ORSYTHIA- levonorgestrel and ethinyl estradiol

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Par Pharmaceutical

INN (International Name):

LEVONORGESTREL

Composition:

LEVONORGESTREL 0.1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ORSYTHIA®  (levonorgestrel and ethinyl estradiol tablets USP) is 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 levonorgestrel implants, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Injectable Progestogen 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, temp

Product summary:

ORSYTHIA® (levonorgestrel (0.1 mg) and ethinyl estradiol (0.02 mg) tablets USP) is packaged in cartons of 3 and 6 blister pack tablet dispensers. Each blister pack tablet dispenser contains 28 tablets as follows:  21 active tablets, pink, round, film-coated tablet debossed with "93" on one side and "684" on the other side. 7 inert tablets, light-green, round, film-coated tablet debossed with "93" on one side and "743" on the other side. Blister pack tablet dispenser NDC 0603-7634-01 Boxes of 3 blister pack tablet dispensers NDC 0603-7634-49 Boxes of 6 blister pack tablet dispensers NDC 0603-7634-17 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

ORSYTHIA- LEVONORGESTREL AND ETHINYL ESTRADIOL
PAR PHARMACEUTICAL
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ORSYTHIA (LEVONORGESTREL (0.1 MG) AND ETHINYL ESTRADIOL (0.02 MG)
TABLETS USP)
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
21 pink active tablets each containing 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 FD&C red #40 aluminum lake,
hypromellose, lactose monohydrate, magnesium stearate,
microcrystalline cellulose, polyethylene
glycol, pregelatinized starch and vitamin E.
7 light-green inert tablets, each containing FD&C blue #2,
hypromellose, iron oxide yellow, lactose
monohydrate, magnesium stearate, polyethylene glycol and
pregelatinized starch.
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 to 22
women under f