ORTHO TRI CYCLEN LO- norgestimate and ethinyl estradiol kit

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

norgestimate (UNII: C291HFX4DY) (norgestimate - UNII:C291HFX4DY), ethinyl estradiol (UNII: 423D2T571U) (ethinyl estradiol - UNII:423D2T571U)

から入手可能:

Janssen Pharmaceuticals, Inc.

INN（国際名）:

norgestimate

構図:

norgestimate 0.18 mg

処方タイプ:

PRESCRIPTION DRUG

適応症:

ORTHO TRI-CYCLEN Lo Tablets are indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14)] . Do not prescribe ORTHO TRI-CYCLEN Lo to women who are known to have the following conditions: - 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 inherited or acquired hypercoagulopathies [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 uncontrolled hypertension [see Warnings and Precautions (5.4)] Have

製品概要:

ORTHO TRI-CYCLEN Lo Tablets are available in a single pouch containing a VERIDATE blister card (refill) of 28 tablets: NDC 50458-251-28. ORTHO TRI-CYCLEN Lo Tablets are packaged in a carton containing 6 pouches and 6 unfilled VERIDATE Tablet Dispensers: NDC 50458-251-06 Each blister card (28 tablets) contains in the following order: ORTHO TRI-CYCLEN Lo Tablets are also available for clinic usage in a VERIDATE Tablet Dispenser (unfilled) and VERIDATE refills: NDC 50458-251-20 and NDC 50458-251-12 ORTHO TRI-CYCLEN Lo Tablets are available in a DIALPAK Tablet Dispenser (unfilled) and DIALPAK refills: NDC 50458-251-00 and NDC 50458-251-15

認証ステータス:

New Drug Application

製品の特徴

ORTHO TRI CYCLEN LO- NORGESTIMATE AND ETHINYL ESTRADIOL
JANSSEN PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ORTHO TRI-CYCLEN LO SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ORTHO TRI-CYCLEN LO.
ORTHO TRI-CYCLEN LO (NORGESTIMATE/ETHINYL ESTRADIOL) TABLETS FOR ORAL
USE
INITIAL U.S. APPROVAL: 1989
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
ORTHO TRI-CYCLEN LO IS CONTRAINDICATED IN WOMEN OVER 35 YEARS OLD WHO
SMOKE. (4)
CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS
FROM COMBINATION ORAL
CONTRACEPTIVES (COC) USE. (4)
RECENT MAJOR CHANGES
Contraindications (4)
08/2017
Warnings and Precautions (5.3)
08/2017
INDICATIONS AND USAGE
ORTHO TRI-CYCLEN Lo is an estrogen/progestin COC, indicated for use by
women to prevent pregnancy. (1.1)
DOSAGE AND ADMINISTRATION
Take one tablet daily by mouth at the same time every day. (2.2)
Take tablets in the order directed on the blister pack. (2.2)
Do not skip or delay tablet intake. (2.2)
DOSAGE FORMS AND STRENGTHS
ORTHO TRI-CYCLEN Lo consists of 28 round, biconvex, coated tablets in
the following order (3):
7 white tablets each containing 0.180 mg norgestimate and 0.025 mg
ethinyl estradiol
7 light blue tablets each containing 0.215 mg norgestimate and 0.025
mg ethinyl estradiol
7 dark blue tablets each containing 0.250 mg norgestimate and 0.025 mg
ethinyl estradiol
7 dark green tablets (inert)
CONTRAINDICATIONS
A high risk of arterial or venous thrombotic diseases (4)
Liver tumors or liver disease (4)
Undiagnosed abnormal uterine bleeding (4)
Pregnancy (4)
Breast cancer or other estrogen- or progestin-sensitive cancer (4)
Co-administration with Hepatitis C drug combinations containing
ombitasvir/paritaprevir/ritonavir, with or without
dasabuvir (4)
WARNINGS AND PRECAUTIONS
Thromboembolic Disorders and Other Vascular Problems: Stop ORTHO
TRI-CYCLEN Lo if a thrombotic event o