Contraceptive Patch Evra Australian
Posted : admin On 30.12.2019Ortho Evra brand of contraceptive patch Background Type Hormonal (combined estrogen + progestin) First use 2002 Failure rates (first year) Perfect use 0.3% Typical use 9% Usage User reminders Weekly application for 3 weeks Advantages and disadvantages protection No Weight No proven effect Period advantages Regulated, may be lighter and less painful Benefits Compared to oral pills, may be less affected by antibiotics Risks rates similar to oral combined pills A contraceptive patch, also known as 'the patch', is a applied to the skin that releases synthetic and hormones to prevent. They have been shown to be as effective as the with perfect use, and the patch may be more effective in typical use. The only currently available contraceptive patches are Xulane in the United States (after Ortho Evra, marketed by was discontinued ), and Evra, marketed in by Janssen-Ortho and in the and other countries. The patches are packaged in boxes of three and are only available by prescription. Contents. Method of use A woman applies her first patch onto her upper outer arm, buttocks, abdomen or thigh on either the first day of her (day 1) or on the first Sunday following that day, whichever she prefers. The day of application is known from that point as patch change day.
Seven days later, when patch change day comes again, the woman removes the patch and applies another to one of the approved locations on the body. This process is repeated again on the next patch change day. On the following patch change day, the patch is removed and not replaced. The woman waits 7 days without a patch in place, and on the next patch change day she applies a new patch., where patches are used for several weeks before a patch-free week, have been studied.
The patch should be applied to skin that is clean, dry, and intact. This means, if skin is red, irritated, or cut, the patch should not be placed in that area. Additionally, avoid using lotions, powder, or makeup around the area where the patch is, or will be placed. Backup contraception. If a woman chooses to begin with her patch change day as day 1 of her menstrual cycle, the patch is able to take effect in time to prevent ovulation (see Mechanism of Action below) and no form of backup contraception is needed at all.
In the case that a woman wishes to begin using the contraceptive patch following a first trimester abortion or miscarriage, patch application can be done immediately afterwards. This can be considered the same as a day 1 start above, and no backup contraception is required. If a woman chooses to begin with her patch change day as the first Sunday following day 1, it is necessary to use a backup form of contraception such as spermicide or condoms for the first week of patch wear. If a woman is late placing her patch in the first week, or more than two days late placing the patch in the second and third weeks, she should apply the patch immediately, and then use a back up form of barrier protection for a week. Mechanism of action. Illustration depicting transdermal contraceptive patch.
Ortho Evra Birth Control Patch
Like all combined hormonal contraceptives, Ortho Evra / Evra works primarily by preventing ovulation. A secondary mechanism of action is inhibition of sperm penetration by changes in the cervical mucus.
Hormonal contraceptives also have effects on the endometrium that theoretically could affect implantation; however, no scientific evidence indicates that prevention of implantation actually results from their use. The 20 cm² Ortho Evra contraceptive patch contains 750 µg (an estrogen) and 6000 µg (a progestin). The 20 cm² Evra contraceptive patch contains 600 µg ethinylestradiol and 6000 µg norelgestromin. The Ortho Evra contraceptive patch and the Evra contraceptive patch are both intended to gradually release into the systemic circulation approximately 20 µg/day of ethinylestradiol and 150 µg/day of norelgestromin.
Benefits Because the Ortho Evra patch works similar to that of birth control pills, many of the benefits are the same. For example, the patch may make a woman's period lighter and more regular. It may also help to clear acne, decrease cramps, and reduce PMS symptoms. Additionally, the patch is associated with an increased protection against iron deficiency anemia, ovarian cysts, and endometrial and ovarian cancer. The patch is a simple and convenient form of birth control that only requires weekly attention. When a woman stops using the patch, her ability to become pregnant returns quickly. Interactions and contraindications Contraceptive effectiveness of the patch or any other hormonal contraceptive may be reduced significantly if administered alongside various, or other drugs that increase metabolism of contraceptive steroids.
