Dicyclomine

What is Dicyclomine?

• Dicyclomine (Bentyl) is an antispasmodic and anticholinergic (antimuscarinic) agent used to treat the symptoms of irritable bowel syndrome.

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Dicyclomine

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What are the uses of this medicine?

• Dicyclomine (Bentyl) is used for the treatment of patients with functional bowel/irritable bowel syndrome.

How does this medicine work?

• Dicyclomine (dye sye' kloe meen) is synthetic tertiary amine, antispasmotic and anticholinergic agent which inhibits the muscarinic actions of acetylcholine on autonomic nerve endings, decreasing gastrointestinal secretions and intestinal motility.
• Dicyclomine has broad activity against muscarinic acetylcholine receptors, but has been used largely for gastrointestinal conditions including peptic ulcer disease and gastrointestinal conditions associated with pain and spasm.

Who Should Not Use this medicine ?

This medicine cannot be used in:

• infants less than 6 months of age

This medicine cannot be used in patients with:

• Nursing mothers
• Unstable cardiovascular status in acute hemorrhage
• Myasthenia gravis
• Glaucoma
• Obstructive uropathy
• Obstructive disease of the gastrointestinal tract
• Severe ulcerative colitis
• Reflux esophagitis

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention 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
• tranquilizers

Is this medicine FDA approved?

• Dicyclomine was approved for use in the United States for the treatment of peptic ulcer disease in 1996, but is now more commonly used as an antispasmotic to treat irritable bowel syndrome.

How should this medicine be used?

Recommended dosage:

• Dosage for dicyclomine hydrochloride tablets must be adjusted to individual patient needs.

Oral in adults: Starting dose:

• 20 mg four times a day.
• After a week treatment with the starting dose, the dose may be escalated to 40 mg four times a day, unless side effects limit dosage escalation
• Discontinue dicyclomine hydrochloride if efficacy not achieved or side effects require doses less than 80 mg per day after two weeks of treatment

Intramuscular Dosage and Administration in Adults:

• The recommended intramuscular dose is 10 mg to 20 mg four times a day.
• Intramuscular injection is about twice as bioavailable as oral dosage forms.

Administration:

• Dicyclomine comes as a capsule, a tablet, and a syrup to take by mouth.
• It is usually taken 4 times a day.
• Your doctor will probably start you on a low dose of dicyclomine and gradually increase your dose.

• Dicyclomine also comes as injection must be administered via intramuscular route.
• Bentyl Intramuscular Injection must be administered via intramuscular route only. Do not administer by any other route.
• The intramuscular injection is to be used only for 1 or 2 days when the patient cannot take oral medication.
• 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.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As as a capsule, a tablet, a syrup and Bentyl injection

This medicine is available in fallowing brand namesː

• Bentyl

What side effects can this medication cause?

The most common side effects of this medicine include:

• dizziness, dry mouth, vision blurred, nausea, somnolence, asthenia and nervousness

Bentyl may cause less common side effects which may include:

• 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 anticholinergic 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: dyspnea, nasal congestion
• Skin and Subcutaneous Tissue Disorder: dermatitis allergic, erythema, rash

What special precautions should I follow?

• Do not to administer dicyclomine hydrochloride in infants less than 6 months of age.
• Advise lactating women that dicyclomine hydrochloride should not be used while breastfeeding their infants.
• Dicyclomine hydrochloride 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 dicyclomine hydrochloride.
• Care is required in patients with coronary heart disease, as ischemia and infarction may be worsened, and in patients with hypertension.
• Heat prostration can occur with drug use (fever and heat stroke due to decreased sweating); drug should be discontinued and supportive measures instituted.
• Psychosis and delirium have been reported in patients sensitive to anticholinergic drugs (such as elderly patients and/or in patients with mental illness). signs and symptoms resolve within 12 to 24 hours after discontinuation of dicyclomine hydrochloride
• overdose may lead to muscular weakness and paralysis. Dicyclomine hydrochloride should be given to patients with myasthenia gravis only to reduce adverse muscarinic effects of an anticholinesterase.
• Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. Treatment with dicyclomine hydrochloride would be inappropriate and possibly fatal.
• Toxic dilatation of intestine and intestinal perforation is possible when anticholinergic agents are administered in patients with Salmonella dysentery.
• Caution should be taken in patients with ulcerative colitis. Dicyclomine hydrochloride is contraindicated in patients with severe ulcerative colitis.
• Dicyclomine hydrochloride should be used with caution in patients with known or suspected prostatic enlargement.
• Dicyclomine hydrochloride should be used with caution in patients with known hepatic and renal impairment.
• 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.
• Dicyclomine has not been implicated in causing liver enzyme elevations or clinically apparent acute liver injury.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• headache
• nausea
• vomiting
• blurred vision
• dilated pupils
• hot, dry skin
• dizziness
• dryness of the mouth
• difficulty in swallowing
• CNS stimulation including convulsion
• numbness on the left side
• cold fingertips
• abdominal and flank pain
• decreased appetite
• nervousness

Management of overdosage:

• In case of an overdose, patients should contact a physician, poison control center (1-800-222-1222), or emergency room.
• It is not known if dicyclomine hydrochloride 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.

Can this medicine be used in pregnancy?

• Pregnancy Category B.
• Adequate and well-controlled studies have not been conducted with dicyclomine hydrochloride in pregnant women at the recommended doses of 80 to 160 mg/day.
• Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• DICYCLOMINE HYDROCHLORIDE

Inactive ingredients:

• ANHYDROUS LACTOSE
• FD&C BLUE NO. 1
• LACTOSE MONOHYDRATE
• MAGNESIUM STEARATE
• CELLULOSE, MICROCRYSTALLINE

Who manufactures and distributes this medicine?

Distributed by:

• Hikma Pharmaceuticals USA Inc.
• Berkeley Heights, NJ

Bentyl® is a registered trademark of Aptalis Pharma Canada ULC, an Allergan affiliate.

Distributed by:

• Allergan USA, Inc.
• Madison, NJ

What should I know about storage and disposal of this medication?

• Store at 20° to 25°C (68° to 77°F).
• Protect from light and moisture.
• To prevent fading, avoid exposure to direct sunlight.
• Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Bentyl Injection:

• 20 mg/2 mL (10 mg/mL) injection supplied in boxes of five 20 mg/2 mL ampules (10 mg/mL).
• Store at room temperature, preferably below 86°F (30°C).
• Protect from freezing.

anticholinergic agents

• Aclidinium
• Atropine
• Homatropine
• Darifenacin
• Dicyclomine
• Fesoterodine
• Flavoxate
• Glycopyrrolate
• Hyoscyamine
• Ipratropium
• Mepenzolate
• Methscopolamine
• Oxybutynin
• Propantheline
• Scopolamine
• Solifenacin
• Tiotropium
• Tolterodine
• Trospium

• Dailymed label info on Dicyclomine
• FDA Dicyclomine

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