Synthetic anticholinergics, esters with tertiary amino group

Dicyclomine Hydrochloride

Approved 28 Jul 1976OralCapsule

The FDA lists this product in 42 strengths and forms.

Indications

Dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome. Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent indicated for the treatment of functional bowel/irritable bowel syndrome ( Error! Hyperlink reference not valid. )

Contraindications

Dicyclomine hydrochloride is contraindicated in infants less than 6 months of age [see Error! Hyperlink reference not valid. ( Error! Hyperlink reference not valid. )] , nursing mothers [see Error! Hyperlink reference not valid. ( Error! Hyperlink reference not valid. )] , and in patients with:

unstable cardiovascular status in acute hemorrhage
myasthenia gravis [see Error! Hyperlink reference not valid. ( 5.4 )]
glaucoma [see Error! Hyperlink reference not valid. ( Error! Hyperlink reference not valid. ) and Error! Hyperlink reference not valid. ( 7.1 )]
obstructive uropathy [see Error! Hyperlink reference not valid. ( 5.8 )]
obstructive disease of the gastrointestinal tract [see Error! Hyperlink reference not valid. ( 5.5 )]
severe ulcerative colitis [see Error! Hyperlink reference not valid. ( 5.7 )]
reflux esophagitis
Infants less than 6 months of age ( Error! Hyperlink reference not valid. )
Glaucoma ( Error! Hyperlink reference not valid. )
Nursing mothers ( Error! Hyperlink reference not valid. )
Obstructive uropathy ( Error! Hyperlink reference not valid. )
Unstable cardiovascular status in acute hemorrhage ( Error! Hyperlink reference not valid. )
Obstructive disease of the gastrointestinal tract ( Error! Hyperlink reference not valid. )
Myasthenia gravis ( Error! Hyperlink reference not valid. )
Severe ulcerative colitis ( Error! Hyperlink reference not valid. )
Reflux esophagitis ( Error! Hyperlink reference not valid. )

Warnings and precautions

Indications

Contraindications

unstable cardiovascular status in acute hemorrhage
myasthenia gravis [see Error! Hyperlink reference not valid. ( 5.4 )]
glaucoma [see Error! Hyperlink reference not valid. ( Error! Hyperlink reference not valid. ) and Error! Hyperlink reference not valid. ( 7.1 )]
obstructive uropathy [see Error! Hyperlink reference not valid. ( 5.8 )]
obstructive disease of the gastrointestinal tract [see Error! Hyperlink reference not valid. ( 5.5 )]
severe ulcerative colitis [see Error! Hyperlink reference not valid. ( 5.7 )]
reflux esophagitis
Infants less than 6 months of age ( Error! Hyperlink reference not valid. )
Glaucoma ( Error! Hyperlink reference not valid. )
Nursing mothers ( Error! Hyperlink reference not valid. )
Obstructive uropathy ( Error! Hyperlink reference not valid. )
Unstable cardiovascular status in acute hemorrhage ( Error! Hyperlink reference not valid. )
Obstructive disease of the gastrointestinal tract ( Error! Hyperlink reference not valid. )
Myasthenia gravis ( Error! Hyperlink reference not valid. )
Severe ulcerative colitis ( Error! Hyperlink reference not valid. )
Reflux esophagitis ( Error! Hyperlink reference not valid. )

Interactions

Antiglaucoma agents : anticholinergics antagonize antiglaucoma agents and may increase intraoccular pressure ( Error! Hyperlink reference not valid. )
Anticholinergic agents : may affect the gastrointestinal absorption of various drugs; may also increase certain actions or side effects of other anticholinergic drugs ( Error! Hyperlink reference not valid. )
Antacids : interfere with the absorption of anticholinergic agents ( Error! Hyperlink reference not valid. )

7.1Antiglaucoma Agents

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. Use of dicyclomine hydrochloride in patients with glaucoma is not recommended [see Error! Hyperlink reference not valid. ( Error! Hyperlink reference not valid. )].

7.2Other Drugs with Anticholinergic Activity

The following agents may increase certain actions or side effects of anticholinergic drugs including dicyclomine hydrochloride: 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.

7.3Other Gastrointestinal Motility Drugs Interaction

with other gastrointestinal motility drugs may antagonize the effects of drugs that alter gastrointestinal motility, such as metoclopramide.

7.4Effect of Antacids

Because antacids may interfere with the absorption of anticholinergic agents including dicyclomine hydrochloride, simultaneous use of these drugs should be avoided.

7.5Effect on Absorption of Other Drugs

Anticholinergic agents may affect gastrointestinal absorption of various drugs by affecting on gastrointestinal motility, such as slowly dissolving dosage forms of digoxin; increased serum digoxin concentration may result.

7.6Effect on Gastric Acid Secretion

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.

Adverse reactions

The pattern of adverse effects seen with dicylomine is mostly related to its pharmacological actions at muscarinic receptors [see Error! Hyperlink reference not valid. ( Error! Hyperlink reference not valid. )] . 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 Error!

Hyperlink reference not valid. ( 5.2 , 5.3 )]. The most serious adverse reactions include cardiovascular and central nervous system symptoms. The most common adverse reactions (> 5% of patients) are dizziness, dry mouth, vision blurred, nausea, somnolence, asthenia and nervousness ( Error! Hyperlink reference not valid. ) To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-432-8534 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical 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 dicyclomine hydrochloride 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.

6.2Postmarketing Experience

The following adverse reactions, presented by system organ class in alphabetical order, have been identified during post approval use of dicyclomine hydrochloride. 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 oedema, angioedema, anaphylactic shock
Nervous system disorders: dizziness, headache, hallucinations insomnia, 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

6.3Adverse 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 dicyclomine hydrochloride.

Dicyclomine Hydrochloride

Indications

Contraindications

Warnings and precautions

Two medicines in one question?

Dicyclomine Hydrochloride

Indications

Contraindications

Warnings and precautions

Two medicines in one question?

5.2Cardiovascular Conditions

5.3Peripheral and Central Nervous System

5.4Myasthenia Gravis

5.5Intestinal Obstruction

5.6Toxic Dilatation of Intestinemegacolon

5.7Ulcerative Colitis

5.8Prostatic Hypertrophy

5.9Hepatic and Renal Disease

5.10Geriatric Population

Interactions

7.1Antiglaucoma Agents

7.2Other Drugs with Anticholinergic Activity

7.3Other Gastrointestinal Motility Drugs Interaction

7.4Effect of Antacids

7.5Effect on Absorption of Other Drugs

7.6Effect on Gastric Acid Secretion

Pregnancy and breastfeeding

8.1Pregnancy Teratogenic Effects: Pregnancy Category B Adequate

Adverse reactions

6.1Clinical Trials Experience

6.2Postmarketing Experience

6.3Adverse Reactions Reported with Similar Drugs with Anticholinergic/Antispasmodic Action

Composition

Strengths and forms

Official product information

At a glance