"The U.S. Food and Drug Administration today announced that it has approved an amended application submitted by Teva Women's Health, Inc. to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years"...
- Patient Information:
Details with Side Effects
Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.
Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception.1 The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.
TABLE I: PERCENTAGE OF WOMEN EXPERIENCING A CONTRACEPTIVE
FAILURE DURING THE FIRST YEAR OF PERFECT USE AND FIRST YEAR OF TYPICAL USE
|% of Women Experiencing an Accidental Pregnancy within the First Year of Use|
|Method||Typical Usea||Perfect Useb|
|Copper T 380A||0.8||0.6|
| Adapted with permission.1
a Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
b Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
DOSAGE AND ADMINISTRATION
To achieve maximum contraceptive effectiveness, oral contraceptives must be taken exactly as directed and at intervals not exceeding 24 hours.
For a DAY 1 START, count the first day of menstrual flow as Day 1 and the first tablet (white) is then taken on Day 1. For a SUNDAY START when menstrual flow begins on or before Sunday, the first tablet (white) is taken on that day. With either a DAY 1 START or SUNDAY START, 1 tablet (white) is taken each day at the same time for 21 days. Then the peach tablets are taken for 7 days, whether bleeding has stopped or not. After all 28 tablets have been taken, whether bleeding has stopped or not, the same dosage schedule is repeated beginning on the following day.
Instructions To patients
- To achieve maximum contraceptive effectiveness, the oral contraceptive pill must be taken exactly as directed and at intervals not exceeding 24 hours.
- Important: Women should be instructed to use an additional method of protection until after the first 7 days of administration in the initial cycle.
- Due to the normally increased risk of thromboembolism occurring postpartum, women should be instructed not to initiate treatment with oral contraceptives earlier than 4 weeks after a full-term delivery. If pregnancy is terminated in the first 12 weeks, the patient should be instructed to start oral contraceptives immediately or within 7 days. If pregnancy is terminated after 12 weeks, the patient should be instructed to start oral contraceptives after 2 weeks.33, 77
- If spotting or breakthrough bleeding should occur, the patient should continue the medication according to the schedule. Should spotting or breakthrough bleeding persist, the patient should notify her physician.
- If the patient misses 1 pill, she should be instructed to take it as soon as she remembers and then take the next pill at the regular time. The patient should be advised that missing a pill can cause spotting or light bleeding and that she may be a little sick to her stomach on the days she takes the missed pill with her regularly scheduled pill. If the patient has missed more than one pill, see DETAILED PATIENT LABELING: HOW TO TAKE THE PILL, WHAT TO DO IF YOU MISS PILLS.
- Use of oral contraceptives in the event of a missed menstrual period:
- If the patient has not adhered to the prescribed dosage regimen, the possibility of pregnancy should be considered after the first missed period and oral contraceptives should be withheld until pregnancy has been ruled out.
- If the patient has adhered to the prescribed regimen and misses consecutive periods, pregnancy should be ruled out before continuing the contraceptive regimen.
Levora® 0.15/30-28 (levonorgestrel and ethinyl estradiol tablets USP): Each white tablet is unscored, round in shape, with 15/30 debossed on one side and WATSON on the other side, and contains 0.15 mg levonorgestrel and 0.03 mg ethinyl estradiol. Levora (levonorgestrel and ethinyl estradiol tablets) ® 0.15/30-28 is packaged in cartons of six tablet dispensers. Each tablet dispenser contains 21 white (active) tablets and 7 peach (inert) tablets. Inert tablets are unscored, round in shape with WATSON debossed on one side and P1 on the other side.
Store at controlled room temperature 15°-25°C (59°-77°F).
1. Hatcher, R.A. Trussell, J. Stewart, F., et al.: Contraceptive Technology: Sixteenth Revised Edition, New York, NY, 1994. 33. Mishell, D.R., et al.: Reproductive Endocrinology, Philadelphia, F.A. Davis Co., 1979. 77. Dickey, R.P.: Managing Contraceptive Pill Patients, Oklahoma, Creative Informatics Inc., 1984.
Address medical inquiries to: Watson Pharma, Inc. Medical Communications P.O. Box 1953 Morristown, NJ 07962-1953. 800-272-5525. Manufactured for: WATSON PHARMA, INC. A subsidiary of Watson Pharmaceuticals, Inc. Corona, CA 92880, USA. by: Patheon Inc. Mississauga, Ontario L5N 7K9 CANADA. Revised: May 2005. FDA Rev date: 8/16/2001
Last reviewed on RxList: 3/26/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Levora Information
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