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norethindrone 0.35 mg tablet generic errin, camila, ortho micronor

Out of Stock Manufacturer GLENMARK PHARMA 68462030529
Out of Stock

Uses

Contraception

Oral Contraceptives

Norethindrone, in small doses (minipills), is used for the prevention of conception in women who elect to use oral contraceptives as a method of contraception. Progestin-only oral contraceptives are generally reserved for women who do not tolerate estrogens or in whom estrogens are contraindicated, since progestin-only oral contraceptives are less effective than estrogen-progestin combinations and require a high level of patient compliance. When taken according to the prescribed regimen, progestin-only oral contraceptives provide almost completely effective contraception. The efficacy of oral contraceptives mainly depends on compliance with the prescribed regimen. Progestin-only oral contraceptives must be taken daily, without interruption, to be effective.

Progestin-only oral contraceptives are reported to be somewhat less effective than estrogen-progestin combinations. The pregnancy rate in women using progestin-only oral contraceptives is generally reported to be about 3 pregnancies per 100 woman-years of use. For information on the pregnancy rates reported with other methods of contraception, including estrogen-progestin combinations, . Pregnancy rates are derived from various studies conducted by different investigators in different population groups and, therefore, cannot be compared precisely.

In women receiving norethindrone, the pregnancy rate, especially during the first 6 months of use, is reportedly greater in women who had not previously received oral contraceptives than in those who had been immediately switched from an estrogen-progestin combination. The reported difference in pregnancy rates probably resulted from failure to comply with the prescribed regimen. Therefore, it is especially important that women who are prescribed progestin-only oral contraceptives as initial oral contraception be advised to strictly adhere to the prescribed regimen.

For the use of norethindrone or norethindrone acetate in combination with estrogens as an oral contraceptive, . For the use of the drugs in the treatment of secondary amenorrhea, endometriosis, or abnormal uterine bleeding,

Intrauterine System

Levonorgestrel-releasing intrauterine system is used for prevention of conception in women who elect to use this method of contraception. The manufacturer states that the system is recommended for use in women who have had one or more children; are in a stable, mutually monogamous relationship; have no history of pelvic inflammatory disease (PID); and have no history of ectopic pregnancy or any condition that would predispose to ectopic pregnancy. Each system may be used for up to 5 years; thereafter, the system should be removed and may be replaced with a new system if continued contraception is desired. The pregnancy rate in women using the levonorgestrel-releasing intrauterine system is reported as up to 0.2 pregnancies per 100 women during the first year of use; the cumulative 5-year pregnancy rate is reported to be approximately 0.7 pregnancies per 100 women.

Subcutaneous Implants

Etonogestrel for subcutaneous implantation (Implanon) is used for prevention of conception in women who elect to use this method of contraception. The system consists of a single rod containing etonogestrel that is implanted subcutaneously in the upper arm to provide contraception for up to 3 years.

Postcoital (Emergency) Contraception

Levonorgestrel is used as an emergency contraceptive (EC) to prevent pregnancy following unprotected intercourse or known or suspected contraceptive failure. To achieve optimal efficacy, the postcoital contraceptive regimen should be initiated as soon as possible within 72 hours of unprotected intercourse. Studies show that emergency contraception is moderately effective when the regimen is administered up to 120 hours after unprotected intercourse. Postcoital contraceptive efficacy diminishes as the time period between intercourse and initiation of contraception increases.

An emergency contraceptive regimen employing a progestin alone (levonorgestrel) appears to be more effective and better tolerated than a common estrogen-progestin emergency contraceptive (''Yuzpe'') regimen when the regimens are initiated within 72 hours of unprotected intercourse; therefore, the progestin-only regimen generally is preferred when readily available. In a double-blind, randomized multicenter study in women who reported unprotected intercourse within 72 hours of receiving emergency contraception, a single-dose of levonorgestrel 1.5 mg was as effective in preventing pregnancy as levonorgestrel 0.75 mg every 12 hours for 2 doses. In a double-blind, randomized, multicenter study in women who reported only one act of unprotected intercourse within 72 hours of receiving emergency contraception, the expected pregnancy (failure) rate of 8% (with no contraception) was reduced to approximately 1% with a progestin-only regimen (levonorgestrel 0.75 mg every 12 hours for 2 doses). In another prospective, randomized study in women who reported a single act of intercourse within 48 hours of receiving emergency contraception, failure rates with the 2-dose levonorgestrel regimen and Yuzpe regimens (levonorgestrel 0.5 mg and 0.1 mg ethinyl estradiol every 12 hours for 2 doses) were similar (2.6 versus 2.4%, respectively). The efficacy of treatment in both studies was greatest when the contraceptive was given during the first 24 hours after unprotected intercourse; efficacy declined during subsequent 24-hour periods. The 2-dose levonorgestrel regimen was better tolerated than the Yuzpe regimen. In these 2 studies, nausea occurred in 23.1 versus 50.5% and in 16.1 versus 46.5% of women receiving the 2-dose levonorgestrel regimen versus the Yuzpe regimen, respectively, while vomiting occurred in 5.6 versus 18.8% and in 2.7 versus 22.4% of women with the 2-dose levonorgestrel regimen or Yuzpe regimen, respectively.

