Copper
FDA Drug Information • Also known as: Cuprum Metallicum, Cuprum Metallicum 6X, Miudella, Paragard T 380A
- Brand Names
- Cuprum Metallicum, Cuprum Metallicum 6X, Miudella, Paragard T 380A
- Drug Class
- Copper-containing Intrauterine Device [EPC]
- Route
- ORAL
- Dosage Form
- PELLET
- Product Type
- HUMAN OTC DRUG
Description
11 DESCRIPTION Figure 10 Figure 11 11.1 Paragard IUS Paragard (intrauterine copper contraceptive) is a T-shaped intrauterine system (IUS), measuring 32 mm horizontally and 36 mm vertically, with a 3 mm diameter bulb at the tip of the vertical stem. (See Figure 10) [see Dosage and Administration (2.3)]. A monofilament polyethylene thread is tied through the tip, resulting in two white threads, each approximately 36.5 cm in length, to aid in detection and removal of the intrauterine system. The T-frame is made of polyethylene with barium sulfate to aid in detecting the intrauterine system under x-ray. 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). The total exposed copper surface area is 380 ± 23 mm². One Paragard weighs less than one (1) gram. Figure 10 – Paragard IUS Paragard, its components, and the packaging are not made with natural rubber latex. 11.2 Inserter Paragard is packaged with a sterile pre-assembled inserter as a single-use, disposable device in a tray and in a Tyvek ® polyethylene pouch. A moveable blue flange on the insertion tube aids in gauging the depth of insertion through the cervical canal and into the uterine cavity (See Figure 11) [see Dosage and Administration ( 2.3 )]. Figure 11 – Paragard with Inserter
What Is Copper Used For?
1 INDICATIONS AND USAGE Paragard is indicated for prevention of pregnancy in females of reproductive potential for up to 10 years. Paragard is a copper-containing intrauterine system (IUS) indicated for prevention of pregnancy in females of reproductive potential for up to 10 years. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Insert a single Paragard at the fundus of the uterine cavity. Remove Paragard no later than 10 years from the date of insertion. ( 2.1 ) Insert and remove Paragard only if you are a healthcare provider trained on these procedures. ( 2.1 ) See the Full Prescribing Information for recommended timing of insertion preparation instructions, insertion procedures, postplacement management, and instructions on removing Paragard. ( 2.2 , 2.3 , 2.4 , 2.5 , 2.6 ) Following the insertion, examine the patient after her first menses to confirm Paragard is still in place. ( 2.5 ) Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Figure 6 Figure 7 Figure 8 Figure 9 2.1 Important Dosage and Administration Instructions Paragard should only be inserted by a healthcare provider trained in Paragard’s insertion procedures, because insertion for Paragard is different from that used for other intrauterine systems. Healthcare providers should become thoroughly familiar with the product, product educational materials, product insertion instructions, and prescribing information before attempting insertion of Paragard. Insert one Paragard at the fundus of the uterine cavity [see Dosage and Administration ( 2.4 )]. Remove Paragard on or before 10 years from the date of insertion [see Dosage and Administration ( 2.6 )]. May replace Paragard at the time of removal with a new Paragard if continued contraceptive protection is desired. Before considering use of Paragard, make sure that the female is an appropriate candidate for Paragard. Exclude pregnancy (consider the possibility of ovulation and conception) prior to use [see Contraindications ( 4 ) and Warnings and Precautions ( 5.2 )]. 2.2 Timing of Insertion Refer to Table 1 for recommended timing of Paragard insertion. Table 1: Recommended Timing of Paragard Insertion Clinical Situation Recommended Timing of Paragard Insertion 1. Start Paragard in females not currently using contraception At any time during the menstrual cycle. 2. Switch to Paragard from an oral, transdermal, or vaginal form of hormonal contraception or an injectable progestin contraceptive At any time during the menstrual cycle; discontinue the previous method. 3. Switch to Paragard from a contraceptive implant or other intrauterine system Same day the implant or IUS is removed (insert at any time during the menstrual cycle). 4. Insert Paragard 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. 5. Insert Paragard 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 [see Warnings and Precautions ( 5.6 , 5.7 )] . There appears to be an...
