PARAGARD T 380A
Clinical safety rating: caution
Comprehensive clinical and safety monograph for PARAGARD T 380A (PARAGARD T 380A).
PARAGARD T 380A is an intrauterine device (IUD) that continuously releases copper ions into the uterine cavity. Copper ions enhance uterine and tubal motility, increase endometrial inflammatory response, and create a spermicidal environment by inhibiting sperm motility and acrosomal enzyme activity, thereby preventing fertilization. Additionally, copper ions may impair blastocyst implantation.
| Metabolism | Copper is not metabolized; copper ions are gradually released from the device and excreted primarily in feces, with minimal systemic absorption. |
| Excretion | Paragard T 380A is a non-hormonal intrauterine device (IUD). The active component is copper. Copper is released locally into the uterine cavity and is not systemically absorbed in significant amounts. Therefore, systemic excretion is negligible. The device is not metabolized and is removed intact. Excretion of the minimal absorbed copper occurs primarily via bile into feces (approximately 80%) and renally (approximately 20%). |
| Half-life | Copper released from the IUD has a local effect; systemic copper levels are minimally increased. The half-life of copper in the body is approximately 4-6 weeks for the slow turnover pool, but for acute copper exposure, it is biphasic: initial rapid phase (hours) and slower phase (weeks). Clinically, copper levels return to baseline within weeks after removal. |
| Protein binding | Copper is extensively bound to plasma proteins: approximately 85-95% bound to ceruloplasmin, with smaller fractions bound to albumin and other proteins. Free copper (unbound) is minimal (<5%). |
| Volume of Distribution | For systemically absorbed copper, the volume of distribution is approximately 0.5-1.0 L/kg, reflecting distribution into total body water and tissues (liver, kidneys, brain). However, since copper from Paragard is primarily local, systemic Vd is not clinically applicable. The local uterine tissue distribution is limited to the endometrium and myometrium. |
| Bioavailability | Copper from Paragard acts locally within the uterine cavity. Systemic bioavailability is negligible (<1%) as copper ions are released directly into the endometrium and are not intended for systemic absorption. Oral or other systemic bioavailability does not apply. |
| Onset of Action | Paragard provides immediate contraceptive effect upon insertion. Onset of action is instantaneous as copper ions create a spermicidal environment and inhibit sperm motility and viability. No systemic onset is relevant. |
| Duration of Action | Approved for up to 10 years of continuous use. The copper core is designed to release copper ions for at least 10 years. Efficacy remains high throughout; removal is recommended after 10 years due to potential decline in copper release and increased risk of pregnancy and complications. |
Intrauterine insertion of a single T 380A device; remains effective for up to 10 years.
| Dosage form | SYSTEM |
| Renal impairment | No dosage adjustment required; systemic absorption minimal and not affected by renal function. |
| Liver impairment | No dosage adjustment required; however, contraindicated in acute liver disease or hepatic tumor. |
| Pediatric use | Not indicated for pediatric use; recommended only for postmenarchal females. |
| Geriatric use | Not indicated for geriatric use; intended for women of reproductive age. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for PARAGARD T 380A (PARAGARD T 380A).
| Breastfeeding | Compatible with breastfeeding. Copper IUD does not affect milk production or infant growth. Minimal systemic absorption of copper; M/P ratio not established but considered safe. |
| Teratogenic Risk | Not applicable as Paragard T 380A is an intrauterine device (IUD) used for contraception. If pregnancy occurs with IUD in situ, there is an increased risk of spontaneous abortion, septic abortion, and preterm delivery. No known teratogenic effects from copper if pregnancy continues to term. |
| Fetal Monitoring |
■ FDA Black Box Warning
None
| Common Effects | Stomach pain Nausea Vomiting |
| Serious Effects |
["Pregnancy or suspected pregnancy","Postpartum endometritis or infected abortion within past 3 months","Known or suspected uterine or cervical malignancy (including abnormal Pap smear)","Genital bleeding of unknown etiology","Acute cervicitis or vaginitis (including bacterial vaginosis) until infection is controlled","Acute pelvic inflammatory disease (PID) or history of PID unless there has been a subsequent intrauterine pregnancy","Conditions increasing susceptibility to PID (e.g., multiple sexual partners, immunosuppression)","Uterine cavity distortion (e.g., fibroids) that precludes proper IUD placement","Wilson's disease or copper allergy","Mucopurulent cervicitis"]
| Precautions | ["Risk of pelvic inflammatory disease (PID) at time of insertion, especially in women with history of sexually transmitted infections","Uterine perforation (risk highest during insertion, especially in lactating or postpartum women)","Expulsion (partial or complete) may occur, particularly in nulliparous women or those with heavy bleeding","Heavier or longer menstrual bleeding and cramping are common, may lead to anemia","Embedment in the myometrium or cervical canal","Bacterial vaginosis and actinomycosis have been reported","Syncope, bradycardia, or seizure during insertion","Copper allergy (rare)"] |
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| If pregnancy occurs with IUD in place, monitor for signs of infection, septic abortion, spontaneous abortion. Ultrasonography to locate IUD relative to gestational sac. If pregnancy continues, remove IUD if strings visible; otherwise, manage as high-risk. |
| Fertility Effects | Reversible. Fertility returns promptly after removal. No long-term effect on fertility. No impairment of future pregnancy outcomes. |