Generic name: medically reviewed
Availability: Prescription only
Pregnancy & Lactation: Risk data not available
What is Clidinium (monograph)?
Introduction
Antimuscarinic; synthetic quaternary ammonium.
Uses for 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.)
Clidinium Dosage and Administration
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
Oral
Usual 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.
Related/similar drugs
famotidine, pantoprazole, Protonix, Pepcid, hyoscyamine, glycopyrrolateWarnings
Contraindications
-
Glaucoma (to avoid mydriasis).
-
Prostatic hypertrophy or benign bladder neck obstruction.
-
Known hypersensitivity to clidinium or any ingredient in the formulation.
Warnings/Precautions
Warnings
CNS Effects
Risk 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 Effects
Exposure 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.
Diarrhea
Diarrhea 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 Combinations
Clidinium is commercially available in the US only in fixed combination with chlordiazepoxide hydrochloride. Consider cautions, precautions, and contraindications associated with chlordiazepoxide.
GI Effects
Caution in patients with ulcerative colitis; large doses may suppress intestinal motility, resulting in paralytic ileus and toxic megacolon.
Specific Populations
Pregnancy
Category C.
Lactation
Not known whether clidinium is distributed into milk.
Risk of lactation suppression.
Pediatric Use
Safety and efficacy of clidinium bromide in fixed combination with chlordiazepoxide hydrochloride not established in pediatric patients.
Geriatric Use
Use 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 Impairment
Use with caution in patients with hepatic disease.
Renal Impairment
Use with caution in patients with renal disease.
Common Adverse Effects
Xerostomia, blurred vision, constipation, urinary hesitancy.
How should I use Clidinium (monograph)
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
Oral
Usual 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.
Related/similar drugs
famotidine, pantoprazole, Protonix, Pepcid, hyoscyamine, glycopyrrolateWhat other drugs will affect Clidinium (monograph)?
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) |