Progesterone Intrauterine Device (IUD)


VA CLASSIFICATION
Primary: GU400

Commonly used brand name(s): Progestasert.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).

Not commercially available in Canada.



Category:


Contraceptive (intrauterine-local)—

Indications

Accepted

Pregnancy (prophylaxis)—Progesterone intrauterine devices are recommended as a contraceptive method, primarily for parous women who are in a mutually monogamous relationship and have no history of pelvic inflammatory disease (PID). {01}
—An IUD may not be an appropriate choice for nulliparous or low parity women whose lifestyle (involvement in multiple relationships or in a nonmonogamous relationship) may expose them to sexually transmitted diseases (STDs) or for women at risk of developing PID because PID, if it develops, potentially may be more severe for these women. {01} {86} The IUD is not generally recommended for women whose uterine cavity measures less than 6.5 centimeters (cm). {01}
—IUDs do not protect against sexually transmitted diseases including human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS). {01} {13}
—The following table presents the results of studies examining contraceptive failure rates calculated using the life-table method. The first column lists the contraceptive method used. The second column indicates the percentage of women experiencing an accidental pregnancy in the first year of use of a contraceptive method while using the method perfectly under clinical conditions. The range of failure rates in the clinical trials may be explained by interstudy variations in study design or patient population characteristics, such as motivation, fecundity, or socioeconomic factors (including education). The third column indicates contraceptive failure rates in the first year of contraceptive use under clinical conditions for typical couples who start using a method (not necessarily for the first time). Failure rates among adolescents may be higher due to poorer compliance than in other age groups. {07} {53} {54}

  Method used
 
Failure rate range
(over 12 months)
in clinical
studies (%)
 
Typical
first year
failure
rate (%)
 
None
78–94
85
Spermicides *
0.3–37
21
Periodic abstinence
13–35
20
Withdrawal
7–22
19
Cervical cap with spermicide
6–27
18
Diaphragm with spermicide
2–23
18
Condom without spermicide
2–14
12
IUD
 
 
  Progesterone-releasing
1.9–2.0
2
  Copper-T 200
3.0–3.6

 
  Copper-T 200Ag
0–1.2

 
  Copper-T 220C §
0.9–1.8

 
  Copper-T 380A
0.5–0.8
0.8
  Copper-T 380S {53} {54}
0.9

 
Oral contraceptive
  3
  Estrogen and progestin
0–6

 
  Progestin only
1–10

 
Medroxyprogesterone
injection (90-day)
0–0.3
0.3
Levonorgestrel (implants)
 
 
  Six capsules
0–0.09
0.09
  Two rods
0–0.2
0.3
Sterilization
 
 
  Female #
0–8
0.4
  Male
0–0.5
0.15
* Spermicides studied include creams, foams, gels, jellies, and suppositories. {53} {54}
 Methods studied include calendar, ovulation method, and symptothermal (cervical mucus method supplemented by basal body temperature in post-ovulatory phases, post-ovulation phases, post-ovulation). {53} {54}
 Life-table method rate is unavailable for Copper-T 200Ag and the Pearl method rate at 12 months was reported; these methods at 12 months are considered comparable. {04} {55} {56} {57}
§ Copper-T 220C is manufactured with copper sleeves instead of copper wire; often used as a control in clinical studies. {07}
# Methods studied include culdotomy, laparoscopy, minilaparotomy, electrocoagulation, laparotomy, tubal diathermy and/or use of rings or clips. {53} {54}



Pharmacology/Pharmacokinetics

Physicochemical characteristics:


Physical description
    The ethylene/vinyl coacetate polymer (EVA) T-shaped body has a 36 millimeter tubular vertical stem that contains a reservoir of 38 mg of microcrystallized progesterone (initially) and radiopaque barium sulfate (to monitor location) dispersed in silicone fluid; the horizontal arms measure 32 millimeters. In addition, the T-shaped body contains two blue-black monofilament threads (to monitor placement and aid in IUD removal) {01}.

