NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Pharmaceuticals Inc.

INN (International Name):

ETHINYL ESTRADIOL

Composition:

ETHINYL ESTRADIOL 0.02 mg

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 Injection: depot medroxyprogesterone acetate  0.3 0.3 IUD       progesterone T  1.5 2.0       copper T 380A  0.6 0.8       LNg 20  0.1 0.1 Condom without spermicides       female  5 21       male  3 14 Cervical Cap with spermicidal cream or jelly       nulliparous  9 20       parous  26 40 Periodic abstinence (all methods)  1-9 25 Withdrawal  4 19 Female sterilization  0.5 0.5 Male sterilization  0.10 0.15  

Product summary:

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.]

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL- NORETHINDRONE ACETATE
AND ETHINYL ESTRADIOL
MYLAN PHARMACEUTICALS INC.
----------
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS USP, 1 MG/0.02 MG
AND
FERROUS FUMARATE TABLETS, 75 MG*
Rx only
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.
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR
EVENTS
Cigarette smoking increases the risk of serious cardiovascular events
from
combination oral contraceptive (COC) use. This risk increases with
age, particularly
in women over 35 years of age, and with the number of cigarettes
smoked. For
this reason, COCs, including norethindrone acetate and ethinyl
estradiol tablets, are
contraindicated in women who are over 35 years of age and smoke (see
CONTRAINDICATIONS and WARNINGS).
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 placebo tablet contains colloidal silicon dioxide,
croscarmellose sodium,
ferrous fumarate, lactose monohydrate, magnesium stearate,
microcrystalline cellulose,
povidone K-90. The fe