MICROGESTIN FE- norethindrone acetate and ethinyl estradiol and ferrous fumarate kit MICROGESTIN- norethindrone acetate and eth

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Physicians Total Care, Inc.

INN（国际名称）:

NORETHINDRONE ACETATE

组成:

NORETHINDRONE ACETATE 1 mg

处方类型:

PRESCRIPTION DRUG

疗效迹象:

MICROGESTIN ® 1/20, MICROGESTIN ® Fe 1/20 , MICROGESTIN ® 1.5/30, and MICROGESTIN ® Fe 1.5/30 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 Thrombophlebitis or thromboembolic disorders - A past history of deep vein thrombophlebitis or thromboembolic disorders A past history of deep vein thrombophlebitis or thromboembolic disorders - Cerebral vascular or coronary artery disease Cerebral vascular or coronary artery dise

產品總結:

MICROGESTIN 1/20: Each dispenser contains 21 norethindrone acetate and ethinyl estradiol tablets. Microgestin is available as round white tablets debossed with WATSON 630 on one side and plain on the other side. Each tablet contains 1 mg of norethindrone acetate and 20 mcg of ethinyl estradiol. They are supplied as follows: 1 dispenser of 21 tablets:                                  NDC-54868-6213-0 MICROGESTIN Fe 1/20: Each dispenser contains 21 norethindrone acetate and ethinyl estradiol tablets and 7 ferrous fumarate tablets. Microgestin Fe is available as round white tablets debossed with WATSON 630 on one side and plain on the other side. Each white tablet contains 1 mg of norethindrone acetate and 20 mcg of ethinyl estradiol. Ferrous fumarate tablets are available as round brown tablets debossed with WATSON 075 on one side and plain on the other side. Each tablet contains 75 mg ferrous fumarate. They are supplied as follows: 1 dispenser of 28 tablets:                                  NDC 54868-4744-0 Store at controlled room temperature 20°C to 25°C (68°F to 77°F). [See USP controlled room temperature.]

授权状态:

Abbreviated New Drug Application

资料单张

MICROGESTIN FE - NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND
FERROUS FUMARATE
MICROGESTIN - NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET
Physicians Total Care, Inc.
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BRIEF SUMMARY PATIENT PACKAGE
INSERT
Oral contraceptives, also known as “birth control pills” or “the
pill,” are taken to prevent pregnancy and,
when taken correctly, have a failure rate of about 1% per year when
used without missing any pills. The
typical failure rate of large numbers of pill users is less than 3%
per year when women who miss pills are
included. For most women oral contraceptives are also free of serious
or unpleasant side effects.
However, forgetting to take pills considerably increases the chances
of pregnancy.
For the majority of women, oral contraceptives can be taken safely.
But there are some women who are at
high risk of developing certain serious diseases that can be
life-threatening or may cause temporary or
permanent disability. The risks associated with taking oral
contraceptives increase significantly if you:
•
Smoke
•
Have high blood pressure, diabetes, high cholesterol
•
Have or have had clotting disorders, heart attack, stroke, angina
pectoris, cancer of the breast or
sex organs, jaundice, or malignant or benign liver tumors.
You should not take the pill if you suspect you are pregnant or have
unexplained vaginal bleeding.
Cigarette
smoking
increases the
risk of serious
cardiovascular
side effects
from oral
contraceptive
use. This risk
increases with
age and with
heavy smoking
(15 or more
cigarettes per
day) and is
quite marked
in women over
35 years of
age. Women
who use oral
contraceptives
are strongly
advised not to
smoke.
Most side effects of the pill are not serious. The most common side
effects are nausea, vomiting, bleeding
between menstrual periods, weight gain, breast tenderness, and
difficulty wearing contact lenses. These
side effects, especially nausea, vomiting, and breakthrough bleeding,
may subside within the first three
months of use.
The serious side effects of the pi

产品特点

MICROGESTIN FE - NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND
FERROUS FUMARATE
MICROGESTIN - NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET
PHYSICIANS TOTAL CARE, INC.
----------
MICROGESTIN 1/20
(NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS USP)
MICROGESTIN FE 1/20
(NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS USP AND FERROUS
FUMARATE TABLETS*)
*FERROUS FUMARATE TABLETS ARE NOT USP FOR DISSOLUTION AND ASSAY.
MICROGESTIN 1.5/30
(NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS USP)
MICROGESTIN FE 1.5/30
(NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS USP AND FERROUS
FUMARATE TABLETS*)
*FERROUS FUMARATE TABLETS ARE NOT USP FOR DISSOLUTION AND ASSAY.
RX ONLY
REVISED: OCTOBER 2007
14786
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV INFECTION (AIDS) AND
OTHER SEXUALLY TRANSMITTED DISEASES.
DESCRIPTION
MICROGESTIN 1/20, MICROGESTIN FE 1/20, MICROGESTIN 1.5/30, and
MICROGESTIN FE 1.5/30 are progestogen-estrogen combinations.
The structural formula of norethindrone acetate (17
alpha-ethinyl-19-nortestosterone acetate) and
ethinyl estradiol (17 alpha-ethinyl-1, 3, 5(10)-estratriene-3, 17
beta-diol) are as follows:
®
®
®
®
®
®
®
®
Microgestin Fe 1/20 provides a continuous dosage regimen consisting of
21 white oral contraceptive
tablets and 7 brown 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, for oral administration, contains 1 mg
norethindrone acetate and 20 mcg ethinyl
estradiol. It also contains the following inactive ingredients:
anhydrous lactose, ethyl alcohol,
magnesium stearate, microcrystalline cellulose, polacrilin potassium,
and povidone.
Each brown tablet for oral administration contains 75 mg ferrous
fumarate, USP, magnesium stearate,
NF, microcrystalline cellulose, NF, sodium starch glycolate, NF.
Microgestin Fe 1.5/30 provides a continuous dosage regimen consisting
of 21 green ora