Bentyl

Name: Bentyl

Other uses for this medicine

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

What special precautions should I follow?

Before taking dicyclomine,

  • tell your doctor and pharmacist if you are allergic to dicyclomine or any other medications.
  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: amantadine (Symmetrel); antacids; antidepressants such as amitriptyline (Elavil), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Adapin, Sinequan), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil); antihistamines; diet pills; digoxin (Lanoxin); ipratropium (Atrovent); isosorbide (Imdur, Ismo, Isordil, others); medications for anxiety, asthma, glaucoma, irregular heartbeat, mental illness, motion sickness, Parkinson's disease, seizures, ulcers, or urinary problems; metoclopramide (Reglan); monoamine oxidase (MAO) inhibitors, including phenelzine (Nardil) and tranylcypromine (Parnate); narcotic pain relievers such as meperidine (Demerol); nitroglycerin (Nitro-Bid, Nitrostat, others); sedatives; sleeping pills; and tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you have or have ever had glaucoma; ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum); an enlarged prostate (prostatic hyperplasia); difficulty urinating; esophageal reflux (heartburn); a blockage in the gastrointestinal tract; myasthenia gravis; high blood pressure; an overactive thyroid gland (hyperthyroidism); nerve disease (autonomic neuropathy); heart failure; rapid or pounding heartbeat; hiatal hernia; or liver, kidney, or heart disease.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking dicyclomine, call your doctor. Do not breast-feed while taking this medication.
  • talk to your doctor about the risks and benefits of taking dicyclomine if you are 65 years of age or older. Older adults should not usually take dicyclomine because it is not as safe or effective as other medications that can be used to treat the same condition.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking dicyclomine.
  • you should know that dicyclomine may make you drowsy or cause blurred vision. Do not drive a car or operate machinery until you know how this medication affects you.
  • remember that alcohol can add to the drowsiness caused by this medication.
  • you should know that dicyclomine reduces the body's ability to cool off by sweating. In very high temperatures, dicyclomine can cause fever and heat stroke.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What side effects can this medication cause?

Dicyclomine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • dry mouth
  • upset stomach
  • vomiting
  • constipation
  • stomach pain
  • gas or bloating
  • loss of appetite
  • dizziness
  • tingling
  • headache
  • drowsiness
  • weakness
  • blurred vision
  • double vision
  • difficulty urinating

Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:

  • hot, flushed, dry skin
  • confusion
  • forgetfulness
  • seeing things or hearing voices that do not exist (hallucinating)
  • unsteadiness
  • coma
  • anxiety
  • excessive tiredness
  • difficulty falling asleep or staying asleep
  • excitement
  • inappropriate mood
  • muscle weakness
  • rapid or pounding heartbeat
  • fainting
  • hives
  • skin rash
  • itching
  • difficulty breathing or swallowing

Dicyclomine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Brand names

  • Bentyl®

How to use

Take this medication by mouth, usually 4 times a day (before meals and at bedtime) or as directed by your doctor. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully.If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose. Mix the dose of liquid with an equal amount of water before taking it.Antacids lower the absorption of dicyclomine. Do not take this medication at the same time as antacids. If you are taking an antacid, take it after meals and take dicyclomine before meals.The dosage is based on your age, medical condition, and response to treatment.Do not increase your dose or take this drug more often without your doctor's approval. Your condition will not improve any faster and the risk of serious side effects may increase.If this medication has been used regularly for a long time or in high doses, withdrawal symptoms (such as dizziness, sweating, vomiting) may rarely occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). Take this medication exactly as prescribed to lessen the risk of addiction.Tell your doctor if your condition persists or worsens.

Pharmacology

Mechanism of Action

Anticholinergic/antispasmodic; no effect on acid secretion, but direct smooth muscle relaxant effects; blocks the action of ACh at parasympathetic sites in smooth muscle, secretory glands, and CNS

Absorption

Bioavailability: PO (67% of IM)

Onset: 1-2 hr

Duration: <4 hr

Peak plasma time: PO (60-90 min)

Distribution

Vd: 3.65 L/kg

Metabolism

Metabolites: Ranitidine N-oxide, desmethylranitidine, ranitidine

Elimination

Half-life: 1.8 hr

Excretion: Urine (80%); feces (8%)

Manufacturer

  • Forest Laboratories, Inc.

