Dicyclomine Hydrochloride (Page 2 of 5)

5.5 Intestinal Obstruction

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

5.6 Toxic Dilatation of Intestinemegacolon

Toxic dilatation of intestine and intestinal perforation is possible when anticholinergic agents are administered in patients with Salmonella dysentery.

5.7 Ulcerative Colitis

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 is contraindicated in patients with severe ulcerative colitis [see Contraindications (4)].

5.8 Prostatic Hypertrophy

Dicyclomine 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)] .

5.9 Hepatic and Renal Disease

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

5.10 Geriatric Population

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

6 ADVERSE REACTIONS

The pattern of adverse effects seen with dicylomine 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)].

6.1 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 4 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 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.

6.2 Postmarketing Experience

The following adverse reactions, presented by system organ class in alphabetical order, have been identified during post approval use of dicyclomine. 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 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: dyspnoea, nasal congestion
  • Skin and Subcutaneous Tissue Disorder: dermatitis allergic, erythema, rash

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