Dicyclomine Hydrochloride Solution Recall
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Questions & Answers
Side Effects & Adverse Reactions
In the presence of a high environmental temperature, heat prostration can occur with drug use (fever and heat stroke due to decreased sweating). If symptoms occur, the drug should be discontinued and supportive measures instituted.
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.
Dicyclomine hydrochloride oral solution may produce drowsiness or blurred vision. The patient should be warned not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery or performing hazardous work while taking this drug.
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 within 12 to 24 hours after discontinuation of the drug.
There are reports that administration of dicyclomine hydrochloride oral soution to infants has been followed by serious respiratory symptoms (dyspnea, shortness of breath, breathlessness, respiratory collapse, apnea, asphyxia), seizures, syncope, pulse rate fluctuations, muscular hypotonia, and coma. Death has been reported. No causal relationship between these effects observed in infants and dicyclomine administration has been established. DICYCLOMINE HYDROCHLORIDE ORAL SOLUTION IS CONTRAINDICATED IN INFANTS LESS THAN 6 MONTHS OF AGE AND IN NURSING MOTHERS. (see CONTRAINDICATIONS and PRECAUTIONS: Nursing MothersNursing Mothers and Pediatric UsePediatric Use).
Safety and efficacy of dicyclomine hydrochloride in pediatric patients have not been established.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
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.
Dicyclomine hydrochloride oral solution is indicated for the treatment of functional bowel/irritable bowel syndrome.
There is currently no drug history available for this drug.
Dicyclomine hydrochloride oral solution is an antispasmodic and anticholinergic (antimuscarinic) agent. Each 5 mL (teaspoonful) of dicyclomine hydrochloride oral solution for oral administration contains:
Dicyclomine HCl …………………………. 10 mg
Also contains glycerin, methylparaben, propylene glycol, propylparaben, purified water, sorbitol solution, sucrose, with D&C Red #33, FD&C Blue #1, FD&C Red #40, FD&C Yellow #6 as coloring, and natural and artificial tropical fruit punch flavoring.
Chemically, dicyclomine hydrochloride is [bicyclohexyl]-1-carboxylic acid, 2-(diethylamino) ethyl ester, hydrochloride. Dicyclomine hydrochloride occurs as a fine, white, crystalline, practically odorless powder with a bitter taste. It is soluble in water, freely soluble in alcohol and chloroform, and very slightly soluble in ether. Its structural formula is as follows:
C19H35NO2 • HCl M.W. 345.95