MIFEPRISTONE tablet

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

MIFEPRISTONE (UNII: 320T6RNW1F) (MIFEPRISTONE - UNII:320T6RNW1F)

Доступна с:

PCI Pharma Services Canada, Inc.

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Mifepristone tablets, 200mg is indicated, in a regimen with misoprostol, for the medical termination of intrauterine pregnancy through 70 days gestation. - Administration of Mifepristone tablets, 200mg and misoprostol for the termination of pregnancy (the “treatment procedure”) is contraindicated in patients with any of the following conditions: Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass (the treatment procedure will not be effective to terminate an ectopic pregnancy) [see Warnings and Precautions (5.4)] Chronic adrenal failure (risk of acute renal insufficiency) Concurrent long-term corticosteroid therapy (risk of acute renal insufficiency) History of allergy to mifepristone, misoprostol, or other prostaglandins (allergic reactions including anaphylaxis, angioedema, rash, hives, and itching have been reported [see Adverse Reactions (6.2]) Hemorrhagic disorders or concurrent anticoagulant therapy (risk of heavy bleeding) - Confirmed or suspected ectopic pregna

Обзор продуктов:

Mifepristone tablets, 200mg is only available through a restricted program called the Mifepristone REMS Program [see Warnings and Precautions (5.3)] Mifepristone tablets, 200mg is supplied as light yellow, circular, bi-convex, uncoated tablets debossed with “S” on one side and plain on other side. Each tablet contains 200mg of mifepristone. One tablet is individually blistered on one blister card that is packaged in an individual package (National Drug Code 43393-001-01). Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature ].

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

MIFEPRISTONE- MIFEPRISTONE TABLET
PCI PHARMA SERVICES CANADA, INC.
----------
BOXED WARNING
WARNING: SERIOUS AND SOMETIMES FATAL INFECTIONS OR BLEEDING
SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.
SERIOUS AND SOMETIMES FATAL INFECTIONS AND BLEEDING OCCUR VERY RARELY
FOLLOWING SPONTANEOUS, SURGICAL, AND MEDICAL ABORTIONS, INCLUDING
FOLLOWING MIFEPRISTONE TABLETS, 200MG USE.
ATYPICAL PRESENTATION OF INFECTION. PATIENTS WITH SERIOUS BACTERIAL
INFECTIONS AND SEPSIS CAN PRESENT WITHOUT FEVER, BACTEREMIA OR
SIGNIFICANT FINDINGS ON PELVIC EXAMINATION. A HIGH INDEX OF SUSPICION
IS
NEEDED TO RULE OUT SERIOUS INFECTION AND SEPSIS.
BLEEDING. PROLONGED HEAVY BLEEDING MAY BE A SIGN OF INCOMPLETE
ABORTION
OR OTHER COMPLICATIONS AND PROMPT MEDICAL OR SURGICAL INTERVENTION MAY
BE NEEDED.
MIFEPRISTONE TABLETS, 200MG IS ONLY AVAILABLE THROUGH A RESTRICTED
PROGRAM CALLED THE MIFEPRISTONE REMS PROGRAM.
BEFORE PRESCRIBING MIFEPRISTONE TABLETS, 200MG, INFORM THE PATIENT
ABOUT THESE RISKS. ENSURE THE PATIENT KNOWS WHOM TO CALL AND WHAT TO
DO IF SHE EXPERIENCES SUSTAINED FEVER, SEVERE ABDOMINAL PAIN,
PROLONGED
HEAVY BLEEDING, OR SYNCOPE, OR IF SHE EXPERIENCES ABDOMINAL PAIN OR
DISCOMFORT OR GENERAL MALAISE FOR MORE THAN 24 HOURS AFTER TAKING
MISOPROSTOL.
ADVISE THE PATIENT TO TAKE THE MEDICATION GUIDE WITH HER IF SHE VISITS
AN EMERGENCY ROOM OR ANOTHER HEALTHCARE PROVIDER WHO DID NOT
PRESCRIBE MIFEPRISTONE TABLETS, 200MG, SO THAT PROVIDER KNOWS THAT SHE
IS UNDERGOING A MEDICAL ABORTION.
1 INDICATIONS AND USAGE
Mifepristone tablets, 200mg is indicated, in a regimen with
misoprostol, for the medical
termination of intrauterine pregnancy through 70 days gestation.
2 DOSAGE AND ADMINISTRATION
2.1 DOSING REGIMEN
For purposes of this treatment, pregnancy is dated from the first day
of the last
menstrual period. The duration of pregnancy may be determined from
menstrual history
and clinical examination. Assess the pregnancy by ultrasonographic
scan if the duration
of pregnancy is uncertain or if ectopic pregnancy is suspected.