Clidinium
Drug class: Antineoplastic Agents
Usage of Clidinium
Peptic Ulcer Disease
Used in fixed combination with chlordiazepoxide as adjunctive therapy in the treatment of peptic ulcer disease; however, no conclusive data that antimuscarinics aid in the healing, decrease the rate of recurrence, or prevent complications of peptic ulcers.
With the advent of more effective therapies for the treatment of peptic ulcer disease, antimuscarinics have only limited usefulness in this condition.
GI Motility Disturbances
Used in fixed combination with chlordiazepoxide in the treatment of functional GI motility disturbances (e.g., irritable bowel syndrome).
Has limited efficacy in treatment of GI motility disturbance and should only be used if other measures (e.g., diet, sedation, counseling, amelioration of environmental factors) have been of little or no benefit.
Acute Enterocolitis
Used in fixed combination with chlordiazepoxide in the treatment of acute enterocolitis. However, antimuscarinics should be used with extreme caution in patients with diarrhea or ulcerative colitis. (See Cautions.)
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How to use Clidinium
Administration
Oral Administration
Administer orally 3 or 4 times daily before meals and at bedtime.
Dosage
Available as clidinium bromide; dosage expressed in terms of the salt.
As with other antimuscarinics, higher than recommended dosage may be required for therapeutic effect.
Clidinium bromide is commercially available in the US only in fixed combination with chlordiazepoxide hydrochloride. Fixed-ratio combination preparations do not permit individual titration of dosages.
Adults
GI Disorders OralUsual maintenance clidinium bromide dosage is 2.5 or 5 mg (1 or 2 capsules of clidinium bromide in fixed combination with chlordiazepoxide hydrochloride) 3 or 4 times daily administered before meals and at bedtime.
Special Populations
Hepatic Impairment
No specific dosage recommendations. Use with caution.
Renal Impairment
No specific dosage recommendations. Use with caution.
Geriatric Patients
Initially, no more than 5 mg of clidinium bromide daily (2 capsules of clidinium bromide in fixed combination with chlordiazepoxide hydrochloride). Gradually increase dosage if needed and tolerated. Administer the smallest effective dosage. (See Geriatric Use under Cautions.)
Debilitated Patients
Initially, administer up to 5 mg of clidinium bromide daily (2 capsules of clidinium bromide in fixed combination with chlordiazepoxide hydrochloride); then adjust subsequent dosages based on patient tolerance and response. Administer the smallest effective dosage.
Warnings
Contraindications
Warnings/Precautions
Warnings
CNS EffectsRisk of drowsiness. Performance of activities requiring mental alertness and physical coordination (e.g., operating a vehicle or other machinery, performing hazardous work) may be impaired. (See Advice to Patients.)
Thermoregulatory EffectsExposure to high environmental temperatures may result in heat prostration in patients receiving antimuscarinics. Increased risk of hyperthermia in patients with fever. Use with caution in patients who may be exposed to elevated environmental temperatures or in febrile patients.
DiarrheaDiarrhea may be an early sign of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy; use with extreme caution.
General Precautions
Use of Fixed CombinationsClidinium is commercially available in the US only in fixed combination with chlordiazepoxide hydrochloride. Consider cautions, precautions, and contraindications associated with chlordiazepoxide.
GI EffectsCaution in patients with ulcerative colitis; large doses may suppress intestinal motility, resulting in paralytic ileus and toxic megacolon.
Specific Populations
PregnancyCategory C.
LactationNot known whether clidinium is distributed into milk.
Risk of lactation suppression.
Pediatric UseSafety and efficacy of clidinium bromide in fixed combination with chlordiazepoxide hydrochloride not established in pediatric patients.
Geriatric UseUse with caution in geriatric patients. Geriatric patients may be prone to adverse effects (e.g., drowsiness, ataxia, confusion) when receiving clidinium bromide in fixed combination with chlordiazepoxide hydrochloride. Such adverse effects may occur even at the lower end of dosage range. (See Geriatric Patients under Dosage and Administration.)
Hepatic ImpairmentUse with caution in patients with hepatic disease.
Renal ImpairmentUse with caution in patients with renal disease.
Common Adverse Effects
Xerostomia, blurred vision, constipation, urinary hesitancy.
What other drugs will affect Clidinium
Drugs with Anticholinergic Effects
Additive adverse effects resulting from cholinergic blockade (e.g., xerostomia, blurred vision, constipation). Advise of possibility of increased anticholinergic effects.
Orally Administered Drugs
Potential pharmacokinetic interaction (altered GI absorption of various drugs). Antimuscarinics may inhibit GI motility, delay gastric emptying, and prolong GI transit time.
Specific Drugs
Drug
Interaction
Comments
Acetaminophen
Decrease rate but not extent of acetaminophen absorption; may delay onset of acetaminophen therapeutic effects
Amantadine
Possible additive adverse anticholinergic effects
Inform patient of possibility
Antacids
Possible decreased absorption of antimuscarinic
Administer antimuscarinic at least 1 hour before antacids
Antiarrhythmic agents, type I (e.g., disopyramide, procainamide, quinidine)
Possible additive adverse anticholinergic effects
Inform patient of possibility
Antidepressants, tricyclic
Possible additive adverse anticholinergic effects
Inform patient of possibility
Antihistamines
Possible additive adverse anticholinergic effects
Inform patient of possibility
Antiparkinsonian agents
Possible additive adverse anticholinergic effects
Inform patient of possibility
Corticosteroids
Possible increased IOP
Digoxin (slow dissolving)
Increased serum digoxin concentration with another anticholinergic drug and slowly-dissolving digoxin tablets
Use digoxin oral solution or rapidly-dissolving tablets; observe for signs of digoxin toxicity
Ketoconazole
Possible decreased ketoconazole absorption
Administer antimuscarinic ≥2 hours after ketoconazole
Levodopa
Possible increased gastric levodopa metabolism, resulting in decreased levodopa absorption
Possible levodopa toxicity if antimuscarinic is discontinued without a concomitant reduction in levodopa dosage
Meperidine
Possible additive adverse anticholinergic effects
Inform patient of possibility
Phenothiazines
Possible additive adverse anticholinergic effects
Inform patient of possibility
Potassium chloride
Antimuscarinics may slow GI transit, increasing risk of potassium chloride GI mucosal toxicity
Administer concomitantly with caution (especially with wax matrix potassium chloride preparations)
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