Tarina® Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets)

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

RPK Pharmaceuticals, Inc.

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Tarina Fe 1/20 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 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. Adapted from RA Hatcher et al, Reference 7. * The authors' best guess of the percentage of women expected to experience an accidental pregnancy among couples who initiate a method (not necessarily for the first time) and who use it consistently and correctly during the first year if they do not stop for any other reason. ** This term represents “typical” couples who initiate use of a method (not necessarily for the first time), who experience an accidental pregnancy during the first year if they do not stop use

제품 요약:

Tarina Fe® 1/20 (norethindrone acetate and ethinyl estradiol tablets USP, 1 mg/0.02 mg and ferrous fumarate tablets, 75 mg) are packaged in a carton (NDC 50102-128-03) of three pouches (NDC 50102-128-01); 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.]

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

TARINA FE 1/20 - NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
RPK PHARMACEUTICALS, INC.
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TARINA® FE 1/20 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS,
USP AND FERROUS
FUMARATE TABLETS)
Rx only
TARINA FE 1/20
(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.
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV INFECTION (AIDS) AND
OTHER SEXUALLY TRANSMITTED DISEASES.
DESCRIPTION
Tarina Fe 1/20 tablets are a progestogen-estrogen combination.
Tarina Fe 1/20 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 lactose anhydrous, _dl_-α-tocopherol,
compressible sugar, crosscarmellose
sodium, lactose monohydrate, magnesium stearate, povidone K-25, sodium
lauryl sulphate.
The structural formulas are as follows:
Each brown tablet contains colloidal silicon dioxide, crosscarmellose
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;
however, the following pharmacokinetic information regarding
n