Bentyl

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include the following:

• headache
• upset stomach
• vomiting
• blurred vision
• dilated pupils
• hot, dry skin
• dizziness
• dry mouth
• difficulty swallowing
• nervousness
• excitement
• seeing things or hearing voices that do not exist (hallucinating)

Pregnancy category: B

Lactation: Enters breast milk; contraindicated

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

The pattern of adverse effects seen with dicyclomine is mostly related to its pharmacological actions at muscarinic receptors [see CLINICAL PHARMACOLOGY]. They are a consequence of the inhibitory effect on muscarinic receptors within the autonomic nervous system. These effects are dose-related and are usually reversible when treatment is discontinued.

The most serious adverse reactions reported with dicyclomine hydrochloride include cardiovascular and central nervous system symptoms [see WARNINGS AND PRECAUTIONS].

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data described below reflect exposure in controlled clinical trials involving over 100 patients treated for functional bowel/irritable bowel syndrome with dicyclomine hydrochloride at initial doses of 160 mg daily (40 mg four times a day)

In these trials most of the side effects were typically anticholinergic in nature and were reported by 61% of the patients. Table 1 presents adverse reactions (MedDRA 13.0 preferred terms) by decreasing order of frequency in a side-by-side comparison with placebo.

Table 1: Adverse reactions experienced in controlled clinical trials with decreasing order of frequency

Nine percent (9%) of patients were discontinued from BENTYL because of one or more of these side effects (compared with 2% in the placebo group). In 41% of the patients with side effects, side effects disappeared or were tolerated at the 160 mg daily dose without reduction. A dose reduction from 160 mg daily to an average daily dose of 90 mg was required in 46% of the patients with side effects who then continued to experience a favorable clinical response; their side effects either disappeared or were tolerated.

Postmarketing Experience

The following adverse reactions, presented by system organ class in alphabetical order, have been identified during post approval use of BENTYL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

• Cardiac disorders: palpitations, tachyarrhythmias
• Eye disorders: cycloplegia, mydriasis, vision blurred
• Gastrointestinal disorders: abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, nausea, vomiting
• General disorders and administration site conditions: fatigue, malaise
• Immune System Disorders: drug hypersensitivity including face edema, angioedema, anaphylactic shock
• Nervous system disorders: dizziness, headache, somnolence, syncope
• Psychiatric disorders: As with the other anti-cholinergic drugs, cases of delirium or symptoms of delirium such as amnesia (or transient global amnesia), agitation, confusional state, delusion, disorientation, hallucination (including visual hallucination) as well as mania, mood altered and pseudodementia, have been reported with the use of Dicyclomine. Nervousness and insomnia have also been reported.
• Reproductive system and breast disorders: suppressed lactation
• Respiratory, thoracic and mediastinal disorders: dyspnoea, nasal congestion
• Skin and subcutaneous tissue disorder: dermatitis allergic, erythema, rash

Cases of thrombosis, thrombophlebitis and injection site reactions such as local pain, edema, skin color change and even reflex sympathetic dystrophy syndrome have been reported following inadverent IV injection of BENTYL.

Adverse Reactions Reported With Similar Drugs With Anticholinergic/Antispasmodic Action

Gastrointestinal: anorexia,

Central Nervous System: tingling, numbness, dyskinesia, speech disturbance, insomnia

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

Ophthalmologic: diplopia, increased ocular tension

Dermatologic/Allergic: urticaria, itching, and other dermal manifestations;

Genitourinary: urinary hesitancy, urinary retention in patients with prostatic hypertrophy

Cardiovascular: hypertension

Respiratory: apnea

Other: decreased sweating, sneezing, throat congestion, impotence. With the injectable form, there may be temporary sensation of light-headedness. Some local irritation and focal coagulation necrosis may occur following the intramuscular injection of BENTYL.

Included as part of the "PRECAUTIONS" Section

In case of an overdose, patients should contact a physician, poison control centre (1-800-222-1222), or emergency room.

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

One reported event included a 37-year-old who 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 four times daily.) These events resolved after discontinuing the dicyclomine.

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

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 [see WARNINGS AND PRECAUTIONS] , the blood concentrations of drug were 200, 220, and 505 ng/mL.

It is not know if BENTYL is dialyzable.

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.

