ParaGard T 380A INTRAUTERINE COPPER CONTRACEPTIVE | ParaGard T 380A [Teva Women's Health, Inc.] | BioPortfolio

12:28 EST 27th January 2019 | BioPortfolio
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P/N 1017005Rev. 9/2014 Rx onlyPRESCRIBING INFORMATION

ParaGardT 380A Intrauterine Copper Contraceptive

Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

ParaGard T 380A Intrauterine Copper Contraceptive should be placed and removed only by healthcare professionals who are experienced with these procedures.

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.

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.

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: 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

 Footnotes to Table 1
Source: Trussel J, Contraceptive efficacy. In Hatcher RA, Trussel J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998.
    % of Women Experiencing
an Accidental Pregnancy within
the First Year of Use
  % of Women Continuing
Use at One Year3
  Method (1)   Typical Use1 (2)   Perfect Use2 (3)   (4)
 Chance4  85  85  
 Spermicides5  26  6  40
 Periodic Abstinence
Ovulation Method
Parous women
Nulliparous women
Parous women
Nulliparous women
 Diaphragm7  20  6  56
 Withdrawal  19  4  
Female (Reality)
Progestin only
Progesterone T
Copper T 380A
LNg 20
 Depo Provera  0.3  0.3  70
 Norplant and Norplant-2  0.05  0.05  88
 Female sterilization  0.5  0.5  100
 Male sterilization  0.15  0.10  100
  Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9
  Lactational Amenorrhea Method: LAM is a highly effective temporary method of contraception.10

ParaGard should not be placed when one or more of the following conditions exist:

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.

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.

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 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.

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.

Partial penetration or embedment of ParaGard in the myometrium can make removal difficult. In some cases, surgical removal may be necessary.

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.

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.

Theoretically, ParaGard can exacerbate Wilson’s disease, a rare genetic disease affecting copper excretion.

Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

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.


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 .)

Some women have vasovagal reactions immediately after insertion. Hence, patients should remain supine until feeling well and should be cautious when getting up.

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.

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.

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.

ParaGard is contraindicated during pregnancy. (See CONTRAINDICATIONS and WARNINGS.)

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.

ParaGard is not indicated before menarche. Safety and efficacy have been established in women over 16 years old.

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.

 Intrauterine pregnancy  Pelvic infection
 Septic abortion  Perforation
 Ectopic pregnancy  Embedment
Table 2. Summary of Rates (No. per 100 Subjects) by Year for Adverse Events Causing Discontinuation
  Adverse Event    Year
  1   2   3   4   5   6   7   8   9   10
  Pregnancy  0.7  0.3  0.6  0.2  0.3  0.2  0.0  0.4  0.0  0.0
  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
  No. of Women at Start of Year  4932  3149  2018  1121  872  621  563  483  423  325
 Anemia  Menstrual flow, prolonged
 Backache  Menstrual spotting
 Dysmenorrhea  Pain and cramping
 Dyspareunia  Urticarial allergic skin reaction
 Expulsion, complete or partial  Vaginitis

The placement technique for ParaGard is different from that used for other IUDs. Therefore, the clinician should be familiar with the following instructions.

ParaGard may be placed at any time during the cycle when the clinician is reasonably certain the patient is not pregnant. For information about timing of postpartum and postabortion insertions, see PRECAUTIONS .

A single ParaGard should be placed at the fundus of the uterine cavity. ParaGard should be removed on or before 10 years from the date of insertion.

Do not bend the arms of ParaGard earlier than 5 minutes before it is to be placed in the uterus. Use aseptic technique when handling ParaGard and the part of the insertion tube that will enter the uterus.


Load ParaGard into the insertion tube by folding the two horizontal arms of ParaGardagainst the stem and push the tips of the arms securely into the inserter tube.

If you do not have sterile gloves, you can do STEPS 1 and 2 while ParaGard is in the sterile package. First, place the package face up on a clean surface. Next, open at the bottom end (where arrow says OPEN). Pull the solid white rod partially from the package so it will not interfere with assembly. Place thumb and index finger on top of package on ends of the horizontal arms. Use other hand to push insertion tube against arms of ParaGard (shown by arrow in Fig. 1). This will start bending the T arms.


