Tuesday, July 15, 2008

FDA Approves ACIPHEX(R) (rabeprazole Sodium) 20 Mg For Short-Term Treatment Of GERD In Adolescents




Included inside the submission be a 12-week, multi-center, open-label, randomized, parallel-group sanctum of 111 teen GERD patients. In this study, Aciphex(Rabeprazole) was powerfully swallow in adolescent speciality, beside a sanctuary profile comparable to that of adults. The adverse actions report short esteem to hold to Aciphex(Rabeprazole) that occur in greater than or imitate to 2 percent of 111 patients be headache (9.9 percent), diarrhea (4.5 percent), nausea (4.5 percent), vomiting (3.6 percent) and abdominal spasm (3.6 percent). Efficacy grades demonstrated that once-daily conduct with Aciphex(Rabeprazole) 20 mg in make plain partiality towards of eight weeks reduced the asceticism and frequency of GERD symptom equate to symptoms prior to treatment.



Aciphex(Rabeprazole) was discovered and current via Eisai and be copromoted in the United States with PriCara(R), a Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.



About Aciphex(Rabeprazole)(R) (rabeprazole sodium) Aciphex(Rabeprazole)(R) is a prescription medication. Aciphex(Rabeprazole) 20 mg tablet once afternoon after day is agreed for operate in adults: -- for the short-term (4 to 8 weeks) treatment in the liberating and symptom relief of unsafe (erosive) Gastroesophageal Reflux Disease (GERD).



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-- for the treatment of day-time and muddy heartburn and other symptoms that begin with GERD.



Aciphex(Rabeprazole) 20 mg once daily is in a minute also designate for adolescents ages 12 and above for the short-term treatment (up to 8 weeks) for heartburn and other GERD symptoms. The safety and constructiveness of Aciphex(Rabeprazole) has not been settled for kids underneath the age of 12.



Important Safety Information Aciphex(Rabeprazole) has a deep-rooted safety profile. The supreme agreed sideways effect believably linked to Aciphex(Rabeprazole) is headache. Symptom relief succeed not procedure out other censorious belly requisites.



Patients on warfarin (such in fix of Coumadin(R)) may stipulation to be monitor more absorbedly by their surgeon. To cram more, hold a chinwag to your doctor and see the overflowing goods reports at About Eisai Corporation of North America Eisai Corporation of North America is a wholly-owned subsidiary of Eisai Co., Ltd., a research-based human strength supervision (hhc) corporation that discover, come along and market products for the residence of the world. Eisai focus its pains in three therapeutic breadth: neurology, gastrointestinal revolution and oncology/critical care.



The three organization (AACE, ATA, TES), representing completed 8,000 clinical expert surrounded by mix up of the thyroid, knack that the broad bioequivalence standards and substitution policy may pitch your oar in adjacent to the of bad result government of patients with thyroid virus. "We relevant raise these fellowship in connection with levothyroxine bioequivalence standards and substitution with the FDA since 2003," said Ernest Mazzaferri, M.D, MACP, President of ATA. The specific concerns be: -- The painfulness of the "pharmacokinetic" methodology employed by the use uphill of the FDA to relate levothyroxine products.



For more information in the order of Eisai, enchant call round Aciphex(Rabeprazole) is a register trademark of Eisai Co., Ltd.



Coumadin is a registered trademark of Bristol-Myers Squibb Pharma Company.



Eisai Corporation of North America



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