LIBRAX Capsule Ref.[50770] Active ingredients: Chlordiazepoxide Clidinium

4.1 Dosing Considerations

• LIBRAX should always be prescribed at the lowest effective dose for the shortest duration possible.
• Dosage should be individualized to each patient.
• Prolonged use of larger than usual therapeutic doses of chlordiazepoxide may result in psychic or physical dependence.

Discontinuation

• LIBRAX can produce withdrawal signs and symptoms or rebound phenomena following abrupt discontinuation or rapid dose reduction (see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX, Withdrawal; 7 WARNINGS AND PRECAUTIONS, Dependence/Tolerance). Abrupt discontinuation should be avoided and treatment – even if only of short duration – should be terminated by gradually tapering the dosage schedule under close monitoring.
• Tapering should be tailored to the specific patient. Special attention should be given to patients with a history of seizure.
• If a patient experiences withdrawal signs and symptoms, consider postponing the taper or raising the benzodiazepine to the previous dosage prior to proceeding with a gradual taper.

Geriatric and/or Debilitated Patients

• Geriatric and debilitated patients may respond to the usual doses with excitement, agitation, drowsiness, or confusion; lower doses may be required for such patients.
• Geriatric patients in particular may be more sensitive to benzodiazepines (see 7 WARNINGS AND PRECAUTIONS, Falls and Fractures).
• Long-term use of LIBRAX should be avoided in geriatric patients. Enhanced monitoring is recommended.

4.2 Recommended Dose and Dosage Adjustment

Recommended Dose

Adults: 1 or 2 capsules, one to four times a day, thirty to sixty minutes before meals or food, the dosage then being adjusted as needed and tolerated.

Prescribing limit: up to a total of 8 capsules daily (40 mg of chlordiazepoxide hydrochloride and 20 mg of clidinium bromide).

Pediatrics (<18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.

Geriatrics (>65 years of age): Initially no more than 1 capsule two times a day, the dosage then being adjusted as needed and tolerated. Dosage should be limited to the smallest effective amount to preclude the development of ataxia, oversedation or confusion.

4.4 Administration

Administration of LIBRAX 30 to 60 minutes before meals is recommended to maximize absorption and, when used for reducing stomach acid formation, to allow its effect to coincide better with any antacid administration following the meal.

4.5 Missed Dose

If the patient misses a dose, instruct the patient to take the dose as soon as they remember. If it is almost time for the next dose, inform the patient to skip the missed dose and continue the regular dosing schedule.

Symptoms

Confusion; difficulty in urination; severe drowsiness; severe dryness of mouth, nose, or throat; fast heartbeat; unusual warmth, dryness, and flushing of the skin.

Treatment

Employ general supportive measures, the recommended treatment of overdosage includes:

• emesis
• subcutaneous administration of 5 mg of pilocarpine, repeated as needed, until mouth is moist
• norepinephrine bitartrate or metaraminol infusions, to restore blood pressure
• caffeine and sodium benzoate, to treat CNS depression
• if excitation occurs, barbiturates should not be used since they may exacerbate excitation and/or prolong CNS depression
• monitor respiration, pulse and blood pressure and provide artificial respiration, if needed, for respiratory depression
• administer i.v. fluids
• symptomatic treatment as necessary
• dialysis is of limited value

For management of a suspected drug overdose, contact your regional poison control centre

Store at room temperature (15°C to 30°C).