DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE)

Absorption and

DistributionIn man, dicyclomine is rapidly absorbed after oral administration, reaching peak values within 60-90 minutes. Mean volume of distribution for a 20 mg oral dose is approximately 3.65 L/kg suggesting extensive distribution in tissues.

EliminationThe metabolism of dicyclomine was not studied. The principal route of excretion is via the urine (79.5% of the dose). Excretion also occurs in the feces, but to a lesser extent (8.4%). Mean half-life of plasma elimination in on...

In controlled clinical trials involving over 100 patients who received drug, 82% of patients treated for functional bowel/irritable bowel syndrome with dicyclomine hydrochloride at initial doses of 160 mg daily (40 mg four times daily) demonstrated a favorable clinical response compared with 55% treated with placebo (p<0.05).

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 ...

Dicyclomine hydrochloride is contraindicated in infants less than 6 months of age [see Use in Specific P opu l a ti on s (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 uro...

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 and delirium have been reported in patients sensitive to anticholinergic drugs (such as elderly patients and/or in patients with mental illness): signs and symptoms resolve within 12 to 24 hours after discontinuation of dicyclomine...

7 DRUG INTERACTIONS Antiglaucoma agents : anticholinergics antagonize antiglaucoma agents and may increase intraoccular pressure (7) Anticholinergic agents : may affect the gastrointestinal absorption of various drugs; may also increase certain actions or side effects of other anticholinergic drugs (7) Antacids : interfere with the absorption of anticholinergic agents (7) 7.1 Antiglaucoma Agents A...