MIFEPRISTONE tablet

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

GenBioPro, Inc.

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Mifepristone tablets, 200 mg is indicated, in a regimen with misoprostol, for the medical termination of intrauterine pregnancy through 70 days gestation. - Administration of Mifepristone tablets, 200 mg 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 adrenal insufficiency) Concurrent long-term corticosteroid therapy (risk of acute adrenal 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) In

Prehľad produktov:

Mifepristone tablets, 200 mg is only available through a restricted program called the Mifepristone REMS Program [see Warnings and Precautions ( 5.3)] Mifepristone tablets, 200 mg is supplied as light yellow, circular, bi-convex, uncoated tablets debossed with “S” on one side and plain on other side. Each tablet contains 200 mg 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 ].

Stav Autorizácia:

Abbreviated New Drug Application

Príbalový leták

MIFEPRISTONE- MIFEPRISTONE TABLET
GenBioPro, Inc.
----------
MEDICATION GUIDE
Mifepristone (MIF-eh-pris-tone) tablets, 200 mg for oral use
Read this information carefully before taking Mifepristone tablets,
200 mg and misoprostol. It will help
you understand how the treatment works. This Medication Guide does not
take the place of talking with
your healthcare provider.
What is the most important information I should know about
Mifepristone tablets, 200 mg?
What symptoms should I be concerned with? Although cramping and
bleeding are an expected part of
ending a pregnancy, rarely, serious and potentially life-threatening
bleeding, infections, or other problems
can occur following a miscarriage, surgical abortion, medical
abortion, or childbirth. Seeking medical
attention as soon as possible is needed in these circumstances.
Serious infection has resulted in death in a
very small number of cases. There is no information that use of
Mifepristone tablets, 200mg and
misoprostol caused these deaths. If you have any questions, concerns,
or problems, or if you are worried
about any side effects or symptoms, you should contact your healthcare
provider. You can write down
your healthcare provider's telephone number here
_______________________.
Be sure to contact your healthcare provider promptly if you have any
of the following:
•
Heavy Bleeding. Contact your healthcare provider right away if you
bleed enough to soak through
two thick full-size sanitary pads per hour for two consecutive hours
or if you are concerned about
heavy bleeding. In about 1 out of 100 women, bleeding can be so heavy
that it requires a surgical
procedure (surgical aspiration or D&C).
•
Abdominal Pain or “Feeling Sick.” If you have abdominal pain or
discomfort, or you are “feeling
sick,” including weakness, nausea, vomiting, or diarrhea, with or
without fever, more than 24
hours after taking misoprostol, you should contact your healthcare
provider without delay. These
symptoms may be a sign of a serious infection or another problem
(inclu

Súhrn charakteristických

MIFEPRISTONE- MIFEPRISTONE TABLET
GENBIOPRO, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MIFEPRISTONE TABLETS,
200MG SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
MIFEPRISTONE TABLETS,
200MG.
MIFEPRISTONE TABLETS, 200MG FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
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,
200 MG 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. ( 5.1)
BLEEDING. PROLONGED HEAVY BLEEDING MAY BE A SIGN OF INCOMPLETE
ABORTION OR OTHER
COMPLICATIONS AND PROMPT MEDICAL OR SURGICAL INTERVENTION MAY BE
NEEDED. ( 5.2)
MIFEPRISTONE TABLETS, 200 MG IS ONLY AVAILABLE THROUGH A RESTRICTED
PROGRAM CALLED THE
MIFEPRISTONE REMS PROGRAM ( 5.3).
BEFORE PRESCRIBING MIFEPRISTONE TABLETS, 200 MG, INFORM THE PATIENT
ABOUT THESE RISKS.
ENSURE THE PATIENT KNOWS WHOM TO CALL AND WHAT TO DO IF THEY
EXPERIENCE SUSTAINED
FEVER, SEVERE ABDOMINAL PAIN, PROLONGED HEAVY BLEEDING, OR SYNCOPE, OR
IF THEY
EXPERIENCE ABDOMINAL PAIN OR DISCOMFORT OR GENERAL MALAISE FOR MORE
THAN 24 HOURS
AFTER TAKING MISOPROSTOL.
INDICATIONS AND USAGE
Mifepristone tablets, 200 mg is a progestin antagonist indicated, in a
regimen with misoprostol, for the
medical termination of intrauterine pregnancy through 70 days
gestation. ( 1)
DOSAGE AND ADMINISTRATION
200 mg Mifepristone on Day 1, followed 24-48 hours after Mifepristone
dosing by 800 mcg buccal
misoprostol. ( 2.1)
Instruct the patient what to do if significant adverse reactions
occur. ( 2.2)
Follow-up is needed to confirm complete termination of pregnancy. (
2.