DROSPIRENONE AND ETHINYL ESTRADIOL 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)

Available from:

Camber Pharmaceuticals, Inc.

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Drospirenone and ethinyl estradiol tablets are indicated for use by females of reproductive potential to prevent pregnancy. Drospirenone and ethinyl estradiol tablets are 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 drospirenone and ethinyl estradiol tablets 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

Product summary:

Drospirenone and ethinyl estradiol tablets, USP are available in packages of one blister pack (NDC 31722-934-31) and three blister packs (NDC 31722-934-32). The active film-coated tablets are rounded with biconvex faces, one side is debossed with 20.  The placebo film-coated tablets are rounded with biconvex faces, one side is debossed with PL. Each blister pack (28 film-coated tablets) contains in the following order: • 24 active pink round, unscored, film-coated tablets debossed with a "20" on one side, each containing 3 mg drospirenone and 0.02 mg ethinyl estradiol • 4 inert white round, unscored, film-coated tablets debossed with a "PL". Store at 20° to 25°C (68º to 77°F); excursions permitted to 15–30°C (59 to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DROSPIRENONE AND ETHINYL ESTRADIOL- DROSPIRENONE AND ETHINYL
ESTRADIOL
CAMBER PHARMACEUTICALS, INC.
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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, 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 tablets are a combination of
drospirenone, a progestin, and ethinyl
estradiol, an estrogen, indicated for use by females of reproductive
potential to:
• 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)
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 film-coated,
biconvex tablets in the following
order (3):
• 24 pink tablets, each containing 3 mg drospirenone (DRSP) and 0.02
mg ethinyl estradiol (EE)
• 4 white inert tablets (3)
CONTRAINDICATIONS
• Renal impairment (4)
• Adrenal insufficiency (4)
• A high risk of arterial or venous thromboti