Since unprotected intercourse that occurs outside the fertile period is unlikely to result in conception, not all women given emergency postcoital contraception are at genuine risk for pregnancy. Therefore, a more accurate indication of the efficacy of postcoital contraceptive regimens would be based on the timing of unprotected intercourse and the probability that pregnancy would occur without treatment. Analysis of data from the multicenter, progestin-only (levonorgestrel) study involving approximately 2000 women suggest that when efficacy of postcoital contraception is based on the observed versus expected number of pregnancies, the levonorgestrel-only regimen would prevent 85% of pregnancies; pooled analysis of observed-versus-expected pregnancy data from other studies employing the Yuzpe regimen suggest that such therapy is approximately 74% effective in preventing pregnancy. However, postcoital (emergency) contraceptive regimens are not as effective as most other forms of long-term contraception.

Since postcoital contraceptive efficacy diminishes as the time period between intercourse and administration of the regimen increases, available data suggest that as with combination estrogen-progestin regimens, progestin-only postcoital contraception should ideally begin within 72 hours of unprotected intercourse. Emergency contraception is moderately effective when the regimen is administered up to 120 hours after unprotected intercourse. The effectiveness of postcoital contraception administered after more than 120 hours has not been established.

The American College of Obstetricians and Gynecologists (ACOG), other experts, and some states (e.g., Alaska, California, Hawaii, Maine, New Mexico, Washington) have advocated increased access to emergency postcoital contraception (e.g., nonprescription access via pharmacies, advance provision by clinicians) as a means of decreasing unintended pregnancy and abortion rates. There is some evidence that increased access to emergency postcoital contraception may not compromise conventional contraceptive use or sexual behavior, potentially allaying some concerns that have prompted others to advocate for restricted access. The FDA has approved the single-dose levonorgestrel regimen (Plan B One-Step) for nonprescription (over-the-counter [OTC]) status for women of childbearing potential regardless of age. Another FDA-approved product (Next Choice One Dose) is commercially available as a single-dose levonorgestrel regimen for OTC status in women 17 years of age or older or as a prescription-only preparation in women younger than 17 years of age. A 2-dose levonorgestrel preparation is also commercially available as a prescription-only preparation for women younger than 17 years of age.

For information on the use of combination estrogen-progestin contraceptives for postcoital contraception, .

Dosage and Administration

Administration

Norethindrone is administered orally once daily. The tablets should be taken at the same time each day and continued daily without interruption, including throughout all bleeding episodes. Women should be advised to inform a clinician if prolonged bleeding, amenorrhea, or severe abdominal pain occurs.

Levonorgestrel is administered orally or as a levonorgestrel-releasing intrauterine device.

If vomiting occurs within 2 hours following administration of levonorgestrel (e.g., Plan B One-Step, Next Choice One Dose) for postcoital contraception, a clinician should be contacted to discuss the need for repeating the dose. If vomiting occurs within 2 hours following administration of the first or second dose of the levonorgestrel 2-dose regimen for emergency contraception, a clinician should be contacted to discuss the need for taking another dose.

Levonorgestrel-releasing intrauterine system should be inserted into the uterine cavity under strict aseptic conditions following a complete review of the patient's medical and social histories, exclusion of pregnancy, and physical examination (including pelvic examination, Papanicolaou test [Pap smear], and appropriate laboratory tests for other genital diseases [e.g., gonorrhea, chlamydia] as indicated). Special attention should be given to determining whether the woman is at risk for ectopic pregnancy or pelvic inflammatory disease (PID). Patients should be reexamined shortly after the first menstrual period following insertion of the device to verify that the device is properly positioned. The manufacturer's labeling should be consulted for proper methods of inserting and removing the levonorgestrel-releasing intrauterine system and for associated precautions.

