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Class: Hormone/contraceptive

 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

SUNDAY-START PACKAGING

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: 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.

 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: 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.

 Precautions

Pregnancy: 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.

PATIENT CARE CONSIDERATIONS

 Administration/Storage

  • Give at same time each day. Efficacy depends on strict adherence to dosage schedule.
  • May be given with or without food.

 Assessment/Interventions

  • Obtain patient medical history, including drug history and any known allergies.
  • Monitor blood glucose levels in patients with diabetes.
  • If spotting or breakthrough bleeding continues past second month, notify physician.
  • Do not administer oral contraceptives to induce withdrawal bleeding as test for pregnancy.
OVERDOSAGE: SIGNS & SYMPTOMS
  Withdrawal bleeding

 Patient/Family Education

  • Advise patient to use additional method of birth control until after first week of administration in initial cycle.
  • 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 take multiple daily vitamin.
  • 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 that oral contraceptives may change the fit of rigid contact lenses.
  • Caution patient to avoid prolonged exposure to sunlight, and to use sunscreen or wear protective clothing to avoid photosensitivity reaction.
  • Advise patient to wait ³ 3 mo after discontinuing oral contraceptives to try to become pregnant.
  • 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.
  • Instruct patient to report symptoms of blood clots (eg, pain, numbness, shortness of breath, visual disturbances).
  • Teach patient routine breast self-examination technique.
  • Warn patient that side effects such as nausea and breakthrough bleeding are common at first.

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