MONO-LINYAH - norgestimate and ethinyl estradiol

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:

A-S Medication Solutions

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Mono-Linyah Tablets are indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies ( 14)] . Do not prescribe Mono-Linyah 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 an

Resumo do produto:

Mono-Linyah Tablets are available in a compact blister card (NDC 16714-360-01) containing 28 tablets in the following order: 21 blue, biconvex, round, coated tablets with "C3" debossed on one side containing 0.25 mg norgestimate and 0.035 mg ethinyl estradiol, and 7 white, biconvex, round, coated tablets with "P" debossed on one side and the "N" debossed on the other side containing inert ingredients. Mono-Linyah Tablets are available in the following configurations: Carton of 1 blister card NDC 16714-360-02 Carton of 3 blister cards NDC 16714-360-03 Carton of 6 blister cards NDC 16714-360-04 Keep out of reach of children.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

MONO-LINYAH - NORGESTIMATE AND ETHINYL ESTRADIOL
A-S MEDICATION SOLUTIONS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MONO-LINYAH SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FORMONO-LINYAH. MONO-LINYAH
(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._
● MONO-LINYAH 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 Precautious (5.3) 08/2017
INDICATIONS AND USAGE
Mono-Linyah is an estrogen/progestin COC, indicated for use by women
to prevent pregnancy. (1.1)
DOSAGE AND ADMINISTRATION
Take one tablet 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
Mono-Linyah consists of 28 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)
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 Mono-Linyah
if a thrombotic event occurs. Stop at least
4 weeks before and through 2 weeks after major surgery. Start no
earlier than 4 weeks after delivery, in women who
are not breastfeeding. (5.1)
Liver disease: Discontinue Mono-Linyah if jaundice occurs. (5.2)
High blood pressure: If used in women with well