Intrauterine copper contraceptives are non-hormonal intrauterine devices (IUDs). Paragard, one marketed copper IUD product, is indicated for prevention of pregnancy in females of reproductive potential for up to 10 years. The Paragard is a T-shaped IUD; the T-frame is made of polyethylene with barium sulfate to aid in detecting the IUD by X-ray; the Paragard also contains copper (approximately 176 mg of wire wrapped around the vertical stem and an approximately 68.7 mg collar placed on each side of the horizontal arm). A copper IUD is a highly effective form of contraception, and may be used in appropriately selected nulliparous and parous patients, including those patients who are breast-feeding.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Other Administration Route(s)
Intrauterine device (IUD) Administration (Paragard)
-IUD is for insertion into the uterus and should only be administered by physicians specifically trained in Paragard's insertion procedures; insertion technique for Paragard IUD is different from that used for other intrauterine systems.
-Follow all instructions for the IUD device regarding preparation of the device and insertion technique before insertion.
-Timing of IUD insertion based on clinical status:
--Starting the IUD in women not currently using hormonal or intrauterine contraception: The IUD system can be inserted any time the provider can be reasonably certain the woman is not pregnant. Consider the possibility of ovulation and conception prior to initiation of this product.
-Switching to the IUD from an oral, transdermal, vaginal hormonal contraceptive, or injectable progestin contraceptive: The IUD may be inserted at any time; discontinue the previous method.
-Switching to the IUD from a contraceptive implant or use of another IUD: Insert the IUD on the same day the implant or IUD is removed (insert at any time during the menstrual cycle).
-Inserting the IUD after abortion or miscarriage: Immediately after abortion, although immediate placement has a slightly higher risk of expulsion than placement at other times. Insertion after second trimester abortion is associated with a higher risk of expulsion than insertion after a first trimester abortion.
-Inserting the IUD after childbirth: May insert immediately postpartum. Insertion before uterine involution is complete, which may not occur until the second postpartum month, has been associated with increased risk of expulsion. There appears to be an increased risk of uterine perforation in lactating women.
-The retrieval threads should be visible after insertion.
-Placement can be checked with ultrasound.
-Patients should be examined after first menses to confirm the IUD is still in place.
-IUD REMOVAL: Remove the IUD on or before 10 years from the date of insertion. Remove the IUD by applying gentle traction on the threads with forceps. The arms of the system will fold upward as it is withdrawn from the uterus. Never reinsert a removed system. A new IUD may be inserted immediately following removal. Removal may be associated with breakage or embedment of the IUD in the myometrium that can make removal difficult. Analgesia, paracervical anesthesia, cervical dilation, alligator forceps or other grasping instrument, or hysteroscopy may be used to assist in removal.
Intrauterine devices (IUDs) increase the risk for pelvic inflammatory disease (PID) infection. In clinical trials with the copper intrauterine device (IUD), the incidence of PID that resulted in the removal of the copper IUD was approximately 0.1%. PID most often occurs within the first year of use and often within the first month of insertion. Pelvic infections can cause tubal damage leading to ectopic pregnancy or infertility, or infrequently can necessitate hysterectomy, or cause death. Endometritis is another infection that may occur soon after IUD insertion. PID or endometritis may be asymptomatic but still result in tubal damage and its sequelae. PID can have serious consequences, such as tubal damage (leading to tubal pregnancy or infertility), hysterectomy, sepsis, and death. The highest risk of PID occurs shortly after insertion (usually within the first 20 days), but PID may present at any time. Endometritis is more common in the first 40 days after insertion. Actinomycosis has been associated with IUD use, including the copper IUD. Symptomatic women with known actinomycosis infection should have the copper IUD removed and receive antibiotics. Actinomycetes can be found in the genital tract cultures in healthy women without IUDs. The significance of actinomyces-like organisms on a Papanicolaou (PAP) smear in an asymptomatic IUD user is unknown, and this finding alone does not always require IUD removal and treatment. When possible, confirm a PAP smear diagnosis with cultures. Severe infection or sepsis, including Group A Streptococcal Sepsis (GAS), have also been reported following insertion of IUDs, including the copper IUD. In some cases, severe pain occurred within hours of insertion followed by sepsis within days. Because death from GAS is more likely if treatment is delayed, it is important to be aware of these rare but serious infections. Aseptic technique during insertion is essential in order to minimize serious infections such as GAS. Teach patients to recognize and report to their healthcare provider promptly any symptoms of pelvic infection to receive evaluation. These symptoms include development of menstrual disorders (prolonged or heavy bleeding), unexplained vaginal bleeding, unusual or odorous vaginal discharge, lower abdominal pain, pelvic tenderness or pain, dyspareunia, chills, and fever, and genital lesions or sores. Some symptoms may overlap with symptoms of tubal pregnancy. Remove the copper IUD in cases of recurrent endometritis or PID, or if an acute pelvic infection is severe or does not respond to treatment. The rates of bleeding and/or pelvic pain leading to discontinuation of the copper IUD during clinical studies ranged from 2.2 to 11.9 patients per 100 subjects, with the highest incidence reported within the first year of IUD insertion.