Etonogestrel is administered as a nonbiodegradable implant that is inserted subcutaneously in the inner aspect of the upper arm. The manufacturer's labeling should be consulted for the proper method of administration and associated precautions.

Dosage

Contraception

Oral Dosage

The daily dose of progestin-only oral contraceptives is 0.35 mg of norethindrone. Therapy should begin on the first day of menstruation and should be continued each day of the year without interruption. If therapy begins on another day, the woman should be advised to use a back-up method of contraception (e.g., condom, spermicide) for each sexual encounter during the first 48 hours. Women who have had a miscarriage or an abortion may begin progestin-only oral contraceptives the next day.Women who are exclusively breast-feeding their infants may begin therapy 6 weeks after delivery; women whose infants are only partially breast-fed may begin therapy with the drug 3 weeks after delivery.

If a norethindrone dose is taken more than 3 hours late or if one or more consecutive doses are missed, the last missed dose should be taken as soon as it is remembered, followed by resumption of the regular schedule; a back-up method of contraception (e.g., condom, spermicide) should be used for each sexual encounter during the next 48 hours. If the woman is unsure of what drug regimen to take as a result of missed doses, a back-up method of contraception should be used for each sexual encounter, and one tablet should be taken each day until the clinician can be contacted.

If vomiting occurs soon after a dose, a back-up method of contraception (e.g., condom, spermicide) should be used for each sexual encounter during the next 48 hours.

If a menstrual period is delayed and norethindrone has not been taken exactly as directed, or if 45 days have elapsed since the beginning of the last menstrual period, the possibility of pregnancy should be excluded. If pregnancy is confirmed, the woman should be advised to discontinue the progestin-only oral contraceptive.

Intrauterine Dosage

Each levonorgestrel-releasing intrauterine system contains 52 mg of the drug and is intended to be used for periods of up to 5 years. When the levonorgestrel-releasing intrauterine system is used for contraception, the system is inserted into the uterine cavity within 7 days of the onset of menses. In postpartum women, the levonorgestrel-releasing intrauterine system should not be inserted until at least 6 weeks postpartum or until involution of the uterus is complete. The system may be inserted immediately after a first-trimester abortion, but insertion following a second-trimester abortion should be delayed until involution of the uterus is complete.

The levonorgestrel-releasing intrauterine system should be removed after 5 years of use, since contraceptive efficacy beyond 5 years has not been established. In women who wish to continue contraception with the levonorgestrel-releasing intrauterine system, a new system may be inserted immediately following removal of the existing system. The system can be removed and replaced with a new system at any time during the menstrual cycle. For women with regular menstrual cycles who wish to initiate an alternative contraceptive method, the intrauterine system should be removed during the first 7 days of a menstrual cycle and the new method started. For those with irregular cycles or amenorrhea or for those in whom the system is removed after the seventh day of the menstrual cycle, the new contraceptive method should be initiated at least 7 days before removal of the intrauterine system.

Subcutaneous Dosage

Etonogestrel implant contains 68 mg of the drug and is intended to be used for periods of up to 3 years.

When an etonogestrel implant is used for contraception, timing of insertion depends on the patient's history. To initiate therapy in women who did not use hormonal contraception in the preceding month, the etonogestrel implant usually is inserted on or before day 5 of the cycle (the first day of bleeding is counted as the first day of the menstrual cycle). When switching from other contraceptive methods, therapy with etonogestrel should be initiated in a manner that ensures continuous contraceptive coverage based on the mechanism of action of both methods (e.g., etonogestrel implant should be inserted within 7 days of the last hormonally active tablet, or removal of a transdermal patch or vaginal ring in women switching from combined estrogen-progestin contraceptives; etonogestrel implant may be inserted on any day of the month in women switching from a progestin-only oral contraceptive [without skipping any day between receiving the last progestin oral contraceptive and the initial administration of the implant]; etonogestrel implant should be inserted within the dosing period recommended for the parenteral contraceptive preparation in women switching from a progestin-only contraceptive injection; etonogestrel implant should be inserted on the same day as a progestin-containing intrauterine device is removed in women switching from this device). The implant may be inserted immediately after a first-trimester abortion or 21-28 days following a second-trimester abortion. Etonogestrel implant may be inserted 21-28 days postpartum in women who are only partially breast-feeding their infant or after the fourth postpartum week in women who are exclusively breast-feeding their infant. The manufacturer states that a back-up method of contraception is not needed when etonogestrel therapy is initiated according to one of these schedules. The implant is removed 3 years after insertion. In women who wish to continue contraception with etonogestrel implant, a new implant should be inserted on the same day as the existing implant is removed.