Bring the thumb and index finger closer together to continue bending the arms until they are alongside the stem. Use the other hand to withdraw the insertion tube just enough so that the insertion tube can be pushed and rotated onto the tips of the arms. Your goal is to secure the tips of the arms inside the tube (Fig. 2). Insert the arms no further than necessary to insure retention. Introduce the solid white rod into the insertion tube from the bottom, alongside the threads, until it touches the bottom of the ParaGard.


Grasp the insertion tube at the open end of the package; adjust the blue flange so that the distance from the top of the ParaGard (where it protrudes from the inserter) to the blue flange is the same as the uterine depth that you measured with the sound. Rotate the insertion tube so that the horizontal arms of the T and the long axis of the blue flange lie in the same horizontal plane (Fig. 3). Now pass the loaded insertion tube through the cervical canal until ParaGard just touches the fundus of the uterus. The blue flange should be at the cervix in the horizontal plane.


To release the arms of ParaGard, hold the solid white rod steady and withdraw the insertion tube no more than one centimeter. This releases the arms of ParaGard high in the uterine fundus (Fig. 4).


Gently and carefully move the insertion tube upward toward the top of the uterus, until slight resistance is felt. This will ensure placement of the T at the highest possible position within the uterus (Fig. 5).


Hold the insertion tube steady and withdraw the solid white rod (Fig. 6).


Gently and slowly withdraw the insertion tube from the cervical canal. Only the threads should be visible protruding from the cervix. (Fig. 7). Trim the threads so that 3 to 4 cm protrude into the vagina. Note the length of the threads in the patient’s records.

If you suspect that ParaGard is not in the correct position, check placement (with ultrasound, if necessary). If ParaGard is not positioned completely within the uterus, remove it and replace it with a new ParaGard. Do not reinsert an expelled or partially expelled ParaGard.

Instrumentation of the cervical os may result in vasovagal reactions, including fainting. Have the patient remain supine until she feels well, and have her get up with caution.

Following placement, examine the patient after her first menses to confirm that ParaGard is still in place. You should be able to see or feel only the threads. If ParaGard has been partially or completely expelled, remove it. You can place a new ParaGard if the patient desires and if she is not pregnant. Do not reinsert a used ParaGard.

Evaluate the patient promptly if she complains of any of the following:

(See WARNINGS, Pelvic Infection, Intrauterine Pregnancy and Ectopic Pregnancy .)

The length of the visible threads may change with time. However, no action is needed unless you suspect partial expulsion, perforation, or pregnancy.

If you cannot find the threads in the vagina, check that ParaGard is still in the uterus. The threads can retract into the uterus or break, or ParaGard can break, perforate the uterus, or be expelled. Gentle probing of the cavity, radiography, or sonography may be required to locate the IUD.

If there is evidence of partial expulsion, perforation, or breakage, remove ParaGard.

Remove ParaGard with forceps, pulling gently on the exposed threads. The arms of ParaGard will fold upwards as it is withdrawn from the uterus. You may immediately insert a new ParaGard if the patient requests it and has no contraindications.

Embedment or breakage of ParaGard in the myometrium can make removal difficult. Analgesia, paracervical anesthesia, and cervical dilation may assist in removing an embedded ParaGard. An alligator forceps or other grasping instrument may be helpful. Hysteroscopy may also be helpful.

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.

ParaGard T 380A Intrauterine Copper Contraceptive

ParaGard T 380A Intrauterine Copper Contraceptive is used to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

It is important for you to understand this brochure and discuss it with your healthcare provider before choosing ParaGardT 380A Intrauterine Copper Contraceptive (ParaGard). You should also learn about other birth control methods that may be an option for you.

ParaGard is a copper-releasing device that is placed in your uterus to prevent pregnancy for up to 10 years.

