Dicyclomine

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Dicyclomine

 Generic name: dicyclomine (oral/injection) (dye SYE kloe meen)

Brand name: Bentyl, Dibent, Dicyclocot
Dosage forms: intramuscular solution (10 mg/mL); oral capsule (10 mg); oral syrup (10 mg/5 mL); oral tablet (20 mg)
Drug class: Anticholinergics / antispasmodics


What is dicyclomine?

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

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

Warnings

Many drugs can affect dicyclomine. Tell your doctor about all your current medicines.





Before taking this medicine

You should not use dicyclomine if you are allergic to it, or if you have:

  • glaucoma;

  • a bladder obstruction or other urination problems;

  • a blockage in your digestive tract (stomach or intestines);

  • severe ulcerative colitis;

  • gastroesophageal reflux disease (GERD);

  • a serious heart condition and active bleeding;

  • myasthenia gravis; or

  • if you are breastfeeding a baby.

Not approved for use by anyone younger than 18 years old. Dicyclomine should never be given to a child younger than 6 months old.

Tell your doctor if you have ever had:

  • heart problems or high blood pressure;

  • a stroke;

  • ulcerative colitis;

  • an ileostomy or colostomy;

  • an enlarged prostate; or

  • liver or kidney disease.

Older adults may be more sensitive to the effects of dicyclomine.

Tell your doctor if you are pregnant.

Do not breastfeed.

Dicyclomine Uses:

  • Gastrointestinal motility disorders and irritable bowel:

    • It is indicated for the treatment of functional bowel disorders like irritable bowel syndrome.

Other drugs recommended for the treatment of IBS include:

  • Lubiprostone (Amitiza) for the treatment of IBS with constipation.
  • Linaclotide (Linzess) for the treatment of chronic constipation and IBS with constipation.
  • Zelnorm (Tegaserod) – a 5 HT-4 agonist for the treatment of IBS with constipation.

Dicyclomine  Dose in the treatment of Gastrointestinal motility disorders and irritable bowel:

  • Initial treatment:
    • 20 mg orally four times a day for seven days.
  • The dose may be increased to 40 mg four times a day after one week.
  • Discontinuation of therapy:

    • If no improvement is noted within 2 weeks or if less than 80 mg per day is used because of intolerable adverse effects, the treatment should be discontinued.
    • The safety of the drug at doses exceeding 80 mg per day for greater than 2 weeks has not been established.
  • IM: 10 to 20 mg four times a day for a day or two and then convert to oral treatment as soon as possible.

 

Dicyclomine  Dose in the treatment of Gastrointestinal motility disorders and irritable bowel syndrome:

  • Infants ≥6 months and Children <2 years:

    • 5 to 10 mg orally three or four times a day administered 15 minutes before feeding.
  • Children 2 years of age or older.

    • 10 mg orally three or four times a day.
  • Adolescents:

    • 10 to 20 mg orally thrice or four times a day.
    • If no improvement is noted within 2 weeks, the treatment should be discontinued.

 

Pregnancy Risk Category: B

        • It has not been shown to have adverse teratogenic effects on fetal outcomes in the first trimester when used at the usual doses.
        • Other medications are recommended for treatment of irritable intestinal syndrome during pregnancy.

    Use of dicyclomine during breastfeeding

      • It is excreted from breastmilk and contraindicated for lactating mothers.
      • Lactation may be affected by anticholinergic drugs. It can also cause severe adverse effects in infants and should be avoided by lactating mothers.

 

Dose in Kidney Disease:

Use with caution in patients with renal impairment. There are no dosage adjustments provided in the manufacturer’s labeling as it has not been studied in patients with kidney disease.

 

Dose in Liver Disease:

Use with caution in patients with liver disease. There are no dosage adjustments provided in the manufacturer’s labeling as it has not been studied in patients with liver disease.

