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12/09/04
From: Duramed
Subsidiary
of Barr Pharmaceuticals, Inc.
Duramed
Pharmaceuticals, Inc., a subsidiary of Barr Pharmaceuticals, Inc., is
pleased to announce the acquisition of Plan B (levonorgestrel)
tablets, 0.75 mg- now the only marketed emergency contraceptive.
Plan B,
currently available by prescription, is a progestin-only pill. Since
Preven (levonorgestrel) 0.25 mg/ethinyl estradiol 0.05 mg
tablet USP) has been discontinued and is no longer manufactured, Plan
B provides a safe and effective alternative for emergency
contraception. If you receive any prescription for Preven, you should
contact the prescriber and offer Plan B as the safe and effective alternative.
Plan B is not
an abortifacient; it is not effective if a women is already pregnant.
Plan B can prevent pregnancy in cases of contraceptive failure or
unprotected intercourse. For optimal efficacy, a woman must take the
first tablet as soon as possible within 72 hours and the second
tablet 12 hours later. Plan B can reduce the risk of pregnancy by 89%
when taken as directed.
Each packet of
Plan B contains a single, 2 tablet course of treatment. The NDC
number is 51285-038-93.
Plan B May be
appropriate when a woman
-Engaged in
intercourse without contraception protection
-Used a
barrier methods of contraception that failed during intercourse or
failed to follow their contraceptive regimen
-Was raped
Plan B
broadens the contraceptive options Duramed offers to women. Our sales
force will provide you with materials to support the use of Plan B.
Information for professionals and patients is available at
www.go2planB.com. Our Plan B information line can be accessed toll
free at 1-800-330-1271 from 8AM to 7PM EST.
Stocking Plan
B is the critical first step. Order Plan B now from your wholesaler
or call 1-800-330-1271. We hope you will help Duramed Pharmaceuticals
provide access to women in need of emergency contraception. Stocking
Plan B is especially important, since timing is critical to the
efficacy of Plan B.
Very Truly Yours,
Ericka Higgins
Product Manager
PS: Coming
soon! Duramed Pharmaceuticals will be conducting a full-scale launch
of Plan B, complete with new materials for professionals and patients
in the near future. In the interim, our sales representatives will be
calling on you with patient materials and literature for professionals.
Plan B is
contraindicated in women with known or suspected pregnancy,
hypersensitivity to any component of the product, or undiagnosed
abnormal genital bleeding.
Plan B is not
recommended for routine use as a contraceptive. Plan B is not
effective in terminating an existing pregnancy. Plan B does not
protect against HIV infection and other sexually transmitted diseases (STDs).
Menstrual
bleeding may be heavier or lighter after taking Plan B. If menses are
delayed beyond one week, pregnancy should be considered. Severe
abdominal pain may signal a tubal (ectopic) pregnancy.
Common side
effects associated with the use of Plan B include nausea, abdominal
pain, fatigue, headache, and menstrual changed.
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