4.1 Dosing Considerations
- ATIVAN should always be prescribed at the lowest effective dose for the shortest duration possible.
- ATIVAN 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. Withdrawal symptoms (e.g., rebound insomnia) can appear following cessation of recommended doses after as little as one week of therapy.
- 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.
Symptoms reported following discontinuation of benzodiazepines include: headache, anxiety, tension, depression, insomnia, restlessness, confusion, irritability, sweating, rebound phenomena, dysphoria, dizziness, derealization, depersonalization, hyperacusis, numbness/tingling of extremities, hypersensitivity to light, noise and physical contact/perceptual changes, involuntary movements, nausea, vomiting, diarrhea, loss of appetite, hallucinations,/delirium, convulsions/seizures, tremor, abdominal and muscle cramps, myalgia, agitation, palpitations, tachycardia, panic attacks, vertigo, hyperreflexia, short-term memory loss, and hyperthermia. Convulsions/seizures may be more common in patients with pre-existing seizure disorders or who are taking other drugs that lower the convulsive threshold, such as antidepressants.
Renal or hepatic disease
The dose should be titrated should ATIVAN be used in patients with mild to moderate hepatic or renal disease. In patients for whom prolonged therapy with ATIVAN is indicated, periodic blood counts and liver function tests should be carried out.
When lorazepam is used in patients with mild to moderate hepatic or renal disease, the lowest effective dose should be considered since drug effect may be prolonged.
(see 7 WARNINGS AND PRECAUTIONS, Renal)
Geriatrics
For geriatric patients and debilitated patients reduce the initial dose by approximately 50% and adjust the dosage as needed and tolerated. Geriatric patients in particular may be more sensitive to benzodiazepines (see 7 WARNINGS AND PRECAUTIONS, Falls and Fractures). Long-term use of ATIVAN should be avoided in geriatric patients. Enhanced monitoring is recommended.(See 7.1.4 Geriatrics)
4.2 Recommended Dose and Dosage Adjustment
The dosage and duration of therapy of ATIVAN (lorazepam) must be individualized and carefully titrated in order to avoid excessive sedation or mental and motor impairment.
As with other anxiolytic sedatives, short courses of treatment should usually be the rule for the symptomatic relief of disabling anxiety in psychoneurotic patients and the initial course of treatment should not last longer than one week without reassessment of the need for a limited extension. Initially, not more than one week's supply of the drug should be provided, and automatic prescription renewals should not be allowed. Subsequent prescriptions, when required, should be limited to short courses of therapy.
The risk of dependence may increase with dose and duration of treatment; therefore, the lowest effective dose should be prescribed for the shortest duration and the need for continued treatment reassessed frequently.
Abrupt discontinuation or rapid dosage reduction of lorazepam after continued use may precipitate withdrawal reactions which can be life threatening, and/or rebound phenomena; therefore, the drug should be discontinued gradually or reduce the dosage (see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX, Withdrawal; 7 WARNINGS AND PRECAUTIONS, Dependence/Tolerance).
Generalized Anxiety Disorder: The recommended initial adult daily oral dosage is 2 mg in divided doses of 0.5, 0.5 and 1mg, or of 1 mg and 1 mg. The daily dosage should be carefully increased or decreased by 0.5 mg depending upon tolerance and response. The usual daily dosage is 2 to 3mg. However, the optimal dosage may range from 1 to 4 mg daily in individual patients. Usually, a daily dosage of 6 mg should not be exceeded.
In geriatric and debilitated patients, the initial daily dose should not exceed 0.5 mg and should be very carefully and gradually adjusted, depending upon tolerance and response.
Excessive Anxiety Prior to Surgical Procedures: Adults: Usually 0.05 mg/kg to a maximum of 4 mg total, given by the sublingual route 1 to 2 hours before surgery. As with all premedicant drugs, the dose should be individualized. Doses of other central nervous system depressant drugs should be ordinarily reduced.
Health Canada has not authorized an indication for pediatric use.
4.4 Administration
The sublingual tablet, when placed under the tongue, will dissolve in approximately 20 seconds. The patients should not swallow for at least 2 minutes to allow sufficient time for absorption.
4.5 Missed Dose
Patients who miss taking a dose should contact their healthcare provider for instructions.