NORGESTIMATE AND ETHINYL ESTRADIOL kit

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Naari Pte Limited

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Norgestimate and ethinyl estradiol tablets USP are indicated for use by females of reproductive potential to prevent pregnancy [see CLINICAL STUDIES ( 14)]. Norgestimate and ethinyl estradiol tablets 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:           o  Smoke, if over age 35 [see BOXED WARNING AND WARNINGS AND PRECAUTIONS ( 5.1)]           o   Have deep vein thrombosis or pulmonary embolism, now or in the past [see WARNINGS AND PRECAUTIONS ( 5.1)]           o   Have inherited or acquired hypercoagulopathies [see WARNINGS AND PRECAUTIONS ( 5.1)]           o   Have cerebrovascular disease [see WARNINGS AND PRECAUTIONS ( 5.1)]           o   Have coronary artery disease [see WARNINGS AND PREC

Přehled produktů:

Norgestimate and ethinyl estradiol tablets USP (0.25 mg/0.035 mg) are available in a blister card: (NDC 79929-008-05). Each blister card (28 tablets) contains in the following order: • 21 dark blue unscored round tablets debossed with on one side with “14”; the tablet contains 0.25 mg norgestimate and 0.035 mg ethinyl estradiol • 7 white round unscored tablets (non-hormonal placebo) debossed on one side with “11”; the tablet contains inert ingredients Norgestimate and Ethinyl Estradiol Tablets USP, (0.25 mg/0.035 mg) are packaged in a carton (NDC 79929-008-05) containing 3 blister cards. VERIDATE Tablet Dispenser is not applicable for the ANDA product     •    Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [see USP controlled room temperature].     •    Protect from light.

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

NORGESTIMATE AND ETHINYL ESTRADIOL- NORGESTIMATE AND ETHINYL
ESTRADIOL
NAARI PTE LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NORGESTIMATE AND
ETHINYL ESTRADIOL TABLETS USP SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS USP. NORGESTIMATE AND
ETHINYL
ESTRADIOL TABLETS USP, FOR ORAL USE INITIAL U.S. APPROVAL: 1989
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
• NORGESTIMATE AND ETHINYL ESTRADIOL TABLET 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
Warnings and Precautions ( 5.11) 12/2021
INDICATIONS AND USAGE
Norgestimate and ethinyl estradiol tablets USP are estrogen/progestin
COCs, 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. ( 2.2)
• Do not skip or delay tablet intake. ( 2.2)
DOSAGE FORMS AND STRENGTHS
Norgestimate and ethinyl estradiol tablets consist 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 white 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)
• Current diagnosis of, or history of, breast cancer, which may be
hormone-sensitive ( 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
norgestimate and ethinyl estradiol
tablets if a thrombotic