Contraceptive Patch The Ortho Evra Skin Patch. What is a contraceptive patch? The Ortho Evra transdemal. Ortho Evra Patch: Contraceptive Information. Ortho Evra Company: Ortho-McNeil. Each patch is worn for seven days. Ortho Evra Contraceptive Skin Patch Worn By NflChoosing a Birth Control Method: Transdermal Patch(Updated June 2. Description. Ortho. Evra. The patch releases 1. Three consecutive 7- day patches (2. What is the Ortho Evra Contraceptive Patch. The patch combines estrogen and progesterone in a skin patch that is worn weekly. The birth control patch is commonly called Ortho Evra. If you use Ortho Evra. You’ll stick one new patch on the skin of your buttocks. Each patch should be worn. No other contraceptive. Ortho Evra patch may cause dark skin. Although it is recommended that women put on a new patch after seven days, the patch contains up to 9 days' worth of contraceptive hormones. The drug is mixed with the adhesive; therefore, patches that do not stick must be replaced to maintain therapeutic levels of hormone. The patch can be worn during exercise, showers, bathing, and swimming; adhesion is not affected by heat, humidity, or exercise. The contraceptive efficacy of the transdermal patch is comparable to that of COCs. The failure rate is 0. Some evidence suggests that efficacy is slightly decreased in women who weigh more than 1. In such cases, provider and patient will need to compare the benefits and drawbacks with those of other contraceptive options. Risks. Venous thromboembolism (see Dispelling Myths About the Contraceptive Patch and VTE box) Side Effects. As described previously for all combined hormonal contraception. In addition, skin irritation at the application site may occur in some users. It should not be placed in areas that receive a lot of friction, such as under bra straps. To avoid the release of hormones into the soil and water supply, a used patch should not be flushed down the toilet. If the patch was off for more than 2. Dispelling Myths About the Contraceptive Patch and VTEBased on prior data, the FDA created a bolded warning for Ortho. Evra about increased risk of venous thromboembolism in 2. However, this increase in relative risk of VTE should be viewed in context. The overall risk of VTE is small, approximately 1. For women 2. 5 to 3. The risk of VTE is significantly higher in pregnancy than from the patch. Currently available evidence suggests that the risk of VTE with the contraceptive patch is similar to that observed with COCs. A contraceptive patch is a transdermal patch applied to the skin that releases synthetic estrogen. The Contraceptive Patch works by slowly releasing a combination of estrogen and. The patch is a skin patch worn on the. Most birth control pills and the Ortho Evra patch contain two different. Effectiveness of Contraceptive. Learn more about Ortho Evra, the birth control patch. This tiny skin patch has the same hormones as. The contraceptive patch prevents pregnancy by. In a case control study of women with VTE, contraceptive patch use was associated with a similar incidence of VTE as COCs with norgestimate and 3. In this study, the incidence of VTE was 5. COC users. Post- marketing data demonstrate a similar risk of VTE among patch users and COC users who are. It contains 6. 0. NGMN) and 0. 7. 5 mg ethinyl estradiol (EE). Systemic exposures (as measured by area under the curve . The backing layer is composed of a beige flexible film consisting of a low- density pigmented polyethylene outer layer and a polyester inner layer. It provides structural support and protects the middle adhesive layer from the environment. The middle layer contains polyisobutylene/polybutene adhesive, crospovidone, non- woven polyester fabric and lauryl lactate as inactive components. The active components in this layer are the hormones, norelgestromin and ethinyl estradiol. The third layer is the release liner, which protects the adhesive layer during storage and is removed just prior to application. It is a transparent polyethylene terephthalate (PET) film with a polydimethylsiloxane coating on the side that is in contact with the middle adhesive layer. The outside of the backing layer is heat- stamped . Norelgestromin is also the primary active metabolite produced following oral administration of norgestimate (NGM), the progestin component of the oral contraceptive products ORTHO- CYCLEN. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which reduce the likelihood of implantation). Receptor and human sex hormone- binding globulin (SHBG) binding studies, as well as studies in animals and humans, have shown that both NGM and NGMN exhibit high progestational activity with minimal intrinsic androgenicity. Transdermally- administered norelgestromin, in combination with ethinyl estradiol, does not counteract the estrogen- induced increases in SHBG, resulting in lower levels of free testosterone in serum compared to baseline. One clinical trial assessed the return of hypothalamic- pituitary- ovarian axis function post- therapy and found that FSH, LH, and Estradiol mean values, though suppressed during therapy, returned to near baseline values during the 6 weeks post therapy. Pharmacokinetics. Absorption. Following a single application of ORTHO EVRA. Pooled data from the 3 clinical studies have demonstrated that steady state is reached within 2 weeks of application. The mean steady state Css concentrations ranged from 0. L for NGMN and from 1. L for EE. Absorption of NGMN and EE following application of ORTHO EVRA. While absorption from the abdomen was slightly lower than from other sites, absorption from these anatomic sites was considered to be therapeutically equivalent. The mean (%CV) pharmacokinetic parameters Css and AUC0- 1. NGMN and EE following a single buttock application of ORTHO EVRA. In multiple dose studies, AUC0- 1. NGMN and EE was found to increase over time (Table 1). In a three- cycle study, these pharmacokinetic parameters reached steady- state conditions during Cycle 3 (Figures 1 and 2). Upon removal of the patch, serum levels of EE and NGMN reach very low or non- measurable levels within 3 days. The results indicated that for NGMN there were no significant treatment effects on Css or AUC when compared to normal wear. For EE, increased exposures were observed due to sauna, whirlpool and treadmill. There was no significant effect of cold water on these parameters. Results from a study of consecutive ORTHO EVRA. By Day 1. 