Lo/Ovral (ethinyl estradiol/norgestrel)
Cigarette smoking increases the risk of serious cardiovascular side effects. Risk increases with age (>35 yrs of age) and extent of smoking (≥15 cigarettes/day). Women who use oral contraceptives should be strongly advised not to smoke.
OTHER BRAND NAMES
Prevention of pregnancy.
1 tab qd at the same time each day for 28 days, then repeat
Start 1st Sunday after menses begin or on 1st day of menses
Switching from 21-Day Regimen:
Wait 7 days after last tab before starting therapy
Switching from 28-Day Regimen:
Start therapy on the day after her last tab; do not wait any days between packs
Switching from Progestin-Only Pill:
Start therapy next day; use a nonhormonal backup method of birth control for first 7 days of therapy
Switching from an Implant or Inj:
Start therapy on the day of implant removal or day the next inj is due; use a nonhormonal backup method of birth control for first 7 days of therapy
If ≥2 white tabs are missed, another method of contraception should be used until a white tab is taken for 7 consecutive days
If ≥1 light-green tabs are missed, no other method of contraception is needed
Not indicated for use premenarche; refer to adult dosing
Other Important Considerations
Postpartum Women Who Do Not Breastfeed/After 2nd Trimester Abortion: Start therapy no earlier than 28 days postpartum; advise to use a nonhormonal backup method for the first 7 days of therapy
1st Trimester Abortion/Miscarriage: May be initiated immediately; backup contraception is not needed if therapy started immediately
Nonlactating Mother: May initiate postpartum
Postpartum Women After Full-Term Delivery: Do not initiate earlier than 4-6 weeks postpartum
Termination of Pregnancy in the First 12 Weeks: Start therapy immediately or w/in 7 days
Termination of Pregnancy After 12 Weeks: Start therapy after 2 weeks
Take dose at intervals not exceeding 24 hrs
Cryselle: Take preferably after pm meal or at hs
Tab: (Ethinyl Estradiol [EE]/Norgestrel) 0.03mg/0.3mg
Thrombophlebitis, thromboembolic disorders, history of deep vein thrombophlebitis/thromboembolic disorders, cerebrovascular disease or coronary artery disease (CAD), known or suspected carcinoma of the breast, carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia, undiagnosed abnormal genital bleeding, cholestatic jaundice of pregnancy or jaundice with prior pill use, known or suspected pregnancy, hepatic adenomas or carcinomas or (Low-Ogestrel) benign liver tumors. (Lo/Ovral) Past history of cerebrovascular disease or CAD, active liver disease, valvular heart disease with thrombogenic complications, thrombogenic rhythm disorders, hereditary or acquired thrombophilias, major surgery with prolonged immobilization, diabetes with vascular involvement, headaches with focal neurological symptoms, uncontrolled HTN, personal history of breast cancer.
Increased risk of myocardial infarction (MI), vascular disease, thromboembolism, stroke, hepatic neoplasia, and gallbladder disease. Increased risk of morbidity and mortality if other risk factors (eg, certain inherited or acquired thrombophilia, HTN, hyperlipidemia, obesity, diabetes) are present. If feasible, d/c at least 4 weeks prior to and for 2 weeks after elective surgery of a type associated with an increased risk of thromboembolism and during and following prolonged immobilization. Start use no earlier than 4-6 weeks after delivery in women who elect not to breastfeed, or a midtrimester pregnancy termination. May increase risk of breast cancer and cancer of the reproductive organs. Retinal thrombosis reported; d/c if there is unexplained partial or complete loss of vision; onset of proptosis or diplopia; papilledema; or if retinal vascular lesions develop. Contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist. Should not be used to induce withdrawal bleeding as a test for pregnancy, nor to treat threatened or habitual abortion during pregnancy. Rule out pregnancy if 2 consecutive periods are missed. May cause glucose intolerance; monitor prediabetic and diabetic patients. May elevate serum TG and LDL levels and may render the control of hyperlipidemias more difficult. Elevations of plasma TGs may lead to pancreatitis and other complications. May elevate BP; monitor closely and d/c use if significant BP elevation occurs. New onset/exacerbation of migraine or recurrent, persistent, severe headache may develop; d/c and evaluate the cause if this occurs. Women with migraine may be at increased risk of stroke. Breakthrough bleeding and spotting reported; rule out malignancy or pregnancy. Post-pill amenorrhea or oligomenorrhea may occur. D/C if jaundice develops. May cause fluid retention. Caution with history of depression; d/c if depression recurs to serious degree. Diarrhea and/or vomiting may reduce hormone absorption. May affect certain endocrine function tests, LFTs, and blood components in lab tests. (Lo/Ovral) Ectopic and intrauterine pregnancy may occur in contraceptive failures. If using Sunday Start method, during the first cycle, contraceptive reliance should not be placed on therapy until a white tab has been taken daily for 7 consecutive days. (Low-Ogestrel) Use an additional method of protection until after the first 7 days of administration in the initial cycle. (Cryselle) During the first cycle, contraceptive reliance should not be placed on therapy until a white tab has been taken daily for 7 consecutive days.
