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	85	85
Spermicides 5	26	6	40
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
Diaphragm	20	6	56
Withdrawal	19	4
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 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.

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.