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PRO-ALPRAZOLAM is a brand name for Alprazolam, 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 ........................................................................................................................................... 5 WARNINGS AND…
Verbatim from this product's HC label. Tap a section to expand.
PRO-ALPRAZOLAM and PRO-ALPRAZOLAM TS (alprazolam) are contraindicated in patients with known hypersensitivity to alprazolam or to any component of the product’s formulation, or other benzodiazepines. PRO-ALPRAZOLAM and PRO-ALPRAZOLAM TS are also contraindicated in patients with myasthenia gravis, severe hepatic insufficiency, severe respiratory insufficiency, sleep apnea syndrome, or acute narrow angle glaucoma.
However, PRO-ALPRAZOLAM and PRO-ALPRAZOLAM TS may be used in patients with open angle glaucoma who are receiving appropriate treatment. Co-administration of PRO-ALPRAZOLAM and PRO-ALPRAZOLAM TS with ketoconazole and itraconazole are contraindicated because these medications significantly impair the metabolism of alprazolam by CYP3A4 (see DRUG INTERACTIONS, Drug-Drug Interactions).
WARNINGS AND PRECAUTIONS Serious Warnings and Precautions Addiction, Abuse and Misuse The use of benzodiazepines, including PRO-ALPRAZOLAM and PRO-ALPRAZOLAM TS, 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 PRO-ALPRAZOLAM and PRO-ALPRAZOLAM TS Monitor all patients regularly for the development of these behaviours or conditions.
PRO-ALPRAZOLAM and PRO-ALPRAZOLAM TS should be stored securely to avoid theft or misuse. Withdrawal Benzodiazepines, like PRO-ALPRAZOLAM and PRO-ALPRAZOLAM TS, can produce severe or life- threatening withdrawal symptoms. Avoid abrupt discontinuation or rapid dose reduction of PRO-ALPRAZOLAM and PRO- ALPRAZOLAM TS.
Terminate treatment with PRO-ALPRAZOLAM and PRO-ALPRAZOLAM TS by gradually tapering the dosage schedule under close monitoring. (see WARNINGS AND PRECAUTIONS, Dependence/Tolerance) Risks from Concomitant use with Opioids Concomitant use of PRO-ALPRAZOLAM and PRO-ALPRAZOLAM TS 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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Alprazolam 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 6 of 41 General PRO-ALPRAZOLAM and PRO-ALPRAZOLAM TS (alprazolam) are not effective in patients with Personality Disorders. PRO-ALPRAZOLAM and PRO-ALPRAZOLAM TS are not recommended for the management of Mood or Psychotic Disorders.
Concomitant use with opioids:
Concomitant use of benzodiazepines, including PRO-ALPRAZOLAM and PRO- ALPRAZOLAM TS, 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 PRO-ALPRAZOLAM and PRO-ALPRAZOLAM TS 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 PRO-ALPRAZOLAM and PRO-ALPRAZOLAM TS than indicated, and titrate based on clinical response.
If an opioid analgesic is initiated in a patient already taking PRO- ALPRAZOLAM and PRO-ALPRAZOLAM TS, 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 OVERDOSAGE).
Advise both patients and caregivers about the risks of respiratory depression and sedation when PRO-ALPRAZOLAM and PRO-ALPRAZOLAM TS 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 PRO-ALPRAZOLAM and PRO-ALPRAZOLAM TS, 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 PRO-ALPRAZOLAM and PRO-ALPRAZOLAM TS with the patient, considering alternative (including non-drug) treatment options. Page 7 of 41 Carefully evaluate each patient’s risk of abuse, misuse and addiction, considering their medical condition and concomitant drug use, prior to prescribing PRO-ALPRAZOLAM and PRO-ALPRAZOLAM TS.
In individuals prone to substance use disorder, PRO- ALPRAZOLAM and PRO-ALPRAZOLAM TS should only be administered if deemed medically necessary, employing extreme caution and close supervision. PRO-ALPRAZOLAM and PRO-ALPRAZOLAM TS should always be prescribed at the lowest effective dose for the shortest duration possible.
All patients receiving benzodiazepines 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.
Dependence and […]