"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"...
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 II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and the IUD, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.
TABLE II: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED
PREGNANCY DURING THE FIRST YEAR OF USE OF A CONTRACEPTIVE METHOD
|Method||Perfect Use||Typical Use|
|Depo-Provera® (injectable progestogen)||0.3||0.3|
|Copper T 380A||0.6||0.8|
|Condom (male) without spermicide||3||14|
|(Female) without spermicide||5||21|
|Diaphragm with spermicidal cream or jelly||6||20|
|Spermicides alone (foam, creams, jellies, and vaginal suppositories)||6||26|
|Periodic abstinence (all methods)||1-9*||25|
|No contraception (planned pregnancy)||85||85|
| NA - not available
* Depending on method (calendar, ovulation, symptothermal, post-ovulation) Adapted from Hatcher RA et al, ContraceptiveTechnology: 17th Revised Edition. NY, NY: Ardent Media, Inc., 1998
DOSAGE AND ADMINISTRATION
To achieve maximum contraceptive effectiveness, Trivora® Tablets (levonorgestrel and ethinyl estradiol tablets-triphasic regimen) must be taken exactly as directed and at intervals not exceeding 24 hours.
Trivora Tablets are a three-phase preparation plus 7 inert tablets. The dosage of Trivora Tablets is one tablet daily for 28 consecutive days per menstrual cycle in the following order: 6 blue tablets (phase 1), followed by 5 white tablets (phase 2), followed by 10 pink tablets (phase 3), plus 7 peach inert tablets, according to the prescribed schedule.
It is recommended that Trivora Tablets be taken at the same time each day, preferably after the evening meal or at bedtime. During the first cycle of medication, the patient should be instructed to take one Trivora Tablet daily in the order of 6 blue, 5 white, 10 pink tablets, and then 7 peach inert tablets for twenty-eight (28) consecutive days, beginning on day one (1) of her menstrual cycle. (The first day of menstruation is day one.) Withdrawal bleeding usually occurs within 3 days following the last pink tablet and may not have finished before the next pack is started. (If Trivora Tablets are first taken later than the first day of the first menstrual cycle of medication or postpartum, contraceptive reliance should not be placed on Trivora Tablets until after the first 7 consecutive days of administration and a nonhormonal back-up method of birth control should be used during those 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.)
When switching from another oral contraceptive, Trivora Tablets should be started on the first day of bleeding following the last active tablet taken of the previous oral contraceptive.
The patient may switch any day from a progestin-only pill and should begin Trivora the next day. If switching from an implant or injection, the patient should start Trivora on the day of implant removal or, if using an injection, the day the next injection would be due. In switching from a progestin-only pill, injection, or implant, the patient should be advised to use a non-hormonal back- up method of birth control for the first 7 days of tablet-taking.
The patient begins her next and all subsequent 28-day courses of Trivora Tablets on the same day of the week that she began her first course, following the same schedule. She begins taking her blue tablets on the next day after ingestion of the last peach tablet, regardless of whether or not a menstrual period has occurred or is still in progress. Any time a subsequent cycle of Trivora Tablets is started later than the next day, the patient should be protected by another means of contraception until she has taken a tablet daily for seven consecutive days.
If spotting or breakthrough bleeding occurs, the patient is instructed to continue on the same regimen. This type of bleeding is usually transient and without significance; however, if the bleeding is persistent or prolonged, the patient is advised to consult her physician. Although the occurrence of pregnancy is highly unlikely if Trivora Tablets are taken according to directions, if withdrawal bleeding does not occur, the possibility of pregnancy must be considered. If the patient has not adhered to the prescribed schedule (missed one or more tablets or started taking them on a day later than she should have), the probability of pregnancy should be considered at the time of the first missed period and appropriate diagnostic measures taken before the medication is resumed. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out before continuing the contraceptive regimen.
The risk of pregnancy increases with each active (blue, white, or pink) tablet missed. For additional patient instructions regarding missed pills, see the "WHAT TO DO IF YOU MISS PILLS" section in the DETAILED PATIENT LABELING below. If breakthrough bleeding occurs following missed active tablets, it will usually be transient and of no consequence. If the patient misses one or more peach tablets, she is still protected against pregnancy provided she begins taking blue tablets again on the proper day.
Trivora may be initiated no earlier than day 28 postpartum in the non-lactating mother or after a second trimester abortion due to the increased risk for thromboembolism (see "CONTRAINDICATIONS", "WARNINGS" and "PRECAUTIONS" concerning thromboembolic disease). The patient should be advised to use a nonhormonal back-up method for the first 7 days of tablet-taking. However, if intercourse has already occurred, pregnancy should be excluded before the start of combined oral contraceptive use or the patient must wait for her first menstrual period. In the case of first-trimester abortion, if the patient starts Trivora immediately, additional contraceptive measures are not needed. It is to be noted that early resumption of ovulation may occur if Parlodel® (bromocriptine mesylate) has been used for the prevention of lactation.
- Trivora® Tablets (levonorgestrel and ethinyl estradiol tablets-triphasic regimen) are available in 28-tablet blister cards. Six blister cards are packaged in a carton. Each cycle contains 28 tablets as follows:
- Six blue tablets containing 0.05 mg of levonorgestrel and 0.03 mg of ethinyl estradiol. The blue tablets are unscored, round in shape with "WATSON" debossed on one side and "50/30" on the other side.
- Five white tablets containing 0.075 mg of levonorgestrel and 0.04 mg of ethinyl estradiol. The white tablets are unscored, round in shape with "WATSON" debossed on one side and "75/40" on the other side.
- Ten pink tablets containing 0.125 mg of levonorgestrel and 0.03 mg of ethinyl estradiol. The pink tablets are unscored, round in shape with "WATSON" debossed on one side and "125/30" on the other side.
- Seven peach inert tablets. The peach inert tablets are unscored, round in shape with "WATSON" debossed on one side and "P1" on the other side.
Store at 20° - 25°C (68 ° - 77°F). [See USP controlled room temperature.]
References available upon request.
Address medical inquiries to: Watson Pharma, Inc. Medical Communications P.O. Box 1953 Morristown, NY 07962-1953. 800-272-5525. Manufactured for: WATSON PHARMA, INC. A subsidiary of Watson Pharmaceuticals, Inc. Corona, CA 92880 USA. Manufactured by: Patheon, Inc. Mississauga, Ontario L5N 7K9 CANADA. IN-5321/S Trivora® (levonorgestrel and ethinyl estradiol tablets USP) triphasic regimen. FDA Rev date: 7/8/1996This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/26/2008
Additional Trivora-28 Information
Trivora-28 - User Reviews
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