Pregnancy, undiagnosed vaginal bleeding, severe arterial disease; liver adenoma, porphyria; after recent evacuation of hydatidiform mole; history of breast cancer; hepatic impairment.
FDA has not yet classified the drug into a specified pregnancy category.
Mode of Action
Levonorgestrel, a nortestosterone derivative, is an active isomer of norgestrel. It is a potent inhibitor of ovulation and has androgenic activity.
Interaction
Reduced efficacy with enzyme-inducing drugs; aminoglutethimide. May inhibit ciclosporin metabolism.
Pregnancy Category Note
Pregnancy
Use of is contraindicated in pregnancy or with a suspected pregnancy because there is no need for pregnancy prevention in a woman who is already pregnant and therapy may cause adverse pregnancy outcomes; if a woman becomes pregnant likelihood of ectopic pregnancy is increased and there is increased risk of miscarriage, sepsis, premature labor, and premature delivery; remove product if possible, if pregnancy occurs in a woman; if product cannot be removed, follow pregnancy closely
Studies report no adverse effects on fetal and infant development associated with long-term use of contraceptive doses of oral progestins in a pregnant woman; however, there have been reported cases of masculinization of external genitalia of female fetus following exposure to progestins at doses greater than those currently used for oral contraception; animal reproduction studies not conducted
Lactation
Published studies report presence of LNG in human milk; small amounts of progestins (approximately 0.1% of total maternal doses) were detected in breast milk of nursing mothers who used other LNG-releasing IUSs, resulting in exposure of LNG to the breastfed infants; there are no reports of adverse effects in breastfed infants with maternal use of progestin-only contraceptives; isolated cases of decreased milk production reported with a LNG-releasing IUS; developmental and health benefits of breastfeeding should be considered along with mother?s clinical need for therapy and any potential adverse effects on breastfed child therapy or from underlying maternal condition
Adult Dose
Oral
Emergency contraception
Adult: 1.5 mg as soon as possible or within 72 hr of coitus.
Alternatively, 750 mcg as soon as possible or within 72 hr of coitus followed by a 2nd dose 12 hr later.
Most effective if taken as soon as possible after unprotected intercourse
Menopausal hormone replacement therapy
Adult: As progestogenic component: 75-250 mcg for 10-12 days of a 28-day cycle.
Contraception
Adult: Monotherapy: 30 or 37.5 mcg daily.
Child Dose
N/A
Renal Dose
N/A
Administration
May be taken with or without food.
Disclaimer
The information provided herein are for informational purposes only and not intended to be a substitute for professional medical advice, diagnosis, or treatment. Please note that this information should not be treated as a replacement for physical medical consultation or advice. Great effort has been placed to provide accurate and comprehensive data. However, Medicart along with its authors and editors make no representations or warranties and specifically disclaim all liability for any medical information provided on the site. The absence of any information and/or warning to any drug shall not be considered and assumed as an implied assurance of the Company.