Menstrual irregularity was the most common medical reason for discontinuation of the copper intrauterine device (IUD). The rates of bleeding and/or pelvic pain leading to discontinuation of the copper IUD during clinical studies ranged from 2.2 to 11.9 patients per 100 subjects; the highest incidence was reported within the first year of IUD insertion and diminishing after that. In clinical trials with the copper IUD and postmarketing, spotting (breakthrough bleeding), dysmenorrhea, oligomenorrhea (prolonged menstrual flow), amenorrhea, anemia, menstrual pain/cramps, vaginitis, and back pain have also been observed. Females complaining of heavy vaginal bleeding should be evaluated and treated, and may need to discontinue the copper IUD.
In copper intrauterine device (IUD) trials, ectopic pregnancy was reported among serious adverse reactions. The incidence of ectopic pregnancy in the clinical trials with the copper IUD (which excluded females with a previous history of ectopic pregnancy) was approximately 0.06%. Up to 50% of pregnancies that occur when an IUD is already in place may be ectopic. The risk of an ectopic pregnancy in women who have a history of ectopic pregnancy is not known; clinical trials excluded patients with a history of ectopic pregnancy, and use in this population is not recommended. Health care providers should be alert to the possibility of ectopic pregnancy in women who become pregnant or complain of lower abdominal pain because a pregnancy that occurs with copper IUD in place is more likely to be ectopic than a pregnancy in the general population. If an intrauterine pregnancy occurs with the copper IUD in place and the strings are visible or can be retrieved from the cervical canal, remove the copper IUD because leaving it in place may increase the risk of spontaneous fetal abortion and preterm labor. Removal of the copper IUD may also result in spontaneous abortion. In the event of an intrauterine pregnancy with the copper IUD, the patient should be informed of the possibility of intrauterine fetal death or miscarriage. In females becoming pregnant with the copper IUD in place, septic abortion, with septicemia, septic shock, and death, may occur. Septic abortion typically requires hospitalization and treatment with intravenous antibiotics. Septic abortion may result in spontaneous abortion or a medical indication for pregnancy termination. A hysterectomy may be required if a severe infectious process of the uterus occurs, which will result in permanent infertility. If the patient who is pregnant refuses to have the copper IUD removed, or if it cannot be removed, the patient should be closely monitored and advised to report any flu-like symptoms, fever or pyrexia, chills, cramping, pain, vaginal bleeding, vaginal discharge or fluid leakage immediately; the risks for miscarriage, and premature labor/delivery are increased if the copper IUD is left in place during pregnancy. Congenital anomalies in live births have occurred infrequently; mo clear trend towards disorders of any kind has been observed.
