DROSPIRENONE AND ETHINYL ESTRADIOL kit

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

Drospirenone (UNII: N295J34A25) (Drospirenone - UNII:N295J34A25), Ethinyl Estradiol (UNII: 423D2T571U) (Ethinyl Estradiol - UNII:423D2T571U)

Mevcut itibaren:

Pharmaceutics International, Inc. (Pii)

INN (International Adı):

Drospirenone

Kompozisyon:

Drospirenone 3 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg are indicated for use by women to prevent pregnancy. Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg 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, USP 3 mg/0.02 mg 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, USP 3 mg/0.02 mg 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)] Have cerebrovascular disease [see Warnin

Ürün özeti:

Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg are available in packages of three blister packs (NDC 61916- 090- 30). The film- coated tablets are rounded with “P” debossed on one side. Each blister pack (28 film- coated tablets) contains in the following order: Store at 25°C (77°F); excursions permitted to 15-30°C (59- 86°F) [see USP Controlled Room Temperature].

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

DROSPIRENONE AND ETHINYL ESTRADIOL- DROSPIRENONE AND ETHINYL ESTRADIOL
PHARMACEUTICS INTERNATIONAL, INC. (PII)
----------
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, USP 3
MG/0.02 MG (4).
CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS
FROM COMBINATION ORAL
CONTRACEPTIVE (COC) USE. (4)
RECENT MAJOR CHANGES
Warnings and Precautions, Hyperkalemia (5.2)
6/2015
INDICATIONS AND USAGE
Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg are an
estrogen/progestin COC, indicated for use by
women to:
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)
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, USP 3 mg/0.02 mg consist
of 28 film-coated, biconvex tablets in the following
order (3):
24 pink tablets, each containing 3 mg drospirenone, USP (DRSP)
(micronized) and 0.02 mg ethinyl estradiol, USP (EE)
(micronize d)
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)
WARNINGS AND PRECAUTIONS
Vascular risks: Stop Drospirenone and Ethinyl Estradiol Tablets, USP 3
mg/0.02 m