However, despite the interactions with many other antibiotics, a clinical pharmacokinetic drug interaction study showed that oral administration of HCl 500 mg for 3 days prior to and 7 days during use of Ortho Evra 'did not reduce effectiveness of Ortho Evra.' This is a significant factor in the common decision to administer tetracycline-derived antibiotics following an (preventatively to fight potential infection) when synthetic hormone contraceptives are to be used afterwards. Drugs containing are also known to affect the effectiveness of hormonal contraceptives. It has also been found that the Ortho Evra patch is less effective in women over 198 pounds (90 kg).
Side effects In three large clinical trials involving a total of 3,330 women using the Ortho Evra / Evra patch for up to one year, 12% of users discontinued the patch because of adverse events. The most frequent adverse events leading to patch discontinuation were: nausea and/or vomiting (2.4%), application site reaction (1.9%), breast discomfort, engorgement or pain (1.9%), headache (1.1%), and emotional lability (1.0%). The most frequent adverse events reported while using the Ortho Evra / Evra patch were: breast discomfort, engorgement or pain (22%), headache (21%), application site reaction (17%), nausea (17%), upper respiratory tract infection (10%), menstrual cramps (10%), and abdominal pain (9%). And/or spotting while using the Ortho Evra / Evra patch was reported by: 18% in cycle 1, 12% in cycle 3, 8% in cycle 6 and cycle 13. Breakthrough bleeding (requiring more than one pad or tampon per day) was reported by: 4% in cycle 1, 3% in cycle 3 and cycle 6, and 1% in cycle 13. Overall, side effects that tend to go away after two or three months include bleeding between periods, breast tenderness, and nausea and vomiting. Symptoms that may last longer include skin irritation around the area where the patch is placed and a change in the woman's sexual desires Additional side effect information is provided in the Ortho Evra label information and the Evra (SPC) and.
Thromboembolic risks All combined products have a very small increased risk of serious or fatal events. There is ongoing research into the thromboembolic risks of Ortho Evra as compared to combined oral contraceptive pills. A recent study found that users of the contraceptive patch may have a twofold increased risk for non-fatal venous thromboembolic events compared with women who took a norgestimate-containing oral contraceptive with 35 µg of estrogen. However, a different study concluded that the risk of nonfatal venous thromboembolism for the contraceptive patch is similar to the risk for oral contraceptives containing 35 µg of ethinylestradiol and. The contradiction in findings between the two studies is not easily resolved, because the for the studies are overlapping.
In studies with oral contraceptives, the risk for cardiovascular disease (such as thromboembolism) is significantly increased in women over the age of 35 years who also. Hence, Ortho-Evra's package insert states: 'Women who use hormonal contraceptives, including ORTHO EVRA, should be strongly advised not to smoke.' According to the manufacturer, the patches introduce a 60% higher level of estrogen into the bloodstream as compared to oral contraceptives; however, the clinical significance of this difference is unknown. On November 10, 2005 Ortho McNeil, in conjunction with the, revised the label for Ortho Evra, including a new bolded warning about higher exposure to estrogen for women using the weekly patch compared to taking a daily birth control pill containing 35 µg of estrogen, noting that higher levels of estrogen may put some women at increased risk for getting blood clots.
The label was again revised in September 2006, and on January 18, 2008, the FDA again updated the label to reflect study results. 'The FDA believes that Ortho Evra is a safe and effective method of contraception when used according to the labeling, which recommends that women with concerns or risk factors for serious blood clots talk with their health care provider about using Ortho Evra versus other contraceptive options.' Lawsuits The Patch has been associated with strokes and thrombosis and the mechanism for hormone absorption and dissipation from the body's tissues is different from 'the pill.'
Several lawsuits have been instigated over these issues. A lawsuit filed in Federal Court in New Jersey on September 2, 2005 by a Georgia woman who suffered a pulmonary embolism alleges the company promoted the patch despite knowledge of its health risks, for financial gain, while failing to warn of the risks of blood clots and other injuries. In November 2005, CBS News aired a story about documents that surfaced in a lawsuit involving a young mother who was paralyzed by a stroke and remained a total invalid, which showed the company had received nearly 500 reports of adverse events between April 2002 and December 2004. During the same time frame, only 61 adverse event reports were filed in connection with all type of birth-control pills.