Postcoital (Emergency) Contraception

When levonorgestrel is used alone as a short-course, progestin-only emergency postcoital contraceptive, a single 1.5-mg dose of levonorgestrel is administered as soon as possible within 72 hours of unprotected intercourse. Alternatively, a levonorgestrel dose of 0.75 mg is administered as soon as possible within 72 hours of unprotected intercourse, followed by a repeat dose of 0.75 mg 12 hours after the first dose. Regardless of regimen, the first dose can be taken up to 120 hours after unprotected intercourse if necessary, but efficacy decreases as initiation of contraception becomes more remote from unprotected intercourse. Commercial preparations containing one levonorgestrel 1.5-mg tablet (e.g., Plan B One-Step, Next Choice One Dose) are available for this purpose. The FDA has approved Plan B One-Step for nonprescription (over-the-counter [OTC]) status for women of childbearing potential regardless of age. A commercial preparation containing 2 levonorgestrel 0.75-mg tablets also is available for postcoital contraception. The levonorgestrel postcoital contraceptive regimens may be used at any time during the menstrual cycle. Since postcoital contraceptive efficacy diminishes as the time period between intercourse and administration of the regimen increases, postcoital contraception with levonorgestrel should begin as soon as possible but within 72-120 hours of unprotected intercourse. The effectiveness of postcoital contraception administered after more than 120 hours has not been established.

Repeated postcoital (emergency) contraception use indicates the need for counseling about other contraceptive options. Safety of recurrent use has not been established but the risk appears to be low, even within the same menstrual cycle. The possibility that risk of adverse effects (e.g., menstrual irregularities) may be increased with frequently repeated postcoital contraception should be considered.

Cautions

Adverse Effects

Although common adverse effects of estrogen-progestin oral contraceptives appear to be mainly caused by the estrogen, it has not been determined whether the adverse effects associated with low-dose oral progestin regimens differ from those resulting from administration of estrogen-progestin combinations. There is some evidence that the progestin component plays a major role in the development of some adverse effects of oral contraceptives when combined with estrogens. The potency and type of progestin in estrogen-progestin combinations appear to have important effects on lipoprotein lipids (high-density and low-density lipoproteins) and may contribute to the increased risk of arteriosclerotic disease in oral contraceptive users. Pending further accumulation of data on progestin-only oral contraceptives, the same precautions associated with estrogen-progestin combination therapy should be observed with progestin-only preparations. For a complete discussion of the cautions, precautions, and contraindications of oral contraceptives,

The most frequent adverse effects of continuous oral low-dose progestin administration are menstrual irregularity, changes in menstrual flow, and/or amenorrhea, which may be difficult to differentiate from pregnancy. In clinical trials, these adverse effects caused a higher drop-out rate than that observed with estrogen-progestin oral contraceptives. Like the estrogen-progestin combination oral contraceptives, progestins can cause breakthrough bleeding, spotting, edema, weight gain, nausea, breast tenderness, headache, and mental depression; however, the incidence and severity of these adverse effects are much less with progestins than with estrogen-progestin combinations. Progestin-only oral contraceptives occasionally may alter lipid metabolism, resulting in decreased concentrations of high-density lipoprotein [HDL]-cholesterol, HDL2, apolipoprotein A-I (apo A-I), and apolipoprotein A-II (apo A-II), and increased concentrations of hepatic lipase. There usually is no effect on concentrations of total cholesterol, HDL3, low-density lipoprotein (LDL)-cholesterol, or very low-density lipoprotein (VLDL)-cholesterol.

Adverse effects reported in 5% or more of women using the levonorgestrel-releasing intrauterine system include abdominal pain, leukorrhea, headache, vaginitis, back pain, breast pain, acne, depression, hypertension, upper respiratory infection, nausea, nervousness, dysmenorrhea, weight increase, skin disorder, decreased libido, abnormal Papanicolaou test (Pap smear), and sinusitis.

Adverse effects reported in 5% or more of women using the etonogestrel implant include headache, vaginitis, weight increase, acne, breast pain, upper respiratory infection, abdominal pain, pharyngitis, leukorrhea, influenza-like symptoms, dizziness, dysmenorrhea, back pain, emotional lability, nausea, pain, nervousness, sinusitis, depression, and insertion site pain.

