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ARANELLE(norethindrone and ethinyl estradiol) kit

2014-09-28 22:36:33 来源: 作者: 【大中小】浏览:462次评论:0条

Aranelle®

(norethindrone and ethinyl estradiol tablets, USP)

28 Day Regimen

9066

Rx only

Iss. 7/2010

11001692

Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

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.

DESCRIPTION

Aranelle® 28-Day Regimen (norethindrone and ethinyl estradiol tablets, USP) provides a continuous oral contraceptive regimen of 7 light yellow tablets, 9 white tablets, 5 more light yellow tablets, and then 7 peach tablets. Each light yellow tablet contains norethindrone 0.5 mg and ethinyl estradiol 0.035 mg, each white tablet contains norethindrone 1 mg and ethinyl estradiol 0.035 mg, and each peach 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

Norethindrone

Ethinyl Estradiol

The light yellow tablet contains the following inactive ingredients, D&C yellow no. 10 aluminum lake, lactose monohydrate, magnesium stearate, and pregelatinized starch.

The white tablet contains the following inactive ingredients, lactose monohydrate, magnesium stearate, and pregelatinized starch.

The inactive peach tablets contain the following inactive ingredients, anhydrous lactose, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, and pregelatinized starch.

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 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 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.

TABLE I 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.

Source: Trussell J, Contraceptive Efficacy Table from 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.

*: Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.
†: 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.
‡: 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.
§: 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.
¶: Foams, creams, gels, vaginal suppositories, and vaginal film.
#: Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.
Þ: With spermicidal cream or jelly.
ß: Without spermicides.
à: 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).
è: 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.