YAZ- drospirenone and ethinyl estradiol kit

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Bayer HealthCare Pharmaceuticals Inc.

INN (Международно Name):

DROSPIRENONE

Композиция:

DROSPIRENONE 3 mg

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Yaz® is indicated for use by females of reproductive potential to prevent pregnancy.  Yaz 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 Yaz 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 mense

Каталог на резюме:

Yaz (drospirenone/ethinyl estradiol tablets) are available in packages of three blister packs (NDC 50419-405-03). The film-coated tablets are rounded with biconvex faces, one side is embossed with DS or DP in a regular hexagon. 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].

Статус Оторизация:

New Drug Application

Данни за продукта

YAZ- DROSPIRENONE AND ETHINYL ESTRADIOL
BAYER HEALTHCARE PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE YAZ
SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR YAZ.
YAZ® (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
Contraindications, Pregnancy (4) Removed 5/2023
INDICATIONS AND USAGE
Yaz is a combination of drospirenone, a progestin, and ethinyl
estradiol, an estrogen, indicated for use by
females of reproductive potential to:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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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 Yaz (4).
Cigarette smoking increases the risk of serious cardiovascular events
from combination oral
contraceptive (COC) use. (4)
Dosage and Administration (2.3) 5/2023
Warnings and Precautions (5.11) Removed 5/2023
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 women at least 14 years old only if the
patient desires an oral contraceptive
for birth control. (1.3)
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)
Yaz consists of 28 film-coated, biconvex tablets in the following
order (3):
24 light pink tablets, each containing 3 mg drospirenone (DRSP) and
0.02 mg ethinyl estradiol (EE) as
betadex clathrate
4 white inert 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 d