Bentyl is a prescription medication used to treat irritable bowel syndrome (IBS).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Bentyl there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Bentyl, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Bentyl or to any of its ingredients
• are a nursing mother
• have acid reflux disease
• have problems urinating
• have heart problems
• have myasthenia gravis
• have glaucoma
• have severe ulcerative colitis
• have an enlarged prostate
• have liver problems
• have kidney problems
• have mental health problems

Bentyl is not for infants younger than 6 months.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are breastfeeding or plan to breastfeed. Bentyl has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Bentyl, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Before using dicyclomine, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by dicyclomine.

Tell your doctor about all other medicines you use, especially:

• amantadine (Symmetrel);

• digoxin (Lanoxin, Lanoxicaps);

• metoclopramide (Reglan);

• atropine (Atreza, Sal-Tropine), belladonna (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm Scop);

• bronchodilators such as ipratropium (Atrovent) or tiotropium (Spiriva);

• bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);

• a heart rhythm medication such as quinidine (Quin-G), procainamide (Procan, Pronestyl), disopyramide (Norpace), flecaininde (Tambocor), mexiletine (Mexitil), propafenone, (Rythmol), and others;

• irritable bowel medications such as hyoscyamine (Hyomax) or propantheline (Pro Banthine);

• an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate);

• nitrate medication, such as nitroglycerin (Nitro Dur, Nitrolingual, Nitrostat, Transderm Nitro, and others), isosorbide dinitrate (Dilatrate, Isordil, Isochron), or isosorbide mononitrate (Imdur, ISMO, Monoket);

• phenothiazines such as chlorpromazine (Thorazine), fluphenazine (Permitil, Prolixin), perphenazine (Trilafon), prochlorperazine (Compazine, Compro), promethazine (Pentazine, Phenergan, Anergan, Antinaus), thioridazine (Mellaril), or trifluoperazine (Stelazine);

• steroid medication such as prednisone and others; or

• ulcer medication such as glycopyrrolate (Robinul) or mepenzolate (Cantil).

This list is not complete and other drugs may interact with dicyclomine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

• Releieves smooth muscle spasm of the GI tract.a

• Exact mechanism(s) of action not been established; appears to act as nonselective smooth muscle relaxant.c

• May have a nonspecific direct action on smooth muscle.c

• Generally has little or no antimuscarinic activity, except at high doses, and little or no effect on gastric secretion.c

• Bentyl 10 mg capsules: blue, imprinted Bentyl 10
• Bentyl 20 mg tablets: compressed, light blue, round, debossed Bentyl 20
  
• Bentyl injection 20 mg/2 mL (10 mg/mL)
  

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

• 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.
• 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.
• Bentyl injection is a sterile, pyrogen-free, aqueous solution for intramuscular injection (NOT FOR INTRAVENOUS USE) supplied as an ampoule containing 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.
  
  Bentyl (dicyclomine hydrochloride) is [bicyclohexyl]-1-carboxylic acid, 2-(diethylamino) ethyl ester, hydrochloride, with a molecular formula of C19H35NO2•HCl and the following structural formula:

Molecular weight: 345.95

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.

Inadvertent Intravenous Administration

Bentyl injection is for intramuscular administration only. Do not administer by any other route. Inadvertent administration may result in thrombosis or thrombophlebitis and injection site such as pain, edema, skin color change and even reflex sympathetic dystrophy syndrome [see Adverse Reactions (6.2)].

Use in Infants

Inform parents and caregivers not to administer Bentyl in infants less than 6 months of age [see Use in Specific Populations (8.4)] .

Use in Nursing Mothers

Advise lactating women that Bentyl should not be used while breastfeeding their infants [see Use in Specific Populations (8.3, 8.4)] .

Peripheral and Central Nervous System

In the presence of a high environmental temperature, heat prostration can occur with Bentyl use (fever and heat stroke due to decreased sweating). If symptoms occur, the drug should be discontinued and a physician contacted. 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 Bentyl. [see Warnings and Precautions (5.3)].

Manufactured for:

Aptalis Pharma US, Inc.

100 Somerset Corporate Boulevard

Bridgewater, NJ 08807 USA

www.aptalispharma.com

Bentyl® is a registered trademark owned by Aptalis Pharma Canada Inc., an affiliated company of Aptalis Pharma US, Inc.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol can increase certain side effects of dicyclomine.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Dicyclomine can decrease your sweating, which can lead to heat stroke in a hot environment.

Stop using dicyclomine and call your doctor right away if you have serious side effects such as confusion, hallucinations, unusual thoughts or behavior, fast or uneven heart rate, or if you urinate less than usual or not at all.

There are many other medicines that can interact with dicyclomine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Your pharmacist can provide more information about dicyclomine.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 5.01. Revision date: 11/8/2011.

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