Revised 11/08
Rx Only

PRECAUTIONS

General:

Use with caution in patients with:

1. Autonomic neuropathy

2. Hepatic or renal disease

3. Ulcerative colitis - large doses may suppress intestinal motility to the point of producing a paralytic ileus and the use of this drug may precipitate or aggravate the serious complication of toxic megacolon (see CONTRAINDICATIONS)

4. Hyperthyroidism

5. Hypertension

6. Coronary heart disease

7. Congestive heart failure

8. Cardiac tachyarrhythmia

9. Hiatal hernia (seeCONTRAINDICATIONS: Reflux esophagitis)

10. Known or suspected prostatic hypertrophy.

Investigate any tachycardia before administration of dicyclomine hydrochloride, since it may increase the heart rate.

With overdosage, a curare-like action may occur (i.e., neuromuscular blockade leading to muscular weakness and possible paralysis).

Information for Patients:

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 to perform hazardous work while taking this drug.

Dicyclomine hydrochloride is contraindicated in infants less than 6 months of age and in nursing mothers. (SeeCONTRAINDICATIONS****,WARNINGS, andPRECAUTIONS: Nursing MothersandPediatric Use****.)

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 a physician contacted.

Drug Interactions:

The following agents may increase certain actions or side effects of anticholinergic drugs: amantadine, antiarrhythmic agents of Class I (e.g., quinidine), antihistamines, antipsychotic agents (e.g., phenothiazines), benzodiazepines, MAO inhibitors, narcotic analgesics (e.g., meperidine), nitrates and nitrites, sympathomimetic agents, tricyclic antidepressants, and other drugs having anticholinergic activity.

Anticholinergics antagonize the effects of antiglaucoma agents. Anticholinergic drugs in the presence of increased intraocular pressure may be hazardous when taken concurrently with agents such as corticosteroids. (See alsoCONTRAINDICATIONS****.)

Anticholinergic agents may affect gastrointestinal absorption of various drugs, such as slowly dissolving dosage forms of digoxin; increased serum digoxin concentrations may result. Anticholinergic drugs may antagonize the effects of drugs that alter gastrointestinal motility, such as metoclopramide. Because antacids may interfere with the absorption of anticholinergic agents, simultaneous use of these drugs should be avoided. The inhibiting effects of anticholinergic drugs on gastric hydrochloric acid secretion are antagonized by agents used to treat achlorhydria and those used to test gastric secretion.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

There are no known human data on long-term potential for carcinogenicity or mutagenicity. Long-term studies in animals to determine carcinogenic potential are not known to have been conducted. In studies in rats at doses of up to 100 mg/kg/day, dicyclomine hydrochloride produced no deleterious effects on breeding, conception, or parturition.

**Pregnancy: Teratogenic Effects: **Pregnancy Category B

Reproduction studies have been performed in rats and rabbits at doses up to 33 times the maximum recommended human dose based on 160 mg/day (3 mg/kg) and have revealed no evidence of impaired fertility or harm to the fetus due to dicyclomine. Epidemiologic studies in pregnant women with products containing dicyclomine hydrochloride (at doses up to 40 mg/day) have not shown that dicyclomine increases the risk of fetal abnormalities if administered during the first trimester of pregnancy. There are, however, no adequate and well- controlled studies in pregnant women at the recommended doses (80-160 mg/day). Because animal reproduction studies are not always predictive of human response, dicyclomine hydrochloride as indicated for functional bowel/irritable bowel syndrome should be used during pregnancy only if clearly needed.

Nursing Mothers:

Since dicyclomine hydrochloride has been reported to be excreted in human milk, DICYCLOMINE HYDROCHLORIDE IS CONTRAINDICATED IN NURSING MOTHERS. (See CONTRAINDICATIONS**,WARNINGS,PRECAUTIONS: Pediatric Use andADVERSE REACTIONS****.**)

Pediatric Use:

(SeeCONTRAINDICATIONS****,WARNINGS, andPRECAUTIONS: Nursing Mothers****.) DICYCLOMINE HYDROCHLORIDE IS CONTRAINDICATED IN INFANTS LESS THAN 6 MONTHS OF AGE.

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use:

Clinical studies of dicyclomine hydrochloride did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

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. (SeeDOSAGE AND ADMINISTRATION.)

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.