pms-Lorazepam

pms-Lorazepam Adverse Reactions

lorazepam

Manufacturer:

Pharmascience

Distributor:

T-BOMA
Full Prescribing Info
Adverse Reactions
Adverse Reaction Overview: The adverse reaction most frequently reported was drowsiness.
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.
Reported adverse reactions (by system) are: Body as a Whole: Angioedema, asthenia, muscle weakness, anaphylactic reactions, change in weight, 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.
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, euphoria, 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.
Respiratory: The extent of respiratory depression with benzodiazepines is dose-dependent - more severe depression at higher doses.
Respiratory depression, apnea, worsening of sleep apnea, worsening of obstructive pulmonary disease, and ear, nose and throat disturbances.
Skin: Allergic skin reactions, alopecia.
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 pms-LORAZEPAM. Severe and life-threatening symptoms have been reported. (See Addiction, Abuse and Misuse under Warnings; Dependence/Tolerance under Precautions.)
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