Dicyclomine

DICYCLOMINE — dicyclomine hydrochloride tablet
REMEDYREPACK INC.

INDICATIONS & USAGE

Dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome.

DOSAGE & ADMINISTRATION

Dosage must be adjusted to individual patient needs.

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.

DOSAGE FORMS & STRENGTHS

  • Dicyclomine Hydrochloride 10 mg capsules: dark blue capsules printed “West-ward 3126″
  • Dicyclomine Hydrochloride 20 mg tablets: Blue, Round Tablets; Embossed “WW27″

CONTRAINDICATIONS

Dicyclomine hydrochloride is contraindicated in infants less than 6 months of age [see Use in Specific Populations (8.4)], nursing mothers [see Use in Specific Populations (8.3)], and in patients with:

  • unstable cardiovascular status in acute hemorrhage
  • myasthenia gravis [see Warnings and Precautions (5.4)]
  • glaucoma [see Adverse Reactions (6.3) and Drug Interactions (7.1)]
  • obstructive uropathy [see Warnings and Precautions (5.8)]
  • obstructive disease of the gastrointestinal tract [see Warnings and Precautions (5.5)]
  • severe ulcerative colitis [see Warnings and Precautions (5.7)]
  • reflux esophagitis

WARNINGS AND PRECAUTIONS

  • Cardiovascular conditions: worsening of conditions (5.2)
  • Peripheral and central nervous system: heat prostration can occur with drug use (fever and heat stroke due to decreased sweating); drug should be discontinued and supportive measures instituted (5.3)
  • Psychosis in patients sensitive to anticholinergic drugs: signs and symptoms resolve within 12 to 24 hours after discontinuation of dicyclomine hydrochloride (5.3)
  • Myasthenia Gravis: 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 (5.4)
  • Incomplete intestinal obstruction: diarrhea may be an early symptom especially in patients with ileostomy or colostomy. Treatment with dicyclomine hydrochloride would be inappropriate and possibly fatal (5.5)
  • Salmonella dysenteric patients: due to risk of toxic megacolon (5.6)
  • Ulcerative colitis: dicyclomine hydrochloride should be used with caution in these patients; large doses may suppress intestinal motility or aggravate the serious complications of toxic megacolon (5.7)
  • Prostatic hypertrophy: dicyclomine hydrochloride should be used with caution in these patients; may lead to urinary retention (5.8)
  • Hepatic and renal disease: should be used with caution (5.9)
  • Geriatric: use with caution in elderly who may be more susceptible to dicyclomine hydrochloride’s adverse events (5.10)

Dicyclomine hydrochloride needs to be used with caution in conditions characterized by tachyarrhythmia such as thyrotoxicosis, congestive heart failure and in cardiac surgery, where they may further accelerate the heart rate. Investigate any tachycardia before administration of dicyclomine hydrochloride. Care is required in patients with coronary heart disease, as ischemia and infarction may be worsened, and in patients with hypertension [see Adverse Reactions (6.3)].

The peripheral effects of dicyclomine hydrochloride are a consequence of their inhibitory effect on muscarinic receptors of the autonomic nervous system. They include dryness of the mouth with difficulty in swallowing and talking, thirst, reduced bronchial secretions, dilatation of pupils (mydriasis) with loss of accommodation (cycloplegia) and photophobia, flushing and dryness of the skin, transient bradycardia followed by tachycardia, with palpitations and arrhythmias, and difficulty in micturition, as well as reduction in the tone and motility of the gastrointestinal tract leading to constipation [see Adverse Reactions (6)].

In the presence of a high environmental temperature heat prostration can occur with drug use (fever and heat stroke due to decreased sweating). It should also be used cautiously in patients with fever. If symptoms occur, the drug should be discontinued and supportive measures instituted. Because of the inhibitory effect on muscarinic receptors within the autonomic nervous system, caution should be taken in patients with autonomic neuropathy. Central nervous system (CNS) signs and symptoms include confusion, disorientation, short-term amnesia, hallucinations, dysarthria, ataxia, coma, euphoria, fatigue, insomnia, agitation and mannerisms, and inappropriate affect. Psychosis has been reported in sensitive individuals given anticholinergic drugs. These CNS signs and symptoms usually resolve within 12 to 24 hours after discontinuation of the drug

Dicyclomine hydrochloride may produce drowsiness, dizziness 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 performing hazardous work while taking dicyclomine hydrochloride.

With overdosage, a curare-like action may occur (i.e., neuromuscular blockade leading to muscular weakness and possible paralysis). It should not be given to patients with myasthenia gravis except to reduce adverse muscarinic effects of an anticholinesterase [see Contraindications (4)]

Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance, treatment with this drug would be inappropriate and possibly harmful [see Contraindications (4)].

Rarely development of Ogilvie’s syndrome (colonic pseudo-obstruction) has been reported. Ogilvie’s syndrome is a clinical disorder with signs, symptoms, and radiographic appearance of an acute large bowel obstruction but with no evidence of distal colonic obstruction.

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. Large doses may suppress intestinal motility to the point of producing a paralytic ileus and the use of this drug may precipitate or aggravate the serious complication of toxic megacolon [see Adverse Reactions (6.3)]. Dicyclomine hydrochloride is contraindicated in patients with severe ulcerative colitis [see Contraindications (4)].

Dicyclomine hydrochloride should be used with caution in patients with known or suspected prostatic enlargement, in whom prostatic enlargement may lead to urinary retention [see Adverse Reactions (6.3)]

Dicyclomine hydrochloride should be used with caution in patients with known hepatic and renal impairment.

Dicyclomine hydrochloride should be used with caution in elderly who may be more susceptible to its adverse effects.

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)].

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 the 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

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 casual 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, hallucinations insomnia, somnolence, syncope
  • Psychiatric disorders: confusional state, nervousness
  • Reproductive system and breast disorders: suppressed lactation
  • Respiratory, thoracic and mediastinal disorders: dyspnoea, nasal congestion
  • Skin and subcutaneous tissue disorder: dermatitis allergic, erythema, rash

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.

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