Limited data from 2 comparative studies in which women receiving emergency postcoital contraception with either an estrogen-progestin regimen (levonorgestrel 0.5 mg and 100 mcg ethinyl estradiol every 12 hours for 2 doses) or a progestin-only regimen (levonorgestrel 0.75 mg every 12 hours for 2 doses) indicate a lower incidence of nausea or vomiting with the progestin-only (levonorgestrel) regimen. In these 2 studies, nausea occurred in 23.1 versus 50.5% and in 16.1 versus 46.5% of women receiving the 2-dose levonorgestrel regimen versus the estrogen-progestin regimen, respectively, while vomiting occurred in 5.6 versus 18.8% and in 2.7 versus 22.4% of women with the levonorgestrel- or estrogen-progestin regimen, respectively. Other adverse effects occurring in one of these studies with the 2-dose levonorgestrel regimen included nausea (23% of patients), abdominal pain (17.6% of patients), fatigue (16.9% of patients), headache (16.8% of patients), heavier or lighter menstrual bleeding (13.8 or 12.5% of patients, respectively), dizziness (11.2% of patients), breast tenderness (10.7% of patients), vomiting (5.6% of patients), or diarrhea (5% of patients). Adverse effects reported with the single-dose levonorgestrel regimen include heavier menstrual bleeding (30.9% of patients), nausea (13.7% of patients), lower abdominal pain (13.3% of patients), fatigue (13.3% of patients), headache (10.3% of patients), dizziness (9.6% of patients), breast tenderness (8.2% of patients), or more than a 7-day delay in menses (4.5% of patients). In addition, some evidence indicates that emergency postcoital contraception may not compromise conventional contraception use or sexual behavior (e.g., promiscuity, sexually transmitted disease [STD] risk).

Other adverse reactions which have been reported in women receiving progestins are weight gain or loss, changes in cervical erosion and secretions, cholestatic jaundice, allergic rash with or without pruritus, melasma or chloasma, breast changes (tenderness, enlargement, and secretion), and hirsutism.

Precautions and Contraindications

It is good medical practice that all women, including those receiving progestin-only oral contraceptives, have a complete medical history and physical examination performed periodically (e.g., annually); the physical examination may be deferred until after initiation of therapy if requested by the woman and judged appropriate by the clinician. Physical examination is not required prior to initiating therapy with oral levonorgestrel for postcoital (emergency) contraception. In women receiving the levonorgestrel-releasing intrauterine system, complete medical and social histories (including those of the partner) and physical examination (including pelvic examination, Papanicolaou test [Pap smear], and appropriate laboratory tests for other genital diseases [e.g., gonorrhea, chlamydia] as indicated) should be performed, and pregnancy should be excluded prior to insertion of the intrauterine system; special attention should be given to determining whether the woman is at risk for ectopic pregnancy or pelvic inflammatory disease (PID).

Safety and efficacy of progestin contraceptives have been established in women of reproductive age. Safety and efficacy of long-term progestin contraceptives are expected to be identical for postpubertal adolescents younger than 16 years of age and women 16 years of age or older. Safety and efficacy of progestin emergency contraceptives are expected to be identical for postpubertal adolescents younger than 17 years of age and women 17 years of age or older. Progestin contraceptives are not indicated before menarche.

Progestin contraceptives have not been evaluated in women older than 65 years of age and these drugs are not indicated for use in postmenopausal women.

Slight deterioration in glucose tolerance, coupled with increases in plasma insulin concentrations, may occur in some patients receiving progestin-only contraceptives. However, in women with diabetes mellitus receiving progestin-only contraceptives, insulin requirements generally are unchanged. Nevertheless, prediabetic or diabetic women should be carefully monitored while receiving these contraceptives.

Headache, including migraine headache, has been reported during progestin-only contraceptive therapy. Progestin-only oral contraceptives should be discontinued and the cause evaluated when migraine occurs or is exacerbated, or when severe, persistent, or recurrent headache develops.

