Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/638
| Predicate | Object |
|---|---|
| rdf:type | |
| rdfs:label |
ParaGard T380A (Intrauterine Device)
|
| dailymed-instance:descripti... |
ParaGard T 380A Intrauterine Copper Contraceptive (ParaGard) is a T-shaped intrauterine device (IUD), measuring 32 mm horizontally and 36 mm vertically, with a 3 mm diameter bulb at the tip of the vertical stem. A monofilament polyethylene thread is tied through the tip, resulting in two white threads, each at least 10.5 cm in length, to aid in detection and removal of thedevice. The T-frame is made of polyethylene with barium sulfate to aid in detecting the device under x-ray. ParaGard also contains copper: approximately 176 mg of wire coiled along the vertical stem and a 68.7 mg collar on each side of the horizontal arm. The total exposed copper surface area is 380��23 mm��. One ParaGard weighs less than one (1) gram. No component of ParaGard or its packaging contains latex. ParaGard is packaged together with an insertion tube and solid white rod in a Tyvek polyethylene pouch that is then sterilized. A moveable flange on the insertion tube aids in gauging the depth of insertion through the cervical canal and into the uterine cavity.
|
| dailymed-instance:clinicalP... |
The contraceptive effectiveness of ParaGard is enhanced by copper continuously released into the uterine cavity. Possible mechanism(s) by which copper enhances contraceptive efficacy include interference with sperm transport or fertilization, and prevention of implantation.
|
| dailymed-instance:activeIng... | |
| dailymed-instance:contraind... |
ParaGard should not be placed when one or more of the following conditions exist:
|
| dailymed-instance:supply |
ParaGardis available in cartons of 1 (one) sterile unit (NDC 50907-0380-6) or cartons of 5 (five) sterile units (NDC 50907-0380-7). Each ParaGardis packaged together with an insertion tube and solid white rod in a Tyvekpolyethylene pouch.
|
| dailymed-instance:activeMoi... | |
| dailymed-instance:inactiveI... | |
| dailymed-instance:precautio... |
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.<br/>1. Information for patients: Before inserting ParaGarddiscuss the Patient Package Insert with the patient, and give her time to read the information. Discuss any questions she may have concerning ParaGardas well as other methods of contraception. Instruct her to promptly report symptoms of infection, pregnancy, or missing strings.<br/>2. Insertion precautions, continuing care, and removal.: (See INSTRUCTIONS FOR USE.)<br/>3. Vaginal bleeding: In the 2 largest clinical trials with ParaGard (see ADVERSE REACTIONS, Table 2), menstrual changes were the most common medical reason for discontinuation of ParaGard. Discontinuation rates for pain and bleeding combined are highest in the first year of use and diminish thereafter. The percentage of women who discontinued ParaGard because of bleeding problems or pain during these studies ranged from 11.9% in the first year to 2.2 % in year 9. Women complaining of heavy vaginal bleeding should be evaluated and treated, and may need to discontinue ParaGard. (See ADVERSE REACTIONS.)<br/>4. Vasovagal reactions, including fainting: Some women have vasovagal reactions immediately after insertion. Hence, patients should remain supine until feeling well and should be cautious when getting up.<br/>5. Expulsion following placement after a birth or abortion: ParaGard has been placed immediately after delivery, although risk of expulsion may be higher than when ParaGard is placed at times unrelated to delivery.However, unless done immediately postpartum, insertion should be delayed to the second postpartum month because insertion during the first postpartum month (except for immediately after delivery) has been associated with increased risk of perforation. ParaGardcan be placed immediately after abortion, although immediate placement has a slightly higher risk of expulsion than placement at other times.Placement after second trimester abortion is associated with a higher risk of expulsion than placement after the first trimester abortion.<br/>6. Magnetic resonance imaging (MRI): Limited data suggest that MRI at the level of 1.5 Tesla is acceptable in women using ParaGard. One study examined the effect of MRI on the CU-7Intrauterine Copper Contraceptive and Lippes Loop���intrauterine devices. Neither device moved under the influence of the magnetic field or heated during the spin-echo sequences usually employed for pelvic imaging.An in vitro study did not detect movement or temperature change when ParaGardwas subjected to MRI.<br/>7. Medical diathermy: Theoretically, medical (non-surgical) diathermy (short-wave and microwave heat therapy) in a patient with a metal-containing IUD may cause heat injury to the surrounding tissue. However, a small study of eight women did not detect a significant elevation of intrauterine temperature when diathermy was performed in the presence of a copper IUD.<br/>8. Pregnancy: ParaGardis contraindicated during pregnancy. (See CONTRAINDICATIONS and WARNINGS.)<br/>9. Nursing mothers: Nursing mothers may use ParaGard . No difference has been detected in concentration of copper in human milk before and after insertion of copper IUDs. The literature is conflicting, but limited data suggest that there may be an increased risk of perforation and expulsion if a woman is lactating.<br/>10. Pediatric use: ParaGardis not indicated before menarche. Safety and efficacy have been established in women over 16 years old.
