OCELLA- drospirenone and ethinyl estradiol kit

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

TEVA PHARMACEUTICALS USA, INC.

ИНН (Международная Имя):

DROSPIRENONE

состав:

DROSPIRENONE 3 mg

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

OCELLA® is indicated for use by females of reproductive potential to prevent pregnancy. OCELLA is contraindicated in females who are known to have or develop the following conditions: There is no use for contraception in pregnancy; therefore, OCELLA 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 OCELLA 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 OCELLA 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 Ocella and any potential adverse effects on the breast-fed child from OCELLAor 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. Safety and efficacy of OCELLA 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. OCELLA has not been studied in postmenopausal women and is not indicated in this population. OCELLA 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)] . OCELLA 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. OCELLA 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)] .

Обзор продуктов:

OCELLA (drospirenone/ethinyl estradiol) tablets are available in packages of three blister packs (NDC 0555-9131-67). The film-coated tablets are rounded with biconvex faces, one side is embossed with a regular hexagon shape with DO or DP. 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].

Статус Авторизация:

New Drug Application Authorized Generic

Характеристики продукта

OCELLA- DROSPIRENONE AND ETHINYL ESTRADIOL
TEVA PHARMACEUTICALS USA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OCELLA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OCELLA.
OCELLA (DROSPIRENONE/ETHINYL ESTRADIOL) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2001
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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RECENT MAJOR CHANGES
INDICATIONS AND USAGE
OCELLA 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
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DOSAGE FORMS AND STRENGTHS
OCELLA consists of 28 film-coated, biconvex tablets in the following
order (3):
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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WOMEN OVER 35 YEARS OLD WHO SMOKE SHOULD NOT USE OCELLA. (4)
CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS
FROM
COMBINATION ORAL CONTRACEPTIVE (COC) USE. (4)
Dosage and Administration (2.3) 5/2023
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)
21 yellow tablets, each containing 3 mg drospirenone (DRSP) and 0.03
mg ethinyl estradiol (EE)
7 inert white tablets
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)
Vascular risks: Stop OCELLA if a thrombotic event occurs. Stop at
least 4 weeks before and through 2
weeks after major surgery. Start no earlier than 4 weeks after
delivery, in women who are not
breastfeeding. (5.1) COCs containing DRSP may be associated with a
higher risk of venous
thromboembolism (VTE) than C