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TEVA-BROMAZEPAM is a brand name for Bromazepam, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE............................................................................... 3 CONTRAINDICATIONS ...................................................................................................... 3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Serious Warnings and Precautions Addiction, Abuse and Misuse The use of benzodiazepines, including Teva-Bromazepam, 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-Bromazepam Monitor all patients regularly for the development of these behaviours or conditions. Teva-Bromazepam should be stored securely to avoid theft or misuse. Withdrawal Benzodiazepines, like Teva-Bromazepam, can produce severe or life-threatening withdrawal symptoms.
Avoid abrupt discontinuation or rapid dose reduction of Teva-Bromazepam. Terminate treatment with Teva-Bromazepam by gradually tapering the dosage schedule under close monitoring. (see WARNINGS AND PRECAUTIONS, Dependence/Tolerance) Risks from Concomitant use with Opioids Concomitant use of Teva-Bromazepam and opioids may result in profound sedation, respiratory depression, coma and death (see WARNINGS AND PRECAUTIONS, General, Concomitant use with opioids).
Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are not possible. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.
General Benzodiazepines are only indicated when the anxiety disorder is severe, disabling or subjecting the individual to extreme distress. Teva-Bromazepam (bromazepam) is not recommended for use in patients with depressive disorders or psychosis.
Anterograde amnesia may occur with therapeutic doses of benzodiazepines and may be associated with inappropriate behaviour, the risk increasing with higher doses (see ADVERSE REACTIONS). Concomitant use of alcohol / CNS depressants The concomitant use of Teva-Bromazepam with alcohol and/or CNS depressants should be avoided.
Such concomitant use has the potential to increase the clinical effects of Teva-Bromazepam possibly including severe sedation, clinically relevant respiratory and/or cardiovascular depression that could result in coma or death (see DRUG INTERACTIONS and OVERDOSAGE sections).
Patients should be advised against the concurrent use of alcohol and other CNS depressant drugs.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Bromazepam 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.
Page 5 of 28 Concomitant use with opioids:
Concomitant use of benzodiazepines, including Teva-Bromazepam, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are not possible (see SERIOUS WARNINGS AND PRECAUTIONS BOX, Risks from Concomitant use with Opioids; DRUG INTERACTIONS, Serious Drug Interactions).
Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioid analgesics alone. Because of similar pharmacological properties, it is reasonable to expect similar risk with the concomitant use of other CNS depressant drugs with benzodiazepines.
If a decision is made to prescribe Teva-Bromazepam concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use. In patients already receiving an opioid analgesic, prescribe a lower initial dose of Teva-Bromazepam than indicated, and titrate based on clinical response.
If an opioid analgesic is initiated in a patient already taking Teva-Bromazepam, prescribe a lower initial dose of the opioid analgesic, and titrate based on clinical response. Follow patients closely for signs and symptoms of respiratory depression and sedation (see OVERDOSE).
Advise both patients and caregivers about the risks of respiratory depression and sedation when Teva-Bromazepam is used with opioids. Advise patients not to drive or operate heavy machinery until the effects of concomitant use of the opioid have been determined.
Dependence/Tolerance Use of benzodiazepines, such as Teva-Bromazepam, can lead to abuse, misuse, addiction, physical dependence (including tolerance) 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.
The risk of dependence increases with higher doses and longer term use but can occur with short- term use at recommended therapeutic doses. The risk of dependence is greater in patients with a history of psychiatric disorders and/or substance (including alcohol) use disorder.
Discuss the risks of treatment with Teva-Bromazepam with the patient, considering alternative (including non-drug) treatment options. Carefully evaluate each patient’s risk of abuse, misuse and addiction, considering their medical condition and concomitant drug use, prior to prescribing Teva-Bromazepam.
In individuals prone to substance use disorder, Teva-Bromazepam should only be administered if deemed medically necessary, employing extreme caution and close supervision. Teva-Bromazepam should always be prescribed at the lowest effective dose for the shortest duration possible.
Page 6 of 28 All patients receiving opioids should be routinely monitored for signs and symptoms of misuse and abuse. If a substance use disorder is suspected, evaluate the patient and refer them for substance abuse treatment, as appropriate.
Withdrawal Benzodiazepines, such as Teva-Bromazepam, can produce withdrawal symptoms, ranging from mild to severe and even life threatening, following abrupt discontinuation or rapid dose reduction. Other factors that may precipitate withdrawal are switching from a long-acting to a short-acting benzodiazepine, decreasing blood levels of the drug or administration of an antagonist.
The risk of withdrawal is higher with higher dosages and/or prolonged use, but can occur with short-term use […]