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TEVA-LORAZEPAM 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: TEVA-LORAZEPAM (lorazepam) is indicated for: • the short-term relief of manifestations of excessive anxiety in patients with anxiety neurosis. Anxiety and tension associated with the stresses of everyday life usually do not require treatment with anxiolytic drugs. 1.1 Pediatrics Pediatrics (< 18 years of age): No data…
Verbatim from this product's HC label. Tap a section to expand.
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 TEVA-LORAZEPAM Page 14 of 33 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 TEVA-LORAZEPAM 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 TEVA-LORAZEPAM 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; Nervous System and Special Senses (benzodiazepine effects on the CNS are dose dependent, TEVA-LORAZEPAM Page 15 of 33 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, 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.
1 Dosing considerations). 2 CONTRAINDICATIONS • Lorazepam is contraindicated in patients with myasthenia gravis or acute narrow angle glaucoma, and in those with known hypersensitivity to benzodiazepines. • Lorazepam 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. 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions Addiction, Abuse and Misuse The use of benzodiazepines, including TEVA-LORAZEPAM can lead to abuse, misuse, addiction, physical dependence and withdrawal reactions.
Abuse and misuse can result in overdose or death, especially when benzodiazepines are combined with other medicines, such as opioids, alcohol or illicit drugs. • Assess each patient’s risk prior to prescribing TEVA-LORAZEPAM TEVA-LORAZEPAM Page 5 of 33 • Monitor all patients regularly for the development of these behaviours or conditions • TEVA-LORAZEPAM should be stored securely to avoid theft or misuse Withdrawal Benzodiazepines, like TEVA-LORAZEPAM can produce severe or life-threatening withdrawal symptoms • Avoid abrupt discontinuation or rapid dose reduction of TEVA-LORAZEPAM • Terminate treatment with TEVA-LORAZEPAM by gradually tapering the dosage schedule under close monitoring (see 7 WARNINGS AND PRECAUTIONS, Dependence/Tolerance) Risks from Concomitant use with Opioids Concomitant use of TEVA-LORAZEPAM and opioids may result in profound sedation, respiratory depression, coma and death (see 7 WARNINGS AND PRECAUTIONS – Risks from concomitant use of opioids and benzodiazapines).
1 Dosing Considerations • TEVA-LORAZEPAM should always be prescribed at the lowest effective dose for the shortest duration possible. • TEVA-LORAZEPAM 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).
• Lorazepam is contraindicated in patients with myasthenia gravis or acute narrow angle glaucoma, and in those with known hypersensitivity to benzodiazepines. • Lorazepam 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.
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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 TEVA-LORAZEPAM. 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).
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. , 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 TEVA-LORAZEPAM Page 6 of 33 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 TEVA-LORAZEPAM be used in patients with mild to moderate hepatic or renal disease.
In patients for whom prolonged therapy with TEVA-LORAZEPAM 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 TEVA-LORAZEPAM should be avoided in geriatric patients. Enhanced monitoring is recommended.
2 Recommended Dose and Dosage Adjustment The dosage and duration of therapy of TEVA-LORAZEPAM (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; TEVA-LORAZEPAM Page 7 of 33 therefore, the […]