RAJANI drospirenone ethinyl estradiol levomefolate calcium

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

DROSPIRENONE (UNII: N295J34A25) (DROSPIRENONE - UNII:N295J34A25)

Verfügbar ab:

Actavis Pharma, Inc.

INN (Internationale Bezeichnung):

DROSPIRENONE

Zusammensetzung:

DROSPIRENONE 3 mg

Verschreibungstyp:

PRESCRIPTION DRUG

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

RAJANI- DROSPIRENONE, ETHINYL ESTRADIOL, LEVOMEFOLATE CALCIUM
ACTAVIS PHARMA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RAJANI SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR RAJANI.
RAJANI (DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM
TABLETS AND LEVOMEFOLATE CALCIUM TABLETS),
FOR ORAL USE
INITIAL U.S. APPROVAL: 2010
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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RECENT MAJOR CHANGES
INDICATIONS AND USAGE
RAJANI is an estrogen/progestin COC containing a folate, indicated for
use by women to:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
RAJANI consists of 28 film-coated, biconvex tablets in the following
order (3):
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CONTRAINDICATIONS
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WOMEN OVER 35 YEARS OLD WHO SMOKE SHOULD NOT USE RAJANI. (4)
CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS
FROM COMBINATION ORAL
CONTRACEPTIVE (COC) USE. (4)
Contraindications (4)08/2017
Warnings and Precautions (5.5) 08/2017
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)
Raise folate levels in women who choose to use an oral contraceptive
for contraception. (1.4)
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)
24 white tablets, each containing 3 mg drospirenone (DRSP), 0.02 mg
ethinyl estradiol (EE) as betadex clathrate and
0.451 mg levomefolate calcium
4 light orange tablets, each containing 0.451 mg levomefolate calcium
Renal impairment (4)
Adrenal insufficiency (4)
A high risk of arterial or venous thrombotic diseases (4)
Undiagnosed abnormal uterine bleeding (4)
Breast cancer or oth