LO LOESTRIN FE- norethindrone acetate and ethinyl estradiol, ethinyl estradiol and ferrous fumarate kit

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Allergan, Inc.

INN (Internationale Bezeichnung):

NORETHINDRONE ACETATE

Zusammensetzung:

NORETHINDRONE ACETATE 1 mg

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Lo Loestrin® Fe is indicated for use by women to prevent pregnancy [ see Clinical Studies (14) ] .   The efficacy of Lo Loestrin Fe in women with a body mass index (BMI) of > 35 kg/m2 has not been evaluated. Lo Loestrin Fe is contraindicated in females who are known to have or develop the following conditions: - A high risk of arterial or venous thrombotic diseases. Examples include women who are known to: • Smoke, if over age 35 [see Boxed Warning   and  Warnings and Precautions (5.1) ] • Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1) ] • Have cerebrovascular disease [see Warnings and Precautions (5.1) ] • Have coronary artery disease [see Warnings and Precautions (5.1) ] • Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions (5.1) ] • Have inherited or acquired hypercoagulopathies [see W

Produktbesonderheiten:

Lo Loestrin® Fe (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets and ferrous fumarate tablets) is available in blister cards (dispensers) containing 28 tablets:  NDC 0430-0420-14             Cartons of 5 blister cards (dispensers) NDC 0430-0420-60             Cartons of 30 blister cards (dispensers) Each blister card (28 tablets) contains in the following order: Store at 25º C (77º F); excursions permitted to 15 - 30º C (59 - 86º F) [see USP Controlled Room Temperature]. Keep this drug and all drugs out of the reach of children.

Berechtigungsstatus:

New Drug Application

Fachinformation

LO LOESTRIN FE- NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, ETHINYL
ESTRADIOL AND FERROUS FUMARATE
ALLERGAN, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LO
LOESTRIN FE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LO LOESTRIN FE.
LO LOESTRIN FE (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS,
ETHINYL ESTRADIOL
TABLETS AND FERROUS FUMARATE TABLETS)
INITIAL U.S. APPROVAL: 1968
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
WOMEN OVER 35 YEARS OLD WHO SMOKE SHOULD NOT USE LO LOESTRIN FE (4)
CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS
FROM
COMBINATION ORAL CONTRACEPTIVE (COC) USE (4)
RECENT MAJOR CHANGES
Warnings and Precautions (5.2) 04/2022
INDICATIONS AND USAGE
Lo Loestrin Fe is a combination of norethindrone acetate, a progestin,
and ethinyl estradiol, an
estrogen, indicated for use by women to prevent pregnancy (1)
The efficacy of Lo Loestrin Fe in women with a body mass index of > 35
kg/m has not been evaluated
(1, 8.8)
DOSAGE AND ADMINISTRATION
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)
DOSAGE FORMS AND STRENGTHS
Lo Loestrin Fe consists of 28 tablets in the following order (3):
24 blue tablets (active), each containing 1 mg norethindrone acetate
and 10 mcg ethinyl estradiol
2 white tablets (active), each containing 10 mcg ethinyl estradiol
2 brown tablets (non-hormonal placebo), each containing 75 mg ferrous
fumarate. The ferrous
fumarate tablets do not serve any therapeutic purpose
CONTRAINDICATIONS
A high risk of arterial or venous thrombotic diseases (4)
Breast cancer (4)
Liver tumors or liver disease (4)
Undiagnosed abnormal uterine bleeding (4)
Co-administration with Hepatitis C drug combinations containing
ombitasvir/paritaprevir/ritonavir, with
or without dasabuvir (4)
WARNINGS AND PRECAUTIONS
Vascular risks: Stop Lo Loe