Mechanism of action/Effect:


Contraceptive, intrauterine-local:

The progesterone intrauterine device prevents pregnancy in 98% of users in the first year of use. The precise mechanism of action has not been fully elucidated; a number of mechanisms may contribute to the contraceptive effect. {01} {19} {20}

Progesterone is thought to enhance an unfavorable uterine environment for implantation by suppressing endometrial proliferation and to inhibit sperm penetration by causing cervical mucus to become thick and scanty. {01} {03} {24} {28} Progesterone also may directly inhibit metabolism, capacitation, and swimming speed of the sperm. Other normal cyclic reproductive function, including ovulation, continues as it does with other IUDs. {01} {03} {04} {28} {39}

In general, IUDs produce cellular reactions that can lead to local superficial ulceration in adjacent uterine cells. {24} {29} {30} This causes a foreign-body inflammatory response {18} {21} {22} leading to biochemical and morphological changes in the endometrial tissue and uterine fluid, including increased infiltration of leukocytes, {18} {29} {30} {31} especially macrophages. {30} {49} This action adds to progesterone's ability to interfere with sperm migration, fertilization and, to a lesser extent, with implantation. {01} {22} {23} {49} {52}



Other actions/effects:

Progesterone may decrease the endometrial content of prostaglandins and decrease the concentration of blood vessels in the endometrium which may result in fewer complaints of dysmenorrhea and a lower total volume of menstrual blood loss in women using a progesterone IUD. {05} {11} {16} {24} {25} {97} {98}

Absorption:

Readily absorbed into uterine epithelium; systemic progesterone absorption is low and not considered to be clinically significant. {01} {06} {26} {27} {39}. Progesterone IUDs release progesterone continuously into the uterus at an average rate of 65 mcg per day by membrane controlled diffusion from the reservoir. {01} This membrane barrier allows delivery of progesterone but prevents diffusion of silicone fluid and barium sulfate from the reservoir. {06}

Distribution:

Local, uterine. {01} {06} {26} {27} {39}

Biotransformation:

Rapid metabolism by endometrium. {26} {27}

Half-life:

Several minutes. {06} {26}

Onset of action:

Local contraceptive action begins immediately after insertion. {02}

Duration of action:

The manufacturer recommends progesterone IUD replacement within 12 months. {01} Local contraceptive action terminates quickly on removal. {02}


Precautions to Consider

Carcinogenicity/Tumorigenicity/Mutagenicity

Studies have not been done in either animals or humans. {92}

Pregnancy/Reproduction
Fertility—
In most women, fertility resumes on removal of the IUD. Up to 76% of women desiring pregnancy conceive successfully within 12 months after IUD removal, and 49% of women conceive within the first 3 months. {01}

Monogamous women with monogamous partners have little risk of primary tubal infertility attributable to progesterone IUDs unless there are other risk factors, such as endometriosis or past history of surgery on the female reproductive system. {01} {12} {14} {15} IUDs increase the risk of tubal infertility caused by obstruction in or damage to the fallopian tubes, which are problems associated with pelvic inflammatory disease (PID) or an infection in the uterus or fallopian tubes. This risk from the insertion procedure is highest within the first few months after IUD insertion. {01} {20}

Pregnancy—
Use of a progesterone IUD is not recommended during pregnancy although there is no clear clinical evidence of adverse effects for infants conceived with an IUD in situ . {07} Long-term effects on the offspring if conceived with a progesterone IUD present are not known. A congenital anomaly, bilateral inguinal hernia, has occurred, but causal relationship was not established. {01} {07}

An IUD in utero during pregnancy has resulted in maternal sepsis (usually, but not exclusively, in the second trimester {01} {43}, secondary to a septic abortion or chorioamnionitis) and, rarely, death. {01} {43} {71} If pregnancy occurs with an IUD in situ , risk-benefit of leaving the IUD in situ versus IUD removal must be carefully considered. {01} If an IUD remains in utero , possible complications include a 50% {10} {18} risk of spontaneous abortion and an increased risk of premature rupture of membranes, labor, and delivery. {01} {10} {71}

If a pregnancy occurs with a progesterone IUD in place, the IUD should be removed if the string is visible and the removal is easy. However, manipulation of the IUD may stimulate spontaneous abortion. If the string is not visible, removal of the IUD may be attempted under ultrasound guidance, and/or the termination of the pregnancy should be considered. {01} {10} {18} {71}

