levora

$420.00

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Drug Description

Levora
(levonorgestrel and ethinyl estradiol)

SUPPLEMENTAL PATIENT MATERIAL

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

DESCRIPTION

Levora (levonorgestrel and ethinyl estradiol tablets) ® 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:

 

Levora (levonorgestrel and ethinyl estradiol) structural formula illustration

 

The white Levora (levonorgestrel and ethinyl estradiol tablets) ® 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 (levonorgestrel and ethinyl estradiol tablets) ® 0.15/30 contain the following inactive ingredients: FD&C Yellow No. 6 Lake, Lactose Anhydrous, Lactose Monohydrate, Magnesium Stearate and Microcrystalline Cellulose.

Indications

INDICATIONS

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
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
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.

 

QUESTION

Which of the following are methods for contraception?See Answer

Dosage

DOSAGE AND ADMINISTRATION

To achieve maximum contraceptive effectiveness, oral contraceptives must be taken exactly as directed and at intervals not exceeding 24 hours.

For a DAY 1 START, count the first day of menstrual flow as Day 1 and the first tablet (white) is then taken on Day 1. For a SUNDAY START when menstrual flow begins on or before Sunday, the first tablet (white) is taken on that day. With either a DAY 1 START or SUNDAY START, 1 tablet (white) is taken each day at the same time for 21 days. Then the peach tablets are taken for 7 days, whether bleeding has stopped or not. After all 28 tablets have been taken, whether bleeding has stopped or not, the same dosage schedule is repeated beginning on the following day.

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