FDA records indicate that there are no current recalls for this drug.
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Side Effects & Adverse Reactions
In the presence of high environmental temperature, heat prostration can occur with drug use (fever and heat stroke due to decreased sweating). Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance, treatment with this drug would be inappropriate and possibly harmful. Like other anticholinergic agents, ANASPAZ may produce drowsiness or blurred vision. In this event, the patient should be warned not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery or to perform hazardous work while taking this drug.
Anticholinergic psychosis has been reported in sensitive individuals given anticholinergic drugs. CNS signs and symptoms include confusion, disorientation, short term memory loss, hallucinations, dysarthria, ataxia, coma, euphoria, decreased anxiety, fatigue, insomnia, agitation and mannerisms, and inappropriate affect. These CNS signs and symptoms usually resolve 12 to 48 hours after drug discontinuation.
Elderly patients may react with excitement, agitation, drowsiness, and other unfavorable manifestations to even small doses of ANASPAZ.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
ANASPAZ is effective as adjunctive therapy in the treatment of peptic ulcer and irritable bowel syndrome (irritable colon, spastic colon, mucous colitis), acute entercolitis and other functional gastrointestinal disorders. It can also be used to control gastric secretion, visceral spasm and hypermotility in cystitis, pylorospasm and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries and diverticulitis. ANASPAZ is indicated (along with appropriate analgesics) in symptomatic relief of biliary and renal colic and as a drying agent in the relief of symptoms of acute rhinitis.
History
There is currently no drug history available for this drug.
Other Information
Each ANASPAZ orally disintegrating tablet contains 1-hyoscyamine sulfate 0.125 mg. ANASPAZ may be taken orally (swallowed or chewed) or sublingually. ANASPAZ tablets are compressed, light yellow and scored with the Ascher logo on one side and 225/295 on the other. Inactive ingredients: DC Yellow #10, FDC yellow #6, lactose NF, magnesium stearate NF, mannitol USP, sorbitol NF, pre-gelatinized starch NF, stearic acid NF.
ANASPAZ is chemically pure 1-hyoscyamine sulfate, one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. Chemically, it is benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo[3.2.1.]oct-3-yl ester, [3(S)-endo]-, sulfate (2:1), dihydrate with the chemical formula (C17H23NO3)2•H2SO4•2H2O
Sources
Anaspaz Manufacturers
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Bf Ascher And Co Inc
Anaspaz | Bf Ascher And Co Inc
Adults and children 12 years of age and older: 1 or 2 tablets every four hours or as needed. Do not exceed 12 tablets in 24 hours. Children 2 to under 12 years of age: 1/2 to 1 tablet every four hours or as needed. Do not exceed 6 tablets in 24 hours.
ANASPAZ may be taken orally (swallowed or chewed) or sublingually. The dosage of ANASPAZ should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse effects.
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