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Mirena should not be inserted until 6 weeks postpartum or until involution of the uterus is complete in order to reduce the incidence of perforation and expulsion. Patients with certain types of valvular or congenital heart disease and surgically constructed systemic-pulmonary shunts are at increased risk of infective endocarditis. Use of Mirena in these patients may represent a potential source of septic emboli. Patients with known congenital heart disease who may be at increased risk should be treated with appropriate antibiotics at the time of insertion and removal. Patients requiring chronic corticosteroid therapy or insulin for diabetes should be monitored with special care for infection. Administration of antibiotics may be considered, but the utility of this treatment is unknown. Carefully sound the uterus prior to Mirena insertion to determine the degree of patency of the endocervical canal and the internal os, and the direction and depth of the uterine cavity. Fundal positioning of Mirena is important to prevent expulsion and maximize efficacy. If the patient develops decreased pulse, perspiration, or pallor, have her remain supine until these signs resolve. Syncope, bradycardia, or other neurovascular episodes may occur during insertion of Mirena, especially in patients with a predisposition to these conditions or cervical stenosis. Reexamine and evaluate patients 4 to 12 weeks after insertion and once a year thereafter, or more frequently if clinically indicated. If the length of the threads has changed from the length at time of insertion, the system may have become displaced. Pregnancy must be excluded and the location of Mirena verified, for example, by sonography, X-ray, or by gentle exploration of the uterine cavity with a probe. A new Mirena may be inserted at that time or during the next menses if it is certain that conception has not occurred. If Mirena is in place with no evidence of perforation, no intervention is indicated. If removal is difficult, the patient should be counseled and offered pregnancy termination. The use of a barrier method as a partial protection against acquiring sexually transmitted diseases should be strongly recommended. Removal of the system should also be considered if any of the following conditions arise for the first time:. Glucose Tolerance Levonorgestrel may affect glucose tolerance, and the blood glucose concentration should be monitored in diabetic users of Mirena. Drug Interactions the influence of drugs on the contraceptive efficacy of Mirena has not been studied. The metabolism of progestogens may be increased by concomitant use of substances known to induce drug-metabolizing liver enzymes, specifically cytochrome P450 enzymes. Nursing Mothers In general, no adverse effects have been found on breastfeeding performance or on the health, growth, or development of the infant. However, isolated post-marketing cases of decreased milk production have been reported. Small amounts of progestins pass into the breast milk of nursing mothers, resulting in detectable steroid levels in infant plasma. Pediatric Use Safety and efficacy of Mirena have been established in women of reproductive age. Geriatric Use Mirena has not been studied in women over age 65 and is not currently approved for use in this population. Return to Fertility About 80% of women wishing to become pregnant conceived within 12 months after removal of Mirena. Very common adverse reactions (>1/10 users) include uterine/vaginal bleeding (including spotting, irregular bleeding, heavy bleeding, oligomenorrhea and amenorrhea) and ovarian cysts. Postmarketing Experience the following adverse reactions have been identified during post approval use of Mirena: device breakage and angioedema. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
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