 

Common Side Effects of Dicyclomine :

  • Central nervous system:

    • Dizziness
  • Gastrointestinal:

    • Xerostomia
    • Nausea
  • Ophthalmic:

    • Blurred vision

Less Common Side Effects of Dicyclomine:

  • Central nervous system:

    • Drowsiness
    • Nervousness
  • Neuromuscular & skeletal:

    • Weakness

 

Contraindications to Dicyclomine :

      • Obstructive diseases of gastrointestinal tract
      • Grave ulcerative colitis
      • Reflux esophagitis
      • Patients with acute hemorhage have unstable cardiovascular status
      • Obstructive Uropathy
      • Glaucoma
      • Myasthenia gravis
      • Breastfeeding women
      • Infants under 6 months old

Canadian labeling: Additional contraindications not in US labeling

      • Hypersensitivity to any drug component or drug ingredient

Warnings and precautions

    • CNS effects

      • Blurred vision and mental impairment may result from the use of this drug. People who are required to be alert for driving or operating heavy machinery should be aware of the dangers.
    • Diarrhea

      • Diarrhea patients who experience diarrhea should stop taking the medication as this could indicate incomplete intestinal obstruction.
    • Heat prostration

      • You should use extreme caution when exercising in hot conditions or when the drug is being administered. In hot weather, heat prostration can occur.
    • Psychosis and Delirium:

      • Patients who are sensitive to anticholinergic drugs (such as those with preexisting mental illnesses or elderly patients) may experience psychosis and delirium if they take too many anticholinergic medications.
    • Cardiovascular disease

      • The drug should not be used by patients with heart disease, hypertension, or coronary artery disease.
      • Before administering the drug, monitor pulse rate and check for tachycardia.
    • Hepatic impairment

      • Patients with liver impairment should be cautious.
    • Hyperthyroidism

      • Hyperthyroid patients should be cautious when taking the drug.
    • Neuropathy

      • Patients suffering from autonomic neuropathy must be cautious when taking the drug.
    • Prostatic hyperplasia

      • Patients with suspected or known prostatic hyperplasia must be cautious when taking the drug.
    • Renal impairment

      • Patients with impaired renal function should be cautious when taking the drug.
    • Salmonella dysentery

      • Anticholinergic drugs should not be used by patients with salmonella dysentery due to the increased risk for toxic intestinal dilation or perforation.
    • Ulcerative colitis

      • Patients with severe ulcerative colitis should be avoided. It should be avoided by patients with mild-moderate ulcerative colitis.

 

Dicyclomine : Drug Interaction

Note: Drug Interaction Categories:

  • Risk Factor C: Monitor When Using Combination
  • Risk Factor D: Consider Treatment Modification
  • Risk Factor X: Avoid Concomitant Use

    Risk Factor C (Monitor therapy).

    Acetylcholinesterase inhibitorsAnticholinergic Agents may have a decreased therapeutic effect. Anticholinergic Agents can decrease the therapeutic effects of Acetylcholinesterase inhibitors.
    AmantadineAnticholinergic Agents may have an enhanced anticholinergic effect.
    Anticholinergic AgentsOther Anticholinergic Agents may have an adverse/toxic effect.
    Botulinum Toxin-Containing ProductAnticholinergic Agents may have an enhanced anticholinergic effect.
    Cannabinoid-Containing ProductAnticholinergic agents may increase the tachycardic effects of Cannabinoid -Containing products. Cannabidiol is an exception.
    Chloral BetaineAnticholinergic Agents may have an adverse/toxic effect.
    Gastrointestinal Agents (Prokinetic).Anticholinergic Agents can reduce the therapeutic effects of Gastrointestinal Agents (Prokinetic).
    GlucagonAnticholinergic agents may increase the toxic/adverse effects of Glucagon. Particularly, there may be an increase in the likelihood of gastrointestinal adverse reactions.
    ItoprideItopride’s therapeutic effects may be diminished by anticholinergic agents.
    MianserinAnticholinergic Agents may have an enhanced anticholinergic effect.
    MirabegronAnticholinergic agents may increase the toxic/adverse effects of Mirabegron.
    NitroglycerinThe absorption of Nitroglycerin may be decreased by anticholinergic agents. Anticholinergic Agents may reduce the dissolution sublingual nitroglycerin tablet, which could impair or slow down nitroglycerin absorbtion.
    Opioid AgonistsOpioid Agonists can have an adverse/toxic effect that may be exacerbated by anticholinergic agents. This combination may increase the likelihood of constipation or urinary retention.
    RamosetronRamosetron’s constipating effects may be enhanced by anticholinergic agents.
    Thiazide and Thiazide – Like DiureticsAnticholinergic Agents can increase serum Thiazide or Thiazide-Like Diuretics.
    TopiramateTopiramate’s toxic/adverse effects may be exacerbated by anticholinergic agents.