Side Effects (Adverse Reactions)
6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: Ectopic pregnancy [see Warnings and Precautions ( 5.1 )] Intrauterine pregnancy [see Warnings and Precautions ( 5.2 )] Septic abortion [see Warnings and Precautions ( 5.2 )] Group A Streptococcal Sepsis (GAS) [see Warnings and Precautions ( 5.3 )] Pelvic Inflammatory Disease and Endometritis [see Warnings and Precautions ( 5.4 )] Embedment [see Warnings and Precautions ( 5.5 )] Perforation [see Warnings and Precautions ( 5.6 )] Expulsion [see Warnings and Precautions ( 5.7 )] Bleeding Pattern Alterations [see Warnings and Precautions ( 5.9 ) ] Adverse reactions reported in clinical trials include: anemia, backache, dysmenorrhea, dyspareunia, expulsion (complete or partial), prolonged menstrual flow, menstrual spotting, pain and cramping, and vaginitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact CooperSurgical, Inc. at 1-877-727-2427 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The data described below reflect exposure in two trials [see Clinical Studies ( 14 )]. The WHO Study 79914 was a randomized, multicenter, multinational study of copper T IUSs, including Paragard in 1,396 women outside the U.S. In the WHO Study, 100% were parous and the mean age at enrollment was 29 years old. The U.S. Composite Study was a meta-analysis that evaluated randomized, double-blind, comparative studies of copper T IUSs, including Paragard in 3,536 women in the U.S. In the U.S. Composite Study, 64% were nulliparous, 49% were nulligravida, 68% were under age 25 at the time of enrollment (median age 23 years old). Table 2 shows discontinuation rates from the two clinical studies by adverse reaction and year. Table 2: Summary of Rates* (No. per 100 Subjects) by Year for Adverse Reactions Causing Discontinuation Year 1 2 3 4 5 6 7 8 9 10 Number of Women at Start of Year 4,932 3,149 2,018 1,121 872 621 563 483 423 325 Expulsion 5.7 2.5 1.6 1.2 0.3 0.0 0.6 1.7 0.2 0.4 Bleeding/Pain 11.9 9.8 7.0 3.5 3.7 2.7 3.0 2.5 2.2 3.7 Other Medical Event 2.5 2.1 1.6 1.7 0.1 0.3 1.0 0.4 0.7 0.3 *Rates were calculated by weighting the annual rates by the number of subjects starting each year for each of the U.S. Composite Study (3536 subjects) and the World Health Organization (1396 subjects) trials. The following adverse reactions have also been observed: anemia, backache, dysmenorrhea, dyspareunia, complete or partial expulsion, prolonged menstrual flow, menstrual spotting, pain and cramping, and vaginitis. Study CSIPD-001 The Paragard inserter that enables single-hand insertion was evaluated in Study CSIPD-001. A total of 117 females of reproductive potential aged 18 to 49 years, underwent Paragard insertion and were followed for up to 12 weeks of Paragard use. Subjects were predominantly white (76%), 45% were parous, and 35% were obese. Successful placement of Paragard with first attempt occurred in 91% of the subjects and 99% with two insertion attempts. Adverse reactions of special interest occurring during the study were IUS expulsion (2.6%), vasovagal reaction (2.6%), IUS malposition (1.7%), partial uterine perforation (0.9%), and IUS embedment (0.9%). 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of Paragard. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Gastrointestinal Disorders: abdominal distension, nausea General Disorders and Administration Site Conditions: device breakage, pyrexia; copper wire breakage Immune System...
Drug Interactions
7 DRUG INTERACTIONS No drug-drug interaction or drug-herbal supplement interaction studies have been conducted with Paragard.
Contraindications
4 CONTRAINDICATIONS The use of Paragard is contraindicated when one or more of the following conditions exist: Pregnancy or suspicion of pregnancy [see Warnings and Precautions ( 5.1 , 5.2 ) and Use in Specific Populations ( 8.1 )] Abnormalities of the uterus resulting in distortion of the uterine cavity Acute pelvic inflammatory disease (PID) [see Warnings and Precautions ( 5.4 )] Postpartum endometritis or postabortal endometritis in the past 3 months [see Warnings and Precautions ( 5.4 )] Known or suspected uterine or cervical malignancy Uterine bleeding of unknown etiology Untreated acute cervicitis or vaginitis or other lower genital tract infection Conditions associated with increased susceptibility to pelvic infections [see Warnings and Precautions ( 5.4 )] Wilson’s disease [see Warnings and Precautions ( 5.8 )] A previously placed IUD or IUS that has not been removed Hypersensitivity to any component of Paragard including to copper or any of the trace elements present in the copper component of Paragard [see Adverse Reactions ( 6.2 ) and Description ( 11 )] Pregnancy or suspicion of pregnancy ( 4 ) Abnormalities of the uterus resulting in distortion of the uterine cavity ( 4 ) Acute pelvic inflammatory disease (PID) ( 4 ) Postpartum endometritis or postabortal endometritis in past 3 months ( 4 ) Known or suspected uterine or cervical malignancy ( 4 ) Uterine bleeding of unknown etiology ( 4 ) Untreated acute cervicitis or vaginitis or other lower genital tract infection ( 4 ) Conditions associated with increased susceptibility to pelvic infections ( 4 ) Wilson’s disease ( 4 ) A previously placed IUD or IUS that has not been removed ( 4 ) Hypersensitivity to any component of Paragard including copper or any trace elements present in the copper components of Paragard ( 4 )
Pregnancy and Breastfeeding
8.1 Pregnancy Risk Summary Use of Paragard is contraindicated for use in pregnant females because there is no need for pregnancy prevention in a female who is already pregnant and Paragard may cause adverse pregnancy outcomes. If a female becomes pregnant with Paragard in place, there is an increased risk of miscarriage, sepsis, premature labor, and premature delivery [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 , 5.2 ) ] . Advise the female of the potential risks if pregnancy occurs with Paragard in place. Published studies on pregnancy outcomes exposed to copper IUSs report up to 27% miscarriage when the IUS was removed compared to 77% miscarriage when the IUS remained in the uterus. Studies on Paragard and birth defects have not been conducted.
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Paragard (intrauterine copper contraceptive) is available in cartons of 1 (one) sterile unit (NDC 59365-5129-1). Each Paragard is white, T-shaped, and measures 32 mm horizontally and 36 mm vertically, with approximately 176 mg of copper wire wrapped around the vertical stem and an approximately 68.7 mg copper wire collar placed on each side of the horizontal arms, and with a monofilament polyethylene thread tied through the tip of the vertical stem [see Dosage and Administration ( 2.3 )]. The T-frame is made of polyethylene with barium sulfate. Each Paragard is packaged with a sterile pre-assembled inserter as a single-use, disposable device in a tray and in a Tyvek ® polyethylene pouch. Store at controlled room temperature: 59° to 86°F (15° to 30°C).
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.