BEYAZ- drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bayer HealthCare Pharmaceuticals Inc.

INN (International Name):

DROSPIRENONE

Composition:

DROSPIRENONE 3 mg

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Beyaz® is indicated for use by females of reproductive potential to prevent pregnancy. Beyaz 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 Beyaz 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 m

Product summary:

Beyaz (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets) are available in packages of three blister packs (NDC 50419-407-03). 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].

Authorization status:

New Drug Application

Summary of Product characteristics

BEYAZ- DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND
LEVOMEFOLATE
CALCIUM
BAYER HEALTHCARE PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BEYAZ SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BEYAZ.
BEYAZ (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
Contraindications, Pregnancy (4) Removed 5/2023
INDICATIONS AND USAGE
Beyaz is 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
Beyaz 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 Beyaz. (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 females of reproductive potential at least 14
years old only if the patient
desires an oral contraceptive for birth control. (1.3)
Raise folate levels in females of reproductive potential who choose to
use an oral contraceptive for
contraception. (1.4)
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)
24 pink tablets, each containing 3 mg drospirenone (DRSP), 0.02 mg
ethinyl estradiol (EE) as betadex
clathrate and 0.451 mg levom