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Copper
Overview
What is ParaGard T 380A?
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 the device. 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.
What does ParaGard T 380A look like?
What are the available doses of ParaGard T 380A?
Sorry No records found.
What should I talk to my health care provider before I take ParaGard T 380A?
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How should I use ParaGard T 380A?
ParaGard is 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:
What interacts with ParaGard T 380A?
- ParaGard should not be placed when one or more of the following conditions exist:
- Pregnancy or suspicion of pregnancy
- Abnormalities of the uterus resulting in distortion of the uterine cavity
- Acute pelvic inflammatory disease, or current behavior suggesting a high risk for pelvic inflammatory disease
- Postpartum endometritis or postabortal endometritis in the past 3 months
- Known or suspected uterine or cervical malignancy
- Genital bleeding of unknown etiology
- Mucopurulent cervicitis
- Wilson’s disease
- Allergy to any component of ParaGard
- A previously placed IUD that has not been removed
What are the warnings of ParaGard T 380A?
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.
2. Ectopic Pregnancy
Women who become pregnant while using ParaGard should 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 ParaGard prevents most pregnancies, women who use ParaGard have a lower risk of an ectopic pregnancy than sexually active women who do not use any contraception.
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 .) 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 of pelvic infection possibly due to actinomyces should be treated and have her IUD removed.
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.
5. Embedment
Partial penetration or embedment of ParaGard in the myometrium can make removal difficult. In some cases, surgical removal may be necessary.
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 ParaGard promptly, 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.
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.
8. Wilson’s Disease
Theoretically, ParaGard can exacerbate Wilson’s disease, a rare genetic disease affecting copper excretion.
What are the precautions of ParaGard T 380A?
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
1. Information for patients
Before inserting ParaGard discuss the Patient Package Insert with the patient, and give her time to read the information. Discuss any questions she may have concerning ParaGard as well as other methods of contraception. Instruct her to promptly report symptoms of infection, pregnancy, or missing strings.
2. Insertion precautions, continuing care, and removal.
(See .)
3. Vaginal bleeding
In the 2 largest clinical trials with ParaGard (see , 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 .)
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.
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.
ParaGard can 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.
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-7 Intrauterine 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 ParaGard was subjected to MRI.
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.
8. Pregnancy
ParaGard is contraindicated during pregnancy. (See and .)
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.
10. Pediatric use
ParaGard is not indicated before menarche. Safety and efficacy have been established in women over 16 years old.
What are the side effects of ParaGard T 380A?
The most serious adverse events associated with intrauterine contraception are discussed in and . 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.
What should I look out for while using ParaGard T 380A?
ParaGard should not be placed when one or more of the following conditions exist:
What might happen if I take too much ParaGard T 380A?
Sorry No Records found
How should I store and handle ParaGard T 380A?
ParaGard is available in cartons of 1 (one) sterile unit (NDC 51285-204-01). Each ParaGard is packaged together with an insertion tube and solid white rod in a Tyvek polyethylene pouch.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The contraceptive effectiveness of ParaGard is enhanced by copper continuously released into the uterine cavity. Mechanism(s) by which copper enhances contraceptive efficacy include interference with sperm transport and fertilization of an egg, and possibly prevention of implantation.
Non-Clinical Toxicology
ParaGard should not be placed when one or more of the following conditions exist:When corticosteroids are administered concomitantly with potassium-depleting agents (e.g., ), patients should be observed closely for development of hypokalemia. In addition, there have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure.
Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance (see ).
Concomitant use of anticholinesterase agents (e.g., ) and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy. If concomitant therapy must occur, it should take place under close supervision and the need for respiratory support should be anticipated.
Coadministration of corticosteroids and usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect.
Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required.
Serum concentrations of may be decreased.
Since systemic steroids, as well as bupropion, can lower the seizure threshold, concurrent administration should be undertaken only with extreme caution; low initial dosing and small gradual increases should be employed.
Cholestyramine may increase the clearance of corticosteroids.
Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use.
Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia.
Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect.
Postmarketing surveillance reports indicate that the risk of tendon rupture may be increased in patients receiving concomitant fluoroquinolones (e.g., ) and corticosteroids, especially in the elderly. Tendon rupture can occur during or after treatment with quinolones.
Drugs which cytochrome P450 3A4 (CYP 3A4) enzyme activity (e.g., ) may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased. Drugs which CYP 3A4 (e.g., ) have the potential to result in increased plasma concentrations of corticosteroids. Glucocorticoids are moderate inducers of CYP 3A4. Coadministration with other drugs that are metabolized by CYP 3A4 (e.g., ) may increase their clearance, resulting in decreased plasma concentration.
Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60%, leading to increased risk of corticosteroid side effects. In addition, ketoconazole alone can inhibit adrenal corticosteroid synthesis and may cause adrenal insufficiency during corticosteroid withdrawal.
Concomitant use of (or other ) and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylates may be increased with concurrent use of corticosteroids; this could lead to decreased salicylate serum levels or increase the risk of salicylate toxicity when corticosteroid is withdrawn.
In postmarketing experience, there have been reports of both increases and decreases in phenytoin levels with dexamethasone coadministration, leading to alterations in seizure control. Phenytoin has been demonstrated to increase the hepatic metabolism of corticosteroids, resulting in a decreased therapeutic effect of the corticosteroid.
Increased doses of quetiapine may be required to maintain control of symptoms of schizophrenia in patients receiving a glucocorticoid, a hepatic enzyme inducer.
Corticosteroids may suppress reactions to skin tests.
Coadministration with thalidomide should be employed cautiously, as toxic epidermal necrolysis has been reported with concomitant use.
Patients on corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response. Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines. Routine administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued if possible (see ).
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
The most serious adverse events associated with intrauterine contraception are discussed in and . 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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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