The parents of a 14-year-old girl from Wisconsin have filed a lawsuit against because they claim that she died from a that arose from her use of the Patch. References. ^ Trussell, James (2011). 'Contraceptive efficacy'.
In Hatcher, Robert A.; Trussell, James; Nelson, Anita L.; Cates, Willard Jr.; Kowal, Deborah; Policar, Michael S. Contraceptive technology (20th revised ed.). New York: Ardent Media.
CS1 maint: Extra text: editors list Table 26–1 =. Trussell, James (2007). In Hatcher, Robert A.; et al. Contraceptive Technology (19th rev. New York: Ardent Media.
Contraceptive Technology, Chapter 12, Contraceptive Patch and Vaginal Contraceptive Ring, by Kavita Nanda, page 272. Stewart FH, Kaunitz AM, Laguardia KD, Karvois DL, Fisher AC, Friedman AJ (June 2005).
'Extended use of transdermal norelgestromin/ethinyl estradiol: a randomized trial'. Obstet Gynecol.
105 (6): 1389–96. Mayo Clinic (2010). 'Ortho Evra (Contraceptive Patch).' Retrieved from, on February 3, 2011. Mayo Clinic. 'Ortho Evra (Contraceptive Patch).' Retrieved from, on February 3, 2011.
Rivera R, Yacobson I, Grimes D (1999). 'The mechanism of action of hormonal contraceptives and intrauterine contraceptive devices'. Am J Obstet Gynecol. 181 (5 Pt 1): 1263–9.
^ (September 20, 2006). Archived from (PDF) on 2007-09-26. Retrieved 2007-07-20. ^ (January 2007). Retrieved 2007-07-20. ^ Bedsider (2010).
Retrieved from, on February 3, 2011. Planned Parenthood (2011).
'Birth Control Patch (Ortho Evra).' Retrieved from, on February 3, 2011. ^ Sibai BM, Odlind V, Meador ML, Shangold GA, Fisher AC, Creasy GW (2002). 'A comparative and pooled analysis of the safety and tolerability of the contraceptive patch (Ortho Evra/Evra)'.
Fertil Steril. 77 (2 Suppl 2): S19–26.
Zieman M, Guillebaud J, Weisberg E, Shangold GA, Fisher AC, Creasy GW GW (2002). 'Contraceptive efficacy and cycle control with the Ortho Evra/Evra transdermal system: the analysis of pooled data'. Fertil Steril. 77 (2 Suppl 2): S13–8.
Bedsider (2010). Retrieved from on February 3, 2011. (January 26, 2007). Retrieved 2007-07-20. Medpage Today. Published February 17, 2006. Cole JA, Norman H, Doherty M, Walker AM (February 2007).
'Venous thromboembolism, myocardial infarction, and stroke among transdermal contraceptive system users'. Obstet Gynecol. 109 (2 Pt 1): 339–46. Jick S, Kaye JA, Li L, Jick H (July 2007). 'Further results on the risk of nonfatal venous thromboembolism in users of the contraceptive transdermal patch compared to users of oral contraceptives containing norgestimate and 35 microg of ethinyl estradiol'. 76 (1): 4–7.
Pitsavos C, Stefanadis C, Toutouzas P (2000). 'Contraception in women at high risk or with established cardiovascular disease'. 900: 215–27. January 18, 2008 External links.
In the June issue of CHOICE in 1963, we heralded the arrival of the oral contraceptive pill to Australia: 'The pill – one of the most effective methods of birth control – is now available in Australia on the prescription of a doctor.' For the princely sum of 15 shillings, we offered our members a copy of The Consumers’ Union Report on Family Planning, 'prepared for the use solely of doctors, clinics, social workers and married couples who are seeking such information on the advice of their doctors'. Half a century has passed since the pill hit our shores, yet it is still the most popular method of contraception. But what was true then is not true now. In practice, the pill is less effective than a large number of products now available on the market – the implant, IUDs and the injection all have higher efficacy rates. So why aren't more people using alternatives to the pill? And what are the alternatives, anyway?
