Prescription drugs info

10 mg blue capsules, imprinted Bentyl 10, NDC 58914-012-10: bottles of 100. Store at room temperature, preferably below 86°F (30°C).

20 mg compressed, light blue, round tablets, debossed Bentyl 20, NDC 58914-013-10: bottles of 100. To prevent fading, avoid exposure to direct sunlight. Store at room temperature, preferably below 86°F (30°C).

10 mg/5 mL pink syrup, NDC 58914-015-16: 16 ounce bottle.
Store at room temperature, preferably below 86°F (30°C). Protect from excessive heat.

20 mg/2 mL (10 mg/mL) injection (for intramuscular use only, NOT FOR INTRAVENOUS USE) NDC 58914-080-52: Boxes of five 20 mg/2 mL ampules (10 mg/mL).
Store at room temperature, preferably below 86°F (30°C). Protect from freezing.

Rx only
Rev. March 2005

Bentyl Capsules, Bentyl Tablets and Bentyl Syrup Manufactured by:
Patheon Pharmaceuticals Inc.
Cincinnati, OH 45215

Bentyl Injection Manufactured by:
Akorn Inc.
Decatur, IL 62522
Manufactured for:
Axcan Scandipharm Inc.
Birmingham, AL 35242
www.axcan.com

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DOSAGE MUST BE ADJUSTED TO INDIVIDUAL PATIENT NEEDS.

Adults-Oral . The only oral dose clearly shown to be effective is 160 mg per day (in 4 equally divided doses). Since this dose is associated with a significant incidence of side effects, it is prudent to begin with 80 mg per day (in 4 equally divided doses). Depending upon the patient’s response during the first week of therapy, the dose should be increased to 160 mg per day unless side effects limit dosage escalation. If efficacy is not achieved within 2 weeks or side effects require doses below 80 mg per day, the drug should be discontinued. Documented safety data are not available for doses above 80 mg daily for periods longer than 2 weeks.

Adults-Intramuscular Injection. NOT FOR INTRAVENOUS USE.

The intramuscular dosage form is to be used temporarily when the patient cannot take oral medication. Intramuscular injection is about twice as bioavailable as oral dosage forms; consequently, the recommended intramuscular dose is 80 mg daily (in 4 equally divided doses). Oral dicyclomine hydrochloride should be started as soon as possible and the intramuscular form should not be used for periods longer than 1 or 2 days.

ASPIRATE THE SYRINGE BEFORE INJECTING TO AVOID INTRAVASUCLAR INJECTION, SINCE THROMBOSIS MAY OCCUR IF THE DRUG IS INADVERTENTLY INJECTED INTRAVASCULARLY. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Elderly: 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.

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

A 37-year-old female reported numbness on the left side, cold fingertips, blurred vision, abdominal and flank pain, decreased appetite, dry mouth, and nervousness following ingestion of 320 mg daily (four 20 mg tablets QID) for four days. These events resolved after discontinuing the dicyclomine.

Oral LD50

The acute oral LD50 of the drug is 625 mg/kg in mice.

Bentyl Minimum Human Lethal Dose/Maximum Human Dose Recorded
The amount of drug in a single dose that is ordinarily associated with symptoms of overdosage or that is likely to be life-threatening, has not been defined. The maximum human oral dose recorded was 600 mg by mouth in a 10-month-old child and approximately 1500 mg in an adult, each of whom survived. In three of the infants who died following administration of dicyclomine hydrochloride, the blood concentrations of drug were 200, 220, and 505 ng/mL, respectively.

Bentyl Dialysis
It is not know if Bentyl is dialyzable.

Bentyl Overdosage Treatment
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.

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Controlled clinical trials have provided frequency information for reported adverse effects of dicyclomine hydrochloride listed in a decreasing order of frequency.

Not all of the following adverse reactions have been reported with dicyclomine hydrochloride. Adverse reactions are included here that have been reported for pharmacologically similar drugs with anticholinergic/antispasmodic action.

Bentyl Gastrointestinal adverse reactions: dry mouth, nausea, vomiting, constipation, bloated feeling, abdominal pain, taste loss, anorexia

Bentyl Central Nervous System adverse reactions: dizziness, light-headedness, tingling, headache, drowsiness, weakness, nervousness, numbness, mental confusion and/or excitement (especially in elderly persons), dyskinesia, lethargy, syncope, speech disturbance, insomnia

Bentyl Ophthalmologic adverse reactions: blurred vision, diplopia, mydriasis, cycloplegia, increased ocular tension

Bentyl Dermatologic/Allergic adverse reactions: rash, urticaria, itching, and other dermal manifestations; severe allergic reaction or drug idiosyncrasies including anaphylaxis

Bentyl Genitourinary adverse reactions: urinary hesitancy, urinary retention

Bentyl Cardiovascular adverse reactions: tachycardia, palpitations

Bentyl Respiratory adverse reactions: dyspnea, apnea, asphyxia.

Bentyl Other adverse reactions: decreased sweating, nasal stuffiness or congestion, sneezing, throat congestion, impotence, suppression of lactation.

With the injectable form, there may be temporary sensation of light-headedness. Some local irritation and focal coagulation necrosis may occur following the I.M. injection of the drug.

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Clinical studies of Bentyl 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.
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.

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Bentyl IS CONTRAINDICATED IN INFANTS LESS THAN 6 MONTHS OF AGE.
Safety and effectiveness in pediatric patients have not been established.

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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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