|
| dailymed-instance:genericMe... |
Copper
|
| dailymed-instance:fullName |
ParaGard T380A (Intrauterine Device)
|
| dailymed-instance:adverseRe... |
The most serious adverse events associated with intrauterine contraception are discussed in WARNINGS and PRECAUTIONS. These include: Table 2 shows discontinuation rates from two clinical studies by adverse event and year. *Rates were calculated by weighting the annual rates by the number of subjects starting each year for each of the Population Council (3,536 subjects) and the World Health Organization (1,396 subjects) trials. The following adverse events have also been observed. These are listed alphabetically and not by order of frequency or severity.
|
| dailymed-instance:warning |
1. Intrauterine Pregnancy: If intrauterine pregnancy occurs with ParaGard in place and the string is visible, ParaGard should be removed because of the risk of spontaneous abortion, premature delivery, sepsis, septic shock, and, rarely, death. Removal may be followed by pregnancy loss. If the string is not visible, and the woman decides to continue her pregnancy, check if the ParaGard is in her uterus (for example, by ultrasound). If ParaGard is in her uterus, warn her that there is an increased risk of spontaneous abortion and sepsis, septic shock, and rarely, death.In addition, the risk of premature labor and delivery is increased. Human data about risk of birth defects from copper exposure are limited. However, studies have not detected a pattern of abnormalities, and published reports do not suggest a risk that is higher than the baseline risk for birth defects.<br/>2. Ectopic Pregnancy: Women who become pregnant while using ParaGardshould be evaluated for ectopic pregnancy. A pregnancy that occurs with ParaGard in place is more likely to be ectopic than a pregnancy in the general population. However, because ParaGardprevents most pregnancies, women who use ParaGard have a lower risk of an ectopic pregnancy than sexually active women who do not use any contraception.<br/>3. Pelvic Infection: Although pelvic inflammatory disease (PID) in women using IUDs is uncommon, IUDs may be associated with an increased relative risk of PID compared to other forms of contraception and to no contraception. The highest incidence of PID occurs within 20 days following insertion. Therefore, the visit following the first post-insertion menstrual period is an opportunity to assess the patient for infection, as well as to check that the IUD is in place. (See INSTRUCTIONS FOR USE, Continuing Care.) Since pelvic infection is most frequently associated with sexually transmitted organisms, IUDs are not recommended for women at high risk for sexual infection. Prophylactic antibiotics at the time of insertion do not appear to lower the incidence of PID. PID can have serious consequences, such as tubal damage (leading to ectopic pregnancy or infertility), hysterectomy, sepsis, and, rarely, death. It is therefore important to promptly assess and treat any woman who develops signs or symptoms of PID. Guidelines for treatment of PID are available from the Centers for Disease Control and Prevention (CDC), Atlanta, Georgia at www.cdc.gov or 1-800-311-3435. Antibiotics are the mainstay of therapy. Most healthcare professionals also remove the IUD. The significance of actinomyces-like organisms on Papanicolaou smear in an asymptomatic IUD user is unknown,and so this finding alone does not always require IUD removal and treatment. However, because pelvic actinomycosis is a serious infection, a woman who has symptoms of pelvic infection possibly due to actinomyces should be treated and have her IUD removed.<br/>4. Immunocompromise: Women with AIDS should not have IUDs inserted unless they are clinically stable on antiretroviral therapy. Limited data suggest that asymptomatic women infected with human immunodeficiency virus may use intrauterine devices. Little is known about the use of IUDs in women who have illnesses causing serious immunocompromise. Therefore these women should be carefully monitored for infection if they choose to use an IUD. The risk of pregnancy should be weighed against the theoretical risk of infection.<br/>5. Embedment: Partial penetration or embedment of ParaGard in the myometrium can make removal difficult. In some cases, surgical removal may be necessary.<br/>6. Perforation: Partial or total perforation of the uterine wall or cervix may occur rarely during placement, although it may not be detected until later. Spontaneous migration has also been reported. If perforation does occur, remove ParaGardpromptly, since the copper can lead to intraperitoneal adhesions. Intestinal penetration, intestinal obstruction, and/or damage to adjacent organs may result if an IUD is left in the peritoneal cavity. Pre-operative imaging followed by laparoscopy or laparotomy is often required to remove an IUD from the peritoneal cavity.<br/>7. Expulsion: Expulsion can occur, usually during the menses and usually in the first few months after insertion. There is an increased risk of expulsion in the nulliparous patient. If unnoticed, an unintended pregnancy could occur.<br/>8. Wilson's Disease: Theoretically, ParaGardcan exacerbate Wilson's disease, a rare genetic disease affecting copper excretion.
|
| dailymed-instance:indicatio... |
ParaGardis indicated for intrauterine contraception for up to 10 years. The pregnancy rate in clinical studies has been less than 1 pregnancy per 100 women each year. Table 1: Percentage of women experiencing an unintended pregnancy during the first year of typical use and first year of perfect use of contraception and the percentage continuing use at the end of the first year: United States
|
| dailymed-instance:represent... | |
| dailymed-instance:routeOfAd... | |
| dailymed-instance:name |
ParaGard T380A
|