ResoundingHealth
Search
  
Basic Drug Info
Drug Name:Dicyclomine Hydrochloride
Manufacturer:Mylan Pharmaceuticals Inc.
Other Info:Mylan Pharmaceuticals Inc.Morgantown, WV 26505REVISED OCTOBER 1999CDICY:R2



Clinical Trials:


Indications and Usage
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 of these formulations.Infants less than 6 months of age.

(See WARNINGS and PRECAUTIONS: Information for Patients.)Nursing mothers.

(See WARNINGS and PRECAUTIONS: Information for Patients.)
Obstructive Uropathy --

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.

Gastro-esophageal reflux disease with esophagitis --

Peptic Esophagitis -- INFLAMMATION of the ESOPHAGUS that is caused by the reflux of GASTRIC JUICE with contents of the STOMACH and DUODENUM.

Glaucoma -- An ocular disease, occurring in many forms, having as its primary characteristics an unstable or a sustained increase in the intraocular pressure which the eye cannot withstand without damage to its structure or impairment of its function. The consequences of the increased pressure may be manifested in a variety of symptoms, depending upon type and severity, such as excavation of the optic disk, hardness of the eyeball, corneal anesthesia, reduced visual acuity, seeing of colored halos around lights, disturbed dark adaptation, visual field defects, and headaches. (Dictionary of Visual Science, 4th ed)

Myasthenia Gravis -- A disorder of neuromuscular transmission characterized by weakness of cranial and skeletal muscles. Autoantibodies directed against acetylcholine receptors damage the motor endplate portion of the NEUROMUSCULAR JUNCTION, impairing the transmission of impulses to skeletal muscles. Clinical manifestations may include diplopia, ptosis, and weakness of facial, bulbar, respiratory, and proximal limb muscles. The disease may remain limited to the ocular muscles. THYMOMA is commonly associated with this condition. (Adams et al., Principles of Neurology, 6th ed, p1459)

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 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 syrup 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 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


This web-site is for informational purposes only and is not intended as a substitute for advice from your doctor. It should not to be used for self-diagnosis or treatment.