When a pregnancy occurs with a progesterone IUD in situ , the possibility of an ectopic pregnancy should be considered as the IUD protects against intrauterine pregnancy more than it protects against extrauterine pregnancy. {01} {10} {66} Studies indicate that about 1 ectopic pregnancy per 200 users per year occurs with a progesterone IUD in situ , a rate similar to that of noncontracepting sexually active women but approximately 6 times higher than that of women using nonmedicated IUDs. {01} {10} {73} {75} {77} Clinical trials also show that the risk of ectopic pregnancy occurring in nulliparous women is twice that of parous women, 1 ectopic pregnancy of 3.6 pregnancies versus 1 ectopic pregnancy in 6.2 pregnancies, respectively. {01} {66}

Diagnosis of ectopic pregnancy may be difficult because early symptoms (enlarged and tender breasts, dizziness, faintness, nausea, unusual tiredness or weakness, lower abdominal pain, cramping or tenderness [possibly severe], vaginal bleeding [possibly heavy and/or unexpected], or absent or delayed menstrual cycle) are nonspecific and variable. Also, 83% of patients continue to have menses, and 53% do not suspect pregnancy. {01} {66} {79}

Delivery—

If an intrauterine pregnancy continues with an IUD in situ , the risk for premature delivery is increased along with the usual complications of premature infants. {01}

Postpartum —
It is recommended that postpartum IUD insertion be performed 8 weeks or more after delivery (interval insertion) or after complete involution of the uterus has occurred, although individual needs and desires should be taken into consideration by the physician. The risk of an IUD expulsion or uterine perforation caused by an IUD is lower for interval insertions than for postplacental insertions (insertions performed within 10 minutes after delivery). Immediate postpartum insertions (insertions performed within 48 hours after delivery) or immediate postabortion insertions may involve a risk of uterine perforation by the IUD similar to that for interval insertions, but the expulsion rate is higher. {20} {81} {82} Higher expulsion rates in postpartum women may be due to the difficulty in placing the IUD sufficiently high in the fundus. {10} {66}

Breast-feeding

Problems in humans have not been documented. IUDs are recommended by the World Health Organization (WHO) for use as a contraceptive method because IUDs do not interfere with lactation. {07}


Adolescents

Sexually active adolescents may be better served with a contraceptive method that also protects against sexually transmitted diseases (STDs). In general, young age and nulliparity in women appear to be associated with a higher expulsion rate, possibly due to a more reactive myometrium and irregular and heavy menses. {01} {17}


Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):


Note: Combinations containing the following medication, depending on the amount present, may also interact with this device.

Anticoagulants{01}    (use of anticoagulants may initially potentiate the risk of abnormal uterine bleeding around the time of the progesterone IUD insertion; risk lessens with use but spotting may persist)



Laboratory value alterations
The following have been selected on the basis of their potential clinical significance (possible effect in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):

With physiology/laboratory test values
Glucose, plasma    (glucose measurements induced by glucose tolerance tests were slightly elevated at 3 hours according to studies in women using progesterone IUDs at 6 and 12 months; fasting and 0.5 hour glucose measurements were unchanged {40} {41})


Insulin concentration, serum    (measurements induced by glucose tolerance tests in women using progesterone IUDs for 12 months have shown that insulin concentrations taken at fasting, 0.5 hour, and 3 hours increased from 10.3, 69, and 40.5 microunits/mL to 18.1, 118.4, and 68.5 microunits/mL, respectively; insulin concentrations at 1 and 2 hours were not significantly changed {40} {41})


Triglyceride, plasma, fasting    (although no change was shown at 6 months, a study showed that triglyceride concentrations decreased at 12 months from 76.3 to 61.8 mg/dL for women using progesterone IUDs for 12 months {40} {41})


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Except under special circumstances, this device should not be used when the following medical problems exist:
» Acquired immunodeficiency syndrome (AIDS) or
» Autoimmune diseases or{01}
» Malignancy treated with antineoplastic agents and/or radiation or{01}
» Malignancy, uterine or cervical, known or suspected or{01}
» Any other condition associated with or resulting in decreased immunity and/or increased susceptibility to infection{01}{20}    (possible increased risk of infection with an IUD when a patient lacks an intact immune system {01} {90})


» Bleeding, genital, of unknown etiology    (insertion of a progesterone IUD may initially exacerbate uterine bleeding, then, with continued use, decrease uterine bleeding; this could mask other serious underlying conditions and delay the diagnosis of the condition {01} {07} {22})


