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Mirena Generic Name & Formulations
Legal Class
Rx
General Description
Levonorgestrel 52mg; intrauterine system.
Pharmacological Class
Progestin IUD.
How Supplied
System—1
Manufacturer
Generic Availability
NO
Mirena Indications
Indications
Intrauterine contraception for up to 8yrs.
Mirena Dosage and Administration
Adult
See full labeling. Insert into uterine cavity as directed. Reexamine 4–6wks after insertion and once a year thereafter, or as clinically indicated. Replace after 8yrs.
Children
Pre-menarche: not indicated.
Mirena Contraindications
Contraindications
For use as post-coital contraception. Congenital or acquired uterine anomaly, including fibroids. Acute or history of pelvic inflammatory disease (PID) unless subsequent intrauterine pregnancy occurred. Postpartum endometritis or septic abortion in past 3months. 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.
Mirena Boxed Warnings
Not Applicable
Mirena Warnings/Precautions
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, within ≤6weeks postpartum, or if inserted in women with fixed retroverted uteri. Increased risk of expulsion 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.
Mirena Pharmacokinetics
See Literature
Mirena Interactions
Interactions
May be antagonized by CYP3A4 inducers. May be potentiated by CYP3A4 inhibitors. Caution with anticoagulants.
Mirena Adverse Reactions
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).
Mirena Clinical Trials
See Literature
Mirena Note
Not Applicable
Mirena Patient Counseling
See Literature
Mirena Generic Name & Formulations
Legal Class
Rx
General Description
Levonorgestrel 52mg; intrauterine system.
Pharmacological Class
Progestin IUD.
How Supplied
System—1
Manufacturer
Generic Availability
NO
Mirena Indications
Indications
Treatment of heavy menstrual bleeding for up to 5yrs in women who choose to use intrauterine contraception as their method of contraception.
Mirena Dosage and Administration
Adult
See full labeling. Insert into uterine cavity as directed. Reexamine 4–6wks after insertion and once a year thereafter, or as clinically indicated. Replace after 5yrs if continued use is needed (limited data beyond 5yrs).
Children
Pre-menarche: not indicated.
Mirena Contraindications
Contraindications
For use as post-coital contraception. Congenital or acquired uterine anomaly, including fibroids. Acute or history of pelvic inflammatory disease (PID) unless subsequent intrauterine pregnancy occurred. Postpartum endometritis or septic abortion in past 3months. 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.
Mirena Boxed Warnings
Not Applicable
Mirena Warnings/Precautions
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, within ≤6weeks postpartum, or if inserted in women with fixed retroverted uteri. Increased risk of expulsion 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.
Mirena Pharmacokinetics
See Literature
Mirena Interactions
Interactions
May be antagonized by CYP3A4 inducers. May be potentiated by CYP3A4 inhibitors. Caution with anticoagulants.
Mirena Adverse Reactions
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).
Mirena Clinical Trials
See Literature
Mirena Note
Not Applicable
Mirena Patient Counseling
See Literature
