NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL kit

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U), NORETHINDRONE ACETATE (UNII: 9S44LIC7OJ) (NORETHINDRONE - UNII:T18F433X4S)

Sẵn có từ:

A-S Medication Solutions

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate 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 I 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. % of Women Experiencing an Unintended Pregnancy in the First Year of Continuous Use Method Lowest Expected* Typical** (No contraception)  (85) (85) Oral contraceptives  3       combined  0.1 N/A ***       progestin only  0.5 N/A *** Diaphragm with spermicidal cream or jelly  6 20 Spermicides alone (foam, creams, gels, vaginal suppositories and vaginal film)  6 26 Vaginal Sponge       nulliparous  9 20       parous 20 40 Implant  0.05 0.05 Inj

Tóm tắt sản phẩm:

Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.02 mg and Ferrous Fumarate Tablets, 75 mg are packaged in a carton of three pouches (NDC 0378-7283-53); each pouch contains a blister pack of 28 tablets. Each blister pack contains 21 white to off-white, round, flat-faced, unscored tablet debossed with 239 on one side and plain on the other side and 7 brown, round, flat-faced, unscored tablets debossed with 291 on one side and plain on the other side. Each brown tablet contains 75 mg ferrous fumarate. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL- NORETHINDRONE ACETATE AND
ETHINYL ESTRADIOL
A-S MEDICATION SOLUTIONS
----------
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS USP, 1 MG/0.02 MG
AND FERROUS FUMARATE
TABLETS, 75 MG*
*FERROUS FUMARATE TABLETS ARE NOT USP FOR DISSOLUTION AND ASSAY
Rx only
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV INFECTION (AIDS) AND
OTHER SEXUALLY TRANSMITTED DISEASES.
DESCRIPTION
Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous
Fumarate Tablets are a
progestogen-estrogen combination.
Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.02 mg
and Ferrous Fumarate Tablets,
75 mg provide a continuous dosage regimen consisting of 21 oral
contraceptive tablets and seven
ferrous fumarate tablets. The ferrous fumarate tablets are present to
facilitate ease of drug
administration via a 28-day regimen, are non-hormonal, and do not
serve any therapeutic purpose.
Each white to off-white tablet contains norethindrone acetate
(19-Norpregn-4-en-20-yn-3-one, 17-
(acetyloxy)-, (17α)), 1 mg; ethinyl estradiol
(19-Norpregna-1,3,5(10)-trien-20-yne-3, 17-diol, (17α)-),
0.02 mg. Also contains compressible sugar, croscarmellose sodium,
_dl_-α-tocopherol, lactose
anhydrous, lactose monohydrate, magnesium stearate, povidone K-25,
sodium lauryl sulphate.
The structural formulas are as follows:
Each brown tablet contains colloidal silicon dioxide, croscarmellose
sodium, ferrous fumarate, lactose
monohydrate, magnesium stearate, microcrystalline cellulose, povidone
K-90.
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
The pharmacokinetics of norethindrone acetate and ethinyl estradiol
tablets have not been characterized;
howev