ELINEST — norgestrel and ethinyl estradiol
Northstar Rx LLC
ORAL CONTRACEPTIVE AGENTS
Each pale pink tablet, for oral administration contains 0.3 mg of norgestrel and 0.03 mg ethinyl estradiol and the following inactive ingredients: titanium dioxide, macrogol/PEG 3350 NF, talc, polyvinyl alcohol, lecithin (soya), FD&C Red #40, FD&C Yellow #6, FD&C Blue #1, lactose monohydrate, magnesium stearate and pregelatinized starch.
Each inactive white tablet, for oral administration, in the 28 day regimen contains the following inactive ingredients: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol 8000, lactose monohydrate, magnesium stearate and pregelatinized corn starch.
Norgestrel is a totally synthetic progestogen, insoluble in water, freely soluble in chloroform, sparingly soluble in alcohol with the chemical name (±)-13-Ethyl-17-hydroxy-18,19-dinor-17 -preg-4-en-20-yn-3-one. Ethinyl estradiol is an estrogen, insoluble in water, soluble in alcohol, in chloroform, in ether, in vegetable oils, and in solutions of fixed alkali hydroxides with the chemical name 19-nor-17 -pregna-1,3,5(10)-trien-20-yne-3,17-diol. Their structural formulae follow:
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).
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 A CONTRACEPTIVE METHOD|
|Method||Perfect Use||Average Use|
|Depo-Provera® (injectable progestogen)||0.30||0.30|
|Copper T 380A||0.60||0.80|
|Condom (male) without spermicide||3||14|
|(female) without spermicide||5||21|
|Never given birth||9||20|
|Never given birth||9||20|
|Diaphragm with spermicidal cream or jelly||6||20|
|Spermicides alone (foam, creams, jellies,and vaginal suppositories)||6||26|
|Periodic abstinence (all methods)||1-9*||25|
|No contraception (planned pregnancy)||85||85|
|NA- not available|
|*Depending on method (calendar, ovulation symptothermal, post-ovulation) Adapted from Hatcher RA et al, Contraceptive Technology : 17t h Revised Edition. NY, NY: Ardent Medi, Inc., 1998|
- Thrombophlebitis or thromboembolic disorders
- A past history of deep vein thrombophlebitis or thromboembolic disorders
- Cerebral vascular or coronary artery disease
- Known or suspected carcinoma of the breast
- Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
- Undiagnosed abnormal genital bleeding
- Cholestatic jaundice of pregnancy or jaundice with prior pill use
- Hepatic adenomas, carcinomas or benign liver tumors
- Known or suspected pregnancy
- Are receiving Hepatitis C drug combinations containing ombitasvir/ paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations (see Warnings,RISK OF LIVER ENZYME ELEVATIONS WITH CONCOMITANT HEPATITIS C TREATMENT).
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.
The information contained in this package insert is principally based on studies carried out in patients who used oral contraceptives with higher formulations of both estrogens and progestogens than those in common use today. The effect of long-term use of the oral contraceptives with lower formulations of both estrogens and progestogens remains to be determined.
Throughout this labeling, epidemiological studies reported are of two types: retrospective or case control studies and prospective or cohort studies. Case control studies provide a measure of the relative risk of a disease. Relative risk, the ratio of the incidence of a disease among oral contraceptive users to that among non-users, cannot be assessed directly from case control studies, but the odds ratio obtained is a measure of relative risk. The relative risk does not provide information on the actual clinical occurrence of a disease. Cohort studies provide not only a measure of relative risk but a measure of attributable risk, which is the difference in the incidence of disease between the oral contraceptive users and non-users. The attributable risk does provide information about the actual occurrence of a disease in the population. (Adapted from ref. 12 and 13 with the author’s permission.) For further information, the reader is referred to a text on epidemiological methods.
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