Bentylol

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 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 to test gastric secretion.

Since dicyclomine has been reported to be excreted in human milk, BENTYLOL is contraindicated in nursing mothers (see Contraindications).

BENTYLOL (dicyclomine) should be used with caution in any patient with, or suspected of having: prostatic hypertrophy, hiatal hernia associated with reflux esophagitis because anticholinergic drugs may aggravate the condition, autonomic neuropathy, hepatic or renal disease, hyperthyroidism, hypertension, coronary heart disease, congestive heart failure, cardiac tachyarrhythmia.

Epidemiologic studies in pregnant women with products containing dicyclomine (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 to 160 mg/day). Animal reproduction studies have revealed no evidence of impaired fertility or harm to the fetus due to dicyclomine. Because animal reproduction studies are not always predictive of human response, BENTYLOL (dicyclomine) should be used during pregnancy only if required.

Each white, round, flat-faced, beveled edged tablet, one side debossed with the letter “M” in a double circle, and the other with the number “10” contains: dicyclomine HCl USP 10 mg. Nonmedicinal ingredients: cornstarch, lactose monohydrate, magnesium stearate, microcrystalline cellulose and talc. Bottles of 100. Store at 15 to 30°C. Protect from excessive heat and moisture.

Each 5 mL of clear, red viscous syrup with a taste characteristic of raspberries, contains: dicyclomine HCl USP 10 mg. Nonmedicinal ingredients: amaranth color, blackcurrant artificial flavour, cherry natural/artificial flavour, citric acid, FD&C Yellow No. 6, glucose, methylparaben, propylene glycol, propylparaben, purified water, raspberry imitation fritzbro, sodium citrate, sodium cyclamate and vanilla flavour imitation. Bottles of 250 mL. Store at 15 to 30°C. Protect from excessive heat.

Each white, round, flat-faced, beveled edged tablet, one side debossed with the letter “M” in a double circle, and the other side scored with the number “20” contains: dicyclomine HCl USP 20 mg. Nonmedicinal ingredients: cornstarch, lactose monohydrate, magnesium stearate, microcrystalline cellulose and talc. Bottles of 100. Store at 15 to 30°C. Protect from excessive heat and moisture.

Dicyclomine 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.

urinary hesitancy, urinary retention.

vomiting, constipation, bloated feeling, abdominal pain, taste loss, anorexia.

rash, urticaria, itching, and other dermal manifestations; severe allergic reaction or drug idiosyncrasies including anaphylaxis.

tingling, headache, numbness, mental confusion and/or excitement (especially in elderly persons), dyskinesia, lethargy, syncope, speech disturbance, insomnia.

decreased sweating, nasal stuffiness or congestion, sneezing, throat congestion, impotence, suppression of lactation (see Precautions).

diplopia, mydriasis, cycloplegia, increased ocular tension.

dyspnea, apnea, asphyxia.

tachycardia, palpitations.

Signs and symptoms of BENTYLOL (dicyclomine) overdosage are headache; nausea; vomiting; blurred vision; dilated pupils; hot, dry skin; dizziness; dry mouth; difficulty in swallowing; and CNS stimulation. A curare-like action may occur (i.e., neuromuscular blockage leading to muscular weakness and possible paralysis).

Treatment should consist of gastric lavage, emetics and activated charcoal. Sedatives (e.g., short-acting barbiturates, benzodiazepines) may be used for management of overt signs of excitement. If indicated, an appropriate parenteral cholinergic agent may be used as an antidote.

Dialysis: It is not known if dicyclomine is dialyzable.