DROSPIRENONE AND ETHINYL ESTRADIOL- drospirenone and ethinyl estradiol kit

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U), DROSPIRENONE (UNII: N295J34A25) (DROSPIRENONE - UNII:N295J34A25)

Boleh didapati daripada:

Lupin Pharmaceuticals, Inc.

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Drospirenone and ethinyl estradiol tablet USP is indicated for use by women to prevent pregnancy. Drospirenone and ethinyl estradiol tablet is contraindicated in females who are known to have or develop the following conditions: - 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 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 hypercoagulopathies [see Warnings and Precautions  (5.1)] Have

Ringkasan produk:

Drospirenone and ethinyl estradiol tablets USP, 3 mg and 0.03 mg are available in a blister pack (NDC 68180-868-71) containing 28 tablets packed in a pouch (NDC 68180-868-71). Such three pouches are packaged in a carton (NDC 68180-868-73). Each blister pack contains 28 tablets in the following order: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

DROSPIRENONE AND ETHINYL ESTRADIOL - DROSPIRENONE AND ETHINYL
ESTRADIOL
LUPIN PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DROSPIRENONE AND ETHINYL
ESTRADIOL TABLETS USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS USP.
DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS USP, 3 MG/0.03 MG, FOR ORAL
USE INITIAL U.S.
APPROVAL: 2001
_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
Warnings and Precautions (5.3)
4/2022
INDICATIONS AND USAGE
Drospirenone and ethinyl estradiol tablets USP are 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
Drospirenone and ethinyl estradiol tablets consists of 28, biconvex
tablets in the following order (3):
21 yellow film-coated tablets, each containing 3 mg drospirenone
(DRSP) and 0.03 mg ethinyl estradiol
(EE),
7 inert white to off-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 (4)
Liver tumors or liver disease (4)
Pregnancy (4)
Co-administration with Hepatitis C drug combinations containing
ombitasvir, paritaprevir/ritonavir, with
or without dasabuvir (4)
WARNINGS AND PRECAUTIONS
Vascular risks : Stop drospirenone and ethinyl estradiol tablets 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)
COCs con