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Since dicyclomine hydrochloride has been reported to be excreted in human milk, Bentyl IS CONTRAINDICATED IN NURSING MOTHERS.

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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, Bentyl as indicated for functional bowel/irritable bowel syndrome should be used during pregnancy only if clearly needed.

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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, Bentyl produced no deleterious effects on breeding, conception, or parturition.

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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.

Anticholinergic agents may affect gastrointestinal absorption of various drugs, such as slowly dissolving dosage forms of digoxin; increased serum digoxin concentration 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.

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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
4. Hyperthyroidism
5. Hypertension
6. Coronary heart disease
7. Congestive heart failure
8. Cardiac tachyarrhythmia
9. Hiatal hernia
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).

Bentyl Information For Patients
Bentyl 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.

Bentyl is contraindicated in infants less than 6 months of age and in nursing mothers.

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.

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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.

Bentyl 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. Bentyl IS CONTRAINDICATED IN INFANTS LESS THAN 6 MONTHS OF AGE AND IN NURSING MOTHERS.

Safety and efficacy of dicyclomine hydrochloride in pediatric patients have not been established.

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1. Obstructive uropathy
2. Obstructive disease of the gastrointestinal tract
3. Severe ulcerative colitis
4. Reflux esophagitis
5. Unstable cardiovascular status in acute hemorrhage
6. Glaucoma
7. Myasthenia gravis
8. Evidence of prior hypersensitivity to dicyclomine hydrochloride or other ingredients of these formulations
9. Infants less than 6 months of age.
10. Nursing Mothers

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For the treatment of functional bowel/irritable bowel syndrome.

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Bentyl Generic Name: dicyclomine hydrochloride
Bentyl Dosage Form: Capsule, Tablet, Syrup, Injection

Bentyl is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following forms:

1. Bentyl capsules for oral use contain 10 mg dicyclomine hydrochloride USP. Bentyl 10 mg capsules also contain inactive ingredients: calcium sulfate, corn starch, FD&C Blue No. 1, FD&C Red No. 40, gelatin, lactose, magnesium stearate, pregelatinized corn starch, and titanium dioxide.

2. Bentyl tablets for oral use contain 20 mg dicyclomine hydrochloride USP. Bentyl 20 mg tablets also contain inactive ingredients: acacia, dibasic calcium phosphate, corn starch, FD&C Blue No. 1, lactose, magnesium stearate, pregelatinized corn starch, and sucrose.

3. Bentyl syrup for oral use contains 10 mg dicyclomine hydrochloride USP in each 5 mL (1 teaspoonful). Bentyl syrup also contains inactive ingredients: citric acid, D&C Red No. 33, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, flavors, glucose, methylparaben, propylene glycol, propylparaben, saccharin sodium, and water.

4. Bentyl injection is a sterile, pyrogen-free, aqueous solution for intramuscular injection (NOT FOR INTRAVENOUS USE).

Ampule. 20 mg/2 mL (10 mg/mL) – Each mL contains 10 mg dicyclomine hydrochloride USP in sterile water for injection, made isotonic with sodium chloride.
Chemically, Bentyl (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.

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Bentyl Dermatologic side effects
Dermatologic side effects commonly observed have included inhibition of exocrine sweat glands. This is usually not clinically significant except when perspiration becomes a major factor in body temperature control.

Bentyl Gastrointestinal side effects
Gastrointestinal side effects have been reported the most frequently. These have included the anticholinergic effects of dry mouth and mucous membranes. Other reported side effects have included delayed gastric emptying time, reduced gastric acid secretion, nausea, constipation, and gastroesophageal reflux.

Bentyl Cardiovascular side effects
Cardiovascular side effects have included tachycardia and palpitations from muscarinic blockade.

Bentyl General side effects
General side effects have included dicyclomine toxicity (anticholinergic side effects) which often presents with fever, tachycardia, agitation, and dry skin/mucous membranes.

Bentyl Genitourinary side effects
Genitourinary side effects have frequently included urinary retention as a result of the anticholinergic effects on the urinary sphincter and dose-related, and impotence in male patients.

Bentyl Nervous system side effects
Nervous system side effects have included lethargy and somnolence. Higher doses may be associated with mental confusion and/or excitement. The elderly appear to be more prone to the anticholinergic effects of dicyclomine on the CNS.

Bentyl Ocular side effects
Ocular side effects due to the anticholinergic activity of dicyclomine have included inhibition of the iris sphincter muscle (possibly resulting in mydriasis), follicular conjunctivitis, and inhibition of the ciliary muscle (which can produce blurred vision). All muscarinic antagonists can precipitate glaucoma.

Bentyl Hypersensitivity side effects
Hypersensitivity side effects have been reported rarely. These have included urticaria, pruritus, edema, hypotension, abdominal pain, tachypnea, and nausea and vomiting.

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