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:

A-S Medication Solutions

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, USP 3 mg/0.02 mg, are available as follows: NDC 68462-720-29 1 carton containing 3 individual pouches. Each pouch contains 1 blister of 28 tablets. Each blister contains 28 film-coated tablets in the following order: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F 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
A-S MEDICATION SOLUTIONS
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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._
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INDICATIONS AND USAGE
Drospirenone and ethinyl estradiol tablets are an estrogen/progestin
COC, indicated for use by women 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 drospirenone and
ethinyl estradiol tablets
(4).
Cigarette smoking increases the risk of serious cardiovascular events
from combination oral
contraceptive (COC) use. (4)
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)
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)
Drospirenone and Ethinyl Estradiol Tablets, USP consist of 28
film-coated, biconvex tablets in the
following order (3):
24 brown to reddish brown tablets, each containing 3 mg drospirenone,
USP (DRSP) and 0.02 mg
ethinyl estradiol, USP (EE)
4 white to off-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 or other estrogen- or progestin-sensitive cancer (4)
Liver tumors or liver disease (4)
Pregnancy (4)
Co-admini