ELLA- ulipristal acetate tablet

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

ULIPRISTAL ACETATE (UNII: YF7V70N02B) (ULIPRISTAL - UNII:6J5J15Q2X8)

Доступна з:

Afaxys Pharma LLC

ІПН (Міжнародна Ім'я):

ULIPRISTAL ACETATE

Склад:

ULIPRISTAL ACETATE 30 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

ella is a progesterone agonist/antagonist emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. ella is not intended for routine use as a contraceptive. ella is contraindicated for use in the case of known or suspected pregnancy. [See Use in Specific Populations (8.1 ).] Risk Summary ella is contraindicated for use during an existing or suspected pregnancy. No signal of concern regarding pregnancy complications was found in postmarketing studies [see Data ]. Isolated cases of major malformations in ella- exposed pregnancies were identified; however, the data are not sufficient to determine a risk for birth defects with inadvertent use of ella during pregnancy. Miscarriage was reported in 14% of the known pregnancy outcomes; a rate that is similar to the U.S background rate for miscarriage. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized p

Огляд продуктів:

ella (ulipristal acetate) tablet, 30 mg is supplied in a PVC-PE-PVDC or PVC-PVDC-aluminum blister. The tablet is a white to off-white, round, curved tablet marked with "ella " on both sides.  NDC 50102-911-01 (1 tablet unit of use package) Store at 20-25°C (68-77°F). [See USP controlled room temperature.] Keep the blister in the outer carton in order to protect from light. Keep out of reach of children .

Статус Авторизація:

New Drug Application

Характеристики продукта

ELLA- ULIPRISTAL ACETATE TABLET
AFAXYS PHARMA LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ELLA
SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ELLA.
ELLA (ULIPRISTAL ACETATE) TABLET,FOR ORAL USE
INITIAL U.S. APPROVAL: 2010
RECENT MAJOR CHANGES
Contraindication (4)
05/2018
Warnings and Precautions, Existing Pregnancy (5.1)
05/2018
Use in Specific Populations (8.1), (8.2 ) (8.3)
05/2018
INDICATIONS AND USAGE
ELLA is a progesterone agonist/antagonist emergency contraceptive
indicated for prevention of pregnancy following
unprotected intercourse or a known or suspected contraceptive failure.
ELLA is not intended for routine use as a
contraceptive. (1)
DOSAGE AND ADMINISTRATION
One tablet taken orally as soon as possible, within 120 hours (5 days)
after unprotected intercourse or a known or
suspected contraceptive failure. (2)
The tablet can be taken with or without food. (2)
DOSAGE FORMS AND STRENGTHS
30 mg tablet (3)
CONTRAINDICATIONS
Known or suspected pregnancy (4)
WARNINGS AND PRECAUTIONS
ELLA is not indicated for termination of an existing pregnancy(5.1)
Subsequent acts of intercourse should be protected by a reliable
barrier method until next menstrual period. If a
woman wishes to use hormonal contraception, she should do so no sooner
than 5 days after intake of ELLA. (5.5)
Ectopic pregnancy: Women who become pregnant or complain of lower
abdominal pain after taking ELLA should be
evaluated for ectopic pregnancy. (5.2)
Effect on menstrual cycle: ELLA may alter the next expected menses. If
menses is delayed beyond 1 week, pregnancy
should be ruled out. (5.6)
ELLA does not protect against STI/HIV. (5.7)
ADVERSE REACTIONS
The most common adverse reactions (≥ 5%) in the clinical trials were
headache (18%), abdominal pain (12%), nausea
(12%), dysmenorrhea (9%), fatigue (6%) and dizziness (5%). (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT AFAXYS PHARMA LLC, AT
1-855-888-2467 OR FDA AT 1-
800-FDA-1088 OR _WWW.FDA.GOV/MEDWAT