» Ectopic pregnancy, history of    (may increase risk of ectopic pregnancy with contraceptive failure, especially in nulliparous women {01} {07} {10} {20} {23} {32} {66} {70} {73} {76} {80})


» Infection or inflammation in female reproductive tract, including
Abortion, recent septic{01}{18}
Cervicitis
Endometritis{01}{79}{85}
Genital actinomyces-like infection{01}{44}{45}{58}{59}
PID, acute or history of{01}{08}{09}{14}{15}{50}{60}{61}{62}{63}{64}{67}{68}{69}{72}{83}{84}{87}
Sexually transmitted diseases during last 12 months{01}{07}{08}{09}{12}{14}{17}{60}{61}{62}{64}{67}{68}{69}{72}{83}{84}{87}
Vaginitis, excluding candidiasis but including bacterial vaginosis, until controlled{01}    (use of an IUD, when any of the above conditions is present, may predispose the patient to upper genital tract infections that may range in severity from mild to life-threatening; risk is highest within the first 30 days after IUD insertion {07} {49} {84})

    (women with a history of PID may be at increased risk of developing PID; nulliparous women may be at greater risk than parous women {07})

    (significant risk of infection progressing to PID may be related to acquisition of or exposure to PID-associated sexually transmitted diseases {01} {07} {08} {09} {12} {14} {17} {60} {61} {62} {64} {67} {68} {69} {72} {83} {84} {85} {86} {87})


» Surgery involving the uterus or fallopian tubes    (women currently using an IUD may have an increased risk of surgical complications; also, in cases of contraception failure, women having had surgery involving the uterus or fallopian tubes may have additional risk for developing an ectopic pregnancy {10} {73} {75} {78} {79})


» Uterine abnormalities or cavity distortion{01}    (possibility of decreased contraceptive effectiveness; {89} increased risk of IUD expulsion or IUD perforation of the uterus)


Risk-benefit should be considered when the following medical problems exist
Bradycardia, neurovascular, history of or
Syncope, neurovascular, history of{01}    (short-term syncope or bradycardia may occur with IUD insertion; increased risk if these conditions are present)


Cervical stenosis{01}{91}    (may prevent ease of insertion of IUD; excessive force to overcome this resistance is not advised)


» Coagulopathy{01}{30}{42}    (use of a progesterone IUD when increased vascularity and permeability and decreased hemostatic response exists may increase risk of of an IUD expulsion)


Diabetes, insulin-dependent{01}    (IUDs may be a good choice for diabetics; however, complications from infection, if infection occurs, are potentially more likely)


Heart defect, valvular or congenital{01}{10}    (insertion of an IUD may represent a potential source of septic emboli, since these patients are prone to develop subacute bacterial endocarditis)



Patient monitoring
The following may be especially important in patient monitoring (other tests may be warranted in some patients, depending on condition; » = major clinical significance):

Papanicolaou (Pap) test    (recommended annually; examination for actinomycosis-like organisms {01} and, if appropriate, gonococcal and chlamydial tests should be performed {01})


» Physical examination    (recommended once during the first 3 months and at 12 months after insertion for removal {01}; special attention should be given to reports of delayed menses and/or pelvic pain because of the possibility of ectopic pregnancies with failed IUD contraception {01})




Side/Adverse Effects

Note: Cervical laceration, cervical or uterine perforations, and/or abdominal displacement of the IUD {01} {66} {91} may progress to peritonitis, sepsis, pelvic inflammatory disease (PID) {01}, abdominal adhesions {01}, intestinal penetration {01}, intestinal obstruction {01}, cystic masses in the pelvis {01}, and local inflammatory reaction with abscess formation, including tubo-ovarian abscess {01} {18}. Certain of these adverse effects of IUDs, although very rare, can lead to a loss of fertility, require partial or total removal of reproductive organs, and, in extremely rare circumstances, cause death. {01} {10} {43} {79} {80} An IUD must be surgically removed as soon as feasible after IUD displacement has been diagnosed {10} {66}.
Because many of the side effects listed below present with uterine bleeding and pain, these symptoms should always be evaluated even though they may not signify a serious problem. Persistent or recurring abnormal uterine bleeding and/or abdominal pain may lessen with continued progesterone IUD use. Other problems such as cervical or uterine perforation, IUD displacement, ectopic pregnancy, PID, and IUD embedment should be ruled out. {66}

