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 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)].
6.1 Clinical Studies 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 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
Nine percent (9%) of patients were discontinued from BENTYL 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 BENTYL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their freqeuncy 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 oedema, angioedema, anaphylactic shock
Nervous system disorders: dizziness, headache, hallucinations insomnia, somnolence, syncope
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