ParaGard T 380A

PARAGARD T 380A- copper intrauterine device
CooperSurgical, Inc.

ParaGard ® T 380A
INTRAUTERINE COPPER CONTRACEPTIVE

P/N 5128520401
Rev. 11/2017
Rx only PRESCRIBING INFORMATION

ParaGard ® T 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.

DESCRIPTION

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 mm2. One ParaGard® weighs less than one (1) gram. No component of ParaGard® or its packaging contains latex.
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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 mm2. 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.

CLINICAL 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.

ParaGard T 380A Indications and Usage

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

% of Women Experiencing an Accidental Pregnancy within the First Year of Use % of Women Continuing Use at One Year 3
Method (1) Typical Use 1 (2) Perfect Use 2 (3) (4)
Chance4 85 85
Spermicides5 26 6 40
Periodic AbstinenceCalendarOvulation MethodSympto-thermal6 Post-ovulation 25 9321 63
Cap7 Parous womenNulliparous women 4020 269 4256
SpongeParous womenNulliparous women 4020 209 4256
Diaphragm7 20 6 56
Withdrawal 19 4
Condom8 Female (Reality)Male 2114 53 5661
PillProgestin onlyCombined 5 0.50.1 71
IUDProgesterone TCopper T 380ALNg 20 2.00.80.1 1.50.60.1 817881
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
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.
  • Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
  • Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any reason.
  • Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.
  • The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percentage who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether.
  • Foams, creams, gels, vaginal suppositories, and vaginal film.
  • Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.
  • With spermicidal cream or jelly.
  • Without spermicides.
  • The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. Preven is the only dedicated product specifically marketed for emergency contraception. The Food and Drug Administration has also declared the following brands of oral contraceptive to be safe and effective for emergency contraception: Ovral (1 dose is 2 white pills), Alesse (1 dose is 5 pink pills), Nordette or Levlen (1 dose is 4 light-orange pills), Lo/Ovral (1 dose is 4 white pills), Triphasil or Tri-Levlen (1 dose is 4 yellow pills).
  • However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age.

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