Tri-norinyl
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Questions & Answers
Side Effects & Adverse Reactions
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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.
| % of Women Experiencing an Unintended | % of Women | |||
| Pregnancy within the First Year of Use | Continuing Use | |||
| at One Year3 | ||||
| Method | Typical use1 | Perfect use2 | ||
| (1) | (2) | (3) | (4) | |
| Chance4 | 85 | 85 | ||
| Spermicides5 | 26 | 6 | 40 | |
| Periodic abstinence | 25 | 63 | ||
| Calendar | 9 | |||
| Ovulation method | 3 | |||
| Sympto-thermal6 | 2 | |||
| Post-ovulation | 1 | |||
| Withdrawal | 19 | 4 | ||
| Cap7 | ||||
| Parous women | 40 | 26 | 42 | |
| Nulliparous women | 20 | 9 | 56 | |
| Sponge | ||||
| Parous women | 40 | 20 | 42 | |
| Nulliparous women | 20 | 9 | 56 | |
| Diaphragm7 | 20 | 6 | 56 | |
| Condom8 | ||||
| Female (Reality) | 21 | 5 | 56 | |
| Male | 14 | 3 | 61 | |
| Pill | 5 | 71 | ||
| Progestin only | 0.5 | |||
| Combined | 0.1 | |||
| IUD | ||||
| Progesterone T | 2.0 | 1.5 | 81 | |
| Copper T 380A | 0.8 | 0.6 | 78 | |
| LNg 20 | 0.1 | 0.1 | 81 | |
| Depo-Provera | 0.3 | 0.3 | 70 | |
| Norplant and Norplant-2 | 0.05 | 0.05 | 88 | |
| Female sterilization | 0.5 | 0.5 | 100 | |
| Male sterilization | 0.15 | 0.10 | 100 | |
| Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9 |
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| Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception.10 | ||||
| Source: Trussell J. Contraceptive Efficacy Table from Hatcher R.A., Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, in Contraceptive Technology: Seventeenth Revised Edition. New York, NY: Irvington Publishers, 1998. |
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| 1 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. |
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| 2 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. |
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| 3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. | ||||
| 4 The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. |
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| 5 Foams, creams, gels, vaginal suppositories, and vaginal film. | ||||
| 6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. |
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| 7 With spermicidal cream or jelly. | ||||
| 8 Without spermicides. | ||||
| 9 The treatment schedule is one dose within 72 hours after unprotected intercourse and a second dose 12 hours after the first dose. The Food and Drug Administration has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral (1 dose is 2 white pills), Aleese (1 dose is 5 pink pills), Nordette or Levlen (1 dose is 2 light-orange pills), Lo/Ovral (1 dose is 4 white pills), Triphasil or Tri-Levlen (1 dose is 4 yellow pills). |
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| 10 However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches six months of age. |
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History
There is currently no drug history available for this drug.
Other Information
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-17α-pregn-4-en-20-yn-3-one. Ethinyl estradiol is an estrogen with the chemical name 19-Nor-17α-pregna-1,3,5 (10)-trien-20-yne-3,17-diol. Their structural formulae follow.
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.
Sources
Tri-norinyl Manufacturers
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Watson Pharma, Inc.
![Tri-norinyl (Norethindrone And Ethinyl Estradiol) Kit [Watson Pharma, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Tri-norinyl | Actavis Pharma, Inc.
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.
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