Levonorgestrel and Ethinyl Estradiol

LEVONORGESTREL AND ETHINYL ESTRADIOL-
Amneal Pharmaceuticals NY LLC

DESCRIPTION

21 white levonorgestrel and ethinyl estradiol tablets, USP each containing 0.15 mg of levonorgestrel, USP, (d(-)-13 beta-ethyl-17-alpha-ethinyl-17-beta-hydroxygon-4-en-3-one), a totally synthetic progestogen, and 0.03 mg of ethinyl estradiol, USP, (19-nor-17α-pregna-1,3,5 (10)-trien-20-yne-3,17-diol), and 7 yellow inert tablets. The inactive ingredients present in both tablets are lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polacrilin potassium. White tablets are coated with Aqua Polish White 014.17 MS which contains hydrogenated cottonseed oil, hydroxypropylcellulose, hydroxypropylmethylcellulose, talc and titanium dioxide. Yellow inert tablets are coated with Aqua Polish Yellow 024.15 MS which contains hydrogenated cottonseed oil, hydroxypropylcellulose, hydroxypropylmethylcellulose, ferric oxide red, ferric oxide yellow, talc, and titanium dioxide.

chem structures
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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

Oral contraceptives 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 and the IUD, 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 USE OF A CONTRACEPTIVE METHOD

Method

PerfectUse

TypicalUse

Levonorgestrel implants

0.05

0.05

Male sterilization

0.1

0.15

Female sterilization

0.5

0.5

Depo-Provera® (injectable progestogen)

0.3

0.3

Oral contraceptives

5

Combined

0.1

NA

Progestin only

0.5

NA

IUD

Progesterone

1.5

2

Copper T 380A

0.6

0.8

Condom (male) without spermicide

3

14

(Female) without spermicide

5

21

Cervical cap

Nulliparous women

9

20

Parous women

26

40

Vaginal sponge

Nulliparous women

9

20

Parous women

20

40

Diaphragm with spermicidal cream or jelly

6

20

Spermicides alone (foam, creams, jellies, and vaginal suppositories)

6

26

Periodic abstinence (all methods)

1 to 9*

25

Withdrawal

4

19

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: 17th Revised Edition. NY, NY: Ardent Media, Inc., 1998.


CONTRAINDICATIONS

Combination oral contraceptives should not be used in women with any of the following conditions:

Thrombophlebitis or thromboembolic disorders.

A past history of deep-vein thrombophlebitis or thromboembolic disorders.

Cerebral-vascular or coronary artery disease.

Thrombogenic valvulopathies.

Thrombogenic rhythm disorders.

Diabetes with vascular involvement.

Uncontrolled hypertension.

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 or carcinomas, or active liver disease, as long as liver function has not returned to normal.

Known or suspected pregnancy.

Hypersensitivity to any of the components of levonorgestrel and ethinyl estradiol tablets.

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).

WARNINGS

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with the extent of smoking (in epidemiologic studies, 15 or more cigarettes per day was associated with a significantly increased risk) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.

The use of oral contraceptives is associated with increased risks of several serious conditions including venous and arterial thrombotic and thromboembolic events (such as myocardial infarction, thromboembolism, and stroke), hepatic neoplasia, gallbladder disease, and hypertension, 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 certain inherited or acquired thrombophilias, hypertension, hyperlipidemias, obesity, and diabetes.

Practitioners prescribing oral contraceptives should be familiar with the following information relating to these risks.

The information contained in this package insert is based principally on studies carried out in patients who used oral contraceptives with higher formulations of 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 disease, namely, a ratio of the incidence of a disease among oral contraceptive users to that among non-users. The relative risk does not provide information on the actual clinical occurrence of a disease. Cohort studies provide a measure of attributable risk, which is the difference in the incidence of disease between oral contraceptive users and non-users. The attributable risk does provide information about the actual occurrence of a disease in the population. For further information, the reader is referred to a text on epidemiological methods.

1. Thromboembolic Disorders and Other Vascular Problems

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