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.)

Relate drugs

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 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.

Warnings

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.

    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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