MICROGESTIN FE 1.5/30- norethindrone acetate and ethinyl estradiol and ferrous fumarate kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

RPK Pharmaceuticals, Inc.

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

MICROGESTIN and MICROGESTIN Fe 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. Oral contraceptives should not be used in women who currently have the following conditions: - Thrombophlebitis or thromboembolic disorders - A past history of deep vein thrombophlebitis or thromboembolic disorders - Cerebral vascular or coronary artery disease - Known or suspected carcinoma of the breast - Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia - Undiagnosed abnormal genital bleeding - Cholestatic jaundice of pregnancy or jaundice with prior pill u

Product summary:

 MICROGESTIN 1/20 is available in dispensers each containing 21 white tablets. Each tablet contains 1 mg of norethindrone acetate and 20 mcg of ethinyl estradiol, with “P-D 915” embossed only on one side. Available in packages of 6 dispensers. NDC  51862-007-06 MICROGESTIN Fe 1/20 is available in dispensers each containing 21 white tablets and 7 brown tablets. Each white tablet contains 1 mg of norethindrone acetate and 20 mcg of ethinyl estradiol, with “P-D 915” embossed only on one side. Each brown tablet contains 75 mg ferrous fumarate, with “624” embossed on one side and “WC” on the other side. Available in packages of 6 dispensers. NDC  51862-012-06 MICROGESTIN 1.5/30 is available in dispensers each containing 21 green tablets. Each tablet contains 1.5 mg of norethindrone acetate and 30 mcg of ethinyl estradiol, with “P-D 916” embossed only on one side. Available in packages of 6 dispensers. NDC  51862-279-06 MICROGESTIN Fe 1.5/30 is available in dispensers each containing 21 green tablets and 7 brown tablets. Each green tablet contains 1.5 mg of norethindrone acetate and 30 mcg of ethinyl estradiol, with “P-D 916” embossed only on one side. Each brown tablet contains 75 mg ferrous fumarate, with “624” embossed on one side and “WC” on the other side. Available in packages of 6 dispensers. NDC  51862-292-06 Store below 30˚ C (86˚ F).

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

MICROGESTIN FE 1.5/30- NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND
FERROUS FUMARATE
RPK PHARMACEUTICALS, INC.
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MICROGESTIN®
(NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS, USP)
MICROGESTIN® 1/20
(Each white tablet contains 1 mg norethindrone acetate and 20 mcg
ethinyl estradiol.)
MICROGESTIN® 1.5/30
(Each green tablet contains 1.5 mg norethindrone acetate and 30 mcg
ethinyl estradiol.)
MICROGESTIN® FE
(NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS, USP AND FERROUS
FUMARATE TABLETS*)
*FERROUS FUMARATE TABLETS ARE NOT USP FOR DISSOLUTION AND ASSAY.
MICROGESTIN® FE 1/20
(Each white tablet contains 1 mg norethindrone acetate and 20 mcg
ethinyl estradiol. Each brown tablet
contains 75 mg ferrous fumarate.)
MICROGESTIN® FE 1.5/30
(Each green tablet contains 1.5 mg norethindrone acetate and 30 mcg
ethinyl estradiol. Each brown tablet
contains 75 mg ferrous fumarate.)
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV INFECTION (AIDS) AND
OTHER SEXUALLY TRANSMITTED DISEASES.
DESCRIPTION
MICROGESTIN and MICROGESTIN Fe are progestogen-estrogen combinations.
MICROGESTIN Fe 1/20 and 1.5/30: Each provides 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 tablet contains norethindrone acetate (17
alpha-ethinyl-19-nortestosterone acetate), 1 mg;
ethinyl estradiol (17 alpha-ethinyl-1,3,5(10)-estratriene-3, 17
beta-diol), 20 mcg. Also contains acacia,
NF; lactose, NF; magnesium stearate, NF; starch, NF; confectioner’s
sugar, NF; talc, USP.
Each green tablet contains norethindrone acetate (17
alpha-ethinyl-19-nortestosterone acetate), 1.5 mg;
ethinyl estradiol (17 alpha-ethinyl-1,3,5(10)-estratriene-3, 17
beta-diol), 30 mcg. Also contains acacia,
NF; lactose, NF; magnesium stearate, NF; starch, NF; confectioner’s
sugar, NF; talc, USP; D&C ye