Long-acting reversible contraception Aside from abstinence and sterilisation, the most effective forms of contraception are long-acting reversible contraception (LARC). According to one national survey, 50% of women in Australia experience an unplanned pregnancy, despite the fact that 70% of women use contraception. The solution, according to experts, is more women using LARCs, because unlike with other forms of contraception, human error has little impact on LARCs. Implants Name: Etonogestrel implant (implant), marketed as Implanon NXT in Australia. Method: A 4cm-long flexible plastic rod is inserted directly under the skin of a woman's upper arm. The implant contains a synthetic hormone resembling progesterone, which is released continuously into the bloodstream for three years.
Fertility returns very quickly upon removal. Price: It costs about $37 for one implant, and is subsidised by the government on the Pharmaceutical Benefits Scheme. Use: Lasts up to three years. Must be prescribed, inserted and removed by a doctor. Efficacy: 99.95% with both perfect use (where all instructions are followed exactly) and typical use (which is how most women tend to use it). Potential side effects: Some women with the implant will experience a dramatic change to their menstrual cycle (or other hormone-related side effects), but experts say women should trial the implant for three months and discuss issues with a doctor before considering removal. The implant is the most effective contraceptive option available; it's even more effective than permanent contraception such as vasectomies, female tubal occlusions and ligations.
Although implants came onto the Australian market in 2001, the old Implanon was replaced by Implanon NXT in 2011. The difference is in the applicator, which is designed to minimise deep insertions leading to difficult and potentially risky removals.
There is no need for an incision when inserting the Implanon NXT. Upon insertion, there's a slight sting and some women may suffer from bruising afterwards. At removal, a two-millimetre incision is made. There's a very small risk of scarring, but this generally only affects people who have a tendency to scar. Intrauterine device Modern IUDs suffer from being tarred with the same brush as their earlier counterparts, with experts blaming a lack of information among women and.
Historically, IUDs have had a bad reputation but today's IUDs are very different from earlier iterations. 'The latest devices are a far cry from earlier prototypes,' says Dr Deborah Bateson, medical director of Family Planning NSW and spokesperson for Sexual Health and Family Planning Australia. 'There is a very low risk of pelvic infection, which is mainly confined to the first 20 days after insertion.
There's no evidence of an increased risk of subsequent infertility for women using an IUD.' 'While more commonly used by women who've completed their family or are spacing pregnancies, they are also useful for younger, childless women.'
There are two types of IUD currently on the market - hormonal and copper. Either form of IUD can be used by women who are breastfeeding. The insertion procedure is generally done by a GP or gynaecologist with experience in insertion, and is relatively brief and painless. 'We get women to take a painkiller beforehand, and most find it's OK,' says Bateson. 'There can be cramping pain when the IUD goes in, and women who haven't had children - or those who have had C-sections - may have more cramping discomfort.'
Hormonal IUD Name: Levonorgestrel IUD (hormonal IUD), known in Australia as Mirena. Method: A small piece of T-shaped plastic is inserted into the uterus. Fine threads attached to it protrude through the cervix, making removal easier. It slowly releases the progestogen-like hormone levonorgestrel for up to five years. Fertility returns very quickly upon removal. Price: It costs about $37 for one IUD, and is available on the PBS.
Use: It lasts for up to five years. It must be prescribed, inserted and removed by a doctor. Efficacy: 99.8% (perfect and typical use) Side effects: In 5% of cases, women may experience an unexpected expulsion of the device. However, women can check whether the device is still in place by feeling for the threads high up in their vagina – something the doctor who inserts the IUD should teach them to do. Hormonal IUDs are particularly useful for women with heavy menstrual bleeding. Like the contraceptive pill and the implant, Mirena can be used to treat excessive menstrual bleeding or protect against endometrial hyperplasia (excessive growth of the lining of the womb).
As with the implant, the menstrual cycle is altered by Mirena, but women usually end up with lighter periods. And a randomised trial of 571 women showed that Mirena is more effective than usual in reducing the effect of heavy menstrual bleeding on quality of life. The trial, conducted by the University of Birmingham in the UK, also found that there were no significant differences in serious adverse events between groups using the IUD and those receiving conventional treatment. Interestingly, a new 'mini Mirena' may soon be available in Australia, according to our experts.
