YASMIN- 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:

Physicians Total Care, Inc.

INN (International Name):

DROSPIRENONE

Composition:

DROSPIRENONE 3 mg

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Yasmin is indicated for use by women to prevent pregnancy. Do not prescribe Yasmin to women who are known to have the following: - Renal impairment - Adrenal insufficiency - A high risk of arterial or venous thrombotic diseases. Examples include women who are known to: Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1)] Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1)] - Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1)] - Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1)] - Have cerebrovascular disease [see Warnings and Precautions (5.1)] - Have coronary artery disease [see Warnings and Precautions (5.1)] - Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions (5.1)] - Have inherited or acquired hypercoagulopa

Product summary:

Yasmin (drospirenone/ethinyl estradiol) tablets are available in blister packs (54868-4590-0). The film-coated tablets are rounded with biconvex faces, one side is embossed with a regular hexagon shape with DO or DP. Each blister pack contains 28 film-coated tablets 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

YASMIN - DROSPIRENONE AND ETHINYL ESTRADIOL
PHYSICIANS TOTAL CARE, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
YASMIN SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR YASMIN.
YASMIN (DROSPIRENONE/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 YASMIN. (4)
CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS
FROM COMBINATION ORAL
CONTRACEPTIVE (COC) USE. (4)
RECENT MAJOR CHANGES
Warnings and Precautions, Thromboembolic Disorders (5.1)2/2012
INDICATIONS AND USAGE
Yasmin is an estrogen/progestin COC indicated for use by women to
prevent pregnancy. (1)
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
Yasmin consists of 28 film-coated, biconvex tablets in the following
order (3):
21 yellow tablets, each containing 3 mg drospirenone (DRSP) and 0.03
mg ethinyl estradiol (EE),
7 inert white 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)
WARNINGS AND PRECAUTIONS
Vascular risks: Stop Yasmin if a thrombotic event occurs. Stop at
least 4 weeks before and through 2 weeks after major
surgery. Start no earlier than 4 weeks after delivery, in women who
are not breastfeeding. (5.1)
Hyperkalemia: DRSP has antimineralocorticoid activity. Do not use in
patients predisposed to hyperkalemia. Check
serum potassium concentration during the first treatment cycle in
women on long-term treatment with medications that
may increase serum potassium concentration. (5.2, 7.3)
L