ORTHO TRI CYCLEN- norgestimate and ethinyl estradiol kit ORTHO CYCLEN- norgestimate and ethinyl estradiol kit

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

NORGESTIMATE (UNII: C291HFX4DY) (NORGESTIMATE - UNII:C291HFX4DY), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)

Disponível em:

Janssen Pharmaceuticals, Inc.

DCI (Denominação Comum Internacional):

norgestimate

Composição:

norgestimate 0.180 mg

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

ORTHO-CYCLEN and ORTHO TRI-CYCLEN Tablets are indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14)] . ORTHO TRI-CYCLEN is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. ORTHO TRI-CYCLEN should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control [see Clinical Studies (14)] . ORTHO-CYCLEN and ORTHO TRI-CYCLEN are contraindicated in females who are known to have or develop 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)]

Resumo do produto:

ORTHO-CYCLEN ® ORTHO-CYCLEN ® Tablets are available in a single pouch containing a VERIDATE ® blister card (refill) of 28 tablets (NDC 50458-197-28). ORTHO-CYCLEN Tablets are packaged in a carton containing 6 pouches and 6 unfilled VERIDATE Tablet Dispensers (NDC 50458-197-06). Each blister card (28 tablets) contains in the following order: ORTHO-CYCLEN Tablets are also available for clinic usage in a VERIDATE Tablet Dispenser (unfilled) and VERIDATE refills (NDC 50458-197-20 and NDC 50458-197-12). ORTHO-CYCLEN Tablets are available in a DIALPAK ® Tablet Dispenser (unfilled) and DIALPAK refills (NDC 50458-197-00 and NDC 50458-197-15). ORTHO TRI-CYCLEN ® ORTHO TRI-CYCLEN ® Tablets are available in a single pouch containing a VERIDATE blister card (refill) of 28 tablets (NDC 50458-191-28). ORTHO TRI-CYCLEN Tablets are packaged in a carton containing 6 pouches and 6 unfilled VERIDATE Tablet dispensers (NDC 50458-191-06). Each blister card (28 tablets) contains in the following order: ORTHO TRI-CYCLEN Tablets are also available for clinic usage in a VERIDATE Tablet Dispenser (unfilled) and VERIDATE refills (NDC 50458-191-20 and NDC 50458-191-12). ORTHO TRI-CYCLEN Tablets are available in a DIALPAK Tablet Dispenser (unfilled) and DIALPAK refills (NDC 50458-191-00 and NDC 50458-191-15).

Status de autorização:

New Drug Application

Características técnicas

ORTHO TRI CYCLEN- NORGESTIMATE AND ETHINYL ESTRADIOL
ORTHO CYCLEN- NORGESTIMATE AND ETHINYL ESTRADIOL
JANSSEN PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ORTHO-CYCLEN OR ORTHO
TRI-CYCLEN SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR ORTHO-CYCLEN AND
ORTHO TRI-CYCLEN.
ORTHO-CYCLEN
AND ORTHO TRI-CYCLEN
(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-CYCLEN OR ORTHO TRI-CYCLEN 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, Pregnancy (4)
Removed 06/2023
INDICATIONS AND USAGE
ORTHO-CYCLEN and ORTHO TRI-CYCLEN are combinations of norgestimate, a
progestin, and ethinyl
estradiol, an estrogen, indicated for use by females of reproductive
potential to prevent pregnancy. ( 1.1)
ORTHO TRI-CYCLEN is indicated for the treatment of moderate acne
vulgaris in females at least 15 years of
age, who have no known contraindications to oral contraceptive therapy
and have achieved menarche.
ORTHO TRI-CYCLEN should be used for the treatment of acne only if the
patient desires an oral
contraceptive for birth control. ( 1.2)
DOSAGE AND ADMINISTRATION
Take one tablet daily by mouth at the same time every day. ( 2.1)
Take tablets in the order directed on the blister pack. ( 2.1)
Do not skip or delay tablet intake. ( 2.1)
DOSAGE FORMS AND STRENGTHS
ORTHO-CYCLEN consists of 28 round, biconvex, coated tablets in the
following order ( 3):
21 blue tablets each containing 0.250 mg norgestimate and 0.035 mg
ethinyl estradiol
7 dark green tablets (inert)
ORTHO TRI-CYCLEN consists of 28 round, biconvex, coated tablets in the
following order ( 3):
7 white tablets each containing 0.180 mg norgestimate and 0.