrhea; temporary infertility after discontinuation; change in cervical erosion and cervical secretions; endocervical hyperplasia; increase in size of uterine leiomyomata; vaginal candidiasis.
HEMA: Thrombophlebitis and thrombosis; arterial thromboembolism.
HEPA: Cholestatic jaundice; gallbladder disease.
RESP: Pulmonary embolism.
OTHER: Raynaud's disease; congenital anomalies; liver tumors; hepatocellular carcinoma; breast tenderness, enlargement, secretion, diminished lactation; edema; weight change; reduced carbohydrate tolerance; prolactin-secreting pituitary tumors; increased prevalence of cervical chlamydia trachomatous.
Decreased effectiveness of oral contraceptive. Use additional form of birth control during concomitant therapy.
Benzodiazepines: Increased benzodiazepine therapeutic effect or toxicity.
Caffeine: Increased caffeine therapeutic effect or toxicity.
Corticosteroids: Increased corticosteroid effect or toxicity.
Metoprolol: Increased metoprolol effect or toxicity.
Theophyllines: Increased theophylline effect or toxicity.
Tricyclic antidepressants: Increased tricyclic antidepressant effect or toxicity.
Troleandomycin: Increased frequency of cholestatic jaundice.
SUNDAY-START PACKAGING