0 of patch administration, both NGMN and EE concentrations had decreased by approximately 2. Day 7 concentrations. Metabolism. Since ORTHO EVRA. Hepatic metabolism of NGMN occurs and metabolites include norgestrel, which is highly bound to SHBG, and various hydroxylated and conjugated metabolites. Ethinyl estradiol is also metabolized to various hydroxylated products and their glucuronide and sulfate conjugates. Distribution. NGMN and norgestrel (a serum metabolite of NGMN) are highly bound (> 9. NGMN is bound to albumin and not to SHBG, while norgestrel is bound primarily to SHBG, which limits its biological activity. Ethinyl estradiol is extensively bound to serum albumin and induces an increase in the serum concentrations of SHBG (See CLINICAL PHARMACOLOGY, Transdermal versus Oral Contraceptives, Table 3). Elimination. Following removal of patches, the elimination kinetics of NGMN and EE were consistent for all studies with half- life values of approximately 2. The metabolites of NGMN and EE are eliminated by renal and fecal pathways. Transdermal versus Oral Contraceptives. The ORTHO EVRA. Figures 3 and 4 present mean pharmacokinetic (PK) profiles for EE and NGMN following administration of an oral contraceptive (containing NGM 2. Figure 3: Mean Serum Concentration- Time Profiles of NGMN Following Once- Daily Administration of an Oral Contraceptive for 2 cycles or Application of ORTHO EVRA. Under steady- state conditions, AUC0- 1. Css for EE were approximately 5. Cmax was about 3. Inter- subject variability (%CV) for the PK parameters following delivery from ORTHO EVRA. The mean pharmacokinetic profiles are different between the two products and caution should be exercised when making a direct comparison of these PK parameters. In Table 3, percent change in concentrations (%CV) of markers of systemic estrogenic activity (Sex Hormone Binding Globulin . Percent change in SHBG concentrations was higher for ORTHO EVRA. Within each group, the absolute values for SHBG were similar for Cycle 1, Day 2. Cycle 2, Day 2. 2. For both NGMN and EE, increasing age, body weight and body surface area each were associated with slight decreases in Css and AUC values. However, only a small fraction (1. NGMN and EE following application of ORTHO EVRA. There was no significant effect of race with respect to Caucasians, Hispanics and Blacks. Renal and Hepatic Impairment. No formal studies were conducted with ORTHO EVRA. Steroid hormones may be poorly metabolized in patients with impaired liver function (see PRECAUTIONS). Drug Interactions. The metabolism of hormonal contraceptives may be influenced by various drugs. Of potential clinical importance are drugs that cause the induction of enzymes that are responsible for the degradation of estrogens and progestins, and drugs that interrupt entero- hepatic recirculation of estrogen (e. Literature suggests possible interactions with the concomitant use of hormonal contraceptives and ampicillin or tetracycline. In a pharmacokinetic drug interaction study, oral administration of tetracycline. HCl, 5. 00 mg q. i. See also PRECAUTIONS, Drug Interactions. Patch Adhesion. In the clinical trials with ORTHO EVRA. The proportion of subjects with at least 1 patch that completely detached ranged from 2% to 6%, with a reduction from Cycle 1 (6%) to Cycle 1. For instructions on how to manage detachment of patches, refer to the DOSAGE AND ADMINISTRATION section. INDICATIONS AND USAGEORTHO EVRA. Healthcare professionals should balance the higher estrogen exposure and the possible increase risk of venous thromboembolism with ORTHO EVRA. In 3 large clinical trials in North America, Europe and South Africa, 3,3. ORTHO EVRA. The racial distribution was 9. Caucasian, 4. 9% Black, 1. Asian, and 2. 4% Other. With respect to weight, 5 of the 1. ORTHO EVRA. The greater proportion of pregnancies among women at or above 1. Health Care Professionals who consider ORTHO EVRA. Table 4 lists the accidental pregnancy rates for users of various methods of contraception. The efficacy of these contraceptive methods, except sterilization,IUD, and Norplant depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1. Among such populations, about 8. This estimate was lowered slightly (to 8. The Food and Drug Administration has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral. This risk increases with age and with heavy smoking (1. Women who use hormonal contraceptives, including ORTHO EVRA. AUC and average concentration at steady state for ethinyl estradiol (EE) are approximately 6. ORTHO EVRA. In contrast, peak concentrations for EE are approximately 2. ORTHO EVRA. Inter- subject variability results in increased exposure to EE in some women using either ORTHO EVRA . However, inter- subject variability in women using ORTHO EVRA. It is not known whether there are changes in the risk of serious adverse events based on the differences in pharmacokinetic profiles of EE in women using ORTHO EVRA. Increased estrogen exposure may increase the risk of adverse events, including venous thromboembolism. Epidemiologic, case- control studies. U. S. NGM is the prodrug for norelgestromin, the progestin in ORTHO EVRA. These studies (see Table 5) used slightly different designs and reported odds ratios ranging from 0. The interpretations of these odds ratios range from no increase in risk to an approximate doubling of risk. One study (i. 3 Ingenix) included patient chart review to confirm the VTE occurrence. As with any combination hormonal contraceptive, the clinician should be alert to the earliest manifestations of thromboembolic disorders (thrombophlebitis, VTE including pulmonary embolism, cerebrovascular disorders, and retinal thrombosis). Should any of these occur or be suspected, ORTHO EVRA. The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as hypertension, hyperlipidemias, obesity and diabetes. Conditions such as inflammatory bowel diseases (e. Crohn's disease or ulcerative colitis) may increase the risk of venous thromboembolic complications and conditions such as systemic lupus erythematosus may increase the risk of arterial thromboembolic complications.
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