The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence more frequent
    
Abdominal pain or cramping on insertion, continuing
    
intermenstrual spotting or uterine bleeding (uterine bleeding between menstrual periods)
    
uterine bleeding on insertion, continuing{33}{34}{35}{36}

Note: Abdominal pain or uterine bleeding should be investigated if it continues beyond several days after IUD insertion. Intermenstrual spotting can be expected for up to 6 months after insertion and intermenstrual uterine bleeding may stop within 3 months. The amount of menstrual blood loss usually is less than preinsertion levels. {01} {18} {33} {34} {35} {36} {37} {38}


Incidence rare
    
Cervical perforation or laceration {01}{18}{35}{37}{66}{81}
    
embedment of IUD or perforation of the uterus (severe abdominal pain or cramping; unexpected, heavy vaginal bleeding, sharp pain on insertion){01}{18}{34}{35}{37}{66}{81}
    
fragmentation of device {01}
    
neurovascular episodes (dizziness; faintness)—at time of insertion{01}{37}
    
PID (dull or aching abdominal pain, continuing; fever; odorous vaginal discharge; unusual tiredness or weakness; unusual uterine bleeding)—2 to 3.1%{01}{08}{37}{61}

Note: Increased risk of PID occurs within the first 3 months of IUD insertion; {01} {10} {66} {69} ectopic pregnancy should be ruled out before treatment of PID because of similar presenting symptoms. Also, PID and actinomycosis-like infection may be asymptomatic. {07} {10} {66}






Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Progesterone Intrauterine Device (IUD).
In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this device

Note: In the U.S., the health care professional is required by U.S. federal regulation to provide a patient information brochure to the patient regarding the use of IUDs for contraception, discussing it and other methods of contraception.

»   Conditions affecting use, especially:

Pregnancy—IUD use is not recommended for women during pregnancy, those planning to become pregnant shortly, or women who have had an ectopic pregnancy. If contraception fails with a progesterone IUD, complications to the mother or infant are possible whether the pregnancy continues with the IUD in situ or the device is removed; also, the risk of uterine perforation and expulsion of the IUD may be increased when an IUD is inserted before 8 weeks postpartum



Use in adolescents—
Sexually active adolescents may be better served with a contraceptive method that also protects against sexually transmitted diseases (STDs); IUD use in adolescents of young age and nulliparous women appears to be associated with a higher expulsion rate

Other medical problems, especially acquired immunodeficiency syndrome (AIDS), autoimmune diseases, immunosuppressive therapy, malignancy of the cervix or uterus, or any other conditions of decreased immunity or increased risk of infection; coagulopathy; genital bleeding of unknown etiology; history of ectopic pregnancy; infection or inflammation in female reproductive tract; surgery involving the uterus or fallopian tubes; or uterine abnormalities or cavity distortion

Proper use of this device
» Reading a copy of the patient information brochure provided by the health care professional helps explain possible side effects, risks, and warning signs of trouble with the IUD

Spermicides are not needed with a properly placed IUD

» Checking for changes in the IUD thread length after the monthly menses, if not more often, as instructed by physician

» Proper dosing, including IUD removal or replacement times

Precautions while using this device
» Visiting physician regularly to check progress, especially within the first 3 months, preferably the first month, and at 12 months for removal

» Alerting medical personnel before having diagnostic or therapeutic procedures such as surgery involving the uterus or fallopian tubes

» Notifying physician immediately if a partial or complete expulsion is suspected; using another form of nonhormonal contraception until evaluated by a physician; patient should not try to remove the IUD or re-insert it

» Reporting missed or scanty menses to physician immediately and using other nonhormonal contraceptive methods

» Reporting symptoms of possible pregnancy, including ectopic pregnancy, to physician in the rare case when IUD contraceptive effects fail

» Notifying physician and using other nonhormonal contraceptive methods if any of the following occur:    —Abnormal vaginal bleeding
   —Exposure to sexually transmitted diseases
   —Feeling the tip of the IUD at the cervix or pain during sexual intercourse
   —Change in length of IUD threads or disappearance of IUD threads on periodic observation after menses
   —Lifestyle change from a mutually monogamous relationship
   —Pelvic/lower abdominal pain or cramping, unusual or severe, possibly with fever
   —Vaginal discharge or signs of genital lesions or sores


