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Paragard T380a (Copper Intrauterine) - Description and Clinical Pharmacology

 
 



1.

  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.

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. Possible mechanism(s) by which copper enhances contraceptive efficacy include interference with sperm transport or fertilization, and prevention of implantation.

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