One of the more common device-related event with the copper intrauterine device (IUD) leading to discontinuation of use was a risk for device expulsion. The incidence of IUD expulsion in the clinical trials with the copper IUD was approximately 5.7% in the first year and diminished after that, with an overall incidence of 2.3%. Consider further diagnostic imaging, such as x-ray, to confirm expulsion if the IUD is not found in the uterus. Remove a partially expelled copper IUD. Partial or complete expulsion of the copper IUD results in the loss of contraceptive protection. Serious, but rare, adverse events associated with the copper IUD include uterine embedment causing cervical or uterine perforation. Partial penetration or embedment of the copper IUD in the myometrium can make removal difficult. In some cases, surgical removal may be necessary. Breakage of an embedded IUD during non-surgical removal has been reported. Partial or total perforation of the uterine wall or cervix may occur during insertions, although the perforation may not be detected until sometime later. Perforation may reduce contraceptive efficacy and result in pregnancy. The incidence of perforation during or following the copper IUD insertion in clinical trials was 0.2% (13 out of 5,344). Delayed detection or removal of the copper IUD in cases of perforation may result in migration outside the uterine cavity, which may cause adhesions, peritonitis, intestinal penetration, intestinal GI obstruction, abscesses and/or damage to adjacent organs. A postmarketing safety study demonstrated an increased risk of uterine perforation in lactating women. The risk of perforation may be increased if an IUD is inserted when the uterus is fixed, retroverted or not completely involuted during the postpartum period. If perforation does occur, locate and remove the copper IUD promptly. Surgery may be required. Preoperative imaging followed by laparoscopy or laparotomy is often required to remove the copper IUD from the peritoneal cavity.
Severe hypersensitivity reactions, including Stevens-Johnson syndrome have been reported during postmarketing use of the copper intrauterine device (IUD). Allergic reaction to metals and other hypersensitivity has also been reported during postmarketing use; the copper IUD should not be used in patients hypersensitive to copper IUD or any trace elements or materials present in the device.
Abdominal distension, nausea, muscle cramps (spasms), and dizziness have been reported during postmarketing use of the copper intrauterine device (IUD).
The copper intrauterine device (IUD) should not be used in patients with a hypersensitivity to copper or any trace elements present in the device. The copper IUD is contraindicated in anyone hypersensitive to the IUD components, which may include barium sulfate and polyethylene.
The copper intrauterine device (IUD) is contraindicated in women with a previously placed IUD that has not been removed.
The insertion of the copper intrauterine device (IUD) requires an experienced clinician who is trained in IUD insertion using aseptic technique. Health care professionals should be thoroughly familiar with insertion procedures, the specific product educational materials, product insertion instructions, prescribing information, and patient labeling before inserting the IUD. Such clinicians should be aware of potential complications of use (including infectious risks, device embedment, uterine perforation, or device expulsion) and their proper management should they occur.
The copper intrauterine device (IUD) may exacerbate Wilson's disease; therefore, the use of the copper IUD is contraindicated in females of reproductive potential with Wilson's disease.
Insertion of a copper intrauterine device (IUD) is contraindicated in patients with a congenital or acquired uterine anomaly, including uterine leiomyomata (fibroids), if such conditions distort the uterine cavity. Sonography may be indicated in some patients to ensure appropriate anatomical conditions for IUD placement. Insertion into a uterine cavity measuring less than 6 cm may increase the incidence of expulsion, bleeding, pain, and perforation. If cervical stenosis is encountered during IUD insertion, avoid undue force. Dilators and analgesia/local anesthesia may be helpful in this situation. The copper IUD is absolutely contraindicated in patients with undiagnosed abnormal vaginal bleeding or incomplete abortion. The copper IUD is also contraindicated in patients with known or suspected cancers of reproductive organs, such as cervical cancer or uterine cancer, except as palliative therapy in selected patients. Because irregular bleeding/spotting is common during the first year of the copper IUD use, exclude endometrial pathology (polyps or cancer) prior to the insertion of the copper IUD in women with persistent or uncharacteristic bleeding.
