Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
MIFEPRISTONE (UNII: 320T6RNW1F) (MIFEPRISTONE - UNII:320T6RNW1F)
PCI Pharma Services Canada, Inc.
ORAL
PRESCRIPTION DRUG
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
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 ].
Abbreviated New Drug Application
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. Belgenin tamamını okuyun