ParaGard is made of white plastic in the shape of a “T.” Copper is wrapped around the stem and arms of the “T”. Two white threads are attached to the stem of the “T”. The threads are the only part of ParaGard that you can feel when ParaGard is in your uterus. ParaGard and its components do not contain latex.

You can keep ParaGard in your uterus for up to 10 years. After 10 years, you should have ParaGard removed by your healthcare provider. If you wish and if it is still right for you, you may get a new ParaGard during the same visit.

Your healthcare provider can remove ParaGard at any time. After discontinuation of ParaGard, its contraceptive effect is reversed.

Ideas about how ParaGard works include preventing sperm from reaching the egg, preventing sperm from fertilizing the egg, and possibly preventing the egg from attaching (implanting) in the uterus. ParaGard does not stop your ovaries from making an egg (ovulating) each month.

Fewer than 1 in 100 women become pregnant each year while using ParaGard.

The table below shows the chance of getting pregnant using different types of birth control. The numbers show typical use, which includes people who don't always use birth control correctly.

Number of women out of 100 women who are likely to get pregnant over one year
  Method of birth control   Pregnancies per 100
women over one year
 No Method  85
 Spermicides  26
 Periodic abstinence  25
 Cap with Spermicides  20
 Vaginal Sponge  20 to 40
 Diaphragm with Spermicides  20
 Withdrawal  19
 Condom without spermicides (female)  21
 Condom without spermicides (male)  14
 Oral Contraceptives  5
 IUDs, Depo-Provera,implants, sterilization  less than 1

You might choose ParaGard if you

You should not use ParaGard if you

ParaGard is placed in your uterus during an office visit. Your healthcare provider first examines you to find the position of your uterus. Next, he or she will cleanse your vagina and cervix, measure your uterus, and then slide a plastic tube containing ParaGard into your uterus. The tube is removed, leaving ParaGard inside your uterus. Two white threads extend into your vagina. The threads are trimmed so they are just long enough for you to feel with your fingers when doing a self-check. As ParaGard goes in, you may feel cramping or pinching. Some women feel faint, nauseated, or dizzy for a few minutes afterwards. Your healthcare provider may ask you to lie down for a while and to get up slowly.

Visit your healthcare provider for a check-up about one month after placement to make sure ParaGard is still in your uterus.

You can also check to make sure that ParaGard is still in your uterus by reaching up to the top of your vagina with clean fingers to feel the two threads. Do not pull on the threads.

If you cannot feel the threads, ask your healthcare provider to check if ParaGard is in the right place. If you can feel more of ParaGard than just the threads, ParaGard is not in the right place. If you can’t see your healthcare provider right away, use an additional birth control method. If ParaGard is in the wrong place, your chances of getting pregnant are increased. It is a good habit for you to check that ParaGard is in place once a month.

You may use tampons when you are using ParaGard.

If you think you are pregnant, contact your healthcare professional right away. If you are pregnant and ParaGard is in your uterus, you may get a severe infection or shock, have a miscarriage or premature labor and delivery, or even die. Because of these risks, your healthcare provider will recommend that you have ParaGardremoved, even though removal may cause miscarriage.

If you continue a pregnancy with ParaGard in place, see your healthcare provider regularly. Contact your healthcare provider right away if you get fever, chills, cramping, pain, bleeding, flu-like symptoms, or an unusual, bad smelling vaginal discharge.

A pregnancy with ParaGard in place has a greater than usual chance of being ectopic (outside your uterus). Ectopic pregnancy is an emergency that may require surgery. An ectopic pregnancy can cause internal bleeding, infertility, and death. Unusual vaginal bleeding or abdominal pain may be signs of an ectopic pregnancy.

Copper in ParaGard does not seem to cause birth defects.

The most common side effects of ParaGard are heavier, longer periods and spotting between periods; most of these side effects diminish after 2-3 months. However, if your menstrual flow continues to be heavy or long, or spotting continues, contact your healthcare provider.