    Risk Factor D (Consider therapy modifications)

    PramlintideAnticholinergic Agents may have an enhanced anticholinergic effect. These effects are only for the GI tract.
    SecretinSecretin’s therapeutic effects may be diminished by anticholinergic agents. Concomitant use: Secretin and anticholinergic agents should be avoided. Stop using anticholinergic drugs for at least five half-lives before administering secretin.
    SincalideSincalide may be less effective if drugs that affect gallbladder function are taken. Management: Before Sincalide is used to stimulate the gallbladder, discontinue any drugs that affect gallbladder motility.

    Risk Factor X (Avoid Combination)

    AclidiniumAnticholinergic Agents may have an enhanced anticholinergic effect.
    CimetropiumCimetropium may have an anticholinergic effect that can be enhanced by the use of anticholinergic agents.
    EluxadolineEluxadoline may cause constipation by using anticholinergic agents.
    Oral InhalationAnticholinergic agents may increase the anticholinergic effects of Glycopyrrolate (Oral inhalation).
    Glycopyrronium (Topical).Anticholinergic Agents may have an enhanced anticholinergic effect.
    Oral Inhalation with IpratropiumAnticholinergic Agents may have an enhanced anticholinergic effect.
    LevosulpirideAnticholinergic Agents can reduce the therapeutic effects of Levosulpiride.
    OxatomideAnticholinergic Agents may have an enhanced anticholinergic effect.
    Potassium ChloridePotassium Chloride may have an ulcerogenic effect that can be exacerbated by anticholinergic agents. Treatment: Patients taking drugs that have significant anticholinergic effects should not consume any oral dose form of potassium chloride.
    Potassium CitratePotassium Citrate may be more ulcerogenic if it is given to anticholinergic agents.
    RevefenacinRevefenacin may be enhanced by anticholinergic agents.
    TiotropiumAnticholinergic agents may increase the anticholinergic effects of Tiotropium.
    UmeclidiniumAnticholinergic Agents may have an enhanced anticholinergic effect.

 

Monitoring parameters:

  • Monitor Pulse, anticholinergic effects, urinary output, and gastrointestinal symptoms.

 

How should I take dicyclomine?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Dicyclomine oral is taken by mouth.

Measure liquid medicine with the supplied syringe or a dose-measuring device (not a kitchen spoon).

Dicyclomine injection is given in a muscle if you are unable to take the medicine by mouth.

Call your doctor if your symptoms do not improve after 2 weeks.

Store at room temperature away from moisture and heat.

 

Mechanism of action of Dicyclomine :

It prevents acetylcholine from acting at parasympathetic locations found in smooth muscles, secretory and central nervous systems.

The onset of action:

  • 1 to 2 hours

Duration:

  • Up to 4 hours

Absorption:

  • It is rapidly absorbed and well absorbed after oral administration.

Metabolism:

  • It undergoes extensive metabolism.

Half-life elimination:

  • Initial phase: About 1.8 hours.
  • The terminal phase is undetermined but is a little longer than the initial phase

Time to peak:

  • 60 to 90 minutes after oral administration

Excretion:

  • 80% of the drug is excreted in urine (a small amount is excreted as unchanged drug);
  • feces (8%)

 

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose can cause nausea, vomiting, dilated pupils, weakness or loss of movement in any part of your body, trouble swallowing, fainting, or seizure (convulsions).



International Brand Names of Dicyclomine:

  • Bentyl
  • Bentylol
  • JAMP-Dicyclomine HCl
  • Protylol
  • RIVA-Dicyclomine
  • Babypasmil
  • Bentyl
  • Blisscolic
  • Coligon
  • Coochil
  • Cyclominol
  • Diclomine
  • Dicymine
  • Merbentyl
  • Nomcramp
  • Notensyl
  • Spasdon Drops
  • Spasmorest
  • Spatomin
  • Swityl
  • Trigan
  • Wintyl

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