Bentyl Interactions

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

  • Antiglaucoma agents
  • Antacids
  • other anticholinergics such as glycopyrrolate (Cuvposa, Robinul), trospium (Sanctura), oxybutynin (Anturol, Gelnique, Oxytrol, Ditropan), solifenacin (Vesicare), propantheline (Pro-Banthine), and atropine (Atropen, Sal-Tropine)

This is not a complete list of Bentyl drug interactions. Ask your doctor or pharmacist for more information.

Bentyl Precautions

Serious side effects have been reported with Bentyl including the following:

  • Psychosis. Tell your healthcare provider right away if you have some or all of the following symptoms of psychosis:
    • Thoughts and speech are unorganized
    • Experience beliefs that are not based in reality 
    • Hear, see, or feel things that are not there

Bentyl can cause drowsiness. Do not drive or operate heavy machinery until you know how Bentyl affects you.

Do not take Bentyl if you:

  • are allergic to Bentyl or to any of its ingredients 
  • are a nursing mother
  • have acid reflux disease
  • have problems urinating
  • have myasthenia gravis. This is a disease that causes extreme weakness in the muscles that you voluntarily control. If you have this, notify your doctor.
  • have glaucoma. Glaucoma is a disease that damages a major nerve in your eye. Notify your doctor if you have vision problems.
  • have severe Ulcerative Colitis. This is a disease where inflammation or sores are present along the inside of your colon or rectum. Notify your doctor if you have been told that you have this.

Bentyl is not for infants younger than 6 months.

Bentyl Usage

Take Bentyl exactly as prescribed.

Bentyl comes in capsule, tablet, and in an oral syrup form. It is taken four times every day.

This medication is also available in an injectable form to be given directly into a muscle (IM) by a healthcare professional.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Bentyl at the same time.

What is Bentyl (dicyclomine)?

Dicyclomine relieves spasms of the muscles in the stomach and intestines.

Dicyclomine is used to treat functional bowel or irritable bowel syndrome.

Dicyclomine may also be used for purposes not listed in this medication guide.

Introduction

Dicyclomine hydrochloride is a synthetic tertiary amine antispasmodic.

Bentyl Dosage and Administration

Dosage must be adjusted to individual patients needs.

Oral Dosage and Administration in Adults

The recommended initial dose is 20 mg four times a day. After one week treatment with the initial dose, the dose may be increased to 40 mg four times a 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.

Intramuscular Dosage and Administration in Adults

Bentyl Intramuscular Injection must be administered via intramuscular route only. Do not administer by an other route. The recommended intramuscular dose is 10 mg to 20 mg four times a day. [see Clinical Pharmacology (12)]
The intramuscular injection is to be used only for 1 or 2 days when the patient cannot take oral medication.

Intramuscular injection is about twice as bioavailable as oral dosage forms.

Preparation for Intramuscular Administration

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Aspirate the syringe before injecting to avoid intravascular injection, since thrombosis may occur if the drug is inadvertently injected intravascularly.

Adverse Reactions

The pattern of adverse effects seen with dicyclomine is mostly related to its pharmacological actions at muscarinic receptors [see Clinical Pharmacology (12)].  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 (5.2,5.3)].

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

MedDRA Preferred Term Dicyclomine Hydrochloride (40 mg four times a day) % Placebo %
Dry Mouth 33 5
Dizziness 40 5
Vision blurred 27 2
Nausea 14 6
Somnolence 9 1
Asthenia 7 1
Nervousness 6 2

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.

Side effects

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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

MedDRA Preferred Term Dicyclomine Hydrochloride (40 mg four times a day) % Placebo %
Dry Mouth 33 5
Dizziness 40 5
Vision blurred 27 2
Nausea 14 6
Somnolence 9 1
Asthenia 7 1
Nervousness 6 2

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.

Read the entire FDA prescribing information for Bentyl (Dicyclomine)

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