Infrequently, serious side effects may occur:

You may have other side effects with ParaGard. For example, you may have anemia (low blood count), backache, pain during sex, menstrual cramps, allergic reaction, vaginal infection, vaginal discharge, faintness, or pain. This is not a complete list of possible side effects. If you have questions about a side effect, check with your healthcare provider.

Call your healthcare provider if you have any concerns about ParaGard. Be sure to call if you

General advice about prescription medicines

This brochure summarizes the most important information about ParaGard. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider for information about ParaGard that is written for healthcare professionals.


This checklist will help you and your healthcare provider discuss the pros and cons of ParaGard for you. Do you have any of the following conditions?

Teva Women's Health, Inc.

A Subsidiary of Teva Pharmaceuticals USA, Inc.

North Wales, PA 19454

Rev. 9/2014

P/N 1017005

    Yes   No   Don't know
 Abnormal Pap smear      
 Abnormalities of the uterus      
 Allergy to copper      
 Anemia or blood clotting problems      
 Bleeding between periods      
 Cancer of the uterus or cervix      
 Fainting attacks      
 Genital sores      
 Heavy menstrual flow      
 HIV or AIDS      
 Infection of the uterus or cervix      
 IUD in place now or in the past      
 More than one sexual partner      
 Pelvic infection (PID)      
 Possible pregnancy      
 Repeated episodes of pelvic infection (PID)      
 Serious infection following a pregnancy or abortion in the past 3 months      
 Severe menstrual cramps      
 Sexual partner who has more than one sexual partner      
 Sexually transmitted disease (STD) such as gonorrhea or chlamydia      
 Wilson's disease      

TEVA Women’s Health



North Wales, PA 19454




intrauterine copper contraceptive

NDC 51285-204-01

Each unit wound with approximately 176 mg of copper wire. In addition, a single copper sleeve is swaged on each of the two transverse arms. Each sleeve contains approximately 68.7 mg of copper.

The total surface area of copper on the device is 380 ± 23mm. IMPORTANT: To be inserted in the uterus only by a licensed clinician or under the supervision of a physician. See detailed instructions

for use. NOTE: A Patient Package Insert is provided with each unit. Please ensure that this package insert is provided to the patient. Review patient brochure with each patient before insertion.

Store at controlled room temperature: 59° to 86°F (15° to 30°C) TEVA WOMEN’S HEALTH, INC., Subsidiary of TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454


Teva Women's Health, Inc.

Active Ingredients


Clinical Trials [13 Associated Clinical Trials listed on BioPortfolio]

A PK Study Comparing VeraCept vs. ParaGard Intrauterine Devices (IUDs)

to Assess the Pharmacokinetic Properties of VeraCept™ Intrauterine Contraceptive vs ParaGard® in Healthy, Post- Menarcheal Women

Compare Two Copper IUDs: Mona Lisa NT Cu380 Mini and ParaGard

This will be a multi-site, participant-blinded, randomized clinical trial. The investigators will randomize 600 eligible participants in a 2:1 ratio to two different copper IUDs: 400 to Mo...

IUD Uterine Vascularization and Side Effects

The aim of this study was to evaluate the effect of the LNG-IUS and TCU 380A users on the sub-endometrial vascularization and the uterine artery blood flow using power Doppler analysis and...

Comparison Between Intrauterine Contraceptive Device Insertion During Cesarean Section Vs Conventional Application

The study aims to compare immediate post-placental (within 10 minutes of placenta delivery) intrauterine contraceptive device (Copper T 380A) insertion versus conventional placement at 6 w...

Maintaining Intrauterine Devices (IUDs) in Teens (MINT): A Randomization Trial

This is a pilot study to determine the feasibility for a randomized controlled trial of two forms of intrauterine contraception: the Levonorgestrel intrauterine system (LNG-IUS) and the Co...

PubMed Articles [1 Associated PubMed Articles listed on BioPortfolio]

Intrauterine Devices: Effective Contraception with Noncontraceptive Benefits for Adolescents.

Although adolescent pregnancy and birth rates have been declining since the early 1990s, the rate of intrauterine device (IUD) use in adolescents remain low. IUDs are a highly effective contraceptive ...

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