Levora

LEVORA- levonorgestrel and ethinyl estradiol
Rebel Distributors Corp

SUPPLEMENTAL PATIENT MATERIAL

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

ORAL CONTRACEPTIVE AGENTS DESCRIPTION

Levora ® 0.15/30-28 Tablets provide an oral contraceptive regimen consisting of 21 white tablets containing levonorgestrel 0.15 mg and ethinyl estradiol 0.03 mg followed by 7 peach tablets containing inert ingredients.

Levonorgestrel is a totally synthetic progestogen with the chemical name (–)-13-Ethyl-17-hydroxy-18,19-dinor-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:

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LEVONORGESTREL

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ETHINYL ESTRADIOL

The white Levora® 0.15/30 tablets contain the following inactive ingredients: croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, and povidone.

The inactive peach tablets in the 28-day regimen of Levora® 0.15/30 contain the following inactive ingredients: FD&C Yellow No. 6 Lake, Lactose Anhydrous, Lactose Monohydrate, Magnesium Stearate and Microcrystalline Cellulose.

CLINICAL PHARMACOLOGY

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).

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.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 A CONTRACEPTIVE FAILURE DURING THE FIRST YEAR OF PERFECT USE AND FIRST YEAR OF TYPICAL USE
% of Women Experiencing an Accidental
Pregnancy within the First Year of Use
Method Typical Usea Perfect Useb
a 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.
b 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.
Chance 85 85
Spermicides 21 6
Periodic abstinence 20 1-9
Withdrawal 19 4
Cap
Parous 36 26
Nulliparous 18 9
Sponge
Parous 36 20
Nulliparous 18 9
Diaphragm 18 6
Condom
Female 21 5
Male 12 3
Pill 3
Progestin only 0.5
Combined 0.1
IUD
Progesterone 2 1.5
Copper T 380A 0.8 0.6
Injection (Depo-Provera) 0.3 0.3
Implants (Norplant) 0.09 0.09
Female sterilization 0.4 0.4
Male sterilization 0.15 0.10
Adapted with permission.1

CONTRAINDICATIONS

Oral contraceptives should not be used in women who have the following conditions:

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

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