LARISSIA- levonorgestrel and ethinyl estradiol kit

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Amneal Pharmaceuticals NY LLC

INN (Nama Internasional):

LEVONORGESTREL

Komposisi:

LEVONORGESTREL 0.1 mg

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Larissia 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 First Year of Use % of Women Continuing Use at One Year3 Method Typical Use1 Perfect Use2 (1) (2) (3) (4) Chance4 Spermicides5 Periodic abstinence Calendar Ovulation Method Sympto-Thermal6 Post-Ovulation Cap7 Parous Women Nulliparous Women Sponge Parous Women Nulliparous Women Diaphragm7 Withdrawal Condom8 Female (Reality) Male Pill Progestin only Combined IUD Progesterone T Copper T380A LNg 20 Depo-Provera® Levonorgestrel Impl

Ringkasan produk:

Larissia (levonorgestrel and ethinyl estradiol tablets, USP, 0.1 mg/0.02 mg) are available as follows: NDC  69238-1531-6 Blister Pack of 28 Tablets 21 active tablets: white, round biconvex, film-coated tablet debossed with “C4” on one side. 7 inert tablets: yellow, round biconvex, film-coated tablet debossed with “C2” on one side. Store at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature]. Made in Germany Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 08-2017-03

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

LARISSIA- LEVONORGESTREL AND ETHINYL ESTRADIOL
AMNEAL PHARMACEUTICALS NY LLC
----------
LARISSIA
(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, USP,
d(-)-13β-ethyl-
17α-ethinyl-17β-hydroxygon-4-en-3-one, a totally synthetic
progestogen, and 0.02 mg
of ethinyl estradiol, USP, 17α-ethinyl-1,3,5(10)-estratriene-3,
17β-diol. The inactive
ingredients present are lactose monohydrate, magnesium stearate,
microcrystalline
cellulose, polacrilin potassium and Aqua Polish White 014.17 MS which
contains
hydroxypropylcellulose, hydrogenated cottonseed oil,
hydroxypropylmethylcellulose,
talc, and titanium dioxide.
Each inactive, yellow tablet (7) contains the following inactive
ingredients: lactose
monohydrate, magnesium stearate, microcrystalline cellulose,
polacrilin potassium and
Aqua Polish Yellow 024.15 MS which contains hydroxypropylcellulose,
hydrogenated
cottonseed oil, hydroxypropylmethylcellulose, ferric oxide red, ferric
oxide yellow, talc,
and titanium dioxide.
TM
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