DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM kit

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

DROSPIRENONE (UNII: N295J34A25) (DROSPIRENONE - UNII:N295J34A25), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U), LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC)

متاح من:

Sandoz Inc

INN (الاسم الدولي):

DROSPIRENONE

تركيب:

DROSPIRENONE 3 mg

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium is indicated for use by females of reproductive potential to prevent pregnancy. Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium is indicated in females of reproductive potential who choose to use an oral contraceptive as their method of contraception, to raise folate levels for the purpose of reducing the risk of a neural tube defect in a pregnancy conceived while taking the product or shortly after discontinuing the product. Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium is contraindicated in females who are known to have or develop the following conditions: There is no use for contraception in pregnancy; therefore, Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium should be discontinued during pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to 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. A retrospective database study of women in Norway, that included 44,734 pregnancies of which 368 were women who inadvertently took drospirenone/ethinyl estradiol during the first trimester of a pregnancy, found there were no adverse effects on pre-term birth, small for gestational age, or birth weight Z-scores. Post-marketing adverse event data on the use of Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium in pregnant women suggest that frequencies of miscarriage and congenital anomalies were not higher than the estimated background risk in the general population. DRSP is present in human milk. After a single oral administration of 3 mg DRSP/0.03 mg EE tablets, DRSP concentration in breast milk over the 24-h period ranged from 1.4 to 7.0 ng/mL, with a mean ± standard deviation value of 3.7 ± 1.9 ng/mL. The estimated mean infant dose was 0.003 mg/day, which is about 0.1% of maternal dose (see Data). There is limited information on the effects of Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium on the breast-fed infant. CHCs can reduce milk production in breast-feeding females. This reduction can occur at any time but is less likely to occur once breast-feeding is well-established. When possible, advise the nursing female to use other methods of contraception until she discontinues breast-feeding [See also Dosage and Administration (2.2)]. Increase in folate concentration in milk is not expected (see Data). The developmental and health benefits of breast-feeding should be considered along with the mother’s clinical need for Safyral and any potential adverse effects on the breast-fed child from Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium or from the underlying maternal condition. An open-label study evaluated the degree of DRSP transfer into milk within 72 hours following a single oral administration of 3 mg DRSP/0.03 mg EE tablets to 6 healthy lactating women who were 1 week to 3 months post-partum. DRSP was present in breast milk with a mean Cmax of 13.5 ng/mL, while the mean Cmax in serum of lactating women was 30.8 ng/mL. The DRSP concentration in breast milk over the 24-hour period following dosing ranged from 1.4 to 7.0 ng/mL, with a mean ± standard deviation value of 3.7 ± 1.9 ng/mL. Based on single dose data, the maximal daily infant dose of DRSP was calculated to be 0.003 mg/day, which represented a mean of 0.1% of the maternal dose. A study in approximately 60 lactating women demonstrated no significant differences in folate concentrations in milk between women who received 416 mcg/day [6S]-5-methyltetrahydrofolate or 400 mcg/day folic acid and women who received placebo over a 16-week period. Studies to date indicate there is no adverse effect of folate on nursing infants. Safety and efficacy of Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium has been established in women of reproductive age. Efficacy is expected to be the same for postpubertal adolescents under the age of 18 and for users 18 years and older. Use of this product before menarche is not indicated. Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium has not been studied in postmenopausal women and is not indicated in this population. Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium is contraindicated in patients with renal impairment [see Contraindications (4) and Warnings and Precautions (5.2)] . In subjects with creatinine clearance (CLcr) of 50–79 mL/min, serum DRSP concentrations were comparable to those in a control group with CLcr ≥ 80 mL/min. In subjects with CLcr of 30–49 mL/min, serum DRSP concentrations were on average 37% higher than those in the control group. In addition, there is a potential to develop hyperkalemia in subjects with renal impairment whose serum potassium is in the upper reference range, and who are concomitantly using potassium-sparing drugs [see Clinical Pharmacology (12.3)] . Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium is contraindicated in patients with hepatic disease [see Contraindications (4) and Warnings and Precautions (5.4)] . The mean exposure to DRSP in women with moderate liver impairment is approximately three times higher than the exposure in women with normal liver function. Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium has not been studied in women with severe hepatic impairment. No clinically significant difference was observed between the pharmacokinetics of DRSP or EE in Japanese versus Caucasian women [see Clinical Pharmacology (12.3)] .

ملخص المنتج:

Drospirenone/Ethinyl Estradiol/Levomefolate Calcium Tablets and Levomefolate Calcium Tablets are available in packages of three blister packs (NDC 0781-4103-15). The film-coated tablets are rounded with biconvex faces, one side is embossed with a regular hexagon shape with Y+ or M+. Each blister pack contains 28 film-coated tablets in the following order: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

الوضع إذن:

New Drug Application

خصائص المنتج

DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND
LEVOMEFOLATE CALCIUM- DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE
CALCIUM AND LEVOMEFOLATE CALCIUM
SANDOZ INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DROSPIRENONE/ETHINYL
ESTRADIOL/LEVOMEFOLATE CALCIUM TABLETS AND LEVOMEFOLATE CALCIUM
TABLETS SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SAFELY AND
EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR DROSPIRENONE/ETHINYL
ESTRADIOL/LEVOMEFOLATE CALCIUM
AND LEVOMEFOLATE CALCIUM.
DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM TABLETS AND
LEVOMEFOLATE
CALCIUM TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2010
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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RECENT MAJOR CHANGES
Dosage and Administration (2.3) 5/2023
Contraindications, Pregnancy (4) Removed 5/2023
Warnings and Precautions (5.11) Removed 5/2023
INDICATIONS AND USAGE
Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate
Calcium is a combination of
drospirenone, a progestin and ethinyl estradiol, an estrogen
containing a folate, indicated for use by
females of reproductive potential to:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate
Calcium consists of 28 film-
coated, biconvex tablets in the following order (3):
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CONTRAINDICATIONS
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•
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•
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WOMEN OVER 35 YEARS OLD WHO SMOKE SHOULD NOT USE DROSPIRENONE/ETHINYL
ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM. (4)
CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS
FROM
COMBINATION ORAL CONTRACEPTIVE (COC) USE. (4)
Prevent pregnancy. (1.1)
Raise folate levels in females of reproductive potential who choose to
use an oral contraceptive for
contraception. (1.2)
Take one tablet daily by mouth at the same time every day. (2.1)
Tablets must be taken in the order directed on the bli