YAZ- drospirenone and ethinyl estradiol kit

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Physicians Total Care, Inc.

INN (International Name):

DROSPIRENONE

Sammensetning:

DROSPIRENONE 3 mg

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Yaz is indicated for use by women to prevent pregnancy. Yaz is also indicated for the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women 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 menses; the disturbance markedly interferes with work or school,

Produkt oppsummering:

Yaz (drospirenone/ethinyl estradiol tablets) are available in blister packs (NDC 54868-5828-0). 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].

Autorisasjon status:

New Drug Application

Preparatomtale

YAZ - DROSPIRENONE AND ETHINYL ESTRADIOL
PHYSICIANS TOTAL CARE, 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.
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 Yaz (4).
Cigarette smoking increases the risk of serious cardiovascular events
from combination oral contraceptive (COC)
use. (4)
RECENT MAJOR CHANGES
Warnings and Precautions (5.1, 5.7) 3/2011
INDICATIONS AND USAGE
Yaz is an estrogen/progestin COC, indicated for use by women to:
Prevent pregnancy. (1.1)
Treat symptoms of premenstrual dysphoric disorder (PMDD) for women 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)
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
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
CONTRAINDICATIONS
Renal impairment or adrenal insufficiency (4)
A high risk of arterial or venous thrombotic diseases (4)
Undiagnosed abnormal uterine bleeding (4)
Breast cancer or other estrogen- or progestin-sensitive cancer (4)
Liver tumors or liver disease (4)
Pregnancy (4)
WARNINGS AND PRECAUTIONS
Vascular risks: Stop Yaz 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)
Hyperkalemia: DRSP has antimineralocorticoid activity. Do not use in
patients predisposed to hyperkalemi