CHARLOTTE 24FE- norethindrone acetate and ethinyl estradiol and ferrous fumarate kit

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Glenmark Pharmaceuticals Inc., USA

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

Charlotte 24 Fe is indicated for use by females of reproductive age to prevent pregnancy [see Clinical Studies (14)] . The efficacy of Charlotte 24 Fe in women with a body mass index (BMI) of more than 35 kg/m2 has not been evaluated. Charlotte 24 Fe is contraindicated in females who are known to have or develop the following conditions: Risk Summary There is no use for contraception in pregnancy; therefore, norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets should be discontinued during pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to COCs before conception or during early pregnancy. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively. Risk Summary Contraceptive hormones and/or metabolites a

Bidhaa muhtasari:

Charlotte 24 Fe is available in blisters (dispensers) containing 28 tablets: NDC 68462-852-29             Cartons of 3 blisters (dispensers) Each blister contains 28 tablets in the following order: Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted between 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature]. Keep this and all drugs out of the reach of children.

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

CHARLOTTE 24FE- NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND
FERROUS
FUMARATE
GLENMARK PHARMACEUTICALS INC., USA
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CHARLOTTE 24 FE SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CHARLOTTE 24 FE.
CHARLOTTE 24 FE (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS
AND FERROUS FUMARATE
TABLETS), FOR ORAL USE
INITIAL U.S. APPROVAL: 1968
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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INDICATIONS AND USAGE
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Charlotte 24 Fe consists of 28 tablets in the following order (3):
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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®
WOMEN OVER 35 YEARS OLD WHO SMOKE SHOULD NOT USE CHARLOTTE 24 FE (4)
CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS
FROM
COMBINATION ORAL CONTRACEPTIVE (COC) USE (4)
Charlotte 24 Fe is a combination of norethindrone acetate, a
progestin, and ethinyl estradiol, an
estrogen, indicated for use by females of reproductive potential to
prevent pregnancy (1)
The efficacy in females of reproductive potential with a body mass
index of more than 35 kg/m has
not been evaluated (1, 8.8)
2
One tablet daily chewed and swallowed or swallowed whole taken at the
same time of day. Follow with
8 ounces of water (2.1)
Take one tablet by mouth at the same time every day for 28 days (2.1)
Take tablets in the order directed on the blister pack (2.1)
Tablets may be administered without regard to meals (12.3)
24 white to off-white chewable tablets (active), each containing 1 mg
norethindrone acetate, USP and
20 mcg ethinyl estradiol, USP
4 brown to dark brown tablets (non-hormonal placebo), each containing
75 mg ferrous fumarate, USP
which do not serve any therapeutic purpose
A high risk of arterial or venous thrombotic diseases (4)
Breast cancer (4)
Liver tumors or liver disea