Because the presence of organisms capable of causing PID cannot be determined by appearance, and because insertion of an intrauterine system may be associated with introduction of vaginal bacteria into the uterus, the levonorgestrel-releasing intrauterine system should be inserted under strict aseptic conditions. Administration of anti-infectives may be considered; however, the benefit of such prophylactic measure is unknown. Syncope, bradycardia, or other neurovascular episodes may occur during insertion or removal of the intrauterine system, particularly in women predisposed to these conditions or in those with cervical stenosis. If decreased pulse, perspiration, or pallor is observed, the woman should remain supine until these signs have disappeared. Women receiving the levonorgestrel-releasing intrauterine system who have certain types of valvular or congenital heart disease and surgically constructed systemic-pulmonary shunts are at increased risk of infective endocarditis and, possibly, septic embolism. Women with known congenital heart disease who may be at increased risk should receive appropriate anti-infectives at the time of insertion and removal of the intrauterine system. Women requiring chronic corticosteroid therapy or insulin for diabetes mellitus should be carefully monitored for development of infection. The levonorgestrel-releasing intrauterine system should be used with caution in women who have a coagulopathy or are receiving anticoagulants. Use of the intrauterine system in women with vaginitis or cervicitis should be postponed until appropriate treatment has eradicated the infection and until it has been determined that the cervicitis is not caused by Neisseria gonorrhoeae or Chlamydia.

Because the levonorgestrel-releasing intrauterine system may be displaced following insertion, women should be reexamined and evaluated shortly after the first postinsertion menses, but definitely within 3 months after insertion. During examination, the removal threads of the intrauterine system should be located; if the threads are not visible, location of the system should be verified (e.g., by radiograph or ultrasound, by gentle exploration of the uterine cavity with a probe). If the intrauterine system is in place with no evidence of perforation, no intervention is indicated. If the system is verified as displaced, it should be removed, and a new system may be inserted at that time or during the next menses if it is certain that conception has not occurred. If expulsion has occurred, the system may be replaced within 7 days of a menstrual period after pregnancy has been excluded. Partial or complete expulsion of any intrauterine system may result in bleeding or pain; however, expulsion may occur without the woman's knowledge.

Concomitant use of progestin-only contraceptives with drugs that induce hepatic microsomal enzymes (e.g., barbiturates, carbamazepine, phenytoin, HIV protease inhibitors, rifampin, St. John's wort [Hypericum perforatum]) reduces contraceptive efficacy, possibly resulting in unintended pregnancy or breakthrough bleeding. Effects of hepatic enzyme inducers on the contraceptive efficacy of the levonorgestrel-releasing intrauterine system have not been evaluated. No significant interaction has been found when progestin-only oral contraceptives are used concomitantly with broad-spectrum anti-infectives.

Women should be informed that progestin-only contraceptives do not protect against human immunodeficiency virus (HIV) infection or other sexually transmitted diseases.

Levonorgestrel 0.75 or 1.5 mg used for postcoital (emergency) contraception is not effective in terminating an existing pregnancy. Rapid return of fertility is likely following use of levonorgestrel for postcoital contraception. Routine methods of contraception should be continued or initiated as soon as possible following use of levonorgestrel to ensure ongoing pregnancy prevention.

Women receiving progestin-only oral contraceptives should be advised to take the tablets exactly as directed and at the same time every day, including throughout all bleeding episodes.(See Dosage and Administration.) Women should be advised to inform a clinician if prolonged bleeding, amenorrhea, or severe abdominal pain occurs. Although progestin-only oral contraceptives do not affect the quality or quantity of breast milk in lactating women, isolated cases of decreased milk production have been reported, and lactating women are advised to contact a clinician if they are not producing enough milk. The World Health Organization states that nursing women can continue to breast-feed without restriction during postcoital (emergency) contraceptive regimens.

Women considering use of the levonorgestrel-releasing intrauterine system should be encouraged to review the manufacturer's patient information and to discuss with a clinician the risks and benefits associated with the use of an intrauterine contraceptive system. Following insertion of the intrauterine system, women should be instructed on how to check after their menstrual period to ensure that the removal threads still protrude from the cervix and should be cautioned not to pull on the threads and displace the system.

Irregular menstrual patterns are common in women receiving progestin-only contraceptives. If genital bleeding patterns are suggestive of infection, malignancy, or other pathologic causes, such causes should be ruled out. If prolonged amenorrhea develops in women receiving progestin-only oral contraceptives, the possibility of pregnancy should be evaluated. In women using the levonorgestrel-releasing intrauterine system, the number of days of bleeding and spotting may be increased and bleeding patterns may be irregular during the first 3-6 months of use; thereafter, bleeding may remain irregular but the number of days with bleeding or spotting is decreased. If bleeding irregularities develop during prolonged use of the levonorgestrel-releasing intrauterine system, pathologic causes should be ruled out. Amenorrhea develops within 1 year in about 20% of women using the levonorgestrel-releasing intrauterine system. The possibility of pregnancy should be considered in women using this contraceptive method if menstruation does not occur within 6 weeks of the onset of the previous menstrual period. Once pregnancy has been excluded, repeated pregnancy tests are not required in women using the levonorgestrel-releasing intrauterine system in the absence of other evidence of pregnancy or unless pelvic pain is present.

