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Basic Drug Info
Drug Name:Dicyclomine Hydrochloride
Manufacturer:MIKART, INC.
Other Info:

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

(See Precautions: Geriatric Use)



Clinical Trials:


Indications and Usage
Dicyclomine hydrochloride oral solution is indicated for the treatment of functional bowel/irritable bowel syndrome.
Irritable Bowel Syndrome -- chronic noninflammatory disease characterized by abdominal pain, altered bowel habits consisting of diarrhea or constipation or both, and no detectable pathologic change; a variant form is characterized by painless diarrhea; it is a common disorder with a psychophysiologic basis; called also spastic or irritable colon.

Contraindications
Obstructive uropathy Obstructive disease of the gastrointestinal tract Severe ulcerative colitis (see PRECAUTIONS) Reflux esophagitis Unstable cardiovascular status in acute hemorrhage Glaucoma Myasthenia gravis Evidence of prior hypersensitivity to dicyclomine hydrochloride or other ingredients in this formulation Infants less than 6 months of age (See WARNINGS and PRECAUTIONS:Information For Patients.) Nursing Mothers (See WARNINGS and PRECAUTIONS:Information For Patients)
Diseases, Obstructive --

Ulcerative Colitis -- Inflammation of the COLON that is predominantly confined to the MUCOSA. Its major symptoms include DIARRHEA, rectal BLEEDING, the passage of MUCUS, and ABDOMINAL PAIN.

Ulcer -- A lesion on the surface of the skin or a mucous surface, produced by the sloughing of inflammatory necrotic tissue.

Warnings

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 Mothers and Pediatric Use.)Safety and efficacy of dicyclomine hydrochloride in pediatric patients have not been established.
Branded Drugs
The following US Branded drugs contain Dicyclomine Hydrochloride


BENTYL -- AXCAN PHARMA US INC

BENTYL PRESERVATIVE FREE -- AXCAN PHARMA US INC

DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE-FREE) -- BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC


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