'We have been trialling it,' says Bateson. 'It's smaller, and lasts up to three years. It might be useful for younger women with smaller uteruses, or women who've experienced side effects from other IUDs.' Copper IUD Name: Copper T 380, Copper T 380 short, Multiload 375 Method: A small piece of T- or U-shaped plastic device wrapped with copper wire is inserted into the uterus.
Fine threads attached to it protrude through the cervix, making removal easier. It primarily inhibits sperm motility and creates an unsuitable environment for implantation. Fertility returns very quickly upon removal. Price: They can cost up to $150, and since they are devices and not drugs, they are not available on the PBS. Use: They last for five (Copper T 380 short, Multiload 375) or ten years (Copper T 380) and must be prescribed, inserted and removed by a doctor.
Efficacy: Copper T380 IUD: 99.2% with typical use, 99.4% with perfect use. Multiload 375 has similar effectiveness. Side effects: In 2-3% of cases, women may experience an unexpected expulsion of the device. However, women can check whether the device is still in place by feeling for the threads high up in their vagina, something the doctor who inserts the IUD should teach them to do. Menstrual cycles generally remain regular, although the amount of bleeding may increase by up to 50%.
Copper IUDs do not contain hormones and are suitable for women who cannot, or prefer not to use a hormonal form of contraception. In Europe, there is also a new generation of copper IUD available, the GyneFix, which is frameless, flexible, and is implanted in the wall of the uterus. It consists of a series of small copper cylinders on a thread and is effective for five years. Trials show that due to the smaller size (compared to other IUDs) it suits younger females, particularly those that have not yet had children, and has fewer complications and side-effects than other IUDs, such as heavy bleeding. At the moment GyneFix can't be purchased in Australia, but Thierry Vancaillie, a clinical professor at the University of New South Wales and Director of the Women's Health and Research Institute of Australia, believes it is 'a great option for contraception and should become available in Australia soon. I am certainly working towards that goal.' Short-term contraception There have also been advances in more short-term contraception, with an injectable contraceptive, a large variety of and a female condom all on the market.
These methods, however, rely more on the individual, and so tend to suffer from lower efficacy rates. Injection Name: Depot medroxyprogesterone acetate injection, marketed in Australia as Depo-Provera or the generic Depo-Ralovera. Method: A synthetic hormone similar to progesterone is injected by a doctor or nurse every 12 weeks. Price: Each injection costs about $26-$30, depending on brand.
Use: It is injected into the buttock or upper arm of a woman, and takes seven days to become effective. It is not immediately reversible, and women can take up to two years to return to full fertility. Efficacy: 94% with typical use, 99.8% with perfect use. Side effects: The injection has an effect on bone density. But for women in their mid-reproductive years, that reduction in bone density is reversible once they stop having the injection. For women under the age of 18 or over 45, the contraceptive injection is not a first choice due to bone density side effects.
However, Bateson says it can be a useful option for some women. 'One advantage for some women is after using the injection for one year, 50% of women have no bleeding, and that percentage increases over time.' Vaginal ring Name: Contraceptive hormone vaginal ring, marketed in Australia as NuvaRing. Method: A soft, plastic ring is inserted by a woman into her vagina. Once inserted, it releases low doses of oestrogen and a progestogen, the same hormones found in the combined oral contraceptive. Price: About $30 per ring.
Use: Once inserted, the ring remains in place for three weeks, and must then be replaced, either in one week after a withdrawal bleed, or immediately to avoid menstruation. The ring is prescribed by a GP. Efficacy: 91% with typical use, 99.7% with perfect use. 'It's an alternative delivery system to the pill,' says Bateson. 'The benefit is you don't have to remember to take a pill every day.
It appears to be relatively beneficial for cycle control, and it's good for women who have breakthrough bleeding with the pill. However, the downside is it's not on the PBS so cost may be an issue.' Another advantage of the NuvaRing is that, unlike the pill, vomiting and diarrhoea does not reduce its effectiveness as the hormones aren't absorbed in the intestinal tract.
