"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.
Levsin®/SL (hyoscyamine sulfate tablets) is effective as adjunctive therapy in the treatment of peptic ulcer. It can also be used to control gastric secretion, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm, and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis, and acute enterocolitis. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also used as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Also used in the treatment of infant colic (elixir and drops). Levsin®/SL (hyoscyamine sulfate tablets) is indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic; as a “drying agent” in the relief of symptoms of acute rhinitis; in the therapy of parkinsonism to reduce rigidity and tremors and to control associated sialorrhea and hyperhidrosis. May be used in the therapy of poisoning by anticholinesterase agents.
DOSAGE AND ADMINISTRATION
Dosage may be adjusted according to the conditions and severity of symptoms. The tablets may be taken sublingually, orally or chewed.
Adults and pediatric patients 12 years of age and older
1 to 2 tablets every four hours or as needed. Do not exceed 12 tablets in 24 hours.
Pediatric patients 2 to under 12 years of age: ½ to 1 tablet every four hours or as needed. Do not exceed 6 tablets in 24 hours.
Levsin®/SL tablets (hyoscyamine sulfate tablets USP) 0.125 mg are round, blue colored tablets that are imprinted with “AP” on one side and “113” on the other.
Bottles of 100 tablets NDC 68220-113-10
Bottles of 500 tablets NDC 68220-113-50
Store at controlled room temperature 20°- 25°C (68° - 77°F); excursions permitted to15°- 30°C (59°- 86°F). Please refer to current USP.
Dispense in tight, light-resistant containers as defined in USP/NF with a child-resistant closure.
KEEP OUT OF REACH OF CHILDREN
Also available as:
|Levsin®||Dosage Strength||Package Size||NDC|
|Injection||0.5mg/mL||Box of 5-1mL||0091-1536-05|
|Levbid® extended-release tablets||0.375mg||100||68220-115-10|
Manufactured for: Alaven Pharmaceutical LLC, Marietta, GA 30067. Address medical inquiries to: Alaven Pharmaceutical LLC, 2260 Northwest Parkway, Suite A, Marietta, GA 30067 Or call toll free 1-888-317-0001. Rev: 02/08.
Last reviewed on RxList: 3/13/2009
This monograph has been modified to include the generic and brand name in many instances.
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