Loading…
LORAZEPAM SUBLINGUAL is a brand name for Lorazepam, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: , 1.2 Geriatrics 06/2023 3 SERIOUS WARNINGS AND PRECAUTIONS BOX 06/2023 4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations 06/2023 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment 06/2023 7 WARNINGS AND PRECAUTIONS 06/2023 7 WARNINGS AND PRECAUTIONS, 7.1.4 Geriatrics 06/2023 TABLE OF…
Verbatim from this product's HC label. Tap a section to expand.
4 Geriatrics 06/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .....................................................................................
1 TABLE OF CONTENTS .......................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION............................................................... 4 1 INDICATIONS ..................................................................................................................
1 Pediatrics................................................................................................................. 2 Geriatrics.................................................................................................................
4 2 CONTRAINDICATIONS ................................................................................................... 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX .......................................................... 4 4 DOSAGE AND ADMINISTRATION ..................................................................................
1 Dosing Considerations ............................................................................................. 2 Recommended D ose and Dosage Adjustment......................................................... 4 Administration ..........................................................................................................
5 Missed Dose............................................................................................................ 7 5 OVERDOSAGE................................................................................................................
7
). Such reactions may be more likely to occur in children and the elderly. Should these occur, use of the drug should be discontinued. 4 Geriatrics Geriatric patients and debilitated patients, or those with organic brain syndrome, have been found to be prone to CNS depression after even low doses of benzodiazepines.
Therefore, medication should be initiated with very low initial doses in these patients, depending on the response of the patient, in order to avoid over sedation or neurological impairment. As with any premedicant, extreme care must be used in administering LORAZEPAM SUBLINGUAL to geriatric patients or very ill patients and to those with limited pulmonary reserve, because of the possibility that apnea and/or cardiac arrest may occur.
Clinical trials have shown that patients over the age of 50 years may have a more profound and prolonged sedation with intravenous lorazepam. For geriatric patients and debilitated patients reduce the initial dose by approximately 50% and adjust the dosage as needed and tolerated.
Long-term use of LORAZEPAM SUBLINGUAL should be avoided in geriatric patients or debilitated patients who may be more sensitive to benzodiazepines. There is an increased risk of cognitive impairment, delirium, falls, fractures, hospitalizations and motor vehicle accidents in these users.
Enhanced monitoring is recommended in this population . 1 Adverse Reaction Overview The adverse reaction most frequently reported was drowsiness.
Reported adverse reactions (by system) are:
Body as a Whole Angioedema, asthenia, muscle weakness, anaphylactic reactions, change in weight, drug withdrawal syndrome, hypersensitivity reactions, hyponatremia, hypothermia, SIADH; Cardiovascular Hypotension, lowering in blood pressure; Digestive Nausea, constipation, change in appetite, increase in bilirubin, jaundice, increase in liver transaminases, increase in alkaline phosphatase; Hematological/Lymphatic Agranulocytosis, pancytopenia, thrombocytopenia; Lorazepam Sublingual (lorazepam) Page 14 of 33 Nervous System and Special Senses (benzodiazepine effects on the CNS are dose dependent, with more severe CNS depression with higher doses) Anterograde amnesia, drowsiness, fatigue, sedation, ataxia, confusion, depression, unmasking of depression, dizziness, change in libido, impotence, decreased orgasm, extrapyramidal symptoms, tremor, vertigo, visual disturbances (including diplopia, and blurred vision), dysarthria/slurred speech, headache, convulsions/seizures, amnesia, disinhibition, euphori a, coma, suicidal ideation/attempt, impaired attention/concentration, balance disorder, paradoxical reactions (including anxiety, agitation, excitation, hostility, aggression, rage, sleep disturbances/insomnia, sexual arousal, hallucinations), psychomotor agitation, drug abuse, drug dependence; Respiratory Respiratory depression, apnea, worsening of sleep apnea (the extent of respiratory depression with benzodiazepines is dose dependent - more severe depression at higher doses), worsening of obstructive pulmonary disease, and ear, nose and throat disturbances; Skin Allergic skin reactions, alopecia.
4 Geriatrics 06/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .....................................................................................
