TRI-NORINYL- norethindrone and ethinyl estradiol
Watson Pharma, Inc.
PHYSICIAN LABELING
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
ORAL CONTRACEPTlVE AGENTS
DESCRIPTION
TRI-NORINYL� provides a continuous oral contraceptive regimen of 7 blue tablets, 9 yellow-green tablets, 5 more blue tablets, and then 7 orange tablets. Each blue tablet contains norethindrone 0.5 mg and ethinyl estradiol 0.035 mg, each yellow-green tablet contains norethindrone 1 mg and ethinyl estradiol 0.035 mg, and each orange tablet contains inert ingredients.
Norethindrone is a potent progestational agent with the chemical name 17-Hydroxy-19-nor-17?-pregn-4-en-20-yn-3-one. Ethinyl estradiol is an estrogen with the chemical name 19-Nor-17?-pregna-1,3,5 (10)-trien-20-yne-3,17-diol.
The yellow-green TRI-NORINYL tablets contain the following inactive ingredients: D&C Green No. 5, D&C Yellow No. 10, lactose, magnesium stearate, povidone, and starch.
The blue TRI-NORINYL tablets contain the following inactive ingredients: FD&C Blue No. 1, lactose, magnesium stearate, povidone, and starch.
The inactive orange tablets contain the following inactive ingredients: FD&C Yellow No. 6, lactose, microcrystalline cellulose, and magnesium stearate.
CLINICAL PHARMACOLOGY
Combination oral contraceptives act by suppression of gonadotrophins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which may reduce the likelihood of implantation).
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 contraceptive products such as Norinyl, which contain 50 mcg of estrogen, should not be used unless medically indicated.
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.
WARNINGS
Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.
The use of oral contraceptives is associated with increased risks of several serious conditions including myocardial infarction, thromboembolism, stroke, hepatic neoplasia, and gallbladder disease, although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors. The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as hypertension, hyperlipidemias, hypercholesterolemia, obesity and diabetes.2-5
Practitioners prescribing oral contraceptives should be familiar with the following information relating to these risks.
WARNINGS
Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.
The use of oral contraceptives is associated with increased risks of several serious conditions including myocardial infarction, thromboembolism, stroke, hepatic neoplasia, and gallbladder disease, although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors. The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as hypertension, hyperlipidemias, hypercholesterolemia, obesity and diabetes.2-5
Practitioners prescribing oral contraceptives should be familiar with the following information relating to these risks.
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 blue tablet is then taken on Day 1. For a SUNDAY START when menstrual flow begins on or before Sunday, the first blue tablet is taken on that day. With either a DAY 1 START or SUNDAY START, 1 blue tablet is taken for 7 days, then 1 yellow-green tablet for 9 days, then 1 blue tablet for 5 days, then 1 orange tablet (inert) for 7 days, whether bleeding has stopped or not. With either a DAY 1 START or SUNDAY START 1 tablet is taken each day at the same time for 28 days. After all 28 tablets are 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 2 consecutive periods, pregnancy should be ruled out before continuing the contraceptive regimen.