Delayed atresia of ovarian follicles, with resulting follicular enlargement, may occur in patients receiving progestins. Follicular enlargement generally is asymptomatic or associated with mild abdominal pain and resolves spontaneously; in rare cases, surgery may be required.

The rate of ectopic pregnancy in women receiving progestin-only oral contraceptives has been reported as 5 ectopic pregnancies per 1000 woman-years of use. Up to 10% of pregnancies reported in clinical trials in women receiving progestin-only oral contraceptives have been ectopic. The possibility of ectopic pregnancy should be considered whenever a patient receiving a low-dose progestin oral contraceptive becomes pregnant or experiences severe lower abdominal pain. A follow-up physical or pelvic examination is recommended by the manufacturers if there is any question regarding the general health or pregnancy status of a woman following administration of levonorgestrel 0.75 or 1.5 mg for postcoital (emergency) contraception. The manufacturers state that a history of ectopic pregnancy does not need to be considered a contraindication to progestin-only oral contraceptives.

The rate of ectopic pregnancy in clinical trials in women using the levonorgestrel-releasing intrauterine system has been reported to be 1 ectopic pregnancy per 1000 woman-years of use, a rate not substantially different from that in sexually active women not using any contraceptive method. About one-half of the pregnancies reported during these clinical trials were ectopic. Patients with a history of ectopic pregnancy were excluded from clinical trials of the levonorgestrel-releasing intrauterine system, and use of this contraceptive method is not recommended in women with a history of ectopic pregnancy or conditions that may predispose to ectopic pregnancy. Women using the levonorgestrel-releasing intrauterine system should be taught to recognize and report symptoms of ectopic pregnancy.

In women who have intrauterine pregnancies while using an intrauterine contraceptive device, septic abortion (resulting in septicemia, septic shock, and death) can occur. If pregnancy occurs in a woman using the levonorgestrel-releasing intrauterine system, the intrauterine system should be removed. Removal or manipulation of the system may result in pregnancy loss. If the system cannot be removed or if the woman chooses not to have the system removed, she should be advised that failure to remove the system increases the risk of miscarriage, sepsis, and premature labor and delivery, and she should be followed closely and advised to report immediately any flu-like symptoms, fever, chills, cramping, pain, bleeding, vaginal discharge, or leakage of fluid. The long-term effects on the fetus of leaving the levonorgestrel-releasing system in place as the pregnancy progresses are unknown. Clinical experience with pregnancy outcomes in such cases is limited, and the possibility of teratogenic effects cannot be completely excluded. Congenital anomalies have been reported infrequently when the levonorgestrel-releasing system was not removed; however, the role of the levonorgestrel-releasing system in the development of these anomalies has not been established.

Group A streptococcal sepsis has been reported rarely following insertion of the levonorgestrel-releasing intrauterine system. Severe pain has occurred within hours of insertion, followed by onset of sepsis within several days. Use of strict aseptic technique during insertion of the device is essential.

Use of intrauterine contraceptive devices is associated with an increased risk of PID, with the highest risk occurring shortly (generally within 20 days) after insertion of the device. The decision to use the levonorgestrel-releasing intrauterine system should include consideration of the risk of PID. If the woman or her partner has multiple sexual partners, risk of PID is increased and the levonorgestrel-releasing intrauterine system should not be used. Risk also is increased in women with a history of PID, and use of the device is contraindicated in such women unless there has been a subsequent intrauterine pregnancy. All women who are considering use of the levonorgestrel-releasing intrauterine system should be informed of the possibility of PID and long-term sequelae (tubal damage resulting in ectopic pregnancy or infertility or, less often, hysterectomy or death) and should be taught to recognize signs and symptoms of PID (e.g., prolonged or heavy bleeding, unusual vaginal discharge, abdominal or pelvic pain or tenderness, dyspareunia, chills, fever). PID may be asymptomatic but still result in tubal damage and long-term sequelae. If PID is suspected or confirmed, the patient should be promptly evaluated and appropriate treatment initiated.

