LEVONORGESTREL AND ETHINYL ESTRADIOL- levonorgestrel and ethinyl estradiol

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U), LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW)

Available from:

A-S Medication Solutions

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Levonorgestrel and ethinyl estradiol tablets, USP are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table II 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, the IUD, and Norplant® System, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. % of Women Experiencing an Unintended Pregnancy Within the First Year of Use % of Women Continuing Use at One Year3 Method Typical Use1 Perfect Use2 (1) (2) (3) (4) Chance4 85 85 Spermicides5 26 6 40 Periodic abstinence 25 63      Calendar 9      Ovulation Method 3      Sympto-Thermal6 2      Post-Ovulation 1 Cap7      Parous women 40 26 42      Nulliparous women 20 9 56 Sponge      Parous women 40 20 42      Nulliparous women 20 9 56 Diaphragm

Product summary:

Levonorgestrel and ethinyl estradiol tablets, USP are available in 28 tablets. Each pack contains: 21 active tablets: light yellow colored, uncoated, round, unscored, flat tablets debossed with 201 on one side and blank on the other side. 7 inert tablets: brown colored, uncoated, round, unscored flat tablets debossed with 271 on one side and blank on the other side. Levonorgestrel and Ethinyl Estradiol Tablets, USP are available as follows: NDC 0378-7287-53, Carton of 3 pouches, each pouch containing 28 tablets NDC 0378-7287-56, Carton of 6 pouches, each pouch containing 28 tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. References available upon request.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LEVONORGESTREL AND ETHINYL ESTRADIOL- LEVONORGESTREL AND ETHINYL
ESTRADIOL
A-S MEDICATION SOLUTIONS
----------
LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS USP, 0.1 MG/0.02 MG
RX ONLY
PATIENTS SHOULD BE COUNSELED THAT ORAL CONTRACEPTIVES DO NOT PROTECT
AGAINST TRANSMISSION OF HIV
(AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES (STDS) SUCH AS
CHLAMYDIA, GENITAL HERPES, GENITAL
WARTS, GONORRHEA, HEPATITIS B, AND SYPHILIS.
DESCRIPTION
Each active, light yellow tablet (21) contains 0.1 mg of
levonorgestrel, d(-)-13-β-ethyl-17-α-ethinyl-17-
β-hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg
of ethinyl estradiol, 17-α-
ethinyl-1,3,5(10)-estratriene-3,17-β-diol. The inactive ingredients
present are croscarmellose sodium,
ferric oxide of iron (yellow), ferric oxide of iron (red), lactose
monohydrate, magnesium stearate,
microcrystalline cellulose, povidone K-25, and sodium lauryl sulfate.
Each inactive, brown tablet (7) contains the following inactive
ingredients: croscarmellose sodium,
ferric oxide of iron (brown), lactose monohydrate, magnesium stearate,
microcrystalline cellulose, and
povidone K-25.
CLINICAL PHARMACOLOGY
MODE OF ACTION
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).
PHARMACOKINETICS
_Absorption_
No specific investigation of the absolute bioavailability of
levonorgestrel and ethinyl estradiol tablets
in humans has been conducted. However, literature indicates that
levonorgestrel is rapidly and
completely absorbed after oral administration (bioavailability about
100%) and is not subject to first-
pass metabolism. Ethinyl estradiol is rapidly and almost completely
absorbed from the gastrointestinal
tract but, due to first-pass metabolism in gut mucosa and liver, the
bioavailability of ethinyl estradiol is