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.

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.

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.

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