LUTERA- levonorgestrel and ethinyl estradiol kit

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

Levonorgestrel (UNII: 5W7SIA7YZW) (Levonorgestrel - UNII:5W7SIA7YZW), Ethinyl Estradiol (UNII: 423D2T571U) (Ethinyl Estradiol - UNII:423D2T571U)

Tilgængelig fra:

Mayne Pharma Inc.

INN (International Name):

Levonorgestrel

Sammensætning:

Levonorgestrel 0.1 mg

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Lutera 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. In a clinical trial with levonorgestrel and ethinyl estradiol 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 the 7,870 cycles; thus all tablets were taken during 6,391 (81.2%) of the 7,870 cycles. Of the total 7,870 cycles, a total of 150 cycles were exclud

Produkt oversigt:

Lutera® tablets (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol) are available in a 28 Tablet Dispenser, arranged in 3 rows of 7 active tablets and 1 row of inert tablets, as follows: 21 active tablets: white, round tablet debossed with "WATSON" on one side and "949" on the other side. 7 inert tablets: peach, round tablet debossed with "WATSON" on one side and "P1" on the other side. Store at 20° to 25°C (68° to 77°F). [See USP controlled room temperature].

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

LUTERA- LEVONORGESTREL AND ETHINYL ESTRADIOL
MAYNE PHARMA INC.
----------
LUTERA®
(LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS USP)
RX ONLY
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV
INFECTION (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 inactive, peach tablet (7) contains the following inactive
ingredients: FD&C Yellow
#6, lactose anhydrous, lactose monohydrate, magnesium stearate, and
microcrystalline
cellulose.
C
H
O M.W. 312.45
C
H
O M.W. 296.4
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
21
28
2
20
24
2
PHARMACOKINETICS
Absorption
No specific investigation of the absolute bioavailability of Lutera 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 Lutera to 22 women under fasting conditions,
maximum serum
concentrations of levonorgestrel are 2.8 ± 0.9 ng/m