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Paragard T380a (Copper Intrauterine) - Indications and Dosage

 
 



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 1
Method (1) Typical Use 2 (2) Perfect Use 3 (3) (4)
Chance 4 8585
Spermicides 5 26640
Periodic Abstinence
Calendar
Ovulation Method
Sympto-thermal 6
Post-ovulation
25
9
3
2
1
63
Cap 7
Parous women
Nulliparous women

40
20

26
9

42
56
Sponge
Parous women
Nulliparous women

40
20

20
9

42
56
Diaphragm20656
Withdrawal194
Condom 8
Female (Reality)
Male

21
14

5
3

56
61
Pill
Progestin only
Combined
5
0.5
0.1
71
IUD
Progesterone T
Copper T 380A
LNg 20

2.0
0.8
0.1

1.5
0.6
0.1


81
78
81

Depo Provera0.30.370
Norplant and Norplant-20.050.0588
Female sterilization0.50.5100
Male sterilization0.150.10100

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.

1 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.
2 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.
3 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.
4 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.
5 Foams, creams, gels, vaginal suppositories, and vaginal film.
6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.
7 With spermicidal cream or jelly.
8 Without spermicides.
9 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).
10 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.

CAUTION

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.

Continuing Care:

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:

  • Abdominal or pelvic pain, cramping, or tenderness; malodorous discharge; bleeding; fever
  • A missed period

(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 ®.

How to 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.

HOW SUPPLIED

ParaGard ® is available in cartons of 1 (one) sterile unit (NDC 50907-0380-6) or cartons of 5 (five) sterile units (NDC 50907-0380-7). Each ParaGard ® is packaged together with an insertion tube and solid white rod in a Tyvek ® polyethylene pouch.

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