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Each Triphasil cycle of 28 tablets consists of three different drug phases as follows: Phase 1 comprised of 6 brown tablets, each containing 0.050 mg of levonorgestrel (d(-)-13 beta-ethyl -17- alpha-ethinyl- 17 -beta-hydroxygon-4-en-3-one), a totally synthetic progestogen, and 0.030 mg of ethinyl estradiol (19- nor- 17(alpha)-pregna -1,3,5(10)- trien -20- yne- 3,17 -diol); phase 2 comprised of 5 white tablets, each containing 0.075 mg levonorgestrel and 0.040 mg ethinyl estradiol; and phase 3 comprised of 10 light-yellow tablets, each containing 0.125 mg levonorgestrel and 0.030 mg ethinyl estradiol; then followed by 7 light-green inert tablets. The inactive ingredients present are cellulose, FD&C Blue 1, iron oxides, lactose, magnesium stearate, polacrilin potassium, polyethylene glycol, titanium dioxide, and hydroxypropyl methylcellulose.
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Levonorgestrel
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See Triphasil®-21.
See Triphasil-21.
See Triphasil-21.
See Triphasil-21.
See Triphasil-21.
See Triphasil-21.
See Triphasil-21.
See Triphasil-21.
See Triphasil-21.
See Triphasil-21.
See Triphasil-21.
See Triphasil-21.
See Triphasil-21.
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. (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. 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 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.
In the nonlactating mother, Triphasil-28 may be initiated postpartum, for contraception. When the tablets are administered in the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered (See " Contraindications ", " ", and " Precautions " concerning thromboembolic disease). It is to be noted that early resumption of ovulation may occur if Parlodel® (bromocriptine mesylate) has been used for the prevention of lactation.
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".
ALSO AVAILABLE:
Triphasil®-28 Tablets (levonorgestrel and ethinyl estradiol tablets--triphasic regimen), NDC 0008-2536, are available in packages of 50 Pilpak® dispensers for clinic use only. 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".
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Available upon request.
Brief Summary Patient Package Insert: See Triphasil-21.
DETAILED PATIENT LABELING: See Triphasil-21.
For Triphasil-28 Dial Dispenser: See Triphasil-21.
For Triphasil-28 Clinic Pilpak®, See below.
This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against transmission of HIV (AIDS) and other sexually transmitted diseases such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.
BEFORE YOU START TAKING YOUR PILLS:
BEFORE YOU START TAKING YOUR PILLS
WHEN TO START THE FIRST PACK OF PILLS
You have a choice of which day to start taking your first pack of pills. Decide with your doctor or clinic which is the best day for you. Pick a time of day which will be easy to remember.
If you MISS 1 brown, white or light-yellow "active" pill:
If you MISS 2 brown, white or light-yellow "active" pills in a row in WEEK 1 OR WEEK 2 of your pack:
If you MISS 2 brown, white or light-yellow "active" pills in a row in THE 3rd WEEK:
If you MISS 3 OR MORE brown, white or light-yellow "active" pills in a row (during the first 3 weeks):
If you forget any of the 7 light-green "reminder" pills in Week 4:
THROW AWAY the pills you missed.
Keep taking 1 pill each day until the pack is empty.
You do not need a back-up method if you start your next pack on time.
Use a BACK-UP METHOD anytime you have sex.
KEEP TAKING ONE PILL EACH DAY until you can reach your doctor or clinic.
The incidence of pill failure resulting in pregnancy is approximately less than 1.0% if taken every day as directed, but more typical failure rates are less than 3.0%. If failure does occur, the risk to the fetus is minimal.
RISKS TO THE FETUS
If you do become pregnant while using oral contraceptives, the risk to the fetus is small, on the order of no more than one per thousand. You should, however, discuss the risks to the developing child with your doctor.
Pregnancy after stopping the pill
There may be some delay in becoming pregnant after you stop using oral contraceptives, especially if you had irregular menstrual cycles before you used oral contraceptives. It may be advisable to postpone conception until you begin menstruating regularly once you have stopped taking the pill and desire pregnancy.
There does not appear to be any increase in birth defects in newborn babies when pregnancy occurs soon after stopping the pill.
Overdosage
Serious ill effects have not been reported following ingestion of large doses of oral contraceptives by young children. Overdosage may cause nausea and withdrawal bleeding in females. In case of overdosage, contact your health-care provider or pharmacist.
Other information
Your health-care provider will take a medical and family history before prescribing oral contraceptives and will examine you. The physical examination may be delayed to another time if you request it and the health-care provider believes that it is appropriate to postpone it. You should be reexamined at least once a year. Be sure to inform your health-care provider if there is a family history of any of the conditions listed previously in this leaflet. Be sure to keep all appointments with your health-care provider, because this is a time to determine if there are early signs of side effects of oral-contraceptive use.
Do not use the drug for any condition other than the one for which it was prescribed. This drug has been prescribed specifically for you; do not give it to others who may want birth-control pills.
HEALTH BENEFITS FROM ORAL CONTRACEPTIVES: See Triphasil-21.
Manufactured by:
Wyeth Laboratories
A Wyeth-Ayerst Company
Philadelphia, PA 19101
CI 4243-3 Revised October 12, 1999
