DROSPIRENONE AND ETHINYL ESTRADIOL- 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:

Nivagen Pharmaceuticals, Inc.

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Drospirenone and ethinyl estradiol tablets are indicated for use by women to prevent pregnancy. Drospirenone and ethinyl estradiol tablets are 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 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 this disorder, these symptoms occur regularly during the luteal

Product summary:

Drospirenone and ethinyl estradiol tablets contain 28 tablets in a blister card (NDC 75834-116-84). Each blister card contains, in the following order, 24 pink tablets and 4 white tablets. Each round, biconvex, pink tablet (debossed with "Z3" on one side) contains 3 mg drospirenone (DRSP) and 0.02 mg ethinyl estradiol (EE). Each round, biconvex, white tablet (debossed with "P" on one side and "N " on the other side) contains inert ingredients. Drospirenone and ethinyl estradiol tablets are available in the following packaging configuration: Carton of 3 blister cards        NDC 75834-116-29 Store at 20° to 25°C (68° to 77°F).[See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DROSPIRENONE AND ETHINYL ESTRADIOL - DROSPIRENONE AND ETHINYL
ESTRADIOL
NIVAGEN 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, 3 MG/0.02 MG, 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
Contraindications (4) 08/2017
Warnings and Precautions (5.5) 08/2017
INDICATIONS AND USAGE
Drospirenone and ethinyl estradiol tablets 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
Drospirenone and ethinyl estradiol tablets consist 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
CONTRAINDICATIONS
Renal impairment (4)
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)
Co-administration with Hepatitis C drug comb