AVIANE 28 DAY- levonorgestrel and ethinyl estradiol kit

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:

Rebel Distributors Corp

INN (International Name):

LEVONORGESTREL

Composition:

LEVONORGESTREL 0.1 mg

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Aviane 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 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 % of Women Continuing Method Typical Use † Perfect Use ‡ Levonorgestrel In a clinical trial with levonorgestrel and ethinyl estradiol 0.10 mg/0.02 mg tablets, 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. This represents an overall pregnancy rate of 0.84 per 100 woman-years. This rate includes patients who did not take the drug correctly. One or more pills were missed during 1,479 (18.8%) of t

Product summary:

Aviane® – 28 tablets (0.10 mg levonorgestrel and 0.02 mg ethinyl estradiol tablets, USP) are packaged in blister cards, each containing 21 orange active tablets and 7 light-green inert tablets. Each orange tablet is round, coated and debossed with dp on one side and 016 on the other side. Each light-green tablet is round and debossed with dp on one side and 519 on the other side. NDC 21695-995-28 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AVIANE 28 DAY- LEVONORGESTREL AND ETHINYL ESTRADIOL
REBEL DISTRIBUTORS CORP
----------
AVIANE - 28 DAY
(LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS, USP)
RX ONLY
Iss. 8/2009
11001539
9045
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES.
DESCRIPTION
21 orange active tablets each containing 0.10 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 Yellow No. 6 Aluminum
Lake, hypromellose, lactose monohydrate, magnesium stearate,
microcrystalline cellulose, polyethylene
glycol, pregelatinized starch, sodium starch glycolate and titanium
dioxide.
7 Light-green, inert tablets each contain: D&C Yellow No. 10 Aluminum
Lake, FD&C Blue No. 1
Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, lactose monohydrate,
magnesium stearate,
microcrystalline cellulose and pregelatinized starch.
LEVONORG ESTREL ETHINYL ESTRADIOL MOLECULAR WEIG HT: 312.4 5 C H O
MOLECULAR WEIG HT: 296.4 0
C
H
O
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 Aviane
(levonorgestrel and ethinyl
estradiol tablets, USP) in humans has been conducted. However,
literature indicates that levonorgestrel
is rapidly and completely absorbed after oral administration
(bioavailability about 100%) and is not
®
21
28
2
20
24
2
®
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
a