1 TABLE OF CONTENTS .......................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION............................................................... 4 1 INDICATIONS ..................................................................................................................
1 Pediatrics................................................................................................................. 2 Geriatrics.................................................................................................................
4 2 CONTRAINDICATIONS ................................................................................................... 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX .......................................................... 4 4 DOSAGE AND ADMINISTRATION ..................................................................................
1 Dosing Considerations ............................................................................................. 2 Recommended D ose and Dosage Adjustment......................................................... 4 Administration ..........................................................................................................
5 Missed Dose............................................................................................................ 7 5 OVERDOSAGE................................................................................................................
7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............................ 8 7 WARNINGS AND PRECAUTIONS................................................................................... 1 Special Populations ...............................................................................................
• LORAZEPAM SUBLINGUAL is contraindicated in patients with myasthenia gravis or acute narrow angle glaucoma and in those with known hypersensitivity to benzodiazepines. • LORAZEPAM SUBLINGUAL is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non -medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Lorazepam in Canada.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
There is evidence that tolerance develops to the sedative effects of benzodiazepines. Release of hostility and other paradoxical effects such as irritability and excitability, are known to occur with the use of benzodiazepines. Paradoxical reactions may be more likely to occur in children or the elderly.
Should paradoxical reactions occur, use of the drug should be discontinued. In addition, hypotension, mental confusion, slurred speech, over sedation and abnormal liver and kidney function tests and hematocrit values have been reported with these drugs.
5 Post-Market Adverse Reactions Injury, Poisoning and Procedural Complications There have been reports of falls and fractures in benzodiazepine users due to adverse reactions such as sedation, dizziness and ataxia. The risk is increased in those taking concomitant sedatives (including alcoholic beverages), geriatric and debilitated patients.
Dependence/Withdrawal Development of physical dependence and withdrawal following discontinuation of therapy has been observed with benzodiazepines such as LORAZEPAM SUBLINGUAL. Severe and life- threatening symptoms have been reported.
(see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX, Addiction, Abuse and Misuse; 7 WARNINGS AND PRECAUTIONS, Dependence/Tolerance). Lorazepam Sublingual (lorazepam) Page 15 of 33
1 Pregnant Women .............................................................................................. 2 Breast-feeding................................................................................................... 3 Pediatrics ..........................................................................................................
4 Geriatrics .......................................................................................................... 13 8 ADVERSE REACTIONS.................................................................................................
1 Adverse Reaction Overview ................................................................................... 5 Post-Market Adverse Reactions ............................................................................. 14 Lorazepam Sublingual (lorazepam) Page 3 of 33 9 DRUG INTERACTIONS..................................................................................................
1 Serious Drug Interactions ....................................................................................... 2 Drug Interactions Overview .................................................................................... 3 Drug-Behavioural Interactions ................................................................................
4 Drug-Drug Interactions........................................................................................... 5 Drug-Food Interactions .......................................................................................... 6 Drug-Herb Interactions...........................................................................................
7 Drug-Laboratory Test Interactions .......................................................................... 16 10 CLINICAL PHARMACOLOGY ....................................................................................... 1 Mechanism of Action..............................................................................................
2 Pharmacodynamics ............................................................................................... 3 Pharmacokinetics ..................................................................................................
18 11 STORAGE, STABILITY AND DISPOSAL ....................................................................... 19 12 SPECIAL HANDLING INSTRUCTIONS.......................................................................... 19 PART II: SCIENTIFIC INFORMATION ..................................................................................
20 13 PHARMACEUTICAL INFORMATION............................................................................. 20 14 CLINICAL TRIALS .........................................................................................................
3 Comparative Bioavailability Studies ......................................................................... 20 15 MICROBIOLOGY ...........................................................................................................
21 16 NON-CLINICAL TOXICOLOGY...................................................................................... 21 17 SUPPORTING PRODUCT MONOGRAPH...................................................................... 24 PATIENT MEDICATION INFORMATION ..............................................................................
25 Lorazepam Sublingual (lorazepam) Page 4 of 33 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS LORAZEPAM SUBLINGUAL is indicated for: • the short-term relief of manifestations of excessive anxiety in patients with anxiety neurosis.
• An adjunct for the relief of excessive anxiety that might be present prior to surgical […]