Contraceptive pill Name: Combined and progestogen-only (mini) oral contraceptive pills, marketed under various brand names including Yasmin, Yaz, Diane 35, Isabelle, Levlen, Microval and many others in Australia and known simply in the vernacular as 'the pill'. Method: Most combined pill packs contain 21 active pills and seven inactive placebo pills, which allow women to menstruate. Each mini pill pack contains 28 active pills. There is leeway of up to 24 hours if a combination pill is missed, or just three for a progesterone-only pill, after which time a woman may no longer be protected against pregnancy.
Price: From about $35 to $290 for a year's supply. Efficacy: 91% with typical use, 99.7% with perfect use. The contraceptive pill is the most common form of contraception used in Australia. 'We've got a lot of data on the pill', says Bateson. 'It can be useful for controlling acne, managing heavy periods and decreasing period pain. Sometimes the pill can control headaches that some women get with their periods.'
One of the main benefits of the combined contraceptive pill is that it gives women the ability to control their menstrual cycle by skipping the placebo pills. 'We now have plenty of data to show that it's safe to have continuous pill use for up to one year.
Some women will get breakthrough bleeding with prolonged use, so we sometimes advise three-month cycling.' Gastric upsets and certain medication can impact on the effectiveness of the pill, as can human error. Yasmin and Yaz controversy There have been reports of serious and even deaths around the world as a result of use of Yasmin and Yaz (and their generic dopplegangers). According to Canada's CBC News, these birth-control pills have been contributors to the deaths of 23 women in that country. A class action has been filed against Bayer, the manufacturer of the pills, in Canada, alleging that the company failed to adequately warn patients and doctors of the pills' association with increased risk of stroke, deep vein thrombosis, pulmonary embolism, heart attack, gall bladder disease and/or removal when compared to other oral contraceptives. There are also reports of thousands of lawsuits against Bayer in the US.
Australian firm Tindall Gask Bentley Lawyers have announced that they are investigating the potential for a class action for women who use the contraceptives here. According to the firm, 'The ingredient in question is the hormone Drospirenone. Pharmaceutical company Bayer, the maker of Yasmin and Yaz, may have misrepresented the risks of harm arising from using either of these tablets.
Around 200,000 Australian women are believed to be using Yasmin and Yaz, which is now the subject of a number of class actions worldwide.' Australian women who believe they may have been adversely affected by Yasmin or Yaz can now for the potential class action.
Emergency contraception Emergency contraception is now available over the counter – useful in cases when contraception is forgotten or may have failed. The most common emergency contraceptive method is a single 1.5mg dose of taken within three days of unprotected contact. It can be used up to five days after, but its effectiveness may be reduced. Experts tell CHOICE that the emergency contraceptive pill is safe and there are no contra-indications as a result of taking it. Copper IUDs may also be used for emergency contraception up to five days after unprotected sex. Other methods Aside from these newer forms of contraception, there are other options that may be suitable. The diaphragm is still favoured by some women, despite its relative lack of efficacy.
With perfect use, it is 94% effective. With typical use, that figure drops to 88%. Female condoms, which can be difficult to find, can be used by those with latex allergies and allow women to protect themselves against STIs. But at about $3 each they're relatively expensive, and their typical-use efficacy rate is low, so they should be used in conjunction with more effective contraception to prevent pregnancy. Withdrawal and fertility awareness (timing of the cycle, temperature-taking) are also less effective forms of contraception. Although with perfect use their efficacy can be high, it drops significantly with typical use – just 78% for withdrawal, and 76% for fertility awareness. Work on a hormonal male contraceptive is ongoing.
Most temporary methods involve blocking sperm. The trouble is, they also block testosterone, which needs to be replaced, and men haven't appeared to be receptive to the method. Researchers in the US believe they have discovered a compound that may be used to make the first hormone-free contraceptive pill for men. The researchers have developed a small molecule that in mice blocks the cell division necessary for normal sperm production, says Professor Robert McLachlan, director of clinical research at Prince Henry's Institute of Medical Research. According to the researchers, the drug has no significant.
However, it is in early stages of development and may take 15 years to become available for human use. In the meantime, there are male condoms. Condoms have an efficacy rate of 82% with typical use, and 98% with perfect use. Their high failure rate is mainly attributed to incorrect or non-use, or condom failure such as breakage.
They provide good (but not 100%) protection from STDs, and can be doubled up with another, more effective contraceptive method.