Copper intrauterine device intrauterine devices (IUDs) are contraindicated for use during pregnancy or suspected pregnancy. Before copper IUD insertion, exclude pregnancy (via pregnancy testing or other confirmation) and confirm that there are no other contraindications to the IUD insertion. Should an intrauterine pregnancy occur while the copper IUD is in place, the prescriber should refer to the specific copper IUD literature and the patient should be informed of the potential reproductive risks. The copper IUD should not be used if there is a suspicion of current ectopic pregnancy. Health care providers should be alert to the possibility of ectopic pregnancy in women who become pregnant or complain of lower abdominal pain because a pregnancy that occurs with copper IUD in place is more likely to be ectopic than a pregnancy in the general population. However, because the copper IUD prevents most pregnancies, females who use copper IUD have a lower risk of an ectopic pregnancy than sexually active females who do not use any contraception. The incidence of ectopic pregnancy in the clinical trials with copper IUD (which excluded females with a previous history of ectopic pregnancy) was approximately 0.06%. Ectopic pregnancy may require surgery and may result in loss of fertility. When pregnancy continues with the copper IUD in place, long-term effects on the offspring are unknown. If an intrauterine pregnancy occurs while a copper IUD is in place, and the strings are visible or can be retrieved from the cervical canal, the copper IUD should be removed because leaving it in place may increase the risk of spontaneous abortion and preterm labor. The patient should be informed of the possibility of intrauterine fetal death or miscarriage. Removal of the copper IUD may also result in spontaneous abortion. In females becoming pregnant with the copper IUD in place, septic abortion, with septicemia, septic shock, and death, may occur. Septic abortion typically requires hospitalization and treatment with intravenous antibiotics. Septic abortion may result in spontaneous abortion or a medical indication for pregnancy termination. A hysterectomy may be required if severe infectious process of the uterus occurs, which will result in permanent infertility. If the patient refuses to have the copper IUD removed, or if it cannot be removed, the patient should be closely monitored and advised to report any flu-like symptoms, fever/chills, cramping, pain, bleeding, vaginal discharge or fluid leakage immediately; the risks for miscarriage, and premature labor/delivery are increased if the copper IUD is left in place. Congenital anomalies in live births have occurred infrequently; no clear trend towards disorders of any kind has been observed.
Experts consider use of the copper IUD compatible with breast-feeding. No difference has been detected in concentration of copper in human milk before and after insertion of the copper intrauterine device (IUD). There is no information on the effect of copper in a breastfed child or the effect on milk production. The developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for the copper IUD and any potential adverse effects on the breastfed child from the copper IUD. A postmarketing safety study with IUDs, including the copper IUD, demonstrated an increased risk of uterine perforation in lactating women. The risk of perforation may be increased if the copper IUD is inserted when the uterus is fixed, retroverted, or not completely involuted during the postpartum period. If perforation does occur, locate and remove the copper IUD promptly. Surgery may be required. Preoperative imaging followed by laparoscopy or laparotomy is often required to remove the copper IUD from the peritoneal cavity.
The copper intrauterine device (IUD) can alter the bleeding pattern and result in menstrual irregularity, specifically heavier and longer menstrual cycles with intermenstrual spotting. Oligomenorrhea and amenorrhea have been reported; however, a causal relationship between the copper IUD and these events could not be established. Menstrual changes were the most common medical reason for discontinuation of the copper IUD. Discontinuation rates for pain and bleeding combined were highest in the first year of use and diminished thereafter. Females complaining of heavy vaginal bleeding should be evaluated and treated, and may need to discontinue the copper IUD.
Copper IUD insertion is contraindicated in patients with known or suspected acute pelvic inflammatory disease (PID) infection. The copper IUD is also contraindicated in patients with a history of postpartum endometritis or infected abortion (septic abortion) in the past 3 months, untreated acute cervicitis or vaginitis (including bacterial vaginosis), known chlamydial or gonococcal cervical infection, genital actinomycosis, or other lower genital tract infections until the infection is controlled, and in patients with conditions associated with an increased risk for pelvic infections. The insertion of a copper intrauterine device (IUD) may increase the risk for pelvic infection and endometritis. In the clinical trials with copper IUD, the incidence of PID that resulted in the removal of the system was approximately 0.1%. PID can have serious consequences, such as tubal damage (leading to ectopic pregnancy or infertility), hysterectomy, sepsis, and death. PID or endometritis may be asymptomatic but still result in tubal damage and its sequelae. Severe infection or sepsis, including Group A Streptococcal Sepsis (GAS), have also been reported following insertion of intrauterine systems, including the copper IUD. In some cases, severe pain occurred within hours of insertion followed by sepsis within days. Because death from GAS is more likely if treatment is delayed, it is important to be aware of these rare but serious infections. Aseptic technique during insertion is essential in order to minimize the risk for serious infections. The highest risk of PID occurs shortly after insertion (usually within the first 20 days), but PID may present at any time. Endometritis is more common in the first 40 days after insertion. Prophylactic antibiotics administered at the time of insertion do not appear to lower the incidence of these infections. Both PID and endometritis are often associated with a sexually transmitted infection (STI), and the copper intrauterine device does not protect against STIs. The risk of PID or endometritis is greater for women who have multiple sexual partners, and also for patients whose sexual partner(s) have multiple sexual partners (i.e., not in monogamous relationships). Women who have had PID or endometritis are at increased risk for a recurrence or re-infection. In particular, ascertain whether the woman is at increased risk of infection (e.g., leukemia, acquired immunodeficiency syndrome (AIDS), or intravenous substance abuse). Counsel patients who receive the copper IUD to notify a healthcare provider if they have complaints of lower abdominal or pelvic pain, odorous vaginal discharge, unexplained bleeding, fever, or genital lesions or sores. Promptly assess and treat any female who develops signs or symptoms of PID. Perform appropriate testing for STI and initiate antibiotic therapy promptly. The copper IUD does not need to be removed immediately. Reassess the patient in 48 to 72 hours. If no clinical improvement occurs, continue antibiotics and consider removal of the copper IUD. If the decision is to remove the copper IUD, start antibiotics prior to removal to avoid the potential risk for bacterial spread resulting from the removal procedure. Remove the copper IUD in cases of recurrent endometritis or PID, or if an acute pelvic infection is severe or does not respond to treatment.
