ESTARYLLA- norgestimate and ethinyl estradiol

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Sandoz Inc

INN (Nama Antarabangsa):

NORGESTIMATE

Komposisi:

NORGESTIMATE 0.25 mg

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Estarylla™ (norgestimate and ethinyl estradiol tablets) are indicated for use by females of reproductive potential to prevent pregnancy [see CLINICAL STUDIES (14)] . Do not prescribe norgestimate and ethinyl estradiol to women who are known to have the following conditions: - Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations [seeWARNINGS AND PRECAUTIONS (5.3) ] There is little or no increased risk of birth defects in women who inadvertently use COCs during early pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb reduction defects) following exposure to low dose COCs prior to conception or during early pregnancy. Do not administer COCs to induce withdrawal bleeding as a test for pregnancy. Do not use COCs during pregnancy to treat threatened or habitual abortion. Advise the nursing mother to use other f

Ringkasan produk:

Estarylla™ (norgestimate and ethinyl estradiol tablets, USP) are available in blisters containing 28 tablets as follows: Each blister card contains 21 active tablets and 7 inactive tablets. The 21 active tablets are blue, round, debossed with SZ on one side and T4 on the other side. The 7 inert tablets are green, round, debossed with SZ on one side and J1 on the other side. Keep out of reach of children

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

ESTARYLLA- NORGESTIMATE AND ETHINYL ESTRADIOL
SANDOZ INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ESTARYLLA™ SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ESTARYLLA™.
ESTARYLLA™ (NORGESTIMATE AND 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._
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RECENT MAJOR CHANGES
Contraindications (4) 08/2017
Warnings and Precautions (5.3) 08/2017
INDICATIONS AND USAGE
Estarylla™ (norgestimate and ethinyl estradiol tablets, USP),are an
estrogen/progestin COCs, indicated for use by women
to prevent pregnancy. (1.1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Estarylla™ (norgestimate and ethinyl estradiol tablets, USP)
consists of 28 round tablets in the following order (3):
21 blue tablets each containing 0.25 mg norgestimate and 0.035 mg
ethinyl estradiol
7 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
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ADVERSE REACTIONS
The most common adverse reactions reported during clinical trials
(≥2%) were:
NORGESTIMATE AND ETHINYL ESTRADIOL ARE 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)
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)
_THROMBOEMBOLIC DISORDERS AND OTHER VASCULAR PROBLEMS:_ Stop
norgestimate and ethinyl estradiol if a thro