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LORAZEPAM is a brand name for Lorazepam, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: , 1.2 Geriatrics 12/2021 3 SERIOUS WARNINGS AND PRECAUTIONS BOX 12/2021 4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations 07/2023 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dosage and Dosage Adjustment 07/2023 7 WARNINGS AND PRECAUTIONS 12/2021 7 WARNINGS AND PRECAUTIONS, Dependence/Tolerance 07/2023 7 WARNINGS…
Verbatim from this product's HC label. Tap a section to expand.
4 Geriatrics 12/2021 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................
2 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............................................................. 5 4 DOSAGE AND ADMINISTRATION ................................................................................. 1 Dosing Considerations ...............................................................................................
2 Recommended Dose and Dosage Adjustment ......................................................... 4 Administration ........................................................................................................... 5 Missed Dose ..............................................................................................................
8 5 OVERDOSAGE ............................................................................................................. 8
1 Adverse Reaction Overview LORAZEPAM INJECTION USP (lorazepam) Page 17 of 35 The adverse reaction most frequently reported was drowsiness, an extension of the central nervous system depressant effects of the drug. Excessive sleepiness and drowsiness are the main side effects; the incidences reported depended on the dosage, route of administration, concomitant use of other central nervous system depressants and the investigators' expectations concerning the degree and duration of sedation.
, acute tubular necrosis) during administration of lorazepam injection at higher than recommended doses. Symptoms may be more likely to develop in patients with renal impairment. Respiratory depression and partial airway obstruction have been observed after injectable lorazepam.
Skin rash, nausea and vomiting have been noted occasionally in patients who have received injectable lorazepam combined with other drugs during anesthesia and surgery.
Reported adverse reactions (by system) are:
Blood and lymphatic system disorders: Agranulocytosis, pancytopenia, thrombocytopenia.
Endocrine disorders:
SIADH.
Gastrointestinal disorders:
Nausea, constipation.
General disorders and administration site conditions:
Fatigue, asthenia, hypothermia, drug withdrawal syndrome.
Local effects:
Pain at the injection site, a sensation of burning, and redness in the same area have been reported after intramuscular administration of injectable lorazepam. Pain in the immediate post injection period and redness at the 24-hours observation period also have been reported after intravenous administration of injectable lorazepam.
4 Geriatrics 12/2021 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................
2 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............................................................. 5 4 DOSAGE AND ADMINISTRATION ................................................................................. 1 Dosing Considerations ...............................................................................................
2 Recommended Dose and Dosage Adjustment ......................................................... 4 Administration ........................................................................................................... 5 Missed Dose ..............................................................................................................
8 5 OVERDOSAGE ............................................................................................................. 8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .................................. 9 7 WARNINGS AND PRECAUTIONS ..................................................................................
LORAZEPAM INJECTION USP (lorazepam) is contraindicated: • in patients with myasthenia gravis • in patients with acute narrow angle glaucoma • in patients who are hypersensitive to this drug, other benzodiazepines, or 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. • LORAZEPAM INJECTION USP should not be injected intra-arterially and care should be taken to prevent its extravasation into tissue adjacent to an artery because of the danger of producing arteriospasm resulting in gangrene which may require amputation.
LORAZEPAM INJECTION USP (lorazepam) Page 5 of 35
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Lorazepam in Canada.
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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.
Hepatobiliary disorders:
Jaundice.
Immune system disorders:
Angioedema, anaphylactic reactions, hypersensitivity reactions.
Investigations:
Change in weight, lowering in blood pressure, increase in bilirubin, increase in liver transaminases, increase in alkaline phosphatase.
Metabolism and nutrition disorders:
Hyponatremia. Nervous system disorders: (Benzodiazepine effects on the CNS are dose dependent, with more severe CNS depression with higher doses). Anterograde amnesia, drowsiness, sedation, ataxia, dizziness, extrapyramidal symptoms, tremor, vertigo, visual disturbances (including diplopia, and blurred vision), dysarthria/slurred speech, headache, convulsions/seizures, amnesia, coma, impaired attention/concentration, balance disorder, psychomotor agitation, muscle weakness.
Psychiatric Disorders:
Confusion, depression, unmasking of depression, change in libido, impotence, decreased orgasm, change in appetite, disinhibition, euphoria, suicidal ideation/attempt, paradoxical LORAZEPAM INJECTION USP (lorazepam) Page 18 of 35 reactions (including anxiety, agitation, excitation, hostility, aggression, rage, sleep disturbances/insomnia, sexual arousal, hallucinations), drug abuse, drug dependance.
Respiratory, thoracic and mediastinal disorders:
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 and subcutaneous tissue disorders:
Allergic skin reactions, alopecia.
Vascular disorders:
Hypotension. 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), the geriatric and debilitated patients.
Dependence/Withdrawal:
Development of physical dependence and withdrawal following discontinuation of therapy has been observed with benzodiazepines such as LORAZEPAM INJECTION USP. 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).
1 Special Populations ................................................................................................. 1 Pregnant Women ....................................................................................................
2 Breast-feeding ......................................................................................................... 3 Pediatrics .................................................................................................................
4 Geriatrics ................................................................................................................. 16 8 ADVERSE REACTIONS ................................................................................................
1 Adverse Reaction Overview .................................................................................... 5 Post-Market Adverse Reactions .............................................................................. 18 LORAZEPAM INJECTION USP (lorazepam) Page 3 of 35 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.......................................................................... 20 10 CLINICAL PHARMACOLOGY .......................................................................................
1 Mechanism of Action .............................................................................................. 2 Pharmacodynamics .................................................................................................
3 Pharmacokinetics .................................................................................................... 22 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 23 12 SPECIAL HANDLING INSTRUCTIONS ...........................................................................
23 PART II: SCIENTIFIC INFORMATION....................................................................................... 23 13 PHARMACEUTICAL INFORMATION ............................................................................ 24 14 CLINICAL TRIALS........................................................................................................
24 15 MICROBIOLOGY ....................................................................................................... 24 16 NON-CLINICAL TOXICOLOGY .....................................................................................
25 17 SUPPORTING PRODUCT MONOGRAPHS .................................................................... 27 PATIENT MEDICATION INFORMATION.................................................................................. 28 LORAZEPAM INJECTION USP (lorazepam) Page 4 of 35 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS LORAZEPAM INJECTION USP (lorazepam) 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 […]