Dicyclomine (Page 2 of 4)

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 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.

6.2 Postmarketing 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.

  • C a r d i a c Disorders: palpitations, tachyarrhythmias
  • E y e Disorders: cycloplegia, mydriasis, vision blurred
  • G a s t r o i n t e s ti n a l Disorders: abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, nausea, vomiting
  • G e n e r a l Disorders and Administration Site Conditions: fatigue, malaise
  • I mm un e System Disorders: drug hypersensitivity including face edema, angioedema, anaphylactic shock
  • N e r v o u s System Disorders: dizziness, headache, somnolence, syncope
  • P s yc h i a t r i c 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.
  • R e p r od u c ti v e System and Breast Disorders: suppressed lactation
  • R e s p i r a t o r y , Thoracic and Mediastinal Disorders: dyspnoea, nasal congestion
  • S k i n and Subcutaneous Tissue Disorder: dermatitis allergic, erythema, rash

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

G a s t r o i n t e s ti n a l : anorexia

C e n t r a l Nervous System: tingling, numbness, dyskinesia, speech disturbance, insomnia

P e r i p h e r a l Nervous System: With overdosage, a curare-like action may occur (i.e., neuromuscular blockade leading to muscular weakness and possible paralysis)

O p h t h a l m o l og i c : diplopia, increased ocular tension

D e r m a t o l og i c / A ll e r g i c : urticaria, itching, and other dermal manifestations

G e n it o u r i n a r y : urinary hesitancy, urinary retention in patients with prostatic hypertrophy

C a r d i o v a s c u l a r : hypertension

R e s p i r a t o r y : apnea

O t h e r : decreased sweating, sneezing, throat congestion, impotence.

To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-800-962-8364 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.com

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