Ortho-Cept (desogestrel/ethinyl estradiol)
Cigarette smoking increases the risk of serious cardiovascular events. Risk increases w/ age (>35 yrs of age) and w/ the number of cigarettes smoked. Should not be used by women who are >35 yrs of age and smoke.
OTHER BRAND NAMES
Desogen, Emoquette, Reclipsen, Apri
Prevention of pregnancy.
1 tab qd at the same time each day for 28 days, then repeat
Start 1st Sunday after menses begin or 1st day of menses
Switching from Another Oral Contraceptive:
Sunday Start (Except Desogen):
Take 1st active tab on the 1st Sunday after the last active tab of the previous product
Start on the same day that a new pack of the previous oral contraceptive would have been started
Miss 1 Active Tab: Take as soon as dose is remembered
Miss 2 Active Tabs in Week 1 or 2: Take 2 active tabs on the day dose is remembered and 2 active tabs the next day, then continue taking 1 tab qd until pack is finished. Use a backup method of birth control (eg, condom, spermicide) if patient has intercourse in the 7 days after missing pills
Miss 2 Active Tabs in Week 3 or Miss ≥3 Consecutive Active Tabs: (Day 1 Start) Throw out rest of the pack and start a new pack that same day. (Sunday Start) Continue to take 1 tab qd until Sunday, then throw out rest of the pack and start a new pack that same day. (Day 1/Sunday Start) Use a backup method of birth control (eg, condom, spermicide) if patient has intercourse in the 7 days after missing pills
Not indicated for use premenarche; refer to adult dosing
Take at intervals not to exceed 24 hrs
Use another method of contraception until after the first 7 consecutive days of administration when initiating Sunday Start regimen
Tab: (Ethinyl Estradiol [EE]/Desogestrel) 0.03mg/0.15mg
Thrombophlebitis or thromboembolic disorders, past history of deep vein thrombophlebitis or thromboembolic disorders, known thrombophilic conditions, cerebrovascular or coronary artery disease (current or history), valvular heart disease w/ complications, persistent BP values of ≥160mmHg systolic or ≥100mmHg diastolic, diabetes w/ vascular involvement, headaches w/ focal neurological symptoms, major surgery w/ prolonged immobilization, known or suspected breast carcinoma (or personal history), carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia, undiagnosed abnormal genital bleeding, cholestatic jaundice of pregnancy or jaundice w/ prior pill use, acute or chronic hepatocellular disease w/ abnormal liver function, hepatic adenomas or carcinomas, known/suspected pregnancy.
When initiating a Sunday Start regimen, use another method of contraception until after the first 7 consecutive days of administration. Not indicated for use in emergency contraception. Increased risk of thromboembolism, MI, stroke, vascular disease, hepatic neoplasia, and gallbladder disease. Increased risk of morbidity and mortality in the presence of other underlying risk factors (eg, HTN, hyperlipidemias, obesity, diabetes). If feasible, d/c at least 4 weeks prior to and for 2 weeks after elective surgery of a type associated w/ an increased risk of thromboembolism, and during and following prolonged immobilization. May increase risk of breast cancer and cancer of the reproductive organs. Start use no earlier than 4 weeks after delivery in women who elect not to breastfeed. Contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist. Retinal thrombosis reported; d/c if unexplained partial or complete loss of vision, onset of proptosis or diplopia, papilledema, or retinal vascular lesions develop. Should not be used to induce withdrawal bleeding as a test for pregnancy, or to treat threatened or habitual abortion during pregnancy. Rule out pregnancy if 2 consecutive periods are missed. May decrease glucose tolerance; monitor prediabetic and diabetic patients. May elevate BP; monitor closely and d/c use if significant BP elevation occurs and cannot be adequately controlled. D/C and evaluate the cause if new onset/exacerbation of migraine or recurrent, persistent, severe headache w/ a new pattern develops. Breakthrough bleeding and spotting reported; rule out malignancy or pregnancy. Post-pill amenorrhea or oligomenorrhea may occur. Ectopic and intrauterine pregnancy may occur in contraceptive failures. D/C if jaundice develops. May cause fluid retention. Monitor closely in patients w/ history of depression; d/c if depression recurs to a serious degree. May elevate serum TG and LDL levels and may render the control of hyperlipidemias more difficult. May affect certain endocrine, LFTs, and blood components in lab tests.
N/V, breakthrough bleeding, spotting, amenorrhea, migraine, vaginal candidiasis, edema, weight changes, melasma, breast changes, changes in cervical erosion and secretion, allergic reaction, mental depression, cholestatic jaundice, GI symptoms (eg, abdominal cramps, bloating).