Like other intrauterine system contraceptives, the copper intrauterine device (IUD) does not protect against the transmission of human immunodeficiency virus (HIV) infection or other sexually transmitted disease (STD). Pelvic inflammatory disease (PID) is often associated with an STD. The copper IUD is contraindicated for use in patients with active untreated STDs such as acute cervicitis or vaginitis (including bacterial vaginosis), known chlamydial or gonococcal cervical infection, genital actinomycosis, or other lower genital tract infections until the infection is controlled. The risk of STD is greater for patients who have multiple sexual partners, and also for patients whose sexual partner(s) have multiple sexual partners. The use of a barrier method as a partial protection against acquiring STDs should be strongly recommended.
Patients using the copper intrauterine device (IUD) can be safely scanned with magnetic resonance imaging (MRI) only under certain MRI system conditions. Should a patient with a copper IUD need to have an examination that involves an MRI, the patient should inform her healthcare provider and scan technician that a copper IUD is in place before the MRI procedure. Refer to the specific information for the copper IUD (an MR conditional device) prior to scheduling any MRI procedure. In addition, medical equipment that contains high level of Radiofrequency (RF) energy such as diathermy may cause health effects (by heating tissue) in patients with a metal-containing IUD inserted, including the copper IUD. Avoid using high medical RF transmitter devices in patients inserted with the copper IUD.
The safety and efficacy of the copper intrauterine device (IUD) have only been established in females of reproductive age. Safety and efficacy of copper IUD is expected to be the same for postmenarchal female children regardless of age. Use of the copper IUD in female children before menarche is not indicated.
Insertion of the copper IUD may be associated with pain and/or bleeding or vasovagal reactions (e.g. syncope, bradycardia, or seizure), especially in patients with a predisposition to these symptoms such as patients with a seizure disorder or history of syncope. Inform patients they may feel dizzy or nauseous during and right after insertion; the patient should remain supine until these symptoms have disappeared. Consider administering analgesics prior to insertion.
For routine contraception:
Intrauterine dosage (Paragard):
Adult and Adolescent females: Insert 1 IUD into the uterus as per device instructions. Provides efficacy for up to 10 years, then remove and replace. Never reinsert a removed system. May insert immediately postpartum.
Maximum Dosage Limits:
-Adults
1 copper intrauterine device (IUD) every 10 years.
-Geriatric
Safety and efficacy have not been established.
-Adolescents
1 copper intrauterine device (IUD) every 10 years. While not specifically studied in females less than 18 years of age, safety and efficacy are expected to be the same for postpubertal adolescents as for adult females.
-Children
Not indicated in prepubescent females.
Patients with Hepatic Impairment Dosing
No dosage adjustments are needed.
Patients with Renal Impairment Dosing
No dosage adjustments are needed.
*non-FDA-approved indication
Chlorpheniramine; Pseudoephedrine: (Major) Orally administered zinc salts compete with copper salts for absorption from the intestines. Since a large portion of administered zinc doses are excreted via biliary and pancreatic secretions, parenteral zinc therapy may also interfere with the oral absorption of copper salts.
