LEVONORGESTREL AND ETHINYL ESTRADIOL kit

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Naari Pte Limited

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

Levonorgestrel and ethinyl estradiol tablets 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 contrac

leaflet_short:

Levonorgestrel and ethinyl estradiol tablets USP 0.1 mg/0.02 mg are available in a blister pack (NDC 79929-004-05) containing 28 tablets, as follows: 21 active tablets: white to off-white, round, flat faced beveled edge, uncoated tablets debossed with ‘EH1’ on one side and plain on other side (0.1 mg levonorgestrel USP and 0.02 mg ethinyl estradiol USP) 7 inert tablets: peach color, round, flat faced beveled edge, uncoated tablets debossed with "EH2" on one side and plain on other side, tablets may have mottled appearance on either of the surface. The blister packs are available in box of  3 (NDC 79929-004-07) Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. ® The brands listed are trademarks of their respective owners. Manufactured For: Naari Pte Limited 36 Robinson Road, #13-01 City House, Singapore 068877 Issued December 2021                                                                                         Levonorgestrel and Ethinyl Estradiol Tablets

authorization_status:

Abbreviated New Drug Application

SPC

LEVONORGESTREL AND ETHINYL ESTRADIOL- LEVONORGESTREL AND ETHINYL
ESTRADIOL
NAARI PTE LIMITED
----------
LEVONORGESTREL AND ETHINYL ESTRADIOL 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
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 monohydrate, magnesium stearate, and pregelatinized starch
(maize).
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
21
28
2
20
24
2
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 between 38%
and 48%.
After a single dose of levonorgestrel and ethinyl estradiol tablets to
22 women under
fasting conditi