DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM kit

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Sandoz Inc

処方タイプ:

PRESCRIPTION DRUG

適応症:

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 also indicated for the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in females of reproductive potential who choose to use an oral contraceptive as their method of contraception. The effectiveness of Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium for PMDD when used for more than three menstrual cycles has not been evaluated. The essential features of PMDD according to the Diagnostic and Statistical Manual-4th edition (DSM-IV) include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in usual activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. In this disorder, these symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school, or with usual social activities and relationships with others. Diagnosis is made by healthcare providers according to DSM-IV criteria, with symptomatology assessed prospectively over at least two menstrual cycles. In making the diagnosis, care should be taken to rule out other cyclical mood disorders. Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium has not been evaluated for the treatment of premenstrual syndrome (PMS). Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium is indicated for the treatment of moderate acne vulgaris in females of reproductive potential at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. 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 Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium 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 416mcg/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)] .

製品概要:

Drospirenone/Ethinyl Estradiol/Levomefolate Calcium Tablets and Levomefolate Calcium Tablets are available in packages of three blister packs (NDC 0781-4075-15). The film-coated tablets are rounded with biconvex faces, one side is embossed with a regular hexagon shape with Z+ or M+. Each blister pack (28 film-coated tablets) contains in the following order: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

認証ステータス:

New Drug Application Authorized Generic

製品の特徴

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
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 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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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)
Treat symptoms of premenstrual dysphoric disorder (PMDD) for females
of reproductive potential who
choose to use an oral contraceptive for contraception. (1.2)
Treat moderate acne for females of reproductive potential at least 14
years old only if the patient
desires an oral contraceptive for birth control. (1.