SRONYX- levonorgestrel and ethinyl estradiol kit

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Mayne Pharma Inc.

INN (Isem Internazzjonali):

Levonorgestrel

Kompożizzjoni:

Levonorgestrel 0.1 mg

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table III 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, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Levonorgestrel and ethinyl estradiol tablets are contraindicated in females who are known to have or develop the following conditions: - Thrombophlebitis or thromboembolic disorders - A past history of deep-vein thrombophlebitis or thromboembolic disorders - Cerebral-vascular or coronary-artery disease - Current diagnosis of, or history of, breast cancer, which may be hormone sensitive - Carcinoma of the endometrium or other known or suspected estrogen dependent neoplasia - Undiagnosed abnormal genital bleeding

Sommarju tal-prodott:

Sronyx® is 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 "967" 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.]

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

SRONYX- LEVONORGESTREL AND ETHINYL ESTRADIOL
MAYNE PHARMA INC.
----------
SRONYX
(LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS USP)
PHYSICIAN LABELING
RX ONLY
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV
INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES.
DESCRIPTION
Each cycle of Sronyx
(Levonorgestrel and Ethinyl Estradiol Tablets USP) consists of 21
white active tablets each containing 0.1 mg levonorgestrel and 0.02 mg
ethinyl estradiol;
and seven peach tablets – inert. The inactive ingredients are
Croscarmellose Sodium NF,
Lactose Monohydrate NF, Magnesium Stearate NF, Microcrystalline
Cellulose (PH 102)
NF, and Povidone (K29/32) NF. Each inactive, placebo tablet contains
the following
inactive ingredients: FD & C Yellow #6 Lake 35-42%, Lactose Anhydrous
(DT Micro) NF,
Lactose Monohydrate (200M) NF, Magnesium Stearate NF and
Microcrystalline Cellulose
NF.
Levonorgestrel has a molecular weight of 312.4 and a molecular formula
of C
H
O .
Ethinyl estradiol has a molecular weight of 296.4 and a molecular
formula of C
H
O .
The structural formulas are as follows:
CLINICAL PHARMACOLOGY
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
®
®
21
28
2
20
24
2
estradiol of Levonorgestrel and Ethinyl Estradiol Tablets USP in
humans has been
conducted. However, literature indicates that levonorgestrel is
rapidly and completely
absorbed after oral administration 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 absolute
bioavailability of
ethinyl es