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

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

A-S Medication Solutions

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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 Warnings and Precautions (5.1) ] • Have uncontrolled hypertension [see Warnings and Precautions (5.5) ] • Have diabetes mellitus with vascular disease [see Warnings and Precautions (5.7) ] • Have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35 [see Warnings and Precautions (5.8) ] - Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see Warnings and Precautions (5.2) ] - Liver tumors, benign or malignant, or liver disease [see Warnings and Precautions (5.3) ] - Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.9) ] - Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations [see Warnings and Precautions (5.4) ] . Risk Summary There is no use for contraception in pregnancy; therefore, Lo Loestrin Fe 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 combined hormonal contraceptives (CHCs) 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. Data Human Data 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 CHCs before conception or during early pregnancy. Risk Summary Contraceptive hormones and/or metabolites are present in human milk. CHCs can reduce milk production in breastfeeding females. This reduction can occur at any time but is less likely to occur once breastfeeding is well-established. When possible, advise the nursing female to use other methods of contraception until she discontinues breastfeeding. [See also Dosage and Administration (2.2) .] The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Lo Loestrin Fe and any potential adverse effects on the breastfed child from Lo Loestrin Fe or from the underlying maternal condition. Safety and efficacy of Lo Loestrin Fe have been established in women of reproductive age. Safety and efficacy are expected to be the same in postpubertal adolescents under the age of 18 years as for users 18 years and older. Use of this product before menarche is not indicated. Lo Loestrin Fe has not been studied in postmenopausal women and is not indicated in this population. The pharmacokinetics of Lo Loestrin Fe has not been studied in subjects with renal impairment.  No studies have been conducted to evaluate the effect of hepatic impairment on the disposition of Lo Loestrin Fe. However, steroid hormones may be poorly metabolized in patients with impaired liver function. Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal and COC causation has been excluded [ s ee Contraindications (4)   and  Warnings and Precautions (5.3) ] . The safety and efficacy of Lo Loestrin Fe in women with a body mass index (BMI) >35 kg/m2 has not been evaluated [ s ee Clinical Studies (14) ] .  

ملخص المنتج:

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.

الوضع إذن:

New Drug Application

خصائص المنتج

LO LOESTRIN FE- NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, ETHINYL
ESTRADIOL AND FERROUS FUMARATE
A-S MEDICATION SOLUTIONS
----------
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: S