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Triphasil (Levonorgestrel / Ethinyl Estradiol) - Indications and Dosage

 
 



INDICATIONS AND USAGE

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
Levonorgestrel implants 0.05 0.05
Male sterilization 0.1 0.15
Female sterilization 0.5 0.5
Depo-Provera®
(injectable progestogen)
0.3 0.3
Oral contraceptives 5
Combined 0.1 NA
Progestin only 0.5 NA
IUD
Progesterone 1.5 2.0
Copper T 380A 0.6 0.8
Condom (male) without
spermicide
3 14
(Female) without spermicide 5 21
Cervical cap
Nulliparous women 9 20
Parous women 26 40
Vaginal sponge
Nulliparous women 9 20
Parous women 20 40
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
Withdrawal 4 19
No contraception
(planned pregnancy)
85 85
NA - not available
*Depending on method (calendar, ovulation, symptothermal, post-ovulation)
Adapted from Hatcher RA et al, Contraceptive Technology: 17th Revised Edition. NY, NY: Ardent Media, Inc., 1998.

DOSAGE AND ADMINISTRATION

To achieve maximum contraceptive effectiveness, Triphasil® -28 Tablets (levonorgestrel and ethinyl estradiol tablets--triphasic regimen) must be taken exactly as directed and at intervals not exceeding 24 hours.

Triphasil-28 Tablets are a three-phase preparation plus 7 inert tablets. The dosage of Triphasil-28 Tablets is one tablet daily for 28 consecutive days per menstrual cycle in the following order: 6 brown tablets (phase 1), followed by 5 white tablets (phase 2), followed by 10 light-yellow tablets (phase 3), plus 7 light-green inert tablets, according to the prescribed schedule.

It is recommended that Triphasil-28 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 Triphasil-28 Tablet daily in the order of 6 brown, 5 white, 10 light-yellow tablets, and then 7 light-green 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 light-yellow tablet and may not have finished before the next pack is started. (If Triphasil-28 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 Triphasil-28 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, Triphasil-28 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 Triphasil-28 the next day. If switching from an implant or injection, the patient should start Triphasil-28 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 Triphasil-28 Tablets on the same day of the week that she began her first course, following the same schedule. She begins taking her brown tablets on the next day after ingestion of the last light-green tablet, regardless of whether or not a menstrual period has occurred or is still in progress. Any time a subsequent cycle of Triphasil-28 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 Triphasil-28 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 (brown, white, or light-yellow) 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 light-green tablets, she is still protected against pregnancy provided she begins taking brown tablets again on the proper day.

Triphasil-28 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 Triphasil-28 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.

HOW SUPPLIED

Triphasil® -28 Tablets (levonorgestrel and ethinyl estradiol tablets--triphasic regimen), NDC 0008-2536, are available in packages of 3 dial dispensers. Each cycle contains 28 round, coated tablets as follows:

NDC 0008-0641, six brown tablets marked "" and "641", each containing 0.050 mg levonorgestrel and 0.030 mg ethinyl estradiol;

NDC 0008-0642, five white to off-white tablets marked "" and "642", each containing 0.075 mg levonorgestrel and 0.040 mg ethinyl estradiol;

NDC 0008-0643, ten light-yellow tablets marked "" and "643", each containing 0.125 mg levonorgestrel and 0.030 mg ethinyl estradiol; and

NDC 0008-0650, seven light-green inert tablets marked "" and "650".

Store at controlled room temperature 20° to 25°C (68° to 77°F).

References available upon request.

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