Emergency contraception (Female Plane B)
Emergency contraception
Levonorgestrel (Plan B)
The FDA originally approved OTC status for the sale of a package containingtwo tablets, each containing 0.75 mg levonorgestrel, as emergency contraceptionif purchased by someone 18 years of age or older.15 The federal courtsin the USA ordered the FDA to make Plan B available to those aged 17 years ofage in spring 2009 because women of that age were included in the clinical trials. The FDA indicated that it intends to comply with the order.16 Drug category and indications for use Progestin only tablets reduce the chance of pregnancy when a woman has unprotected intercourse or if there is failure of some form of contraception.
Rx–OTC switched drug: levonorgestrel The FDA approved the switch of levonorgestrel, a progestin, to OTC status,but it may only be purchased from a pharmacist as a behind-the-counter drug.
Mode of action
Progestin therapy may prevent release of the ovum if taken before ovulation or it may prevent fertilization from occurring. It may also prevent implantation of a fertilized ovum in the uterus.
Warnings and precautions
Women who are pregnant should not use levonorgestrel because it is not effective if they are already pregnant. It should not be used as a routine form of contraception. The woman’s next menstrual cycle should occur within 3 days of the expected date. If menstruation is more than a week late, the woman should consider taking a pregnancy test.
Levonorgestrel does not provide any protection from STDs. Adverse effects include nausea, vomiting, abdominal discomfort or pain, fatigue, headache, alteration in the amount of bleeding during the period, and breast tenderness.
Recommended dose
Levonorgestrel is most effective when taken within 72 hours after unprotected intercourse. One tablet of levonorgestrel 0.75 mg should be taken as soon as possible and the second tablet should be taken 12 hours later. The greater the time elapsed between intercourse and taking the first dose, the less effective the drug is in preventing pregnancy.
If vomiting occurs within 1 to 2 hours after taking the first tablet, the dose must be repeated and a second dose must be taken 12 hours later. (Since the package contains only two tablets, if the woman vomits after the first tablet, a second purchase may be necessary because two doses of levonorgestrel are necessary for the drug to be effective.) The cost of Plan B (two tablets) is around $40.00.
Product
Levonorgestrel (Plan B: Next Choice (available in Fall 2009; newly approved generic)). NOTE. On July 16, 2009 the FDA approved Plan B One Stage which contain 1.5 mg of levonorgestrel in one tablet instead of the two tablet dose.
