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:

Lupin Pharmaceuticals, Inc.

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Levonorgestrel and ethinyl estradiol tablets USP, 0.1 mg and 0.02 mg 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. Emergency Contraceptive Pills: The FDA has concluded that certain combined oral contraceptives containing ethinyl estradiol and norgestrel or levonorgestrel are safe and effective for use as postcoital emergency contraception. Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9 Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraceptio

Product summary:

Levonorgestrel and ethinyl estradiol tablets USP, 0.1 mg/0.02 mg are available in 3 wallets, each containing 28 tablets as follows. Each wallet contains 21 white to off white round bevel edged tablets each containing 0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol, debossed with "LU" on one side and "T21" on the other side and 7 orange round bevel edged inert tablets debossed with "LU" on one side and "T22" on the other side. They are supplied as follows: Levonorgestrel and ethinyl estradiol tablets USP, 0.1 mg/0.02 mg are available in a wallet (NDC 68180-854-11) of 28 tablets, such 3 wallets are packed in a carton (NDC 68180-854-13). Store at 25° C (77° F); excursions permitted to 15°- 30° C (59°- 86° F) [see USP Controlled Room Temperature]

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LEVONORGESTREL AND ETHINYL ESTRADIOL - LEVONORGESTREL AND ETHINYL
ESTRADIOL
LUPIN PHARMACEUTICALS, INC.
----------
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, white tablet (21) contains 0.1 mg of levonorgestrel,
d(-)-13β- ethyl-17α-ethinyl-17β-
hydroxygon-4-en-3-one, a totally synthetic progestogen, and 0.02 mg of
ethinyl estradiol, 17α-ethinyl-
1,3,5(10)-estratriene-3, 17β-diol. The inactive ingredients present
are croscarmellose sodium, lactose
monohydrate, magnesium stearate, microcrystalline cellulose and
povidone.
Each inert, orange tablet (7) contains the following inactive
ingredients: croscarmellose sodium, FD&C
Yellow #6, lactose monohydrate, magnesium stearate, and
microcrystalline cellulose.
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 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
between 38% and 48%.
After a single dose of levonorgestrel and ethinyl estradiol tablets to
22 women under fasting conditions,
maximum