May decrease levels and potentially diminish effectiveness or increase breakthrough bleeding when used concomitantly w/ drugs or herbal products that induce certain enzymes, including CYP3A4 (eg, bosentan, rifabutin, St. John's wort); use an alternative or backup method of contraception and continue backup contraception for 28 days after discontinuing the enzyme inducer. Atorvastatin or rosuvastatin may increase EE exposure; ascorbic acid and acetaminophen (APAP) may increase EE levels. CYP3A4 inhibitors (eg, itraconazole, voriconazole, ketoconazole) may increase levels. Significant changes (decreased/increased) sometimes noted in estrogen and/or progestin levels when coadministered w/ HIV protease inhibitors (decreased [eg, nelfinavir, darunavir/ritonavir, (fos)amprenavir/ritonavir] or increased [eg, indinavir, atazanavir/ritonavir])/HCV protease inhibitors (decreased [eg, boceprevir, telaprevir]), or w/ non-nucleoside reverse transcriptase inhibitors (decreased [eg, nevirapine] or increased [eg, etravirine]). Colesevelam reported to significantly decrease EE exposure; decreased drug interaction reported when the 2 drug products are given 4 hrs apart. May inhibit metabolism and increase levels of other compounds (eg, cyclosporine, prednisolone, voriconazole). May decrease levels of APAP, clofibric acid, morphine, salicylic acid, and temazepam. May significantly decrease levels of lamotrigine and may reduce seizure control; dosage adjustment of lamotrigine may be needed. May need to increase dose of thyroid hormone in patients on thyroid hormone replacement therapy due to increased thyroid-binding globulin.
PREGNANCY AND LACTATION
Category X, not for use in nursing.
MECHANISM OF ACTION
Estrogen/progestogen oral contraceptive; acts by suppressing gonadotropins, primarily inhibiting ovulation, and causing other alterations, including changes in the cervical mucus (increases difficulty of sperm entry into the uterus) and the endometrium (reduces likelihood of implantation).
Absorption: Rapid and almost complete. Desogestrel: (3-keto-desogestrel) (Steady state) Cmax=5840pg/mL, Tmax=1.4 hrs, AUC0-24 hrs=52,299pg/mL•hr. EE: (Steady state) Cmax=141pg/mL, Tmax=1.4 hrs, AUC0-24 hrs=1117pg/mL•hr. Distribution: Found in breast milk. Metabolism: Desogestrel: 3-keto-desogestrel (active metabolite). EE: Conjugation; 2-OH-ethinyl estradiol and 2-methoxy-ethinyl estradiol (metabolites). Elimination: Desogestrel: (3-keto-desogestrel) T1/2=38 hrs. EE: T1/2=26 hrs.
Assess for hypersensitivity to drug, thrombophlebitis or thromboembolic disorders, HTN, hyperlipidemia, diabetes, breast cancer, endometrial cancer or other estrogen-dependent neoplasia, undiagnosed abnormal genital bleeding, cholestatic jaundice of pregnancy or jaundice w/ prior pill use, pregnancy/nursing status, and for any other conditions where treatment is contraindicated/cautioned. Assess for possible drug interactions.
Monitor for MI, thromboembolism, stroke, hepatic neoplasia, and other adverse effects. Monitor BP w/ history of HTN, serum glucose levels in diabetic or prediabetic patients, lipid levels w/ hyperlipidemia, and for signs of worsening depression w/ previous history. Monitor liver function. Refer contact lens wearers to an ophthalmologist if visual changes or changes in lens tolerance develop. Monitor women who have strong family history of breast cancer or have breast nodules. Perform annual 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. Counsel that cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels and that women who are >35 yrs of age and smoke, should not use oral contraceptives. Instruct to take exactly ud and at intervals not exceeding 24 hrs. Instruct on what to do if pills are missed. Instruct to use additional method of protection until after the 1st week of administration in the initial cycle when utilizing the Sunday Start regimen. Counsel that efficacy may decrease if vomiting/diarrhea develops; instruct to use a backup method of contraception and notify physician. Inform that spotting, light bleeding, or stomach sickness may occur during first 1-3 packs of pills; advise not to d/c medication and to notify physician if symptoms persist. Instruct to d/c if pregnancy is confirmed/suspected during treatment. Instruct to notify physician if breastfeeding. If scheduled for any lab test, advise patient to inform physician of birth control pills usage. Inform that certain drugs may make therapy less effective and additional contraception may be needed.
25°C (77°F); excursions permitted to 15-30°C (59-86°F).
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