DROSPIRENONE AND ETHINYL ESTRADIOL- drospirenone and ethinyl estradiol kit

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U), DROSPIRENONE (UNII: N295J34A25) (DROSPIRENONE - UNII:N295J34A25)

Հասանելի է:

Lupin Pharmaceuticals, Inc.

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

Drospirenone and ethinyl estradiol tablet USP is indicated for use by females of reproductive potential to prevent pregnancy. Drospirenone and ethinyl estradiol tablet is contraindicated in females who are known to have or develop the following conditions: - Renal impairment - Adrenal insufficiency  - 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 (5.6) ] - ○        Have diabetes mellitus with vascular disease [see Warnings and Precautions (5.8) ] - ○        Have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35 [see Warnings And  Precautions (5.9) ] - Undiagnosed abnormal uterine      bleeding [see Warnings and Precautions      (5.10) ] - Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see Warnings      And Precautions (5.3) ] - Liver tumor (benign or      malignant) or liver disease [see Warnings and      Precautions (5.4) and Use in Specific      Populations (8.7) ] - 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 (5.5) and Drug      Interactions (7.2) ]. Risk Summary There is no use for contraception in pregnancy, therefore drospirenone and ethinyl estradiol tablets 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. Data Human Data 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 and ethinyl estradiol tablets USP in pregnant women suggest that frequencies of miscarriage and congenital anomalies were not higher than the estimated background risk in the general population. Risk Summary 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 and ethinyl estradiol tablets 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)]. The developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for drospirenone and ethinyl estradiol tablets and any potential adverse effects on the breast-fed child from drospirenone and ethinyl estradiol tablets or from the underlying maternal condition. Data Human Data 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. Safety and efficacy of drospirenone and ethinyl estradiol tablets have 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 and ethinyl estradiol tablets have not been studied in postmenopausal women and are not indicated in this population. Drospirenone and ethinyl estradiol tablets are contraindicated in patients with renal impairment [see CONTRAINDICATIONS (4) and WARNINGS AND PRECAUTIONS (5.2) ]. In subjects with creatinine clearance (CLcr) of 50 to 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 to 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 and ethinyl estradiol tablets are 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 and ethinyl estradiol tablets have 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) ].

Ապրանքի ամփոփագիր:

Drospirenone and ethinyl estradiol tablets USP, 3 mg and 0.03 mg are available in a blister pack (NDC 68180-868-71) containing 28 tablets packed in a pouch (NDC 68180-868-71). Such three pouches are packaged in a carton (NDC 68180-868-73). Each blister pack contains 28 tablets in the following order: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

DROSPIRENONE AND ETHINYL ESTRADIOL - DROSPIRENONE AND ETHINYL
ESTRADIOL
LUPIN PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DROSPIRENONE AND
ETHINYL ESTRADIOL TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS.
DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS, 3 MG/0.03 MG, FOR ORAL USE
INITIAL U.S. APPROVAL: 2001.
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 DROSPIRENONE AND
ETHINYL
ESTRADIOL TABLETS. (4)
CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS
FROM
COMBINATION ORAL CONTRACEPTIVE (COC) USE. (4)
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 and ethinyl estradiol tablet USP is a combination of
drospirenone, a progestin, and ethinyl
estradiol, an estrogen, indicated for use by females of reproductive
potential to prevent pregnancy. (1)
DOSAGE AND ADMINISTRATION
Take one tablet daily by mouth at the same time every day. (2.1)
Tablets must be taken in the order directed on the blister pack. (2.1)
DOSAGE FORMS AND STRENGTHS
Drospirenone and ethinyl estradiol tablets consists of 28, biconvex
tablets in the following order (3): (3)
21 yellow film-coated tablets, each containing 3 mg drospirenone
(DRSP) and 0.03 mg ethinyl estradiol
(EE),
7 inert white to off-white tablets
CONTRAINDICATIONS
Renal impairment (4)
Adrenal insufficiency (4)
A high risk of arterial or venous thrombotic diseases (4)
Undiagnosed abnormal uterine bleeding (4)
Breast cancer (4)
Liver tumors or liver disease (4)
Co-administration with Hepatitis C drug combinations containing
ombitasvir, paritaprevir/ritonavir, with
or without dasabuvir (4)
WARNINGS AND PRECAUTIONS
Vascular risks: Stop drospirenone and ethin