Ibritumomab Tiuxetan: (Moderate) It has been reported that high intakes of phosphates, such as are found in dietary supplements or food additives, can interfere with absorption of trace nutrients such as iron, copper, and zinc. The magnitude of the effect may be small, and the interactions require further study to judge clinical significance. The theorized mechanism is the formation of insoluble complexes within the gut. Until more data are available, it may be helpful to separate administration times of phosphorus salts by as much as possible from the oral administration of iron (e.g., iron salts or polysaccharide-iron complex), copper salts, or zinc salts to limit any potential interactions.
Phosphorated Carbohydrate Solution: (Moderate) It has been reported that high intakes of phosphates, such as are found in dietary supplements or food additives, can interfere with absorption of trace nutrients such as iron, copper, and zinc. The magnitude of the effect may be small, and the interactions require further study to judge clinical significance. The theorized mechanism is the formation of insoluble complexes within the gut. Until more data are available, it may be helpful to separate administration times of phosphorus salts by as much as possible from the oral administration of iron (e.g., iron salts or polysaccharide-iron complex), copper salts, or zinc salts to limit any potential interactions.
Phosphorus: (Moderate) It has been reported that high intakes of phosphates, such as are found in dietary supplements or food additives, can interfere with absorption of trace nutrients such as iron, copper, and zinc. The magnitude of the effect may be small, and the interactions require further study to judge clinical significance. The theorized mechanism is the formation of insoluble complexes within the gut. Until more data are available, it may be helpful to separate administration times of phosphorus salts by as much as possible from the oral administration of iron (e.g., iron salts or polysaccharide-iron complex), copper salts, or zinc salts to limit any potential interactions.
Potassium Phosphate: (Moderate) It has been reported that high intakes of phosphates, such as are found in dietary supplements or food additives, can interfere with absorption of trace nutrients such as iron, copper, and zinc. The magnitude of the effect may be small, and the interactions require further study to judge clinical significance. The theorized mechanism is the formation of insoluble complexes within the gut. Until more data are available, it may be helpful to separate administration times of phosphorus salts by as much as possible from the oral administration of iron (e.g., iron salts or polysaccharide-iron complex), copper salts, or zinc salts to limit any potential interactions.
Potassium Phosphate; Sodium Phosphate: (Moderate) It has been reported that high intakes of phosphates, such as are found in dietary supplements or food additives, can interfere with absorption of trace nutrients such as iron, copper, and zinc. The magnitude of the effect may be small, and the interactions require further study to judge clinical significance. The theorized mechanism is the formation of insoluble complexes within the gut. Until more data are available, it may be helpful to separate administration times of phosphorus salts by as much as possible from the oral administration of iron (e.g., iron salts or polysaccharide-iron complex), copper salts, or zinc salts to limit any potential interactions.
Trientine: (Major) In general, oral mineral supplements should not be given since they may block the oral absorption of trientine. However, iron deficiency may develop, especially in children and menstruating or pregnant women, or as a result of the low copper diet recommended for Wilson's disease. If necessary, iron may be given in short courses, but since iron and trientine each inhibit oral absorption of the other, 2 hours should elapse between administration of trientine and iron doses.
Zinc Salts: (Major) Orally administered zinc salts compete with copper salts for absorption from the intestines. Since a large portion of administered zinc doses are excreted via biliary and pancreatic secretions, parenteral zinc therapy may also interfere with the oral absorption of copper salts.
Zinc: (Major) Orally administered zinc salts compete with copper salts for absorption from the intestines. Since a large portion of administered zinc doses are excreted via biliary and pancreatic secretions, parenteral zinc therapy may also interfere with the oral absorption of copper salts.
Intrauterine devices (IUDs) are considered highly effective for contraception, with a pregnancy rate of less than 1 pregnancy per 100 women in 1 year (first year, 0.7 pregnancies per 100 patients based on clinical studies with the copper IUD). Copper continuously released into the uterine cavity contributes to the contraceptive effectiveness of the IUD. Copper enhances contraceptive efficacy by interference with sperm transport and fertilization of an egg, and possibly prevention of implantation.
The copper intrauterine contraceptive device (IUD) is inserted into the uterus. Specific pharmacokinetic data are not available.