Necon 0.5/35
NECON 0.5/35- norethindrone and ethinyl estradiol tablets
Rebel Distributors Corp
Necon® 1/35
(Norethindrone and Ethinyl
Estradiol Tablets USP)
Necon® 0.5/35
(Norethindrone and Ethinyl
Estradiol Tablets USP)
Necon® 10/11
(Norethindrone and Ethinyl
Estradiol Tablets USP)
Necon® 1/50
(Norethindrone and Mestranol Tablets USP)
Rx only
Revised: December 2008 14601-1
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
DESCRIPTION
Each of the following products is a combination oral contraceptive containing the progestational compound norethindrone and the estrogenic compound ethinyl estradiol:
Necon ® 1/35: Each dark yellow tablet contains 1 mg of norethindrone and 0.035 mg of ethinyl estradiol. Inactive ingredients include D&C Yellow No. 10 Aluminum Lake, microcrystalline cellulose, lactose (anhydrous), magnesium stearate, polacrilin potassium, and povidone. Each white tablet in the Necon® 1/35 package contains only inert ingredients, as follows: microcrystalline cellulose, lactose (anhydrous), and magnesium stearate.
Necon® 0.5/35: Each light yellow tablet contains 0.5 mg of norethindrone and 0.035 mg of ethinyl estradiol. Inactive ingredients include D&C Yellow No. 10 Aluminum Lake, microcrystalline cellulose, lactose (anhydrous), magnesium stearate, polacrilin potassium, and povidone. Each white tablet in the Necon® 0.5/35 package contains only inert ingredients as listed under white tablets in Necon® 1/35.
Necon® 10/11: Each light yellow tablet (10) contains 0.5 mg of norethindrone and 0.035 mg of ethinyl estradiol. Each dark yellow tablet (11)contains 1 mg of norethindrone and 0.035 mg of ethinyl estradiol. Inactive ingredients include D&C Yellow No. 10 Aluminum Lake, microcrystalline cellulose, lactose (anhydrous), magnesium stearate, polacrilin potassium, and povidone. Each white tablet in the Necon® 10/11 package contains only inert ingredients as listed under white tablets in Necon® 1/35.
Each of the following products is a combination oral contraceptive containing the progestational compound norethindrone and the estrogenic compound mestranol:
Necon® 1/50: Each light blue tablet contains1 mg of norethindrone and 0.05 mg of mestranol. Inactive ingredients include FD&C Blue No. 1 Aluminum Lake, microcrystalline cellulose, lactose (anhydrous), magnesium stearate, polacrilin potassium, and povidone. Each white tablet in the Necon® 1/50 package contains only inert ingredients as listed under white tablets in Necon® 1/35.
The chemical name for norethindrone is 17-hydroxy-19-nor -17α-pregn-4-en-20-yn-3-one, for ethinyl estradiol is 19-nor-17α-pregna-1,3,5(10)-trien-20-yn-3,17-diol, and for mestranol is 3-methoxy-19-nor-17α-pregna-1,3,5(10)-trien-20-yn-17-ol. The structural formulas are as follows:
norethindrone Molecular formula C20 H26 O2 M.W. = 298.43
ethinyl estradiol Molecular formula C20 H24 O2 M.W. = 296.41
mestranol Molecular formula C21 H26 O2 M.W. = 310.44
CLINICAL PHARMACOLOGY
Combination oral contraceptives act by suppression of gonadotropins. 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 reduce the likelihood of implantation).
INDICATIONS AND USAGE
Necon® 1/35, Necon® 0.5/35, Necon® 10/11, and Necon® 1/50 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 I 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, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.
% of Women Experiencing anUnintended Pregnancywithin the First Year of Use | % of WomenContinuing Useat One Year3 – | ||
Method(1) | Typical Use1 – (2) | Perfect Use2 – (3) | (4) |
Adapted from Hatcher et al., 1998 Ref. #1. | |||
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. | |||
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 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 |
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