Monograph Details

Ob/Gyn > Contraception
MIRENA
Manufacturer
Bayer Corp, Pharmaceutical Div.
Legal Classification
Rx
Pharmacological Class
Progestin IUD.
Generic Name
Levonorgestrel 52mg; intrauterine contraceptive system (IUD).
Indications
Intrauterine contraception in women who have had at least 1 child, and are in a stable, mutually monogamous relationship.
Children
Not recommended.
Adults
See literature. Insert into uterine cavity as directed. Reexamine after next menses (within 3 months). Replace at least every 5 years.
Contraindications
Uterine abnormality. History or risk of ectopic pregnancy. History of pelvic inflammatory disease (PID) unless subsequent intrauterine pregnancy occurred. Postpartum endometritis or septic abortion in past 3 months. Uterine or cervical neoplasia. Unresolved abnormal Pap smear. Abnormal genital bleeding. Untreated acute cervicitis or vaginitis. Acute liver disease or liver tumor. Immunosuppressed. IV drug abuse. Multiple sexual partners for patient or partner. Genital actinomycosis. Retained IUD. Breast carcinoma. Pregnancy (Cat.X).
Precautions
Assure suitable uterine anatomy before inserting. Endocarditis risk. Anticoagulant therapy or coagulopathies. Cervical stenosis. Predisposition to syncope, bradycardia, other neurovascular episodes. Remove device if any of these occur: menorrhagia, metrorrhagia producing anemia, STDs, AIDS, endometritis, severe dyspareunia, intractable pelvic pain, uterine or cervical perforation, pregnancy, any sign of expulsion. Consider removal if first migraine, transient cerebral ischemia, severe headache, jaundice, marked increase in BP, or severe arterial disease occurs. Check placement regularly. Nursing mothers (increased risk of uterine perforation).
Adverse Reactions
Amenorrhea, irregular bleeding, cramps, adhesions, peritonitis, intestinal perforations or obstruction, abcesses, erosion, ovarian cysts, PID, ectopic pregnancy, GI disturbances, leukorrhea, headache, vaginitis, breast or back pain, acne, depression, hypertension, nervousness, weight gain, glucose intolerance, decreased libido, abnormal Pap smear. Syncope, bradycardia, other neurovascular episodes, perforation, loss of pregnancy, sepsis (during insertion or removal). If pregnancy occurs: sepsis, miscarriage, premature labor or delivery.
How Supplied
System—1
Additional Resources
Related Prescribing Note