Progesterone IUDs should not interfere with the proper use of other vaginal products such as tampons or condoms


Side/adverse effects
Signs of potential side effects, especially abdominal pain or cramping on insertion (continuing), intermenstrual spotting or uterine bleeding, uterine bleeding on insertion (continuing), cervical perforation or laceration, embedment of IUD, fragmentation of device, perforation of the uterus, neurovascular episodes on insertion, pelvic inflammatory disease (PID)


General Dosing Information
In the U.S., the health care professional is required by U.S. Federal Regulations (21 CFR 310.502) to give the patient a copy of the Patient Information for an Informed Decision to ensure complete understanding of the risks and benefits, safety, and efficacy of the progesterone IUD. {93}

It is generally believed that perforations occur at the time of insertion, although they may not be detected until later. {01} {18} {37} Adequate training of those health care professionals inserting the device may help prevent cervical or uterine perforation. A number of supervised insertions may be necessary before a solo attempt. The degree of training needed depends on the health care professional's skill and experience with IUD aseptic insertion techniques and uterus manipulation. {01}

The manufacturer's product information should be consulted for specific directions. {46}

The IUD may be inserted at any time during the menstrual cycle. Many physicians prefer insertion at the end of or within 2 days after a menstrual period to reduce the possibility of inserting an IUD in the presence of an undiagnosed pregnancy. {01} {18} However, the optimal time for insertion appears to be the periovulatory period. Caution should be used to avoid inserting a second IUD, as patients may forget about a previously inserted IUD or may assume it to be expelled. {01} {51}

Using aseptic technique and removing the IUD from the sterile packaging no more than 5 minutes before the insertion procedure are recommended. {01} Prophylactic treatment with antibiotics theoretically may reduce the risk of infection, {60} which is 6 times higher within the first 20 days after insertion. {01} {09} {50} {67} Regimens include doxycycline 200 mg orally one hour before insertion, or erythromycin 500 mg orally one hour before insertion and 500 mg orally six hours after insertion. {01} This may be of limited benefit and unnecessary for women at low risk of sexually transmitted disease (STDs).

It is recommended that an IUD be removed for the following medical reasons: pelvic infection, {01} {10} {37} genital actinomycosis, {01} {10} dyspareunia, {01} pregnancy (when able to remove the IUD), {01} {10} endometrial or cervical malignancy, {01} {10} uterine or cervical perforation, {01} {10} or partial expulsion {01} {10}.

If the retrieval threads cannot be seen, they may have retracted into the uterus or have been broken, or the IUD may have been expelled. Pregnancy, both uterine and ectopic, should be considered before attempting to locate the IUD. Although ultrasound is the preferred method of locating a malpositioned IUD, high- or intermediate-strength magnetic resonance imaging (MRI), uterine probe, or x-rays may also be used. {65} {71}

Removing an intraperitoneal progesterone IUD as soon as medically feasible after the diagnosis is recommended because of the possibility of abdominal adhesion formation, intestinal penetration, and local inflammatory reaction with abscess formation and erosion of adjacent viscera, maternal sepsis, or, rarely, death. {43} {71}

The manufacturer's information should be consulted for the recommended removal procedure. If an IUD is difficult to remove, the procedure may need to be done in a hospital or operating room. {01} {81} {91} Another type of contraception should begin immediately after IUD removal if contraception is desired. {74}

For treatment of adverse effects
Recommended treatment consists of the following:    • For pain—Treating with mild analgesics for several hours after IUD insertion. {18}
   • For pelvic inflammatory disease (PID)—Removing the progesterone IUD and treating the patient with appropriate broad-spectrum antibiotics; the patient's partner may require treatment with broad-spectrum antibiotics as well. {69}
Note: HIV-infected women with PID who are immunocompromised may be at increased risk of a complicated clinical course and should be hospitalized for intravenous therapy. {69}





Intrauterine Dosage Form

PROGESTERONE INTRAUTERINE CONTRACEPTIVE SYSTEM USP

Usual adult and adolescent dose
Contraceptive
Intrauterine, one device; the maximum duration of use is 12 months. {01}


Strength(s) usually available
U.S.—


38 mg progesterone (Rx) [Progestasert{01}]

Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. {01} Preserve in sealed, single-unit containers. {48}

Note: Provide patient with patient package insert (PPI).




Revised: 06/16/1997



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