DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM- drospirenone, ethinyl estradiol and levomefol

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

DROSPIRENONE (UNII: N295J34A25) (DROSPIRENONE - UNII:N295J34A25), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U), LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC)

थमां उपलब्ध:

Lupin Pharmaceuticals, Inc.

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets are indicated for use by women to prevent pregnancy. Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets are 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 drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets 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 associat

उत्पाद समीक्षा:

Drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets are available in 28 tablets wallet containing 28 tablets packed in a pouch (NDC 68180-894-11). Such three pouches are packaged in a carton (NDC 68180-894-13). Each Wallet contains 28 film-coated 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].

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

सूचना पत्रक

DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM AND
LEVOMEFOLATE CALCIUM - DROSPIRENONE, ETHINYL ESTRADIOL AND
LEVOMEFOLATE CALCIUM AND
LEVOMEFOLATE CALCIUM
Lupin Pharmaceuticals, Inc.
----------
FDA Approved Patient Labeling
Guide for Using Drospirenone, Ethinyl Estradiol and Levomefolate
Calcium Tablets and Levomefolate
Calcium Tablets
WARNING TO WOMEN WHO SMOKE
Do not use drospirenone, ethinyl estradiol and levomefolate calcium
tablets and levomefolate calcium
tablets if you smoke cigarettes and are over 35 years old. Smoking
increases your risk of serious
cardiovascular side effects (heart and blood vessel problems) from
birth control pills, including death
from heart attack, blood clots or stroke. This risk increases with age
and the number of cigarettes you
smoke.
Birth control pills help to lower the chances of becoming pregnant
when taken as directed. They do not
protect against HIV infection (AIDS) and other sexually transmitted
diseases.
What are Drospirenone, Ethinyl Estradiol and Levomefolate Calcium
Tablets and Levomefolate Calcium
Tablets?
Drospirenone, ethinyl estradiol and levomefolate calcium tablets and
levomefolate calcium tablets are
birth control pill. It contains two female hormones, a synthetic
estrogen called ethinyl estradiol and a
progestin called drospirenone. Drospirenone, ethinyl estradiol and
levomefolate calcium tablets and
levomefolate calcium tablets also contains levomefolate calcium, which
is a B vitamin.
The progestin drospirenone may increase potassium. Therefore, you
should not take drospirenone, ethinyl
estradiol and levomefolate calcium tablets and levomefolate calcium
tablets if you have kidney, liver or
adrenal disease because this could cause serious heart and health
problems. Other drugs may also increase
potassium. If you are currently on daily, long-term treatment for a
chronic condition with any of the
medications below, you should consult your healthcare provider about
whether drospirenone, ethinyl
estradiol and levomefolate calcium tablets and levomefolate

उत्पाद विशेषताएं

DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM AND
LEVOMEFOLATE CALCIUM - DROSPIRENONE, ETHINYL ESTRADIOL AND
LEVOMEFOLATE CALCIUM AND
LEVOMEFOLATE CALCIUM
LUPIN PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DROSPIRENONE, ETHINYL ESTRADIOL AND
LEVOMEFOLATE CALCIUM TABLETS AND LEVOMEFOLATE CALCIUM TABLETS SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE
CALCIUM TABLETS AND LEVOMEFOLATE
CALCIUM TABLETS.
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_
Women over 35 years old who smoke should not use drospirenone, ethinyl
estradiol and levomefolate calcium
tablets and levomefolate calcium tablets. (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
Drospirenone, ethinyl estradiol and levomefolate calcium tablet and
levomefolate calcium tablet is an estrogen/progestin
COC containing a folate, indicated for use by women to: (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 wallet. (2.1)
DOSAGE FORMS AND STRENGTHS
Drospirenone, ethinyl estradiol and levomefolate calcium tablets and
levomefolate calcium tablets consist of 28 film-coated,
biconvex tablets in the following order (3):
24 pink tablets, each containing 3 mg drospirenone (DRSP), 0.02 mg
ethinyl estradiol (EE) and 0.451 mg levomefolate
calcium
4 light orange tablets, each containing 0.451 mg levomefolate calcium
CONTRAINDICATIONS
Renal impairment (4)
Adrenal insufficiency (4)
A high risk of arterial or venous thromb