"The U.S. Food and Drug Administration today approved Viberzi (eluxadoline) and Xifaxan (rifaximin), two new treatments, manufactured by two different companies, for irritable bowel syndrome with diarrhea (IBS-D) in adult men and women.
(Generic versions may still be available.)
Based on a review of this drug by the National Academy of Sciences - National Research Council and/or other information, FDA has classified the indications as follows:
"Possibly" effective: as adjunctive therapy in the treatment of peptic ulcer and in the treatment of the irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis.
Final classification of the less-than-effective indications requires further investigation.
DOSAGE AND ADMINISTRATION
Because of the varied individual responses to tranquilizers and anticholinergics, the optimum dosage of Librax varies with the diagnosis and response of the individual patient. The dosage, therefore, should be individualized for maximum beneficial effects. The usual maintenance dose is 1 or 2 capsules, 3 or 4 times a day administered before meals and at bedtime.
Dosage should be limited to the smallest effective amount to preclude the development of ataxia, oversedation or confusion. The initial dose should not exceed 2 Librax capsules per day, to be increased gradually as needed and tolerated.
Librax is available in green capsules, each containing 5 mg chlordiazepoxide hydrochloride and 2.5 mg clidinium bromide - bottles of 100 (NDC 0187-4100-10).
Store at 25°C (77°F); excursions permitted to 15°C - 30°C (59°F - 86°F).
Manufactured in Canada by: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada. Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA. Revised: Jan 2014This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 9/20/2016
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