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MIRENA
Contraception
Menorrhagia
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Drug Name:

MIRENA Rx

Generic Name and Formulations:
Levonorgestrel 52mg; intrauterine system.

Company:
Bayer Healthcare Pharmaceuticals Inc.

Therapeutic Use:

Indications for MIRENA:

Intrauterine contraception for up to 5yrs.

Adult:

See full labeling. Insert into uterine cavity as directed. Reexamine 4–6 weeks after insertion and once a year thereafter, or as clinically indicated. Replace after 5 years.

Children:

Pre-menarche: not indicated.

Contraindications:

Congenital or acquired uterine anomaly. Acute or history of pelvic inflammatory disease (PID) unless subsequent intrauterine pregnancy occurred. Postpartum endometritis or septic abortion in past 3 months. Uterine or cervical neoplasia. Breast or other progestin-sensitive cancer. Uterine bleeding of unknown cause. Untreated acute cervicitis or vaginitis. Acute liver disease or liver tumor. Conditions associated with increased susceptibility to pelvic infections. Retained IUD. Pregnancy.

Warnings/Precautions:

History or risk of ectopic pregnancy. Assure suitable uterine anatomy before inserting. Risk of spontaneous abortion, miscarriage, sepsis, premature labor or delivery, congenital anomalies: remove if pregnant. Consider risks of PID before using. Exclude endometrial pathology if bleeding irregularities develop with prolonged treatment. Risk of perforation, expulsion and ovarian cysts. Increased risk of perforation in lactating women or if inserted in women with fixed retroverted uteri or during postpartum period; delay insertion a minimum ≥6wks or until involution is complete after delivery or a second trimester abortion. Remove device if any of these occur: PID, endometritis, genital actinomycosis, perforation, any sign of expulsion. Consider removal if coagulopathy, migraine, transient cerebral ischemia, severe headache, marked increase in BP, severe arterial disease (eg, stroke, MI), jaundice or uterine/cervical malignancy occurs. Nursing mothers.

Interactions:

May be antagonized by CYP3A4 inducers (eg, barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John's wort, topiramate). May be potentiated by CYP3A4 inhibitors (eg, itraconazole, ketoconazole). May be potentiated or antagonized with concomitant protease inhibitors or NNRTIs. Caution with anticoagulants.

Pharmacological Class:

Progestin IUD.

Adverse Reactions:

Menstrual bleeding pattern changes, abdominal or pelvic pain, amenorrhea, headache, migraine, genital discharge, vulvovaginitis; ectopic or intrauterine pregnancy, PID, perforation, ovarian cysts, sepsis (during insertion).

How Supplied:

System—1

Indications for MIRENA:

Treatment of heavy menstrual bleeding in women who choose to use intrauterine contraception as their method of contraception.

Adult:

See full labeling. Insert into uterine cavity as directed. Reexamine 4–6 weeks after insertion and once a year thereafter, or as clinically indicated. Replace after 5 years.

Children:

Pre-menarche: not indicated.

Contraindications:

Congenital or acquired uterine anomaly. Acute or history of pelvic inflammatory disease (PID) unless subsequent intrauterine pregnancy occurred. Postpartum endometritis or septic abortion in past 3 months. Uterine or cervical neoplasia. Breast or other progestin-sensitive cancer. Uterine bleeding of unknown cause. Untreated acute cervicitis or vaginitis. Acute liver disease or liver tumor. Conditions associated with increased susceptibility to pelvic infections. Retained IUD. Pregnancy.

Warnings/Precautions:

History or risk of ectopic pregnancy. Assure suitable uterine anatomy before inserting. Risk of spontaneous abortion, miscarriage, sepsis, premature labor or delivery, congenital anomalies: remove if pregnant. Consider risks of PID before using. Exclude endometrial pathology if bleeding irregularities develop with prolonged treatment. Risk of perforation, expulsion and ovarian cysts. Increased risk of perforation in lactating women or if inserted in women with fixed retroverted uteri or during postpartum period; delay insertion a minimum ≥6wks or until involution is complete after delivery or a second trimester abortion. Remove device if any of these occur: PID, endometritis, genital actinomycosis, perforation, any sign of expulsion. Consider removal if coagulopathy, migraine, transient cerebral ischemia, severe headache, marked increase in BP, severe arterial disease (eg, stroke, MI), jaundice or uterine/cervical malignancy occurs. Nursing mothers.

Interactions:

May be antagonized by CYP3A4 inducers (eg, barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John's wort, topiramate). May be potentiated by CYP3A4 inhibitors (eg, itraconazole, ketoconazole). May be potentiated or antagonized with concomitant protease inhibitors or NNRTIs. Caution with anticoagulants.

Pharmacological Class:

Progestin IUD.

Adverse Reactions:

Menstrual bleeding pattern changes, abdominal or pelvic pain, amenorrhea, headache, migraine, genital discharge, vulvovaginitis; ectopic or intrauterine pregnancy, PID, perforation, ovarian cysts, sepsis (during insertion).

How Supplied:

System—1

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