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:

Proficient Rx LP

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 indicated for the treatment of moderate acne vulgaris in women at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Drospirenone and ethinyl estradiol tablets should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. Do not prescribe drospirenone and ethinyl estradiol tablets to women who are known to have the following: There is little or no increased risk of birth defects in women who inadvertently use COCs during early pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to low dose COCs prior to conception or during early pregnancy. The administration of COCs to induce withdrawal bleeding should not be u

Product summary:

Drospirenone and Ethinyl Estradiol Tablets USP, 3 mg/0.02 mg, are available as follows: NDC 71205-144-28 1 carton containing 3 individual pouches. Each pouch contains 1 blister card of 28 tablets. Each blister card contains 28 film-coated tablets in the following order: Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 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
PROFICIENT RX LP
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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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RECENT MAJOR CHANGES
Contraindications (4) 08/2017
Warnings and Precautions (5.5) 08/2017
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 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-administration with Hepatitis C drug combinations containing