N/V, breakthrough bleeding, spotting, amenorrhea, migraine, depression, vaginal candidiasis, edema, weight changes, change in cervical erosion and secretion, menstrual flow changes, GI symptoms (eg, abdominal pain, cramps, bloating), rash (allergic).
(Lo/Ovral) Reduced effects resulting in pregnancy or breakthrough bleeding may occur with antibiotics, anticonvulsants, and other drugs that increase the metabolism of contraceptive steroids (eg, rifabutin, primidone, dexamethasone, modafinil); consider back up nonhormonal method of birth control. Significant changes (increase or decrease) in estrogen and progestin levels noted in some cases with anti-HIV protease inhibitors. Herbal products containing St. John's wort may induce hepatic enzymes (cytochrome P450) and p-glycoprotein transporter and may reduce the effectiveness of contraceptive steroids, and may also result in breakthrough bleeding. Atorvastatin increases EE exposure; ascorbic acid and acetaminophen (APAP) increases EE bioavailability. CYP3A4 inhibitors (eg, indinavir, itraconazole, ketoconazole) increase levels. Troleandomycin may increase risk of intrahepatic cholestasis. Increased plasma concentrations of cyclosporine, prednisolone and other corticosteroids, and theophylline. Decreased plasma concentrations of APAP. Increased clearance of temazepam, salicylic acid, morphine, and clofibric acid. (Cryselle/Low-Ogestrel) Reduced efficacy and increased incidence of breakthrough bleeding and menstrual irregularities with rifampin, barbiturates, phenylbutazone, phenytoin sodium, and possibly with griseofulvin, ampicillin, and tetracyclines.
PREGNANCY AND LACTATION
Category X, not for use in nursing.
MECHANISM OF ACTION
Estrogen/progestogen oral contraceptive; acts by suppression of gonadotropins, primarily inhibiting ovulation and causing other alterations, including changes in the cervical mucus (increases difficulty of sperm entry into uterus) and the endometrium (reduces likelihood of implantation).
Distribution: Found in breast milk.
Assess for hypersensitivity to drug, breast cancer, estrogen-dependent neoplasia, abnormal genital bleeding, thrombophlebitis, thromboembolic disorders, past history of deep vein thrombophlebitis or thromboembolic disorders, cerebrovascular disease or CAD, known/suspected pregnancy, or any other conditions where treatment is cautioned/contraindicated. Assess nursing status and for possible drug interactions.
Monitor for MI, stroke, hepatic neoplasia, bleeding irregularities, thromboembolism, onset or exacerbation of headaches or migraines, and other adverse reactions. Monitor serum glucose levels in diabetic and prediabetic patients, BP with history of HTN, lipid levels with history of hyperlipidemia, and for signs of worsening depression with previous history of the disorder. Monitor liver function. Monitor women with strong family history of breast cancer or with breast nodules. Refer contact lens wearers to an ophthalmologist if visual changes develop. Perform periodic medical history and physical exam.
Inform of the benefits and risks of therapy. Inform that drug does not protect against HIV infection (AIDS) and other sexually transmitted diseases. Advise to avoid smoking. Instruct to take exactly ud at intervals not exceeding 24 hrs. Advise about risks of pregnancy if dose is missed. Instruct that if one dose is missed, to take as soon as possible and take next pill at regular scheduled time. Inform that spotting, light bleeding, or nausea may occur during the first 1-3 packs of pills; advise not to d/c medication and if symptoms persist, to notify physician. Instruct to d/c if pregnancy is confirmed/suspected. Inform that certain drugs may make therapy less effective and the possible need to use additional contraception. Instruct to notify physician if breastfeeding. If scheduled for any lab test, advise patient to inform physician that taking birth control pills.
20-25°C (68-77°F). (Low-Ogestrel) 15-25°C (59-77°F).
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