Tri Linyah

TRI-LINYAH™ (Norgestimate and Ethinyl Estradiol Tablets USP) are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.

TRI-LINYAH™ is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. TRI-LINYAH™ should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control.

Oral contraceptives are highly effective for pregnancy prevention. 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, the IUD, and the Norplant System, 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 Typical Use and the First Year of Perfect Use of Contraception and the Percentage Continuing Use at the End of the First Year. United States.
% of Women Experiencing an
Unintended Pregnancy
within the First Year of Use
% of Women Continuing Use
at One Year3
Method
(1)
Typical Use1
(2)
Perfect Use2
(3)
(4)
Hatcher et al, 1998, Ref. # 1.
Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9
Lactational Amenorrhea Method: LAM is highly effective, temporary method of contraception.10
Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998.
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.
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.
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.
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.
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), Alesse® (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).
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.
Chance4 85 85
Spermicides5 26 6 40
Periodic abstinence 25 63
   Calendar 9
   Ovulation Method 3
   Sympto-Thermal6 2
   Post-Ovulation 1
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
Withdrawal 19 4
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 T380A 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

TRI-LINYAH™ (Norgestimate and Ethinyl Estradiol Tablets USP) has not been studied for and is not indicated for use in emergency contraception.

In four clinical trials with norgestimate and ethinyl estradiol tablets, a total of 4,756 subjects completed 45,244 cycles, and the use-efficacy pregnancy rate was approximately 1 pregnancy per 100 women-years.

Norgestimate and ethinyl estradiol tricyclic tablets were evaluated for the treatment of acne vulgaris in two randomized, double-blind, placebo-controlled, multicenter, Phase 3, six (28 day) cycle studies. 221 patients received norgestimate and ethinyl estradiol tablets and 234 patients received placebo. Mean age at enrollment for both groups was 28 years. At the end of 6 months, the mean total lesion count changes from 55 to 31 (42% reduction) in patients treated with norgestimate and ethinyl estradiol tablets and from 54 to 38 (27% reduction) in patients similarly treated with placebo. Table III summarizes the changes in lesion count for each type of lesion in the ITT population. Based on the investigator’s global assessment conducted at the final visit, patients treated with norgestimate and ethinyl estradiol tablets showed a statistically significant improvement in total lesions compared to those treated with placebo.

Table III: Acne Vulgaris Indication. Combined Results: Two Multicenter, Placebo-Controlled Trials.Observed Means at Six Months (LOCF)* and at Baseline. Intent-to-Treat Population.
Norgestimate and ethinyl estradiol tricyclic tablets
(N=221)
Placebo
(N=234)
Difference in
Counts between norgestimate and ethinyl estradiol tricyclic tablets and Placebo at 6 Months
*LOCF: Last Observation Carried Forward

# of Lesions

Counts
%
Reduction

Counts
%
Reduction
INFLAMMATORY
LESIONS
   Baseline Mean 19 19
   Sixth Month Mean 10 48% 13 30% 3 (95% CI: -1.2, 5.1)
NON-INFLAMMATORY LESIONS
   Baseline Mean 36 35
   Sixth Month Mean 22 34% 25 21% 3 (95% CI: -0.2, 7.8)
TOTAL LESIONS
   Baseline Mean 55 54
   Sixth Month Mean 31 42% 38 27% 7 (95% CI: 2.0, 11.9)

Tri Linyah Description

Each of the following products are a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol.

TRI-LINYAH™ (Norgestimate and Ethinyl Estradiol Tablets USP)

Each green tablet contains 0.18 mg of the progestational compound, norgestimate (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime,(17?)-(+)-) and 0.035 mg of the estrogenic compound, ethinyl estradiol (19-nor-17?-pregna,1,3,5(10)-trien-20-yne-3,17-diol). Inactive ingredients include FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 5 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, titanium dioxide, iron oxide black, macrogol/polyethylene glycol 3350 NF, lecithin, talc, polyvinyl alcohol, lactose, magnesium stearate and pregelatinized corn starch.

Each light blue tablet contains 0.215 mg of the progestational compound norgestimate (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-,oxime,(17?)-(+)-) and 0.035 mg of the estrogenic compound, ethinyl estradiol (19-nor-17?-pregna,1,3,5(10)-trien-20-yne-3,17-diol). Inactive ingredients include FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 5 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, titanium dioxide, iron oxide black, polyvinyl alcohol, talc, macrogol/polyethylene glycol 3350 NF, lecithin, lactose, magnesium stearate and pregelatinized corn starch.

Each blue tablet contains 0.25 mg of the progestational compound norgestimate (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-,oxime,(17?)-(+)-) and 0.035 mg of the estrogenic compound, ethinyl estradiol (19-nor-17?-pregna,1,3,5(10)-trien-20-yne-3,17-diol). Inactive ingredients include FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 5 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, titanium dioxide,  polyvinyl alcohol, talc, macrogol/polyethylene glycol 3350 NF, lecithin, lactose, magnesium stearate and pregelatinized corn starch.

Each white tablet contains only inert ingredients, as follows: Titanium dioxide, polydextrose, hypromellose, triacetin, polyethylene glycol, lactose, magnesium stearate and pregelatinized corn starch.

Tri Linyah Reviews

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Satisfaction
(1.0)
Effectiveness
(1.0)
Recommended
(1.0)
Overall Rating (1)
Review:
Birth control is the devils work. By using it you are preventing gods work and engaging in lust without moral reason even within marriage. Stop killing innocent babies with your birth control, the effects are definitely not worth the risk!
by
Satisfaction
(5.0)
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(5.0)
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(5.0)
Overall Rating (5)
Review:
Just posting to counter that last reviewer. I used Tri Linyah for years without having sex simply to regulate my cycle so I don't randomly start bleeding everywhere. You really should try to fully understand something before adding your religious view to it.
by
Effectiveness
(5.0)
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(5.0)
Recommended
(3.0)
Overall Rating (4.3)
Review:
My pharmacy changed brands and I got this one now and absolutely hate the packaging!!! Wish they package it a different way. Otherwise it does what it's supposed to!

Active Tri Linyah Ingredients

Tri Linyah NDC Codes

NDC Quantity Package
16714-0363-01 1 Blister Pack 1 Packet
16714-0363-02 1 Blister Pack 1 Carton
16714-0363-03 3 Blister Pack 1 Carton
16714-0363-04 6 Blister Pack 1 Carton

Tri Linyah Structured Product Labels

SPL Manufacturer
b71a2b34-95bf-4430-83a0-1a4d1218ea3c Northstar Rx LLC

Tri Linyah Overview

Overall Rating
Medication Type
Prescription
Approval Date
Aug 01, 2012
DEA Schedule
Not Classified

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