VESTURA- drospirenone and ethinyl estradiol

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Actavis Pharma, Inc.

Designació comuna internacional (DCI):

DROSPIRENONE

Composición:

DROSPIRENONE 3 mg

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Vestura is indicated for use by women to prevent pregnancy. Vestura is 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 Vestura 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 phase and remit within a few days following onset of menses; the disturbance markedly interferes with work

Resumen del producto:

Vestura™ (drospirenone/ethinyl estradiol tablets USP) is available in packages of three blister packs (NDC 52544-982-31). The uncoated tablets are round, flat-face, bevel edge, embossed with "982 " or "983 " on one side and "WATSON " on the other side. Each blister pack (28 uncoated tablets) contains in the following order: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

VESTURA- DROSPIRENONE AND ETHINYL ESTRADIOL
ACTAVIS PHARMA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VESTURA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR VESTURA.
VESTURA (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 VESTURA (4).
CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS
FROM COMBINATION ORAL
CONTRACEPTIVE (COC) USE. (4)
RECENT MAJOR CHANGES
Contraindications (4) 08/2017
Warnings and Precautions (5.5) 08/2017
INDICATIONS AND USAGE
Vestura is an estrogen/progestin COC, indicated for use by women to:
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)
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
Vestura consist of 28 uncoated, flat-face bevel edge tablets in the
following order (3):
24 pink tablets, each containing 3 mg drospirenone, USP (DRSP) and
0.02 mg ethinyl estradiol, USP (EE) (stabilized
using vitamin E and an enhanced processing technique)
4 peach 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)
Co-administration with Hepatitis C drug combinations containing
ombitasvir, paritaprevir/ritonavir, with or without
dasabuvir (4)
WARNINGS AND PRECAUTIONS
Vascular risks: Stop Ve