Monday, October 5, 2009

Mifepristone..200 mg :: Mifebort :: tablets :: medical termination of intrauterine pregnancy

Taj Brands

Therapeutic Index
Mifebort Tablets
MIFEBORT
Each film coated tablet contains:

Composition:
Mifepristone.....................................................................200 mg
Excipients........ .......................................................................q.s.

Indications:
Mifebort is indicated for the medical termination of intrauterine pregnancy through 49 days pregnancy. For purposes of this treatment, pregnancy is dated from the first day of the last menstrual period in a presumed 28 day cycle with ovulation occurring at mid-cycle. Any intrauterine device [IUD] should be removed before treatment with Mifebort begins. Patients taking Mifebort must take 400 mg of Misobort two days after taking mifepristone unless a complete abortion has already been confirmed before that time (see Dosage And Administration). Pregnancy termination by surgery is recommended in cases when Mifebort and Misobort fail to cause termination of intrauterine pregnancy.

Description:
Mifepristone blocks the hormone progesterone needed to maintain the pregnancy. Because this hormone is blocked, the uterine lining begins to shed, the cervix begins to soften and bleeding may occur. With the later addition of the second medication, misoprostol, the uterus contracts and the pregnancy is usually expelled within 6 to 8 hours.
Because the woman decides when to take the second medication within the time frame of 24 to 72 hours after the first medication, she has some control over when she experiences the miscarriage and its side effects. Some women choose the Abortion Pill because of the privacy it offers. Some women feel empowered by taking an active role in the process.
Mifepristone effect on reproductive system
Side Effects
Most of the side effects when using this early abortion option are caused by the second medication, misoprostol. Side-effects may include heavy bleeding, headache, nausea, vomiting, diarrhea, and heavy cramping.

Dosage :
Treatment with Mifebort and Misobort for the termination of pregnancy requires three office visits by the patient. Mifebort may be administered only in a clinic, medical office, or hospital, by or under the supervision of a gynecologist, able to assess the gestational age of an embryo and to diagnose ectopic pregnancies. Gynecologist must also be able to provide surgical intervention in cases of incomplete abortion or severe bleeding, if necessary. Mifebort. Unless abortion has occurred and has been confirmed by clinical examination or ultrasonographic scan, the patient takes two 200 mg tablets (400 mg) of Misobort orally.

Presentations : 1 tablet
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Structural Formula

Mifepristone

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Mifepristone
Systematic (IUPAC) name
11β-[p-(Dimethylamino)phenyl]-
17β-hydroxy-17-(1-propynyl)estra-
4,9-dien-3-one
Identifiers
CAS number 84371-65-3
ATC code G03XB01
PubChem 55245
DrugBank APRD00432
ChemSpider 49889
Chemical data
Formula C29H35NO2
Mol. mass 429.60 g/mol
Pharmacokinetic data
Bioavailability 69%
Metabolism hepatic
Half life 18 hours
Excretion Fecal: 83%; Renal: 9%
Therapeutic considerations
Pregnancy cat. X(US) Used for terminating pregnancy
Legal status -only(US)
Routes Oral
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Mifepristone is a synthetic steroid compound used as a pharmaceutical. It is used as an abortifacient in the first two months of pregnancy, and in smaller doses as an emergency contraceptive. During early trials, it was known as RU-486, its designation at the Roussel Uclaf company, which designed the drug. The drug was initially made available in France, and other countries then followed—often amid controversy. It is marketed under tradenames Mifegyne and Mifeprex.

History

The compound was discovered by researchers at Roussel Uclaf of France in 1980 (the "RU" in RU-486) while they were studying glucocorticoid receptor antagonists. Étienne-Émile Baulieu recognized its anti-progesterone activities and saw its potential for the induction of a medical abortion. Clinical testing began in 1982. The drug was first licensed in France in 1988, for use in combination with a prostaglandin, under the name Mifegyne. After license approval but before market release, Roussel Uclaf announced it would abandon distribution of the drug, bowing to pressure from pro-life groups and the threat of a boycott. However, two days later, the French government, part owner of Roussel Uclaf, intervened, leading to the resumption of production and distribution of RU-486. The French Health Minister, explaining the government's intervention, stated, "I could not permit the abortion debate to deprive women of a product that represents medical progress. From the moment Government approval for the drug was granted, RU-486 became the moral property of women."[1]





API Complex -
Taj Pharmaceuticals Ltd. bulk drug complex located at Vapi (State of Gujrat) is one of the largest integrated antibiotic manufacturing complexes in its class. This facility specializes in the manufacture of cephalosporin API's (Active Pharmaceutical Ingredients) and has an installed manufacturing capacity of over 800 MT per annum. Set in a total land area of nearly 50,000 sq. mts., this facility is a massive, state-of-the-art, most modern manufacturing complex that produces a wide range of new generation cephalosporin bulk actives.
This facility has over 85 reactors of varied metallurgy including titanium, cast alloy, graphite, PVDF and PTFE with over 300 kl of handling capacity together with several centrifuges, driers and varied production equipment. The facilities are versatile and are capable of carrying out varied reactions ranging from -70°c to +150°c.
Taj Pharmaceuticals Ltd. is known for its world-class crystallisation and lyophillisation facilities, which provide a global competitive edge in sterile product manufacture. Taj also has a unique spray drying facility, which ensures the lowest levels of moisture content.
Taj Pharmaceuticals Ltd. has the capability to handle highly complex and hazardous reactions with utmost safety and productivity. Taj operations are backed by a full spectrum of utilities including a captive power generation plant, high technology solvent recovery facilities, sophisticated quality control equipment and a 'zero discharge' environment-friendly effluent treatment plant.
Business today face far more competition and external influences then they did five to 10 years ago. Competing in today's global economy can be tough for the small to midsize business (SMB). Smaller organization faces the same market pressure as the Global 2000. They are challenged by the need the customer and compliance mandates, manage supplier effectively, control Costs, and gain new customers to grow the business.
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