Actinomycosis also has been reported in association with intrauterine contraceptive devices. If symptomatic actinomycosis occurs, the intrauterine system should be removed and appropriate anti-infective treatment initiated. Management of asymptomatic patients is controversial.

Partial penetration or embedment of the levonorgestrel-releasing intrauterine system in the myometrium may decrease contraceptive efficacy and make removal of the device difficult. If perforation of the uterus or cervix occurs, the device must be removed and surgery may be required. Potential complications include adhesions, peritonitis, intestinal perforation or obstruction, abscesses, and erosion of adjacent viscera. The risk of perforation is increased in lactating women. To decrease the risk of perforation in postpartum women and in women who have undergone a second-trimester abortion, insertion of the device should be delayed until uterine involution is complete.

The levonorgestrel-releasing intrauterine system should be removed if any of the following occur: menorrhagia and/or metrorrhagia producing anemia, HIV infection, sexually transmitted disease, pelvic infection, endometritis, symptomatic genital actinomycosis, intractable pelvic pain, severe dyspareunia, pregnancy, endometrial or cervical malignancy, or uterine or cervical perforation. Removal of the intrauterine system also should be considered if any of the following conditions arise for the first time: migraine, focal migraine with asymmetrical visual loss or other manifestations indicating transient cerebral ischemia, exceptionally severe headache, jaundice, marked increase of blood pressure, or severe arterial disease (e.g., stroke, myocardial infarction).

The manufacturers state that progestin-only oral contraceptives are contraindicated in women who are hypersensitive to the drug or any ingredient in the formulation and in those with known or suspected pregnancy, undiagnosed abnormal genital bleeding, active liver disease, benign or malignant liver tumor, or known or suspected carcinoma of the breast. In addition to the usual contraindications associated with oral progestin therapy, the levonorgestrel-releasing intrauterine system is contraindicated in patients with congenital or acquired uterine anomalies (including fibroids) if they distort the uterine cavity, acute PID or a history of PID unless there has been a subsequent intrauterine pregnancy, postpartum endometritis or infected abortion in the previous 3 months, known or suspected uterine or cervical neoplasia or an unresolved abnormal Papanicolaou test (Pap smear) result, untreated acute cervicitis or vaginitis (including bacterial vaginosis or other lower genital tract infection until the infection is controlled), conditions associated with increased susceptibility to infection (e.g., leukemia, acquired immunodeficiency syndrome [AIDS], IV drug abuse), genital actinomycosis, or a history of ectopic pregnancy or any condition that would predispose to ectopic pregnancy. The levonorgestrel-releasing intrauterine system also is contraindicated if a previously inserted intrauterine contraceptive device has not been removed or if the woman or her partner has multiple sexual partners.

Most experts state that there currently is no real contraindication to postcoital (emergency) contraception with the recommended regimens and that the benefits generally outweigh any theoretical or proven risk. Levonorgestrel for emergency contraception should not be used as a woman's routine form of contraception. In addition, use of levonorgestrel for emergency contraception is not recommended in women who are hypersensitive to the drug or any ingredient in the formulation or in those with known or suspected pregnancy.

Drug Interactions

For information on drug interactions associated with oral contraceptives, .

Pharmacokinetics

For a discussion on the absorption, distribution, and elimination of oral contraceptive steroids, including norethindrone, .

Following insertion of an intrauterine system containing 52 mg of levonorgestrel (Mirena), the drug is initially released into the uterine cavity at a rate of 20 mcg per day. The rate of drug release decreases progressively to about one-half of the initial rate after 5 years of use. Plasma levonorgestrel concentrations stabilize at 150-200 pg/mL a few weeks following insertion of the system; concentrations at 12, 24, and 60 months following insertion of the device reportedly average 180, 192, and 159 pg/mL, respectively.

Following subcutaneous insertion of etonogestrel implant, the drug is released at a rate of 60-70 mcg per day at week 5-6; the rate decreases to 35-45 mcg per day at the end of the first year, to 30-40 mcg per day at the end of the second year, and then to 25-30 mcg per day at the end of the third year. Plasma etonogestrel concentrations of 781-894 pg/mL are achieved within a few weeks following insertion of the implant; concentrations at 12, 24, and 36 months following insertion of the device reportedly average 192-261, 154-194, and 156-177 pg/mL, respectively.

Following oral administration of a single 0.75- or 1.5-mg dose of levonorgestrel, the drug is rapidly and completely absorbed with peak plasma concentrations of 14 or 19 ng/mL achieved in 1.6 or 1.7 hours, respectively.

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