Procyclidine 5 mg

Urinary retention and urinary hesitancy may occur.

Dry mouth is common. Saliva substitutes may be helpful if this occurs. Nausea, vomiting, epigastric distress, constipation and paralytic ileus have also occurred.

Disorientation, confusion, memory loss, hallucinations, agitation, nervousness, depression, drowsiness, giddiness and lightheadedness may occur.

The adverse effects of procyclidine are usually an extension of its pharmacologic action. They are usually dose related and may be reduced by lowering the dosage and administering the drug after meals. Children and the elderly may be particularly susceptible (see Warnings and Precautions, Geriatrics and Warnings and Precautions, Pediatrics).

Hyperthermia has occurred secondary to decreased sweating.

Mydriasis and blurred vision may occur.

Rash, urticaria and decreased sweating have been reported.

Tachycardia, palpitations or orthostatic hypotension may occur.

Treatment is symptomatic and supportive. Consider the use of activated charcoal in significant ingestions. Do not induce vomiting due to the possible rapid onset of CNS and cardiovascular symptoms. Monitor the patient's urine output, vital signs and bowel sounds. If poisoning is severe, monitor the ECG. Maintain the patient's fluid and electrolyte balance. Mydriasis and cycloplegia may be treated with a local miotic such as pilocarpine. Manage hyperthermia with physical measures and control of agitation. Treat agitation and seizures with i.v. benzodiazepines. Avoid the use of physical restraints in agitated patients due to the risk of hyperthermia and rhabdomyolysis. Also avoid the use of antipsychotics and other drugs with anticholinergic effects. If patients have severe CNS symptoms without evidence of AV widening or block and it is certain they have not ingested other medications, especially tricyclic antidepressants, a small dose of physostigmine can be slowly infused. (Physostigmine is not currently marketed in Canada but is available through the Special Access Program—Appendix 2.)

Symptoms of overdose are primarily extensions of procyclidine's anticholinergic actions. Tachycardia; Flushed, hot, dry skin, tachycardia, dry mucous membranes, mydriasis and blurred vision are common. Drowsiness, lightheadedness and nervousness may progress to or alternate with agitation, confusion, delirium and hallucinations, especially in children or the elderly. Urinary retention, hypertension, hyperthermia, photophobia, thirst and decreased gastrointestinal motility are also seen. Pupils may be fixed. In severely poisoned patients coma or seizures may occur. Psychosis, rash, dystonic reactions, ataxia, weakness, respiratory depression, cardiac arrhythmias and rhabdomyolysis have been reported.

Use with caution in patients with renal disease.

Use procyclidine with extreme caution in patients with mild to moderate ulcerative colitis since antimuscarinic agents may suppress intestinal motility and produce paralytic ileus with resultant precipitation or aggravation of toxic megacolon. Use procyclidine cautiously in patients with known or suspected gastrointestinal infections since it may decrease gastrointestinal motility and prolong symptomatology by causing retention of the causative organism or toxin. In patients with gastric ulcer antimuscarinics in general may delay gastric emptying with possible antral stasis; therefore, procyclidine should be used cautiously in these patients. Antimuscarinics may also relax the lower esophageal sphincter. This, combined with their effect on gastric emptying, may result in increased gastroesophageal reflux in patients with GERD or hiatus hernia associated with reflux esophagitis.

Procyclidine has been abused for its euphoric effects. Clinicians should remain aware of this possibility.

Due to its drying effects on bronchial secretions, procyclidine should be used with caution in patients with COPD.

Procyclidine is contraindicated in patients with angle-closure glaucoma. Patients with primary open-angle glaucoma controlled with medications are at minimal risk of induction of an increase in intraocular pressure and many clinicians do not consider this condition a contraindication to therapy with procyclidine.

Safety and efficacy in the pediatric population have not been established. Children are especially sensitive to anticholinergic drug effects. The use of procyclidine in this age group requires that potential benefits be weighed against the possible hazards to the child.

It is not known if procyclidine crosses the placenta. The safe use of procyclidine in pregnancy has not been established. The use of procyclidine during pregnancy requires that potential benefits be weighed against the possible hazards to the mother and fetus.

When procyclidine is used to treat parkinsonian symptoms caused by antipsychotic therapy in patients with a psychiatric illness, there may be an intensification of psychiatric illness. When using procyclidine in these patients, they should be carefully observed, especially at the beginning of treatment or if dosage is increased. Tardive dyskinesia may appear in some patients on long-term treatment with antipsychotics or related agents, or may occur after these drugs are discontinued. Anticholinergic agents such as procyclidine usually do not alleviate these symptoms and in some instances may aggravate or unmask them. Procyclidine is not recommended in tardive dyskinesia.

Use with caution in patients with hepatic disease.

Geriatric patients are particularly susceptible to the adverse effect of anticholinergic agents, including procyclidine. These patients may require lower doses, especially at the onset of therapy, and slower dose titration than younger adults. In many instances, other therapeutic classes may be preferred. Some clinicians recommend that baseline cognitive evaluations, psychiatric history, and supine and standing blood pressure be obtained in older patients before initiation of anticholinergic therapy.

Use with caution in patients with prostatic hypertrophy or partial obstruction of the genitourinary tract.

Procyclidine should be used with extreme caution in patients with autonomic neuropathy or other dementias.

Procyclidine, alone or in combination with antipsychotics or other anticholinergics, may cause anhidrosis and/or hyperthermia, which may be fatal. Patients should avoid becoming overheated from prolonged exposure to high environmental temperatures and/or sustained heavy exercise. The elderly, the chronically ill, alcoholics and those with CNS disease may be particularly vulnerable. If there is evidence of anhidrosis, dosage should be reduced so that the ability to maintain body temperature equilibrium by perspiration is not impaired. Procyclidine should also be used with caution in patients experiencing fever.

Since antimuscarinics may produce drowsiness, dizziness or blurred vision, patients should be warned not to engage in activities that require mental alertness or visual acuity while taking procyclidine.

It is not known if procyclidine is excreted into breast milk.

Use with caution in patients with tachyarrhythmias, congestive heart failure, ischemic heart disease, hypertension or hypotension.

Procyclidine hydrochloride is well-absorbed from the GI tract. Its bioavailability ranges from 52% to 97% and its T_max from 1.1 to 2 hours. Its elimination half-life has been reported to range from 11.5 to 12.6 hours and its duration of action is approximately 4 hours.

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